Ignite Creation Date:
2025-12-24 @ 11:58 PM
Ignite Modification Date:
2026-01-05 @ 9:33 PM
Study NCT ID:
NCT00662558
Status:
COMPLETED
Last Update Posted:
2021-02-21
First Post:
2007-12-06
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Six Week Study Of The Pain Relieving Effects Of Celecoxib 200 Mg Twice Daily Compared To Tramadol 50 Mg Four Times Daily In Patients With Chronic Low Back Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017116', 'term': 'Low Back Pain'}], 'ancestors': [{'id': 'D001416', 'term': 'Back Pain'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068579', 'term': 'Celecoxib'}, {'id': 'D014147', 'term': 'Tramadol'}], 'ancestors': [{'id': 'D000096926', 'term': 'Benzenesulfonamides'}, {'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D011720', 'term': 'Pyrazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D003511', 'term': 'Cyclohexanols'}, {'id': 'D000441', 'term': 'Hexanols'}, {'id': 'D005233', 'term': 'Fatty Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D004123', 'term': 'Dimethylamines'}, {'id': 'D008744', 'term': 'Methylamines'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D008055', 'term': 'Lipids'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials.govCallCenter@pfizer.com', 'phone': '1-800-718-1021', 'title': 'Pfizer ClinicalTrials.gov Call Center', 'organization': 'Pfizer, Inc.'}, 'certainAgreement': {'otherDetails': 'Pfizer has the right to review disclosures, requesting a delay of \\< 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), \\< 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Celecoxib', 'description': '200 mg capsules two times a day (BID) for 6 weeks', 'otherNumAffected': 89, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Tramadol HCL', 'description': '50 mg capsules four times a day (QID) for 6 weeks', 'otherNumAffected': 171, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 396, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 396, 'numAffected': 25}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v11.0)'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 396, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 396, 'numAffected': 20}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 396, 'numAffected': 31}, {'groupId': 'EG001', 'numAtRisk': 396, 'numAffected': 70}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 396, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 396, 'numAffected': 28}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 396, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 396, 'numAffected': 53}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 396, 'numAffected': 41}, {'groupId': 'EG001', 'numAtRisk': 396, 'numAffected': 54}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 396, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 396, 'numAffected': 44}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 396, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 396, 'numAffected': 23}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Coronary artery bypass', 'stats': [{'groupId': 'EG000', 'numAtRisk': 396, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 396, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v11.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Treatment Responders Based on the Numerical Rating Scale-Pain (NRS-Pain)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '396', 'groupId': 'OG000'}, {'value': '396', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Celecoxib', 'description': '200 mg capsules two times a day (BID) for 6 weeks'}, {'id': 'OG001', 'title': 'Tramadol HCL', 'description': '50 mg capsules four times a day (QID) for 6 weeks'}], 'classes': [{'title': 'Responders', 'categories': [{'measurements': [{'value': '254', 'groupId': 'OG000'}, {'value': '218', 'groupId': 'OG001'}]}]}, {'title': 'Non-responders', 'categories': [{'measurements': [{'value': '142', 'groupId': 'OG000'}, {'value': '178', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciPctValue': '95', 'paramValue': '0.0910', 'ciLowerLimit': '0.0255', 'ciUpperLimit': '0.1565', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'Differences in treatment proportions and the 95% confidence interval (CI) around the difference were estimated by calculating the risk difference between the treatment arms using a generalized linear model with treatment and center as factors. A lower 95% CI for the risk difference greater than -0.10 would demonstrate that celecoxib 200 mg BID is not inferior to tramadol hydrochloride 50 mg QID.'}, {'pValue': '0.008', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'groupDescription': 'If celecoxib 200 mg BID was found to be non-inferior to tramadol hydrochloride 50 mg QID then the second step was to test the superiority of celecoxib 200 mg BID over tramadol hydrochloride 50 mg QID using a two-sided test of proportions. Differences in proportions were tested using the General Association Test of the Cochran-Mantel-Haenszel (CMH) procedure stratified by center.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 6 or Early Termination (ET)', 'description': "A subject who met the following criteria was considered as a successful responder at Week 6: completed 6 weeks of treatment with study medication and had a 30% improvement from Baseline to Week 6/ET on the NRS-Pain. NRS-Pain scale assessed the severity of a subject's lower back pain on a scale of 0 (No pain) and 10 (Worst possible pain).", 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat = all subjects who were randomized and received at least one dose of study medication. Missing values were imputed using last observation carried forward (LOCF).