Ignite Creation Date:
2025-12-24 @ 10:32 PM
Ignite Modification Date:
2026-01-05 @ 5:14 PM
Study NCT ID:
NCT01675635
Status:
COMPLETED
Last Update Posted:
2018-02-26
First Post:
2012-04-25
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
OxyNorm Capsules in Post-Operative Pain Study
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009020', 'term': 'Morphine'}], 'ancestors': [{'id': 'D009022', 'term': 'Morphine Derivatives'}, {'id': 'D009019', 'term': 'Morphinans'}, {'id': 'D053610', 'term': 'Opiate Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006572', 'term': 'Heterocyclic Compounds, Bridged-Ring'}, {'id': 'D006576', 'term': 'Heterocyclic Compounds, 4 or More Rings'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D010616', 'term': 'Phenanthrenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'medical.mcpc@mundipharma.com.cn', 'phone': '0086-10-65636800', 'title': 'Ms. Dan Zhu, Clinical operation and quality lead of the study', 'organization': 'Mundipharma (China) pharmaceutical Co, LTD.'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'The protocol requires safety follow up until 24 hours after the last study medication dosing. So the longest time one subject in the study is 48 hours after the 1st study medication doing, include taking full of the 4 times dosing(intotal 24 hours) following by safety follow up for 24 hours.', 'eventGroups': [{'id': 'EG000', 'title': 'OxyNorm Capsules', 'description': 'To determine the efficacy and safety of OxyNorm Capsules.\n\nOxyNorm Capsules: dosage:5mg,l0mg and 20mg dosage form:capsule frequency:every 6h, duration:24 hours', 'otherNumAtRisk': 117, 'deathsNumAtRisk': 117, 'otherNumAffected': 35, 'seriousNumAtRisk': 117, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Morphine Tablet', 'description': 'To determine the efficacy and safety of Morphine tablet.\n\nMorphine tablet: dosage: 10mg and 20mg; dosage form: tablet; frequency: every 6h; duration: 24 hours.', 'otherNumAtRisk': 117, 'deathsNumAtRisk': 117, 'otherNumAffected': 35, 'seriousNumAtRisk': 117, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numEvents': 15, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 117, 'numEvents': 15, 'numAffected': 14}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 117, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 117, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 117, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'backache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 117, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'postoperative infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 117, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 117, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'serum creatinine increase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 117, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'alanine aminotransferase increase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 117, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 117, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 117, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'high tension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 117, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'muculoskeletalache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 117, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'expectoration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 117, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 117, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'epigastric pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 117, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'aspartate aminotransferase increase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 117, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 117, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'glycosylated hemoglobin derease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 117, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'blood glucose increase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 117, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'leucocyte count increase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 117, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 117, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'dyspnea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 117, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 117, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'chest uncomfortable', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 117, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'blood urea increase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 117, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 117, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0.0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Visual Analogue Scale (VAS) in Resting Stage at 6hour (6hour±20 Minutes After Administration of First Dose)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '113', 'groupId': 'OG000'}, {'value': '113', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'OxyNorm Capsules', 'description': 'To determine the efficacy and safety of OxyNorm Capsules.