Ignite Creation Date:
2025-12-25 @ 2:10 AM
Ignite Modification Date:
2026-01-23 @ 4:15 PM
Study NCT ID:
NCT01843660
Status:
COMPLETED
Last Update Posted:
2013-08-26
First Post:
2013-04-26
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
An Efficacy and Safety Study of Tramadol Hydrochloride-Paracetamol in Treatment of Moderate to Severe Acute Neck-Shoulder Pain and Low Back Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017116', 'term': 'Low Back Pain'}, {'id': 'D020069', 'term': 'Shoulder Pain'}, {'id': 'D019547', 'term': 'Neck 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'}, {'id': 'D018771', 'term': 'Arthralgia'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '+86-10-58218709', 'title': 'Therapeutic Area Physician', 'organization': 'Janssen China, Beijing'}, 'certainAgreement': {'otherDetails': 'Disclosure restriction on the PI is that the PI should submit manuscript to the Sponsor for review no less than 60 days prior to public release. Only with written approval of the Sponsor, the results communications could be public released.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': "Results are reported for 'number of participants who required additional dosage administration' instead of 'time to achieve analgesic effect' due to change in planned analysis."}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Tramadol Hydrochloride (HCl)-Paracetamol', 'description': 'Participants received 1 to 2 tablets of tramadol HCl-paracetamol orally once daily (each tablet containing tramadol 37.5 milligram \\[mg\\] and paracetamol 325 mg) for up to a total duration of 6 hours.', 'otherNumAtRisk': 1059, 'otherNumAffected': 86, 'seriousNumAtRisk': 1059, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1059, 'numAffected': 35}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'No coding applied'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1059, 'numAffected': 9}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'No coding applied'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1059, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'No coding applied'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1059, 'numAffected': 31}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'No coding applied'}, {'term': 'Lethargy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1059, 'numAffected': 14}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'No coding applied'}, {'term': 'Weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1059, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'No coding applied'}, {'term': 'Skin itch', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1059, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'No coding applied'}, {'term': 'Others', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1059, 'numAffected': 19}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'No coding applied'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Pain Intensity Score Based on Numeric Rating Scale (NRS) at Hour 0.5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1029', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tramadol Hydrochloride (HCl)-Paracetamol', 'description': 'Participants received 1 to 2 tablets of tramadol HCl-paracetamol orally once daily (each tablet containing tramadol 37.5 milligram \\[mg\\] and paracetamol 325 mg) for up to a total duration of 6 hours.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.29', 'spread': '2.07', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Hour 0.5', 'description': 'Pain intensity was measured using NRS (0=painless and 10=most severe pain). Score of 1-3 means mild pain; 4-6 means moderate pain and 7-10 means severe pain.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Per protocol population included all participants who completed the clinical trial according to the trial protocol.'}, {'type': 'PRIMARY', 'title': 'Pain Intensity Score Based on Numeric Rating Scale (NRS) at Hour 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1029', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tramadol Hydrochloride (HCl)-Paracetamol', 'description': 'Participants received 1 to 2 tablets of tramadol HCl-paracetamol orally once daily (each tablet containing tramadol 37.5 milligram \\[mg\\] and paracetamol 325 mg) for up to a total duration of 6 hours.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.32', 'spread': '2.20', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Hour 1', 'description': 'Pain intensity was measured using NRS (0=painless and 10=most severe pain). Score of 1-3 means mild pain; 4-6 means moderate pain and 7-10 means severe pain.