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Severity of Chronic Low Back Pain as Measured by NRS-Pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '396', 'groupId': 'OG000'}, {'value': '396', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Celecoxib', 'description': '200 mg capsules two times a day (BID) for 6 weeks'}, {'id': 'OG001', 'title': 'Tramadol HCL', 'description': '50 mg capsules four times a day (QID) for 6 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.38', 'spread': '0.12', 'groupId': 'OG000'}, {'value': '-3.25', 'spread': '0.13', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.234', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '-0.20', 'ciLowerLimit': '-0.53', 'ciUpperLimit': '0.13', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.17', 'estimateComment': 'The mean difference reported is the least squares (LS) mean difference.', 'groupDescription': 'The change from Baseline was compared between the two treatment groups using analysis of covariance (ANCOVA), with treatment and center as factors, and Baseline value as a covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 6/ET', 'description': "NRS-Pain scale assessed the severity of a subject's lower back pain on a scale of 0 (No pain) and 10 (Worst possible pain). NRS-Pain scale: Change = mean score at Week 6/ET minus mean score at Baseline.", 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT. Missing values were imputed by LOCF. Number of subjects with NRS-Pain scale scores at Baseline and Week 6/ET: celecoxib n=386, tramadol HCl n=385.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Severity of Low Back Pain as Measured by Visual Analogue Scale (VAS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '396', 'groupId': 'OG000'}, {'value': '396', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Celecoxib', 'description': '200 mg capsules two times a day (BID) for 6 weeks'}, {'id': 'OG001', 'title': 'Tramadol HCL', 'description': '50 mg capsules four times a day (QID) for 6 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-34.78', 'spread': '1.33', 'groupId': 'OG000'}, {'value': '-34.27', 'spread': '1.42', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.595', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '-0.94', 'ciLowerLimit': '-4.39', 'ciUpperLimit': '2.52', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.76', 'estimateComment': 'The mean difference reported is the LS mean difference.', 'groupDescription': 'The change from Baseline was compared between the two treatment groups using ANCOVA, with treatment and center as factors, and Baseline value as a covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 6/ET', 'description': 'VAS was a 100 millimeter (mm) scale that subjects used to assess the severity of their lower back pain. Based on the following question, "During the past day, how much back pain did you have?", the subject was instructed to place a vertical line on the VAS to indicate the magnitude of his/her lower back pain. 0 mm = no pain and 100 mm = worst possible pain. VAS: Change = mean score at Week 6/ET minus mean score at Baseline.', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT. Missing values were imputed by LOCF. Number of subjects with VAS scores at Baseline and Week 6/ET: celecoxib n=386, tramadol HCl n=385.'}, {'type': 'SECONDARY', 'title': "Patient's Global Assessment of Disease Activity", 'denoms': [{'units': 'Participants', 'counts': [{'value': '396', 'groupId': 'OG000'}, {'value': '396', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Celecoxib', 'description': '200 mg capsules two times a day (BID) for 6 weeks'}, {'id': 'OG001', 'title': 'Tramadol HCL', 'description': '50 mg capsules four times a day (QID) for 6 weeks'}], 'classes': [{'title': 'Improved', 'categories': [{'measurements': [{'value': '108', 'groupId': 'OG000'}, {'value': '107', 'groupId': 'OG001'}]}]}, {'title': 'No Change', 'categories': [{'measurements': [{'value': '264', 'groupId': 'OG000'}, {'value': '259', 'groupId': 'OG001'}]}]}, {'title': 'Worsened', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.829', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'groupDescription': 'CMH tests using row mean score and adjusted for center was used to compare the two treatment groups.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 6/ET', 'description': 'Number of subjects with a graded level of disease activity using the Patient\'s Global Assessment of Disease Activity 5-point scale (1=very good, 2=good, 3=fair, 4=poor, and 5=very poor). Subjects were classified as "Improved" if their assessment reduced at least 2 grades from baseline or if their assessment changed to Grade 1 (Very Good). Subjects were classified as "Worsened" if their assessment increased at least 2 grades from baseline or if their assessment changed to Grade 5 (Very Poor). Subjects were classified as "No Change" otherwise.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': "ITT. Number of subjects with Patient's Global Assessment of Disease Activity scores at Week 6/ET: celecoxib n=375, tramadol HCl n=367."}, {'type': 'SECONDARY', 'title': "Physician's Global Assessment of Disease Activity", 'denoms': [{'units': 'Participants', 'counts': [{'value': '396', 'groupId': 'OG000'}, {'value': '396', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Celecoxib', 'description': '200 mg capsules two times a day (BID) for 6 weeks'}, {'id': 'OG001', 'title': 'Tramadol HCL', 'description': '50 mg capsules four times a day (QID) for 6 weeks'}], 'classes': [{'title': 'Improved', 'categories': [{'measurements': [{'value': '113', 'groupId': 'OG000'}, {'value': '102', 'groupId': 'OG001'}]}]}, {'title': 'No Change', 'categories': [{'measurements': [{'value': '253', 'groupId': 'OG000'}, {'value': '258', 'groupId': 'OG001'}]}]}, {'title': 'Worsened', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.470', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'groupDescription': 'CMH tests using row mean score and adjusted for center was used to compare the two treatment groups.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 6/ET', 'description': 'Number of subjects with a physician\'s grading of disease activity using the Physician\'s Global Assessment of Disease Activity 5-point scale ((1=very good, 2=good, 3=fair, 4=poor, and 5=very poor). Subjects were classified as "Improved" if their assessment reduced at least 2 grades from baseline or if their assessment changed to Grade 1 (Very Good). Subjects were classified as "Worsened" if their assessment increased at least 2 grades from baseline or if their assessment changed to Grade 5 (Very Poor). Subjects were classified as "No Change" otherwise.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': "ITT. Number of subjects with Physician's Global Assessment of Disease Activity scores at Week 6/ET: celecoxib n=368, tramadol HCl n=361."