\n\nOxyNorm Capsules: dosage: l0mg dosage form:capsule frequency:every 6h, duration:24 hours'}, {'id': 'OG001', 'title': 'Morphine Tablet', 'description': 'To determine the efficacy and safety of Morphine tablet.\n\nMorphine tablet: dosage: 20mg; dosage form: tablet; frequency: every 6h; duration: 24 hours.'}], 'classes': [{'title': 'baseline of Visual Analogue Scale', 'categories': [{'measurements': [{'value': '46.21', 'spread': '9.53', 'groupId': 'OG000'}, {'value': '45.48', 'spread': '7.94', 'groupId': 'OG001'}]}]}, {'title': '6th hours Visual Analogue Scale', 'categories': [{'measurements': [{'value': '20.21', 'spread': '15.66', 'groupId': 'OG000'}, {'value': '19.94', 'spread': '15.68', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 6h (±20min)', 'description': 'To measure resting VAS at 6h(±20min) after administration of first dose, assessing the intensity of pain, and to conduct inter-group comparison\n\nVisual Analogue Scale\n\n0 10 20 30 40 50 60 70 80 90 100\n\n0 means no pain; 100 means pain as bad as you can image at resting stage', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '234 subjects in Full Analysis Set (FAS) in which 4 subjects from each group was excluded for Per Protocol(PP) population, so 113 subjects in PP population in each group for the primary endpoint analysis.'}, {'type': 'SECONDARY', 'title': 'VAS in Both Resting and Coughing Stage at 0.5h, 2h and 24h After Administration of First Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '113', 'groupId': 'OG000'}, {'value': '113', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'OxyNorm Capsules', 'description': 'To determine the efficacy and safety of OxyNorm Capsules.\n\nOxyNorm Capsules: dosage:l0mg dosage form:capsule frequency:every 6h, duration:24 hours'}, {'id': 'OG001', 'title': 'Morphine Tablet', 'description': 'To determine the efficacy and safety of Morphine tablet.\n\nMorphine tablet: dosage: 20mg; dosage form: tablet; frequency: every 6h; duration: 24 hours.'}], 'classes': [{'title': 'Resting baseline of Visual Analogue Scale', 'categories': [{'measurements': [{'value': '46.21', 'spread': '9.53', 'groupId': 'OG000'}, {'value': '45.48', 'spread': '7.96', 'groupId': 'OG001'}]}]}, {'title': 'Resting visual analogue scale before first dose', 'categories': [{'measurements': [{'value': '46.21', 'spread': '9.53', 'groupId': 'OG000'}, {'value': '45.48', 'spread': '7.96', 'groupId': 'OG001'}]}]}, {'title': 'Resting VAS 0.5 hour after first dose', 'categories': [{'measurements': [{'value': '29.87', 'spread': '13.59', 'groupId': 'OG000'}, {'value': '29.80', 'spread': '12.39', 'groupId': 'OG001'}]}]}, {'title': 'Resting VAS 2 hours after first dose', 'categories': [{'measurements': [{'value': '20.58', 'spread': '14.40', 'groupId': 'OG000'}, {'value': '20.89', 'spread': '12.70', 'groupId': 'OG001'}]}]}, {'title': 'Resting VAS 24 hours after first dose', 'categories': [{'measurements': [{'value': '9.73', 'spread': '12.52', 'groupId': 'OG000'}, {'value': '9.75', 'spread': '11.19', 'groupId': 'OG001'}]}]}, {'title': 'Coughing baseline of Visual Analogue Scale', 'categories': [{'measurements': [{'value': '55.16', 'spread': '12.15', 'groupId': 'OG000'}, {'value': '53.91', 'spread': '10.39', 'groupId': 'OG001'}]}]}, {'title': 'Coughing visual analogue scale before first dose', 'categories': [{'measurements': [{'value': '55.20', 'spread': '12.12', 'groupId': 'OG000'}, {'value': '53.91', 'spread': '10.39', 'groupId': 'OG001'}]}]}, {'title': 'Coughing VAS 0.5 hour after first dose', 'categories': [{'measurements': [{'value': '39.21', 'spread': '16.56', 'groupId': 'OG000'}, {'value': '37.96', 'spread': '13.61', 'groupId': 'OG001'}]}]}, {'title': 'Coughing VAS 2hours after first dose', 'categories': [{'measurements': [{'value': '29.68', 'spread': '17.91', 'groupId': 'OG000'}, {'value': '29.30', 'spread': '13.76', 'groupId': 'OG001'}]}]}, {'title': 'Coughing VAS 24hours after first dose', 'categories': [{'measurements': [{'value': '17.11', 'spread': '13.51', 'groupId': 'OG000'}, {'value': '16.27', 'spread': '12.58', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline,0.5h (±5min), 2h (±10min) and 24h (±20min)', 'description': 'To measure the resting and coughing VAS as 0.5h (±5min), 2h (±10min) and 24h (±20min) after administration of first dose, assessing the intensity of pain and to conduct inter-group comparison', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'The Use of Rescue Analgesics During the 24-hour Observation Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '117', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'OxyNorm Capsules', 'description': 'To determine the efficacy and safety of OxyNorm Capsules.