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Per protocol population included all participants who completed the clinical trial according to the trial protocol.'}, {'type': 'PRIMARY', 'title': 'Pain Intensity Score Based on Numeric Rating Scale (NRS) at Hour 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1029', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tramadol Hydrochloride (HCl)-Paracetamol', 'description': 'Participants received 1 to 2 tablets of tramadol HCl-paracetamol orally once daily (each tablet containing tramadol 37.5 milligram \\[mg\\] and paracetamol 325 mg) for up to a total duration of 6 hours.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.52', 'spread': '2.14', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Hour 2', 'description': 'Pain intensity was measured using NRS (0=painless and 10=most severe pain). Score of 1-3 means mild pain; 4-6 means moderate pain and 7-10 means severe pain.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Per protocol population included all participants who completed the clinical trial according to the trial protocol.'}, {'type': 'PRIMARY', 'title': 'Pain Intensity Score Based on Numeric Rating Scale (NRS) at Hour 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1029', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tramadol Hydrochloride (HCl)-Paracetamol', 'description': 'Participants received 1 to 2 tablets of tramadol HCl-paracetamol orally once daily (each tablet containing tramadol 37.5 milligram \\[mg\\] and paracetamol 325 mg) for up to a total duration of 6 hours.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.93', 'spread': '2.00', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Hour 3', 'description': 'Pain intensity was measured using NRS (0=painless and 10=most severe pain). Score of 1-3 means mild pain; 4-6 means moderate pain and 7-10 means severe pain.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Per protocol population included all participants who completed the clinical trial according to the trial protocol.'}, {'type': 'PRIMARY', 'title': 'Pain Intensity Score Based on Numeric Rating Scale (NRS) at Hour 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1029', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tramadol Hydrochloride (HCl)-Paracetamol', 'description': 'Participants received 1 to 2 tablets of tramadol HCl-paracetamol orally once daily (each tablet containing tramadol 37.5 milligram \\[mg\\] and paracetamol 325 mg) for up to a total duration of 6 hours.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.56', 'spread': '1.92', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Hour 4', 'description': 'Pain intensity was measured using NRS (0=painless and 10=most severe pain). Score of 1-3 means mild pain; 4-6 means moderate pain and 7-10 means severe pain.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Per protocol population included all participants who completed the clinical trial according to the trial protocol.'}, {'type': 'PRIMARY', 'title': 'Pain Intensity Score Based on Numeric Rating Scale (NRS) at Hour 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1029', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tramadol Hydrochloride (HCl)-Paracetamol', 'description': 'Participants received 1 to 2 tablets of tramadol HCl-paracetamol orally once daily (each tablet containing tramadol 37.5 milligram \\[mg\\] and paracetamol 325 mg) for up to a total duration of 6 hours.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.39', 'spread': '1.97', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Hour 6', 'description': 'Pain intensity was measured using NRS (0=painless and 10=most severe pain). Score of 1-3 means mild pain; 4-6 means moderate pain and 7-10 means severe pain.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Per protocol population included all participants who completed the clinical trial according to the trial protocol.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Pain Relief Score at Hour 0.5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1029', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tramadol Hydrochloride (HCl)-Paracetamol', 'description': 'Participants received 1 to 2 tablets of tramadol HCl-paracetamol orally once daily (each tablet containing tramadol 37.5 milligram \\[mg\\] and paracetamol 325 mg) for up to a total duration of 6 hours.'