}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Roland-Morris Disability Questionnaire (RMDQ) Total Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '396', 'groupId': 'OG000'}, {'value': '396', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Celecoxib', 'description': '200 mg capsules two times a day (BID) for 6 weeks'}, {'id': 'OG001', 'title': 'Tramadol HCL', 'description': '50 mg capsules four times a day (QID) for 6 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-4.90', 'spread': '0.26', 'groupId': 'OG000'}, {'value': '-4.45', 'spread': '0.25', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.339', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '-0.31', 'ciLowerLimit': '-0.95', 'ciUpperLimit': '0.33', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.32', 'estimateComment': 'The mean difference reported is the LS mean difference.', 'groupDescription': 'The change from Baseline was compared between the two treatment groups using ANCOVA, with treatment and center as factors, and Baseline value as a covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 6/ET', 'description': 'Each subject assessed his/her own disability due to low back pain using the RMDQ worksheet, which consisted of 24 statements of disability. The RMDQ total score was calculated as the total number of statements that were checked; the RMDQ total scores could have ranged from 0 to 24, with higher scores indicating greater disability. RMDQ: Change = mean score at Week 6/ET minus mean score at Baseline.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT. Missing values were imputed by LOCF. Number of subjects with Roland-Morris Disability total scores at Baseline and Week 6/ET= celecoxib n=391, tramadol n=389.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Modified Brief Pain Inventory (m-BPI-sf)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '396', 'groupId': 'OG000'}, {'value': '396', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Celecoxib', 'description': '200 mg capsules two times a day (BID) for 6 weeks'}, {'id': 'OG001', 'title': 'Tramadol HCL', 'description': '50 mg capsules four times a day (QID) for 6 weeks'}], 'classes': [{'title': 'How Much Pain Now', 'categories': [{'measurements': [{'value': '-2.87', 'spread': '0.12', 'groupId': 'OG000'}, {'value': '-2.88', 'spread': '0.13', 'groupId': 'OG001'}]}]}, {'title': 'Worst Pain in Past 24 Hours', 'categories': [{'measurements': [{'value': '-2.84', 'spread': '0.13', 'groupId': 'OG000'}, {'value': '-2.87', 'spread': '0.13', 'groupId': 'OG001'}]}]}, {'title': 'Average Pain in Past 24 Hours', 'categories': [{'measurements': [{'value': '-2.64', 'spread': '0.11', 'groupId': 'OG000'}, {'value': '-2.59', 'spread': '0.13', 'groupId': 'OG001'}]}]}, {'title': 'Pain Interfered With General Activity', 'categories': [{'measurements': [{'value': '-2.62', 'spread': '0.12', 'groupId': 'OG000'}, {'value': '-2.57', 'spread': '0.13', 'groupId': 'OG001'}]}]}, {'title': 'Pain Interfered With Mood', 'categories': [{'measurements': [{'value': '-2.38', 'spread': '0.14', 'groupId': 'OG000'}, {'value': '-2.25', 'spread': '0.15', 'groupId': 'OG001'}]}]}, {'title': 'Pain Interfered With Walking Activity', 'categories': [{'measurements': [{'value': '-2.26', 'spread': '0.13', 'groupId': 'OG000'}, {'value': '-2.36', 'spread': '0.13', 'groupId': 'OG001'}]}]}, {'title': 'Pain Interfered With Relations With Others', 'categories': [{'measurements': [{'value': '-1.79', 'spread': '0.13', 'groupId': 'OG000'}, {'value': '-1.74', 'spread': '0.14', 'groupId': 'OG001'}]}]}, {'title': 'Pain Interfered With Sleep', 'categories': [{'measurements': [{'value': '-2.52', 'spread': '0.13', 'groupId': 'OG000'}, {'value': '-2.51', 'spread': '0.15', 'groupId': 'OG001'}]}]}, {'title': 'Pain Interfered With Normal Work', 'categories': [{'measurements': [{'value': '-2.57', 'spread': '0.13', 'groupId': 'OG000'}, {'value': '-2.46', 'spread': '0.15', 'groupId': 'OG001'}]}]}, {'title': 'Pain Interfered With Enjoyment of Life', 'categories': [{'measurements': [{'value': '-2.43', 'spread': '0.14', 'groupId': 'OG000'}, {'value': '-2.43', 'spread': '0.15', 'groupId': 'OG001'}]}]}, {'title': 'Pain Interference Subscale', 'categories': [{'measurements': [{'value': '-2.37', 'spread': '0.11', 'groupId': 'OG000'}, {'value': '-2.33', 'spread': '0.12', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.741', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '-0.05', 'ciLowerLimit': '-0.36', 'ciUpperLimit': '0.25', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.16', 'estimateComment': 'The mean difference reported is the LS mean difference.', 'groupDescription': 'How Much Pain Now. The change from Baseline was compared between the two treatment groups using ANCOVA, with treatment and center as factors, and Baseline value as a covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.796', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '-0.04', 'ciLowerLimit': '-0.38', 'ciUpperLimit': '0.29', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.17', 'estimateComment': 'The mean difference reported is the LS mean difference.', 'groupDescription': 'Worst Pain in Past 24 Hours. The change from Baseline was compared between the two treatment groups using ANCOVA, with treatment and center as factors, and Baseline value as a covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.492', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '-0.11', 'ciLowerLimit': '-0.41', 'ciUpperLimit': '0.20', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.16', 'estimateComment': 'The mean difference reported is the LS mean difference.', 'groupDescription': 'Average Pain in Past 24 Hours. The change from Baseline was compared between the two treatment groups using ANCOVA, with treatment and center as factors, and Baseline value as a covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.893', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '0.02', 'ciLowerLimit': '-0.28', 'ciUpperLimit': '0.33', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.16', 'estimateComment': 'The mean difference reported is the LS mean difference.', 'groupDescription': 'Pain Interfered With General Activity. The change from Baseline was compared between the two treatment groups using ANCOVA, with treatment and center as factors, and Baseline value as a covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.618', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '-0.08', 'ciLowerLimit': '-0.40', 'ciUpperLimit': '0.24', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.16', 'estimateComment': 'The mean difference reported is the LS mean difference.', 'groupDescription': 'Pain Interfered With Mood. The change from Baseline was compared between the two treatment groups using ANCOVA, with