\n\nOxyNorm Capsules: dosage:l0mg dosage form:capsule frequency:every 6h, duration:24 hours'}, {'id': 'OG001', 'title': 'Morphine Tablet', 'description': 'To determine the efficacy and safety of Morphine tablet.\n\nMorphine tablet: dosage:20mg; dosage form: tablet; frequency: every 6h; duration: 24 hours.'}], 'classes': [{'title': 'First dose interval(0-6h)', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Second dose interval(7-12h)', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Third dose interval(13-18)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Fourth dose interval(19-24h)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '24 hours after the first dose.', 'description': 'To calculate the subject who used rescue analgesics during the 4 dose interval within the 24-hour observation period and to conduct inter-group comparison', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'in FAS population'}, {'type': 'SECONDARY', 'title': 'VAS in Coughing Stage at 6h (6h±20min After Administration of First Dose)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '113', 'groupId': 'OG000'}, {'value': '113', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'OxyNorm Capsules', 'description': 'To determine the efficacy and safety of OxyNorm Capsules.\n\nOxyNorm Capsules: dosage:l0mg dosage form:capsule frequency:every 6h, duration:24 hours'}, {'id': 'OG001', 'title': 'Morphine Tablet', 'description': 'To determine the efficacy and safety of Morphine tablet.\n\nMorphine tablet: dosage: 20mg; dosage form: tablet; frequency: every 6h; duration: 24 hours.'}], 'classes': [{'title': 'Visual Analogue Scale of baseline coughing', 'categories': [{'measurements': [{'value': '55.16', 'spread': '12.15', 'groupId': 'OG000'}, {'value': '53.91', 'spread': '10.39', 'groupId': 'OG001'}]}]}, {'title': 'Visual Analogue Scale after 6hours coughing', 'categories': [{'measurements': [{'value': '28.81', 'spread': '17.58', 'groupId': 'OG000'}, {'value': '28.15', 'spread': '16.79', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 6h (±20min)', 'description': 'To measure coughing VAS at 6h (±20min) after administration of first dose, assessing the intensity of pain, and to conduct inter-group comparison\n\nVisual Analogue Scale\n\n0 10 20 30 40 50 60 70 80 90 100\n\n0 means no pain; 100 means pain as bed as you can image applicable for both resting and coughing stage', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '234 subjects in Full Analysis Set (FAS) in which 4 subjects from each group was excluded for Per Protocol(PP) population, so 113 subjects in PP population in each group for the primary endpoint analysis.'}, {'type': 'SECONDARY', 'title': 'Sleeping Quality Assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '113', 'groupId': 'OG000'}, {'value': '113', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'OxyNorm Capsules', 'description': 'To determine the efficacy and safety of OxyNorm Capsules.\n\nOxyNorm Capsules: dosage:5mg,l0mg and 20mg dosage form:capsule frequency:every 6h, duration:24 hours'}, {'id': 'OG001', 'title': 'Morphine Tablet', 'description': 'To determine the efficacy and safety of Morphine tablet.\n\nMorphine tablet: dosage: 10mg and 20mg; dosage form: tablet; frequency: every 6h; duration: 24 hours.'}], 'classes': [{'title': 'Very Good', 'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}]}, {'title': 'Good', 'categories': [{'measurements': [{'value': '38', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}]}, {'title': 'Fair', 'categories': [{'measurements': [{'value': '38', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}]}, {'title': 'Bad', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Very Bad', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '24 hours after administration of first dose', 'description': 'To assess Sleeping quality assessment during 24 hours after administration of first dose and to conduct inter-group comparison\n\nSleeping quality scale\n\n1. Very Good\n2. Good\n3. Fair\n4. Bad\n5. Very Bad', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '234 subjects in Full Analysis Set (FAS) in which 4 subjects from each group was excluded for Per Protocol(PP) population, so 113 subjects in PP population in each group for the primary endpoint analysis.'}, {'type': 'SECONDARY', 'title': 'Satisfaction With Pain Control', 'denoms': [{'units': 'Participants', 'counts': [{'value': '113', 'groupId': 'OG000'}, {'value': '113', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'OxyNorm Capsules', 'description': 'To determine the efficacy and safety of OxyNorm Capsules.