}], 'classes': [{'title': 'Complete', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}, {'title': 'Significant', 'categories': [{'measurements': [{'value': '92', 'groupId': 'OG000'}]}]}, {'title': 'Moderate', 'categories': [{'measurements': [{'value': '209', 'groupId': 'OG000'}]}]}, {'title': 'Mild', 'categories': [{'measurements': [{'value': '326', 'groupId': 'OG000'}]}]}, {'title': 'None', 'categories': [{'measurements': [{'value': '394', 'groupId': 'OG000'}]}]}, {'title': 'Exacerbated', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Hour 0.5', 'description': 'Pain relief was measured using 6-point Likert Scale (4=complete, 3=significant/comparatively large, 2=moderate, 1=mild/slight, 0=none, -1=exacerbated/heavier).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Per protocol population included all participants who completed the clinical trial according to the trial protocol.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Pain Relief Score at Hour 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1029', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tramadol Hydrochloride (HCl)-Paracetamol', 'description': 'Participants received 1 to 2 tablets of tramadol HCl-paracetamol orally once daily (each tablet containing tramadol 37.5 milligram \\[mg\\] and paracetamol 325 mg) for up to a total duration of 6 hours.'}], 'classes': [{'title': 'Complete', 'categories': [{'measurements': [{'value': '46', 'groupId': 'OG000'}]}]}, {'title': 'Significant', 'categories': [{'measurements': [{'value': '226', 'groupId': 'OG000'}]}]}, {'title': 'Moderate', 'categories': [{'measurements': [{'value': '271', 'groupId': 'OG000'}]}]}, {'title': 'Mild', 'categories': [{'measurements': [{'value': '332', 'groupId': 'OG000'}]}]}, {'title': 'None', 'categories': [{'measurements': [{'value': '154', 'groupId': 'OG000'}]}]}, {'title': 'Exacerbated', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Hour 1', 'description': 'Pain relief was measured using 6-point Likert Scale (4=complete, 3=significant/comparatively large, 2=moderate, 1=mild/slight, 0=none, -1=exacerbated/heavier).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Per protocol population included all participants who completed the clinical trial according to the trial protocol.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Pain Relief Score at Hour 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1029', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tramadol Hydrochloride (HCl)-Paracetamol', 'description': 'Participants received 1 to 2 tablets of tramadol HCl-paracetamol orally once daily (each tablet containing tramadol 37.5 milligram \\[mg\\] and paracetamol 325 mg) for up to a total duration of 6 hours.'}], 'classes': [{'title': 'Complete', 'categories': [{'measurements': [{'value': '104', 'groupId': 'OG000'}]}]}, {'title': 'Significant', 'categories': [{'measurements': [{'value': '351', 'groupId': 'OG000'}]}]}, {'title': 'Moderate', 'categories': [{'measurements': [{'value': '270', 'groupId': 'OG000'}]}]}, {'title': 'Mild', 'categories': [{'measurements': [{'value': '230', 'groupId': 'OG000'}]}]}, {'title': 'None', 'categories': [{'measurements': [{'value': '74', 'groupId': 'OG000'}]}]}, {'title': 'Exacerbated', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Hour 2', 'description': 'Pain relief was measured using 6-point Likert Scale (4=complete, 3=significant/comparatively large, 2=moderate, 1=mild/slight, 0=none, -1=exacerbated/heavier).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Per protocol population included all participants who completed the clinical trial according to the trial protocol.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Pain Relief Score at Hour 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1029', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tramadol Hydrochloride (HCl)-Paracetamol', 'description': 'Participants received 1 to 2 tablets of tramadol HCl-paracetamol orally once daily (each tablet containing tramadol 37.5 milligram \\[mg\\] and paracetamol 325 mg) for up to a total duration of 6 hours.'}], 'classes': [{'title': 'Complete', 'categories': [{'measurements': [{'value': '179', 'groupId': 'OG000'}]}]}, {'title': 'Significant', 'categories': [{'measurements': [{'value': '392', 'groupId': 'OG000'}]}]}, {'title': 'Moderate', 'categories': [{'measurements': [{'value': '307', 'groupId': 'OG000'}]}]}, {'title': 'Mild', 'categories': [{'measurements': [{'value': '99', 'groupId': 'OG000'}]}]}, {'title': 'None', 'categories': [{'measurements': [{'value': '52', 'groupId': 'OG000'}]}]}, {'title': 'Exacerbated', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Hour 3', 'description': 'Pain relief was measured using 6-point Likert Scale (4=complete, 3=significant/comparatively large, 2=moderate, 1=mild/slight, 0=none, -1=exacerbated/heavier).