treatment and center as factors, and Baseline value as a covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.440', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '0.12', 'ciLowerLimit': '-0.19', 'ciUpperLimit': '0.43', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.16', 'estimateComment': 'The mean difference reported is the LS mean difference.', 'groupDescription': 'Pain Interfered With Walking Activity. The change from Baseline was compared between the two treatment groups using ANCOVA, with treatment and center as factors, and Baseline value as a covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.806', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '0.04', 'ciLowerLimit': '-0.25', 'ciUpperLimit': '0.32', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.14', 'estimateComment': 'The mean difference reported is the LS mean difference.', 'groupDescription': 'Pain Interfered With Relations With Others. The change from Baseline was compared between the two treatment groups using ANCOVA, with treatment and center as factors, and Baseline value as a covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.739', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '-0.05', 'ciLowerLimit': '-0.38', 'ciUpperLimit': '0.27', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.17', 'estimateComment': 'The mean difference reported is the LS mean difference.', 'groupDescription': 'Pain Interfered With Sleep. The change from Baseline was compared between the two treatment groups using ANCOVA, with treatment and center as factors, and Baseline value as a covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.992', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '0.00', 'ciLowerLimit': '-0.32', 'ciUpperLimit': '0.33', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.17', 'estimateComment': 'The mean difference reported is the LS mean difference.', 'groupDescription': 'Pain Interfered With Normal Work. The change from Baseline was compared between the two treatment groups using ANCOVA, with treatment and center as factors, and Baseline value as a covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.793', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '0.04', 'ciLowerLimit': '-0.28', 'ciUpperLimit': '0.36', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.16', 'estimateComment': 'The mean difference reported is the LS mean difference.', 'groupDescription': 'Pain Interfered With Enjoyment of Life. The change from Baseline was compared between the two treatment groups using ANCOVA, with treatment and center as factors, and Baseline value as a covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.973', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '0.00', 'ciLowerLimit': '-0.27', 'ciUpperLimit': '0.28', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.14', 'estimateComment': 'The mean difference reported is the LS mean difference.', 'groupDescription': 'Pain Interference Subscale. The change from Baseline was compared between the two treatment groups using ANCOVA, with treatment and center as factors, and Baseline value as a covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 6/ET', 'description': 'm-BPI-sf scale assessed pain severity (0 = no pain to 10 = worst possible pain), and pain interference of functional activities (0 = does not interfere to 10 = completely interferes) during the 24 hour follow-up period. Subjects indicated: how much pain now; worst pain; average level of pain; how much pain interfered with general activity, mood, walking ability, relations with other people, sleep, normal work (including housework), and enjoyment of life. m-BPI-sf: Change = mean score at Week 6/ET minus mean score at Baseline.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT. Missing values were imputed by LOCF. Number of subjects with m-BPI-sf scores at Baseline and Week 6/ET: celecoxib n=373, tramadol HCl n=367.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '396', 'groupId': 'OG000'}, {'value': '396', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Celecoxib', 'description': '200 mg capsules two times a day (BID) for 6 weeks'}, {'id': 'OG001', 'title': 'Tramadol HCL', 'description': '50 mg capsules four times a day (QID) for 6 weeks'}], 'classes': [{'title': 'Sleep Disturbance (n=374, 367)', 'categories': [{'measurements': [{'value': '-17.91', 'spread': '1.23', 'groupId': 'OG000'}, {'value': '-16.34', 'spread': '1.17', 'groupId': 'OG001'}]}]}, {'title': 'Snoring (n=372, 365)', 'categories': [{'measurements': [{'value': '-7.53', 'spread': '1.31', 'groupId': 'OG000'}, {'value': '-5.10', 'spread': '1.28', 'groupId': 'OG001'}]}]}, {'title': 'Awaken Shortness of Breath, Headache (n=374, 367)', 'categories': [{'measurements': [{'value': '-8.61', 'spread': '1.27', 'groupId': 'OG000'}, {'value': '-6.21', 'spread': '1.34', 'groupId': 'OG001'}]}]}, {'title': 'Quantity of Sleep (n=373, 365)', 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.23', 'groupId': 'OG000'}, {'value': '0.58', 'spread': '0.28', 'groupId': 'OG001'}]}]}, {'title': 'Sleep Adequacy (n=373, 367)', 'categories': [{'measurements': [{'value': '7.32', 'spread': '1.48', 'groupId': 'OG000'}, {'value': '9.67', 'spread': '1.34', 'groupId': 'OG001'}]}]}, {'title': 'Somnolence (n=374, 366)', 'categories': [{'measurements': [{'value': '-9.63', 'spread': '1.05', 'groupId': 'OG000'}, {'value': '-7.01', 'spread': '1.16', 'groupId': 'OG001'}]}]}, {'title': 'Sleep Problem Index I (n=373, 367)', 'categories': [{'measurements': [{'value': '-11.59', 'spread': '0.96', 'groupId': 'OG000'}, {'value': '-10.54', 'spread': '0.92', 'groupId': 'OG001'}]}]}, {'title': 'Sleep Problem Index II (n=373, 367)', 'categories': [{'measurements': [{'value': '-12.97', 'spread': '0.94', 'groupId': 'OG000'}, {'value': '-11.82', 'spread': '0.89', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.392', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '-1.29', 'ciLowerLimit': '-4.26', 'ciUpperLimit': '1.67', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.51', 'estimateComment': 'The mean difference reported is the LS mean difference.', 'groupDescription': 'Sleep Disturbance. The change from Baseline was compared between the two treatment groups using ANCOVA, with treatment and center as factors, and Baseline value as a covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.691', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '-0.66', 'ciLowerLimit': '-3.94', 