\n\nOxyNorm Capsules: dosage: l0mg dosage form:capsule frequency:every 6h, duration:24 hours'}, {'id': 'OG001', 'title': 'Morphine Tablet:', 'description': 'To determine the efficacy and safety of Morphine tablet.\n\ndosage: 20mg dosage form: tablet; frequency: every 6h; duration: 24 hours.'}], 'classes': [{'categories': [{'title': 'Very Satisfied', 'measurements': [{'value': '38', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}, {'title': 'Satisfied', 'measurements': [{'value': '54', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}, {'title': 'Fair', 'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}, {'title': 'Not Satisfied', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Not Satisfied at all', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '24 hours after administration of first dose', 'description': 'To assess the Satisfaction with pain control during 24 hours after administration of first dose and to conduct inter-group comparison\n\n1. Very Satisfied\n2. Satisfied\n3. Fair\n4. Not Satisfied\n5. Not Satisfied at all', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '234 subjects in Full Analysis Set (FAS) in which 4 subjects from each group was excluded for Per Protocol(PP) population, so 113 subjects in PP population in each group for the primary endpoint analysis.'}, {'type': 'SECONDARY', 'title': 'Comparison of the Total Amount of Study Drugs Used During the 24 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '113', 'groupId': 'OG000'}, {'value': '113', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'OxyNorm Capsules', 'description': 'To determine the efficacy and safety of OxyNorm Capsules.\n\nOxyNorm Capsules: dosage: l0mg dosage form:capsule frequency:every 6h, duration:24 hours'}, {'id': 'OG001', 'title': 'Morphine Tablet', 'description': 'To determine the efficacy and safety of Morphine tablet.\n\nMorphine tablet: dosage: 20mg; dosage form: tablet; frequency: every 6h; duration: 24 hours.'}], 'classes': [{'categories': [{'measurements': [{'value': '18.50', 'spread': '10.37', 'groupId': 'OG000'}, {'value': '39.82', 'spread': '21.79', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 hours after administration of first dose', 'description': 'To calculate the total amount of study drugs used during the 24 hours and to conduct inter-group comparison\n\nThe study drug administration is average 6 hours,so the maximal is use 4 times in 24 hours. The investigate to evaluate if the subject need to take the 2nd, 3rd and 4th dose after the mandatory the 1st dose.', 'unitOfMeasure': 'mg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '234 subjects in Full Analysis Set (FAS) in which 4 subjects from each group was excluded for Per Protocol(PP) population, so 113 subjects in PP population in each group for the primary endpoint analysis.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'OxyNorm Capsules', 'description': 'To determine the efficacy and safety of OxyNorm Capsules.\n\nOxyNorm Capsules: dosage:l0mg dosage form:capsule frequency:every 6h, duration:24 hours'}, {'id': 'FG001', 'title': 'Morphine Tablet', 'description': 'To determine the efficacy and safety of Morphine tablet.\n\nMorphine tablet: dosage: 20mg; dosage form: tablet; frequency: every 6h; duration: 24 hours.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '117'}, {'groupId': 'FG001', 'numSubjects': '117'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '117'}, {'groupId': 'FG001', 'numSubjects': '117'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'This study is a randomized, double blind, double dummy, multicenter, parallel group, comparative study to compare the efficacy and safety of oxycodone capsule versus morphine tablet. The subject recruited from hospitalized patients poor with moderate to severe pain following surgery. The duration of the study from 2011 Jul to 2011 Dec.', 'preAssignmentDetails': 'There is no run-in or wash out period involved in this study.\n\nOn the protocol 240 subjects was planned to be enrolled, but actually 234 subjects was screened and all randomized. Zero screen failure is reasonable for the indication with this study design.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '117', 'groupId': 'BG000'}, {'value': '117', 'groupId': 'BG001'}, {'value': '234', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'OxyNorm Capsules', 'description': 'To determine the efficacy and safety of OxyNorm Capsules.\n\nOxyNorm Capsules: dosage:5mg,l0mg and 20mg dosage form:capsule frequency:every 6h, duration:24 hours'}, {'id': 'BG001', 'title': 'Morphine Tablet', 'description': 'To determine the efficacy and safety of Morphine tablet.\n\nMorphine tablet: dosage: 10mg and 20mg; dosage form: tablet; frequency: every 6h; duration: 24 hours.