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Per protocol population included all participants who completed the clinical trial according to the trial protocol.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Pain Relief Score at Hour 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1029', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tramadol Hydrochloride (HCl)-Paracetamol', 'description': 'Participants received 1 to 2 tablets of tramadol HCl-paracetamol orally once daily (each tablet containing tramadol 37.5 milligram \\[mg\\] and paracetamol 325 mg) for up to a total duration of 6 hours.'}], 'classes': [{'title': 'Complete', 'categories': [{'measurements': [{'value': '222', 'groupId': 'OG000'}]}]}, {'title': 'Significant', 'categories': [{'measurements': [{'value': '484', 'groupId': 'OG000'}]}]}, {'title': 'Moderate', 'categories': [{'measurements': [{'value': '194', 'groupId': 'OG000'}]}]}, {'title': 'Mild', 'categories': [{'measurements': [{'value': '86', 'groupId': 'OG000'}]}]}, {'title': 'None', 'categories': [{'measurements': [{'value': '43', 'groupId': 'OG000'}]}]}, {'title': 'Exacerbated', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Hour 4', 'description': 'Pain relief was measured using 6-point Likert Scale (4=complete, 3=significant/comparatively large, 2=moderate, 1=mild/slight, 0=none, -1=exacerbated/heavier).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Per protocol population included all participants who completed the clinical trial according to the trial protocol.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Pain Relief Score at Hour 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1029', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tramadol Hydrochloride (HCl)-Paracetamol', 'description': 'Participants received 1 to 2 tablets of tramadol HCl-paracetamol orally once daily (each tablet containing tramadol 37.5 milligram \\[mg\\] and paracetamol 325 mg) for up to a total duration of 6 hours.'}], 'classes': [{'title': 'Complete', 'categories': [{'measurements': [{'value': '304', 'groupId': 'OG000'}]}]}, {'title': 'Significant', 'categories': [{'measurements': [{'value': '377', 'groupId': 'OG000'}]}]}, {'title': 'Moderate', 'categories': [{'measurements': [{'value': '218', 'groupId': 'OG000'}]}]}, {'title': 'Mild', 'categories': [{'measurements': [{'value': '78', 'groupId': 'OG000'}]}]}, {'title': 'None', 'categories': [{'measurements': [{'value': '51', 'groupId': 'OG000'}]}]}, {'title': 'Exacerbated', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Hour 6', 'description': 'Pain relief was measured using 6-point Likert Scale (4=complete, 3=significant/comparatively large, 2=moderate, 1=mild/slight, 0=none, -1=exacerbated/heavier).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Per protocol population included all participants who completed the clinical trial according to the trial protocol.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Required Additional Dosage Administration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1029', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tramadol Hydrochloride (HCl)-Paracetamol', 'description': 'Participants received 1 to 2 tablets of tramadol HCl-paracetamol orally once daily (each tablet containing tramadol 37.5 milligram \\[mg\\] and paracetamol 325 mg) for up to a total duration of 6 hours.'}], 'classes': [{'categories': [{'measurements': [{'value': '97', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to Hour 2', 'description': 'Number of participants who additionally required a second tablet within 2 hours after the first administration of the investigational drug was reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Per protocol population included all participants who completed the clinical trial according to the trial protocol.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Analgesic Satisfaction Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1029', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tramadol Hydrochloride (HCl)-Paracetamol', 'description': 'Participants received 1 to 2 tablets of tramadol HCl-paracetamol orally once daily (each tablet containing tramadol 37.5 milligram \\[mg\\] and paracetamol 325 mg) for up to a total duration of 6 hours.'