'ciUpperLimit': '2.61', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.67', 'estimateComment': 'The mean difference reported is the LS mean difference.', 'groupDescription': 'Snoring. The change from Baseline was compared between the two treatment groups using ANCOVA, with treatment and center as factors, and Baseline value as a covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.549', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '-0.87', 'ciLowerLimit': '-3.70', 'ciUpperLimit': '1.97', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.45', 'estimateComment': 'The mean difference reported is the LS mean difference.', 'groupDescription': 'Awaken Shortness of Breath or Headache. The change from Baseline was compared between the two treatment groups using ANCOVA, with treatment and center as factors, and Baseline value as a covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.336', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '-0.22', 'ciLowerLimit': '-0.67', 'ciUpperLimit': '0.23', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.23', 'estimateComment': 'The mean difference reported is the LS mean difference.', 'groupDescription': 'Quantity of Sleep. The change from Baseline was compared between the two treatment groups using ANCOVA, with treatment and center as factors, and Baseline value as a covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.370', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '-1.51', 'ciLowerLimit': '-4.83', 'ciUpperLimit': '1.80', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.69', 'estimateComment': 'The mean difference reported is the LS mean difference.', 'groupDescription': 'Sleep Adequacy. The change from Baseline was compared between the two treatment groups using ANCOVA, with treatment and center as factors, and Baseline value as a covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.341', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '-1.27', 'ciLowerLimit': '-3.90', 'ciUpperLimit': '1.35', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.34', 'estimateComment': 'The mean difference reported is the LS mean difference.', 'groupDescription': 'Somnolence. The change from Baseline was compared between the two treatment groups using ANCOVA, with treatment and center as factors, and Baseline value as a covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.604', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '-0.59', 'ciLowerLimit': '-2.85', 'ciUpperLimit': '1.66', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.15', 'estimateComment': 'The mean difference reported is the LS mean difference.', 'groupDescription': 'Sleep Problem Index I. The change from Baseline was compared between the two treatment groups using ANCOVA, with treatment and center as factors, and Baseline value as a covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.547', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '-0.68', 'ciLowerLimit': '-2.92', 'ciUpperLimit': '1.55', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.14', 'estimateComment': 'The mean difference reported is the LS mean difference.', 'groupDescription': 'Sleep Problem Index II. The change from Baseline was compared between the two treatment groups using ANCOVA, with treatment and center as factors, and Baseline value as a covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 6/ET', 'description': 'MOS sleep scale included the following attributes: sleep disturbance, snoring, awaken shortness of breath or headache, quantity of sleep, sleep adequacy, somnolence, Sleep Problem Index I, and Sleep Problem Index II. Score ranged from 0-100, with a higher score indicating more of the scale attribute (e.g., more sleep disturbance, etc.). A negative change indicated subject improvement. MOS sleep scale: Change = mean score at Week 6/ET minus mean score at Baseline.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT. Number of subjects with MOS scores at Baseline and Week 6/ET: n=celecoxib, tramadol HCl.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Change From Baseline in MOS Optimal Sleep Scale Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '396', 'groupId': 'OG000'}, {'value': '396', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Celecoxib', 'description': '200 mg capsules two times a day (BID) for 6 weeks'}, {'id': 'OG001', 'title': 'Tramadol HCL', 'description': '50 mg capsules four times a day (QID) for 6 weeks'}], 'classes': [{'title': '0 to 1 (Improvement)', 'categories': [{'measurements': [{'value': '82', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}]}, {'title': '1 to 1 (No change)', 'categories': [{'measurements': [{'value': '94', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}]}, {'title': '0 to 0 (No change)', 'categories': [{'measurements': [{'value': '171', 'groupId': 'OG000'}, {'value': '192', 'groupId': 'OG001'}]}]}, {'title': '1 to 0 (worsening)', 'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.196', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'groupDescription': 'Optimal sleep was analyzed using CMH general association test.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Week 6/ET', 'description': 'The Optimal Scale is scaled from 0 or 1 with 1 indicating 7 or 8 hours of sleep per night and 0 otherwise. Number of subjects with change of improvement (0 to 1), no change (1 to 1 or 0 to 0), or worsening (1 to 0) from baseline as indicated by the MOS Optimal sleep scale.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT. Number of subjects with MOS Optimal sleep scale scores at Week 6/ET: celecoxib n=373, tramadol HCl n=365.