Ignite Creation Date:
2025-12-25 @ 2:18 AM
Ignite Modification Date:
2026-02-21 @ 9:24 PM
Study NCT ID:
NCT01902134
Status:
COMPLETED
Last Update Posted:
2016-03-07
First Post:
2013-07-15
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Oral Treatment for Orthopaedic Post-operative Pain With Dexketoprofen Trometamol and Tramadol Hydrochloride
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059787', 'term': 'Acute Pain'}, {'id': 'D010149', 'term': 'Pain, Postoperative'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C118296', 'term': 'dexketoprofen trometamol'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ACapriati@menarini-ricerche.it', 'phone': '+3905556809933', 'title': 'Dr. Angela Capriati, Corporate Director of Clinical Research', 'organization': 'Menarini Ricerche S.p.A.'}, 'certainAgreement': {'otherDetails': 'Prior to submitting the results of this study for publication or presentation, the PI will allow the Sponsor at least 60 days to review and comment upon the publication manuscript. The Sponsor will provide any manuscript of the results of this study at least 60 days before publishing to the authors for a complete review.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Study duration for patients was up to 6 weeks.', 'description': 'Analyzed for the Safety population (all randomized patients who received at least one dose of the study treatment). Includes adverse events emerging after at least one dose of active study treatment.', 'eventGroups': [{'id': 'EG000', 'title': 'DKP/TRAM Followed by DKP/TRAM', 'description': 'Dexketoprofen/Tramadol-single dose followed by Dexketoprofen/Tramadol-multiple doses.', 'otherNumAtRisk': 159, 'otherNumAffected': 15, 'seriousNumAtRisk': 159, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'DKP Followed by DKP', 'description': 'Dexketoprofen-single dose followed by Dexketoprofen-multiple doses.', 'otherNumAtRisk': 161, 'otherNumAffected': 18, 'seriousNumAtRisk': 161, 'seriousNumAffected': 3}, {'id': 'EG002', 'title': 'TRAM Followed by TRAM', 'description': 'Tramadol-single dose followed by Tramadol-multiple doses.', 'otherNumAtRisk': 160, 'otherNumAffected': 24, 'seriousNumAtRisk': 160, 'seriousNumAffected': 1}, {'id': 'EG003', 'title': 'Placebo Followed by DKP/TRAM', 'description': 'Placebo single dose followed by Dexketoprofen/Tramadol-multiple doses.', 'otherNumAtRisk': 54, 'otherNumAffected': 9, 'seriousNumAtRisk': 54, 'seriousNumAffected': 1}, {'id': 'EG004', 'title': 'Placebo Followed by DKP', 'description': 'Placebo single dose followed by Dexketoprofen-multiple doses.', 'otherNumAtRisk': 53, 'otherNumAffected': 2, 'seriousNumAtRisk': 53, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'Placebo Followed by TRAM', 'description': 'Placebo single dose followed by Tramadol-multiple doses.', 'otherNumAtRisk': 54, 'otherNumAffected': 5, 'seriousNumAtRisk': 54, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Anaemia postoperative', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 161, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 160, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 54, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 161, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 160, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 161, 'numEvents': 10, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 160, 'numEvents': 12, 'numAffected': 11}, {'groupId': 'EG003', 'numAtRisk': 54, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 53, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 54, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 161, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 160, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 54, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}], 'seriousEvents': [{'term': 'Bone operation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 161, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 160, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Heart valve replacement', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 161, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 160, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Vascular graft', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 161, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 160, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Device dislocation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 161, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 160, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Face oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 161, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 160, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Laryngeal oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 161, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 160, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 161, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 160, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Cardiac disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 161, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 160, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Periorbital oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 161, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 160, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Duodenal ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 161, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 160, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Soft tissue infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 161, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 160, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Periprosthetic fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 161, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 160, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Haematuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 161, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 160, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'SPID8 (Sum of Pain Intensity Differences Over 8 