}], 'classes': [{'title': 'Very good', 'categories': [{'measurements': [{'value': '128', 'groupId': 'OG000'}]}]}, {'title': 'Good', 'categories': [{'measurements': [{'value': '659', 'groupId': 'OG000'}]}]}, {'title': 'Average', 'categories': [{'measurements': [{'value': '212', 'groupId': 'OG000'}]}]}, {'title': 'Poor', 'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}]}]}, {'title': 'Missing', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Hour 6', 'description': 'Participants evaluated their satisfaction with the analgesic effect of the study drug using a 4-point scale (4=very good, 3=good, 2=average, 1=poor). Number of participants in each category was reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Per protocol population included all participants who completed the clinical trial according to the trial protocol.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Overall Analgesic Satisfaction Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1029', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tramadol Hydrochloride (HCl)-Paracetamol', 'description': 'Participants received 1 to 2 tablets of tramadol HCl-paracetamol orally once daily (each tablet containing tramadol 37.5 milligram \\[mg\\] and paracetamol 325 mg) for up to a total duration of 6 hours.'}], 'classes': [{'title': "Participants' evaluation: Very unsatisfied", 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': "Participants' evaluation: Unsatisfied", 'categories': [{'measurements': [{'value': '39', 'groupId': 'OG000'}]}]}, {'title': "Participants' evaluation: Average", 'categories': [{'measurements': [{'value': '207', 'groupId': 'OG000'}]}]}, {'title': "Participants' evaluation: Satisfied", 'categories': [{'measurements': [{'value': '669', 'groupId': 'OG000'}]}]}, {'title': "Participants' evaluation: Very satisfied", 'categories': [{'measurements': [{'value': '111', 'groupId': 'OG000'}]}]}, {'title': "Physicians' evaluation: Very unsatisfied", 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': "Physicians' evaluation: Unsatisfied", 'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000'}]}]}, {'title': "Physicians' evaluation: Average", 'categories': [{'measurements': [{'value': '159', 'groupId': 'OG000'}]}]}, {'title': "Physicians' evaluation: Satisfied", 'categories': [{'measurements': [{'value': '710', 'groupId': 'OG000'}]}]}, {'title': "Physicians' evaluation: Very satisfied", 'categories': [{'measurements': [{'value': '126', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Hour 6', 'description': 'Participants and physicians separately evaluated their satisfaction with the analgesic effect of the study drug using a 5-point scale (1=very unsatisfied, 2 =unsatisfied, 3=average, 4= satisfied and 5=very satisfied). Number of participants in each category was reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Per protocol population included all participants who completed the clinical trial according to the trial protocol.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Tramadol Hydrochloride (HCl)-Paracetamol', 'description': 'Participants received 1 to 2 tablets of tramadol HCl-paracetamol orally once daily (each tablet containing tramadol 37.5 milligram \\[mg\\] and paracetamol 325 mg) for up to a total duration of 6 hours.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1059'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1029'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}]}], 'dropWithdraws': [{'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '30'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '1035', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Tramadol Hydrochloride (HCl)-Paracetamol', 'description': 'Participants received 1 to 2 tablets of tramadol HCl-paracetamol orally once daily (each tablet containing tramadol 37.5 milligram \\[mg\\] and paracetamol 325 mg) for up to a total duration of 6 hours.'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '42.43', 'spread': '12.34', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '493', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '542', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Out of a total of 1059 participants, baseline characteristic (age and gender) was available for only 1035 participants who were included in the full analysis set.