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Work Limitations Questionnaire (WLQ)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '396', 'groupId': 'OG000'}, {'value': '396', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Celecoxib', 'description': '200 mg capsules two times a day (BID) for 6 weeks'}, {'id': 'OG001', 'title': 'Tramadol HCL', 'description': '50 mg capsules four times a day (QID) for 6 weeks'}], 'classes': [{'title': 'Time Scale (n=241, 239)', 'categories': [{'measurements': [{'value': '-11.55', 'spread': '1.65', 'groupId': 'OG000'}, {'value': '-13.58', 'spread': '1.52', 'groupId': 'OG001'}]}]}, {'title': 'Physical Scale (n=270, 254)', 'categories': [{'measurements': [{'value': '-13.68', 'spread': '1.52', 'groupId': 'OG000'}, {'value': '-12.65', 'spread': '1.45', 'groupId': 'OG001'}]}]}, {'title': 'Output Scale (n=256, 246)', 'categories': [{'measurements': [{'value': '-11.44', 'spread': '1.54', 'groupId': 'OG000'}, {'value': '-11.69', 'spread': '1.70', 'groupId': 'OG001'}]}]}, {'title': 'Mental-Interpersonal Scale (n=266, 252)', 'categories': [{'measurements': [{'value': '-9.06', 'spread': '1.35', 'groupId': 'OG000'}, {'value': '-9.54', 'spread': '1.51', 'groupId': 'OG001'}]}]}, {'title': 'Index Scale (n=223, 220)', 'categories': [{'measurements': [{'value': '-3.10', 'spread': '0.36', 'groupId': 'OG000'}, {'value': '-3.14', 'spread': '0.37', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.252', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '2.19', 'ciLowerLimit': '-1.56', 'ciUpperLimit': '5.94', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.91', 'estimateComment': 'The mean difference reported is the LS mean difference.', 'groupDescription': 'Time Scale. The change from Baseline was compared between the two treatment groups using ANCOVA, with treatment and center as factors, and Baseline value as a covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.798', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '0.48', 'ciLowerLimit': '-3.21', 'ciUpperLimit': '4.17', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.88', 'estimateComment': 'The mean difference reported is the LS mean difference.', 'groupDescription': 'Physical Scale. The change from Baseline was compared between the two treatment groups using ANCOVA, with treatment and center as factors, and Baseline value as a covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.700', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '0.74', 'ciLowerLimit': '-3.03', 'ciUpperLimit': '4.51', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.92', 'estimateComment': 'The mean difference reported is the LS mean difference.', 'groupDescription': 'Output Scale. The change from Baseline was compared between the two treatment groups using ANCOVA, with treatment and center as factors, and Baseline value as a covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.902', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '0.21', 'ciLowerLimit': '-3.16', 'ciUpperLimit': '3.59', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.72', 'estimateComment': 'The mean difference reported is the LS mean difference.', 'groupDescription': 'Mental-Interpersonal Scale. The change from Baseline was compared between the two treatment groups using ANCOVA, with treatment and center as factors, and Baseline value as a covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.581', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '0.25', 'ciLowerLimit': '-0.65', 'ciUpperLimit': '1.16', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.46', 'estimateComment': 'The mean difference reported is the LS mean difference.', 'groupDescription': 'Index Scale. The change from Baseline was compared between the two treatment groups using ANCOVA, with treatment and center as factors, and Baseline value as a covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 6/ET', 'description': 'The WLQ included the following: Time Scale, Physical Scale, Output Scale, Mental-Interpersonal Scale, and Index Scale. The scales ranged from 0 (Limited none of the time) to 100 (Limited all of the time). A negative change indicated subject improvement.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT. Number of subjects with WLQ scores at Baseline and Week 6/ET: n=celecoxib, tramadol HCl.'}, {'type': 'SECONDARY', 'title': "Patient's Global Evaluation of Study Medication", 'denoms': [{'units': 'Participants', 'counts': [{'value': '396', 'groupId': 'OG000'}, {'value': '396', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Celecoxib', 'description': '200 mg capsules two times a day (BID) for 6 weeks'}, {'id': 'OG001', 'title': 'Tramadol HCL', 'description': '50 mg capsules four times a day (QID) for 6 weeks'}], 'classes': [{'title': 'Week 1, Excellent', 'categories': [{'measurements': [{'value': '46', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}]}, {'title': 'Week 1, Very Good', 'categories': [{'measurements': [{'value': '97', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}]}]}, {'title': 'Week 1, Good', 'categories': [{'measurements': [{'value': '126', 'groupId': 'OG000'}, {'value': '137', 'groupId': 'OG001'}]}]}, {'title': 'Week 1, Fair', 'categories': [{'measurements': [{'value': '78', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}]}, {'title': 'Week 1, Poor', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}]}, {'title': 'Week 3, Excellent', 'categories': [{'measurements': [{'value': '52', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}]}, {'title': 'Week 3, Very Good', 'categories': [{'measurements': [{'value': '104', 'groupId': 'OG000'}, {'value': '97', 'groupId': 'OG001'}]}]}, {'title': 'Week 3, Good', 'categories': [{'measurements': [{'value': '122', 'groupId': 'OG000'}, {'value': '105', 'groupId': 'OG001'}]}]}, {'title': 'Week 3, Fair', 'categories': [{'measurements': [{'value': '53', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}]}, {'title': 'Week 3, Poor', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}, {'title': 'Week 6/ET, Excellent', 'categories': [{'measurements': [{'value': '91', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}]}, {'title': 'Week 6/ET, Very Good', 'categories': [{'measurements': [{'value': '123', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}]}]}, {'title': 'Week 6/ET, Good', 'categories': [{'measurements': [{'value': '76', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}]}]}, {'title': 'Week 6/ET, Fair', 'categories': [{'measurements': [{'value': '51', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}]}, {'title': 'Week 6/ET, Poor', 'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.614', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'groupDescription': 'P-value reported is the overall p-value for Week 1.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.786', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'groupDescription': 'P-value reported is the overall p-value for Week 3.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.044', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'groupDescription': 'P-value reported is the overall p-value for Week 6/ET.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'NUMBER', 'timeFrame': 'Weeks 1, 3, and 6/ET', 'description': 'Number of subjects with an overall response to study medication of poor, fair, good, very good, and excellent.