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '43.44', 'spread': '11.06', 'groupId': 'BG000'}, {'value': '43.29', 'spread': '10.53', 'groupId': 'BG001'}, {'value': '43.37', 'spread': '10.77', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '101', 'groupId': 'BG000'}, {'value': '93', 'groupId': 'BG001'}, {'value': '194', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '116', 'groupId': 'BG000'}, {'value': '117', 'groupId': 'BG001'}, {'value': '233', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'China', 'categories': [{'measurements': [{'value': '117', 'groupId': 'BG000'}, {'value': '117', 'groupId': 'BG001'}, {'value': '234', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Electrocardiogram test', 'classes': [{'title': 'normal', 'categories': [{'measurements': [{'value': '88', 'groupId': 'BG000'}, {'value': '76', 'groupId': 'BG001'}, {'value': '164', 'groupId': 'BG002'}]}]}, {'title': 'abnormal, not clinical significant', 'categories': [{'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '63', 'groupId': 'BG002'}]}]}, {'title': 'abnormal,clinical significant', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'the judgement of result normal, abnormal non clinical significant or abnormal clinical significant was made by the doctor according to the clinical practice. the study protocol does not have additional or particular requirement.', 'unitOfMeasure': 'Participants'}, {'title': 'America Society of Anesthesiologist classification', 'classes': [{'title': 'P1(Class I)', 'categories': [{'measurements': [{'value': '61', 'groupId': 'BG000'}, {'value': '57', 'groupId': 'BG001'}, {'value': '118', 'groupId': 'BG002'}]}]}, {'title': 'P2(Class II)', 'categories': [{'measurements': [{'value': '56', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '116', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'ASA Physical Status Classification System\n\nP1 A normal healthy patient P2 A patient with mild systemic disease P3 A patient with severe systemic disease P4 A patient with severe systemic disease that is a constant threat to life P5 A moribund patient who is not expected to survive without the operation P6 A declared brain-dead patient whose organ are being removed for donor purposes.', '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': 240}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-11', 'completionDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-02-23', 'studyFirstSubmitDate': '2012-04-25', 'resultsFirstSubmitDate': '2017-11-21', 'studyFirstSubmitQcDate': '2012-08-29', 'lastUpdatePostDateStruct': {'date': '2018-02-26', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-02-23', 'studyFirstPostDateStruct': {'date': '2012-08-30', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-02-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual Analogue Scale (VAS) in Resting Stage at 6hour (6hour±20 Minutes After Administration of First Dose)', 'timeFrame': 'Baseline and 6h (±20min)', 'description': 'To measure resting VAS at 6h(±20min) after administration of first dose, assessing the intensity of pain, and to conduct inter-group comparison\n\nVisual Analogue Scale\n\n0 10 20 30 40 50 60 70 80 90 100\n\n0 means no pain; 100 means pain as bad as you can image at resting stage'}], 'secondaryOutcomes': [{'measure': 'VAS in Both Resting and Coughing Stage at 0.5h, 2h and 24h After Administration of First Dose', 'timeFrame': 'Baseline,0.5h (±5min), 2h (±10min) and 24h (±20min)', 'description': 'To measure the resting and coughing VAS as 0.5h (±5min), 2h (±10min) and 24h (±20min) after administration of first dose, assessing the intensity of pain and to conduct inter-group comparison'}, {'measure': 'The Use of Rescue Analgesics During the 24-hour Observation Period', 'timeFrame': '24 hours after the first dose.', 'description': 'To calculate the subject who used rescue analgesics during the 4 dose interval within the 24-hour observation period and to conduct inter-group comparison'}, {'measure': 'VAS in Coughing Stage at 6h (6h±20min After Administration of First Dose)', 'timeFrame': 'Baseline and 6h (±20min)', 'description': 'To measure coughing VAS at 6h (±20min) after administration of first dose, assessing the intensity of pain, and to conduct inter-group comparison\n\nVisual Analogue Scale\n\n0 10 20 30 40 50 60 70 80 90 100\n\n0 means no pain; 100 means pain as bed as you can image applicable for both resting and coughing stage'}, {'measure': 'Sleeping Quality Assessment', 'timeFrame': '24 hours after administration of first dose', 'description': 'To assess Sleeping quality assessment during 24 hours after administration of first dose and to conduct inter-group comparison\n\nSleeping quality scale\n\n1. Very Good\n2. Good\n3. Fair\n4. Bad\n5. Very Bad'}, {'measure': 'Satisfaction With Pain Control', 'timeFrame': '24 hours after administration of first dose', 'description': 'To assess the Satisfaction with pain control during 24 hours after administration of first dose and to conduct inter-group comparison\n\n1. Very Satisfied\n2. Satisfied\n3. Fair\n4. Not Satisfied\n5. Not Satisfied at all'}, {'measure': 'Comparison of the Total Amount of Study Drugs Used During the 24 Hours', 'timeFrame': '24 hours after administration of first dose', 'description': 'To calculate the total amount of study drugs used during the 24 hours and to conduct inter-group comparison\n\nThe study drug administration is average 6 hours,so the maximal is use 4 times in 24 hours. The investigate to evaluate if the subject need to take the 2nd, 3rd and 4th dose after the mandatory the 1st dose.