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1059}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-06', 'completionDateStruct': {'date': '2008-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-06-18', 'studyFirstSubmitDate': '2013-04-26', 'resultsFirstSubmitDate': '2013-06-18', 'studyFirstSubmitQcDate': '2013-04-26', 'lastUpdatePostDateStruct': {'date': '2013-08-26', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-06-18', 'studyFirstPostDateStruct': {'date': '2013-04-30', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-08-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain Intensity Score Based on Numeric Rating Scale (NRS) at Hour 0.5', 'timeFrame': 'Hour 0.5', 'description': 'Pain intensity was measured using NRS (0=painless and 10=most severe pain). Score of 1-3 means mild pain; 4-6 means moderate pain and 7-10 means severe pain.'}, {'measure': 'Pain Intensity Score Based on Numeric Rating Scale (NRS) at Hour 1', 'timeFrame': 'Hour 1', 'description': 'Pain intensity was measured using NRS (0=painless and 10=most severe pain). Score of 1-3 means mild pain; 4-6 means moderate pain and 7-10 means severe pain.'}, {'measure': 'Pain Intensity Score Based on Numeric Rating Scale (NRS) at Hour 2', 'timeFrame': 'Hour 2', 'description': 'Pain intensity was measured using NRS (0=painless and 10=most severe pain). Score of 1-3 means mild pain; 4-6 means moderate pain and 7-10 means severe pain.'}, {'measure': 'Pain Intensity Score Based on Numeric Rating Scale (NRS) at Hour 3', 'timeFrame': 'Hour 3', 'description': 'Pain intensity was measured using NRS (0=painless and 10=most severe pain). Score of 1-3 means mild pain; 4-6 means moderate pain and 7-10 means severe pain.'}, {'measure': 'Pain Intensity Score Based on Numeric Rating Scale (NRS) at Hour 4', 'timeFrame': 'Hour 4', 'description': 'Pain intensity was measured using NRS (0=painless and 10=most severe pain). Score of 1-3 means mild pain; 4-6 means moderate pain and 7-10 means severe pain.'}, {'measure': 'Pain Intensity Score Based on Numeric Rating Scale (NRS) at Hour 6', 'timeFrame': 'Hour 6', 'description': 'Pain intensity was measured using NRS (0=painless and 10=most severe pain). Score of 1-3 means mild pain; 4-6 means moderate pain and 7-10 means severe pain.'}, {'measure': 'Number of Participants With Pain Relief Score at Hour 0.5', 'timeFrame': 'Hour 0.5', 'description': 'Pain relief was measured using 6-point Likert Scale (4=complete, 3=significant/comparatively large, 2=moderate, 1=mild/slight, 0=none, -1=exacerbated/heavier).'}, {'measure': 'Number of Participants With Pain Relief Score at Hour 1', 'timeFrame': 'Hour 1', 'description': 'Pain relief was measured using 6-point Likert Scale (4=complete, 3=significant/comparatively large, 2=moderate, 1=mild/slight, 0=none, -1=exacerbated/heavier).'}, {'measure': 'Number of Participants With Pain Relief Score at Hour 2', 'timeFrame': 'Hour 2', 'description': 'Pain relief was measured using 6-point Likert Scale (4=complete, 3=significant/comparatively large, 2=moderate, 1=mild/slight, 0=none, -1=exacerbated/heavier).'}, {'measure': 'Number of Participants With Pain Relief Score at Hour 3', 'timeFrame': 'Hour 3', 'description': 'Pain relief was measured using 6-point Likert Scale (4=complete, 3=significant/comparatively large, 2=moderate, 1=mild/slight, 0=none, -1=exacerbated/heavier).'}, {'measure': 'Number of Participants With Pain Relief Score at Hour 4', 'timeFrame': 'Hour 4', 'description': 'Pain relief was measured using 6-point Likert Scale (4=complete, 3=significant/comparatively large, 2=moderate, 1=mild/slight, 0=none, -1=exacerbated/heavier).'}, {'measure': 'Number of Participants With Pain Relief Score at Hour 6', 'timeFrame': 'Hour 6', 'description': 'Pain relief was measured using 6-point Likert Scale (4=complete, 3=significant/comparatively large, 2=moderate, 1=mild/slight, 0=none, -1=exacerbated/heavier).'}], 'secondaryOutcomes': [{'measure': 'Number of Participants Who Required Additional Dosage Administration', 'timeFrame': 'Baseline up to Hour 2', 'description': 'Number of participants who additionally required a second tablet within 2 hours after the first administration of the investigational drug was reported.'}, {'measure': 'Number of Participants With Analgesic Satisfaction Score', 'timeFrame': 'Hour 6', 'description': 'Participants evaluated their satisfaction with the analgesic effect of the study drug using a 4-point scale (4=very good, 3=good, 2=average, 1=poor). Number of participants in each category was reported.'}, {'measure': 'Number of Participants With Overall Analgesic Satisfaction Score', 'timeFrame': 'Hour 6', 'description': 'Participants and physicians separately evaluated their satisfaction with the analgesic effect of the study drug using a 5-point scale (1=very unsatisfied, 2 =unsatisfied, 3=average, 4= satisfied and 5=very satisfied). Number of participants in each category was reported.