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT.'}, {'type': 'SECONDARY', 'title': "Patient's Satisfaction Questionnaire (With Pain Relief Scale)", 'denoms': [{'units': 'Participants', 'counts': [{'value': '396', 'groupId': 'OG000'}, {'value': '396', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Celecoxib', 'description': '200 mg capsules two times a day (BID) for 6 weeks'}, {'id': 'OG001', 'title': 'Tramadol HCL', 'description': '50 mg capsules four times a day (QID) for 6 weeks'}], 'classes': [{'title': '1', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}]}, {'title': '2', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}]}, {'title': '3', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}]}, {'title': '4', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}]}, {'title': '5', 'categories': [{'measurements': [{'value': '44', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}]}, {'title': '6', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}]}, {'title': '7', 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}]}, {'title': '8', 'categories': [{'measurements': [{'value': '63', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}]}, {'title': '9', 'categories': [{'measurements': [{'value': '53', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}]}]}, {'title': '10', 'categories': [{'measurements': [{'value': '87', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.870', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'groupDescription': 'CMH tests using row mean score and adjusted for center was used to compare the two treatment groups.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 6/ET', 'description': 'Number of subjects at varying levels of pain relief (1 = very dissatisfied to 10 = very satisfied).', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': "ITT. 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'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '14'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '12'}]}, {'type': 'Randomized But Did Not Receive Treatment', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '8'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '396', 'groupId': 'BG000'}, {'value': '396', 'groupId': 'BG001'}, {'value': '792', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Celecoxib', 'description': '200 mg capsules two times a day (BID) for 6 weeks'}, {'id': 'BG001', 'title': 'Tramadol HCL', 'description': '50 mg capsules four times a day (QID) for 6 weeks'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '18 to 44 years', 'categories': [{'measurements': [{'value': '164', 'groupId': 'BG000'}, {'value': '167', 'groupId': 'BG001'}, {'value': '331', 'groupId': 'BG002'}]}]}, {'title': '45 to 64 years', 'categories': [{'measurements': [{'value': '191', 'groupId': 'BG000'}, {'value': '182', 'groupId': 'BG001'}, {'value': '373', 'groupId': 'BG002'}]}]}, {'title': '> = 65 years', 'categories': [{'measurements': [{'value': '41', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '88', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '237', 'groupId': 'BG000'}, {'value': '213', 'groupId': 'BG001'}, {'value': '450', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '159', 'groupId': 'BG000'}, {'value': '183', 'groupId': 'BG001'}, {'value': '342', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 802}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2008-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-01-29', 'studyFirstSubmitDate': '2007-12-06', 'resultsFirstSubmitDate': '2009-09-10', 'studyFirstSubmitQcDate': '2008-04-17', 'lastUpdatePostDateStruct': {'date': '2021-02-21', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2009-10-21', 'studyFirstPostDateStruct': {'date': '2008-04-21', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2009-11-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Treatment Responders Based on the Numerical Rating Scale-Pain (NRS-Pain)', 'timeFrame': 'Week 6 or Early Termination (ET)', 'description': "A subject who met the following criteria was considered as a successful responder at Week 6: completed 6 weeks of treatment with study medication and had a 30% improvement from Baseline to Week 6/ET on the NRS-Pain. NRS-Pain scale assessed the severity of a subject's lower back pain on a scale of 0 (No pain) and 10 (Worst possible pain)."}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Severity of Chronic Low Back Pain as Measured by NRS-Pain', 'timeFrame': 'Baseline, Week 6/ET', 'description': "NRS-Pain scale assessed the severity of a subject's lower back pain on a scale of 0 (No pain) and 10 (Worst possible pain). NRS-Pain scale: Change = mean score at Week 6/ET minus mean score at Baseline."}, {'measure': 'Change From Baseline in Severity of Low Back Pain as Measured by Visual Analogue Scale (VAS)', 'timeFrame': 'Baseline, Week 6/ET', 'description': 'VAS was a 100 millimeter (mm) scale that subjects used to assess the severity of their lower back pain. Based on the following question, "During the past day, how much back pain did you have?", the subject was instructed to place a vertical line on the VAS to indicate the magnitude of his/her lower back pain. 0 mm = no pain and 100 mm = worst possible pain. VAS: Change = mean score at Week 6/ET minus mean score at Baseline.'}, {'measure': "Patient's Global Assessment of Disease Activity", 'timeFrame': 'Week 6/ET', 'description': 'Number of subjects with a graded level of disease activity using the Patient\'s Global Assessment of Disease Activity 5-point scale (1=very good, 2=good, 3=fair, 4=poor, and 5=very poor). Subjects were classified as "Improved" if their assessment reduced at least 2 grades from baseline or if their assessment changed to Grade 1 (Very Good). Subjects were classified as "Worsened" if their assessment increased at least 2 grades from baseline or if their assessment changed to Grade 5 (Very Poor). Subjects were classified as "No Change" otherwise.'}, {'measure': "Physician's Global Assessment of Disease Activity", 'timeFrame': 'Week 6/ET', 'description': 'Number of subjects with a physician\'s grading of disease activity using the Physician\'s Global Assessment of Disease Activity 5-point scale ((1=very good, 2=good, 3=fair, 4=poor, and 5=very poor). Subjects were classified as "Improved" if their assessment reduced at least 2 grades from baseline or if their assessment changed to Grade 1 (Very Good). Subjects were classified as "Worsened" if their assessment increased at least 2 grades from baseline or if their assessment changed to Grade 5 (Very Poor). Subjects were classified as "No Change" otherwise.'