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Postoperative Pain']}, 'descriptionModule': {'briefSummary': 'The efficacy and safety of oxycodone capsules compared with morphine tablets in hospitalized patients with moderate to severe pain following surgery.', 'detailedDescription': 'To evaluate the efficacy and safety of oxycodone immediate-release capsules compared with morphine immediate-release tablets in hospitalized patients with moderate to severe pain following surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients of either sex aged 18 to 80 years inclusive.\n2. Patients who have given written informed consent to participate in the study.\n3. Able and willing to communicate with the investigator and his/her staff.\n4. Free of anesthesia as assessed through question and answer interaction with nurse at which time oral medication is indicated.\n5. Reporting "moderate" or "severe" pain (VAS ≥ 4) related to surgery and requesting analgesics for pain relief.\n\nExclusion Criteria:\n\n1. Patients have developed tolerance to or dependence on narcotic analgesics and/or alcohol.\n2. Patients with ASA ≥ 3 .\n3. Have any concomitant medical condition that would be adversely affected by analgesics or confound the quantification of analgesia, or could affect the absorption, metabolism or excretion of the study drugs in any clinically significant fashion.\n4. Have known hypersensitivity to any of the study medications or related agents.\n5. Have taken analgesic medications within three hours (wash-out) prior to dosing.\n6. Have developed complications from the surgical procedure that would confound the study.\n7. Have a history of severe iatrogenic adverse experiences.\n8. Mothers nursing their infant during the 24 hours following study drug administration, or pregnant women.\n9. Patient with Nothing Per Os (NPO) as stated in patient\'s chart or physician\'s order.\n10. Surgery in patients with epidural anesthesia\n11. Patients with Severe impairment of liver at preoperative stage (ALT, AST ≥ 1.5 times upper limit) and abnormal renal function.\n12. Patients with medical history of recovering from abnormal surgery anesthesia.\n13. Patients with medical history of hypertension (Systolic blood pressure ≥ 180Hg, Diastolic blood pressure 110Hg).\n14. Patients with shock.\n15. Patients with COPD.\n16. According to investigator to determine, patients are in addition the inclusion criteria and exclusion criteria for any other reason than not suitable in this study.'}, 'identificationModule': {'nctId': 'NCT01675635', 'briefTitle': 'OxyNorm Capsules in Post-Operative Pain Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Mundipharma (China) Pharmaceutical Co. Ltd'}, 'officialTitle': 'A Double-blind, Randomized, Parallel Group Study to Compare the Efficacy and Safety, of Oxycodone Immediate-release Capsules Versus Morphine Immediate-release Tablets in Hospitalized Patients With Moderate to Severe Pain Following Surgery.', 'orgStudyIdInfo': {'id': 'OXYC11-CN-304'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'OxyNorm Capsules', 'description': 'To determine the efficacy and safety of OxyNorm Capsules.', 'interventionNames': ['Drug: OxyNorm Capsules']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Morphine tablet', 'description': 'To determine the efficacy and safety of Morphine tablet.', 'interventionNames': ['Other: Morphine tablet']}], 'interventions': [{'name': 'OxyNorm Capsules', 'type': 'DRUG', 'otherNames': ['OxyNorm'], 'description': 'dosage:5mg,l0mg and 20mg dosage form:capsule frequency:every 6h, duration:24 hours', 'armGroupLabels': ['OxyNorm Capsules']}, {'name': 'Morphine tablet', 'type': 'OTHER', 'otherNames': ['Morphine'], 'description': 'dosage: 10mg and 20mg; dosage form: tablet; frequency: every 6h; duration: 24 hours.', 'armGroupLabels': ['Morphine tablet']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'XinMin Wu, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Peking University 1st Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mundipharma (China) Pharmaceutical Co. Ltd', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}