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Low back pain', 'Shoulder pain', 'Neck pain', 'Tramadol hydrochloride', 'Paracetamol'], 'conditions': ['Low Back Pain', 'Shoulder Pain', 'Neck Pain']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the efficacy and safety of tramadol hydrochloride-paracetamol tablets in treatment of moderate (medium level of seriousness) to severe (very serious) acute neck, shoulder and low back pain in orthopedics (pertaining to the bones) outpatient or emergency setting.', 'detailedDescription': "This is an open-label (all people know the identity of the intervention), non-randomized, multi-center (when more than one hospital or medical school team work on a medical research study) and prospective (study following participants forward in time) study of tramadol hydrochloride-paracetamol tablets. Participants will receive 1 to 2 tablets of tramadol hydrochloride-paracetamol orally once daily (each tablet containing tramadol 37.5 milligram \\[mg\\] and paracetamol 325mg). Participants may be given the additional dose according to the clinical requirement. The total treatment duration will be 6 hours. The total study duration will be 4 months. Efficacy will be evaluated primarily by pain intensity and pain relief. Participants will evaluate the pain severity and pain relief at 0.5, 1, 2, 3, 4 and 6 hours respectively after the first dose; and the drug efficacy and overall satisfaction level at the end of 6 hours after the first dose. Participants' safety will be monitored throughout the study."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Intermittent or persistent pain for less than 3 months, required analgesic therapy, orthopedic surgery and emergency call participants suffering with severe neck, shoulder, low back pain or chronic neck, shoulder, lower back pain, acute (a quick and severe form of illness in its early stage) exacerbation pain\n* Pain intensity to be assessed using Numerical Rating Scale (NRS), NRS score more than or equal to 4 (from 0 to 10, 0 = no pain, 10 = extreme pain)\n* During normal pain and stable feeling, can study pain assessment methods and can fill in pain control diary\n* Be willing to participate in the study and must give written informed consent\n\nExclusion Criteria:\n\n* Have used strong opium kind of medication 7 days prior to the enrolment\n* Have severe mental disease or using antipsychotic (agent that control agitated psychotic behavior, alleviate acute psychotic states, reduce psychotic symptoms, and exert a quieting effect) medication for medical treatment\n* Drug abuse/dependence, or chronic alcohol abuse/depend on history\n* Pregnant or lactating women\n* Unable to tolerate tramadol or any failed treatment in past by using tramadol\n* Comparatively more severe pain in other parts of the body than that of the pain mentioned in the research'}, 'identificationModule': {'nctId': 'NCT01843660', 'briefTitle': 'An Efficacy and Safety Study of Tramadol Hydrochloride-Paracetamol in Treatment of Moderate to Severe Acute Neck-Shoulder Pain and Low Back Pain', 'organization': {'class': 'INDUSTRY', 'fullName': 'Xian-Janssen Pharmaceutical Ltd.'}, 'officialTitle': 'The Clinical Efficacy and Safety Study of Tramadol Hydrochloride - Paracetamol Tablets in the Treatment of Moderate to Severe Acute Neck-shoulder Pain and Low Back Pain in Orthopaedics Outpatient or Emergency Setting', 'orgStudyIdInfo': {'id': 'CR016117'}, 'secondaryIdInfos': [{'id': 'TRAMAPPAI4035'}, {'id': 'TRAMAP-CHN-MA-02'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Tramadol Hydrochloride (HCl)-Paracetamol', 'interventionNames': ['Drug: Tramadol HCl-Paracetamol']}], 'interventions': [{'name': 'Tramadol HCl-Paracetamol', 'type': 'DRUG', 'description': 'Participants will receive 1 to 2 tablets of tramadol HCl-paracetamol orally once daily (each tablet containing tramadol 37.5 milligram \\[mg\\] and paracetamol 325mg) for up to a total duration of 6 hours. Additional dose may be given based upon the clinical requirement.', 'armGroupLabels': ['Tramadol Hydrochloride (HCl)-Paracetamol']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Xian-Janssen Pharmaceutical Ltd., China Clinical Trial', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Xian-Janssen Pharmaceutical Ltd.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Xian-Janssen Pharmaceutical Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}