}, {'measure': 'Change From Baseline in Roland-Morris Disability Questionnaire (RMDQ) Total Score', 'timeFrame': 'Baseline, Week 6/ET', 'description': 'Each subject assessed his/her own disability due to low back pain using the RMDQ worksheet, which consisted of 24 statements of disability. The RMDQ total score was calculated as the total number of statements that were checked; the RMDQ total scores could have ranged from 0 to 24, with higher scores indicating greater disability. RMDQ: Change = mean score at Week 6/ET minus mean score at Baseline.'}, {'measure': 'Change From Baseline in Modified Brief Pain Inventory (m-BPI-sf)', 'timeFrame': 'Baseline, Week 6/ET', 'description': 'm-BPI-sf scale assessed pain severity (0 = no pain to 10 = worst possible pain), and pain interference of functional activities (0 = does not interfere to 10 = completely interferes) during the 24 hour follow-up period. Subjects indicated: how much pain now; worst pain; average level of pain; how much pain interfered with general activity, mood, walking ability, relations with other people, sleep, normal work (including housework), and enjoyment of life. m-BPI-sf: Change = mean score at Week 6/ET minus mean score at Baseline.'}, {'measure': 'Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale', 'timeFrame': 'Baseline, Week 6/ET', 'description': 'MOS sleep scale included the following attributes: sleep disturbance, snoring, awaken shortness of breath or headache, quantity of sleep, sleep adequacy, somnolence, Sleep Problem Index I, and Sleep Problem Index II. Score ranged from 0-100, with a higher score indicating more of the scale attribute (e.g., more sleep disturbance, etc.). A negative change indicated subject improvement. MOS sleep scale: Change = mean score at Week 6/ET minus mean score at Baseline.'}, {'measure': 'Number of Subjects With Change From Baseline in MOS Optimal Sleep Scale Scores', 'timeFrame': 'Baseline, Week 6/ET', 'description': 'The Optimal Scale is scaled from 0 or 1 with 1 indicating 7 or 8 hours of sleep per night and 0 otherwise. Number of subjects with change of improvement (0 to 1), no change (1 to 1 or 0 to 0), or worsening (1 to 0) from baseline as indicated by the MOS Optimal sleep scale.'}, {'measure': 'Change From Baseline in Work Limitations Questionnaire (WLQ)', 'timeFrame': 'Baseline, Week 6/ET', 'description': 'The WLQ included the following: Time Scale, Physical Scale, Output Scale, Mental-Interpersonal Scale, and Index Scale. The scales ranged from 0 (Limited none of the time) to 100 (Limited all of the time). A negative change indicated subject improvement.'}, {'measure': "Patient's Global Evaluation of Study Medication", 'timeFrame': 'Weeks 1, 3, and 6/ET', 'description': 'Number of subjects with an overall response to study medication of poor, fair, good, very good, and excellent.'}, {'measure': "Patient's Satisfaction Questionnaire (With Pain Relief Scale)", 'timeFrame': 'Week 6/ET', 'description': 'Number of subjects at varying levels of pain relief (1 = very dissatisfied to 10 = very satisfied).'}, {'measure': "Patient's Satisfaction Questionnaire (With Walking and Bending Ability Scale)", 'timeFrame': 'Week 6/ET', 'description': 'Number of subjects at varying levels of pain relief (1 = very dissatisfied to 10 = very satisfied).'}, {'measure': "Chronic Low Back Pain Responders Based on VAS, Patient's Global, and RMDQ", 'timeFrame': 'Week 6/ET', 'description': "Subjects were successful responders if they had: \\> = 30% improvement from baseline to final visit in VAS assessment (as identified by 100 millimeter scale); \\> = 30% improvement from baseline to final visit in Patient's Global assessment (classified as improved if assessment reduced at least 2 grades from baseline or if assessment changed to Grade 1, worsened if assessment increased at least 2 grades from baseline or if assessment changed to Grade 5, or no change; and \\< 20% worsening from baseline to final visit in RMDQ assessment (lower scores indicated greater disability)."}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Chronic low back pain'], 'conditions': ['Low Back Pain']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A3191338&StudyName=A%20Six%20Week%20Study%20Of%20The%20Pain%20Relieving%20Effects%20Of%20Celecoxib%20200%20Mg%20Twice%20Daily%20Compared%20To%20Tramadol%2050%20Mg%20Four%20Times%20Daily%20In%20', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'To compare the analgesic effectiveness of celecoxib and tramadol in subjects with Chronic Low Back Pain measured by the Numerical Rating Scale (NRS-Pain) at Week 6'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The subject presents with duration of chronic low back pain of \\> 3 months requiring regular use of analgesics (\\> 4 days/week), except for acetaminophen which cannot have been the sole analgesic used\n\nExclusion Criteria:\n\n* The subject has chronic low back pain, which is neurologic in etiology (i.e., radiculopathy, neuropathy, myelopathy)'}, 'identificationModule': {'nctId': 'NCT00662558', 'briefTitle': 'A Six Week Study Of The Pain Relieving Effects Of Celecoxib 200 Mg Twice Daily Compared To Tramadol 50 Mg Four Times Daily In Patients With Chronic Low Back Pain', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A Six Week Double-Blind, Randomized, Multicenter Comparison Study Of The Analgesic Effectiveness Of Celecoxib 200 Mg BID Compared To Tramadol Hydrochloride 50 Mg QID In Subjects With Chronic Low Back Pain', 'orgStudyIdInfo': {'id': 'A3191338'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'celecoxib', 'interventionNames': ['Drug: celecoxib']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'tramadol', 'interventionNames': ['Drug: tramadol HCL']}], 'interventions': [{'name': 'celecoxib', 'type': 'DRUG', 'description': '200 mg capsules BID for 6 weeks', 'armGroupLabels': ['celecoxib']}, {'name': 'tramadol HCL', 'type': 'DRUG', 'description': '50 mg capsules QID for 6 weeks', 'armGroupLabels': ['tramadol']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35126', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 33.52066, 'lon': 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