Hours)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '159', 'groupId': 'OG000'}, {'value': '161', 'groupId': 'OG001'}, {'value': '160', 'groupId': 'OG002'}, {'value': '161', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'DKP/TRAM', 'description': 'Drug: Dexketoprofen/Tramadol single oral dose (first 8 hours); Arm type: experimental; Dexketoprofen/Tramadol single oral dose (first 8 hours);'}, {'id': 'OG001', 'title': 'DEXKETOPROFEN', 'description': 'Drug: Dexketoprofen single oral dose (first 8 hours); Arm type: active comparator; Dexketoprofen single oral dose (first 8 hours);'}, {'id': 'OG002', 'title': 'TRAMADOL', 'description': 'Drug: Tramadol single oral dose (first 8 hours); Arm type: active comparator; Tramadol single oral dose (first 8 hours);'}, {'id': 'OG003', 'title': 'PLACEBO', 'description': 'Drug: Placebo; Arm type: PLACEBO comparator; Placebo single oral dose (first 8 hours);'}], 'classes': [{'categories': [{'measurements': [{'value': '246.9', 'spread': '156.50', 'groupId': 'OG000'}, {'value': '208.8', 'spread': '154.69', 'groupId': 'OG001'}, {'value': '204.6', 'spread': '145.79', 'groupId': 'OG002'}, {'value': '151.1', 'spread': '158.51', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'over 8 hours after the first dose', 'description': 'Sum of Pain Intensity Differences calculated as the weighted sum of the PI-VAS differences over 8 hour period. PI-VAS corresponds to the pain intensity measured by a 0-100 visual analogue scale (0=no pain to 100=worst pain imaginable) which was measured at 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, and 8h after the first dose. A higher value in SPID indicates greater pain relief.\n\nThe analysis was performed combining all randomization arms including placebo into one group, which resulted in the following 4 analysis groups: DKP/TRAM, DEXKETOPROFEN, TRAMADOL, and Placebo.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'SPID48 (Sum of Pain Intensity Differences Over First 48 Hours of the Multiple-dose Phase)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '213', 'groupId': 'OG000'}, {'value': '214', 'groupId': 'OG001'}, {'value': '214', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'DKP/TRAM', 'description': 'Drug: Dexketoprofen/Tramadol multiple doses; Arm type: experimental; Dexketoprofen/Tramadol multiple oral doses t.i.d. for 5 days (a total of 12 doses)'}, {'id': 'OG001', 'title': 'DEXKETOPROFEN', 'description': 'Drug: Dexketoprofen multiple doses; Arm type: active comparator; Dexketoprofen multiple oral doses t.i.d. for 5 days (a total of 12 doses)'}, {'id': 'OG002', 'title': 'TRAMADOL', 'description': 'Drug: Tramadol multiple doses; Arm type: active comparator; Tramadol multiple oral doses t.i.d. for 5 days (a total of 12 doses)'}], 'classes': [{'categories': [{'measurements': [{'value': '1943.7', 'spread': '1000.51', 'groupId': 'OG000'}, {'value': '1677.5', 'spread': '1070.91', 'groupId': 'OG001'}, {'value': '1765.6', 'spread': '963.49', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'over 48 hours of the multiple-dose phase', 'description': 'Sum of Pain Intensity Differences calculated as the weighted sum of the PI-VAS differences over 48 hours of the multiple-dose phase.\n\nPI-VAS corresponds to the pain intensity measured by a 0-100 visual analogue scale (0=no pain to 100=worst pain imaginable) which was measured every two hours over the first 48 hours of the multiple-dose phase. A higher value in SPID indicates greater pain relief.\n\nThe analysis was performed combining all randomization arms including the same active treatment, which resulted in the following 3 analysis groups: DKP/TRAM, DEXKETOPROFEN, and TRAMADOL.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percentage of Responders According to PI-VAS (Pain Intensity - Visual Analogue Scale)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '213', 'groupId': 'OG000'}, {'value': '214', 'groupId': 'OG001'}, {'value': '214', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'DKP/TRAM', 'description': 'Drug: Dexketoprofen/Tramadol multiple doses; Arm type: experimental; Dexketoprofen/Tramadol multiple oral doses t.i.d. for 5 days (a total of 12 doses)'}, {'id': 'OG001', 'title': 'DEXKETOPROFEN', 'description': 'Drug: Dexketoprofen multiple doses; Arm type: active comparator; Dexketoprofen multiple oral doses t.i.d. for 5 days (a total of 12 doses)'}, {'id': 'OG002', 'title': 'TRAMADOL', 'description': 'Drug: Tramadol multiple doses; Arm type: active comparator; Tramadol multiple oral doses t.i.d. for 5 days (a total of 12 doses)'}], 'classes': [{'categories': [{'measurements': [{'value': '90.1', 'groupId': 'OG000'}, {'value': '76.6', 'groupId': 'OG001'}, {'value': '82.2', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'over 48 hours of the multiple-dose phase', 'description': 'Percentage of responders; response defined as achievement a mean pain intensity, PI-VAS \\< 40 mm (PI-VAS corresponds to the pain intensity measured by a 0-100 visual analogue scale, 0=no pain to 100=worst pain imaginable),over 48 hours of the multiple-dose phase.\n\nThe analysis was performed combining all randomization arms including the same active treatment, which resulted in the following 3 analysis groups: DKP/TRAM, DEXKETOPROFEN, and TRAMADOL.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percentage of Responders According to 50% Max TOTPAR (Total Pain Relief)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '159', 'groupId': 'OG000'}, {'value': '161', 'groupId': 'OG001'}, {'value': '160', 'groupId': 'OG002'}, {'value': '161', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'DKP/TRAM', 'description': 'Drug: Dexketoprofen/Tramadol single oral dose (first 8 hours); Arm type: experimental; Dexketoprofen/Tramadol single oral dose (first 8 hours);'}, {'id': 'OG001', 'title': 'DEXKETOPROFEN', 'description': 'Drug: Dexketoprofen single oral dose (first 8 hours); Arm type: active comparator; Dexketoprofen single oral dose (first 8 hours);'}, {'id': 'OG002', 'title': 'TRAMADOL', 'description': 'Drug: Tramadol single oral dose (first 8 hours); Arm type: active comparator; Tramadol single oral dose (first 8 hours);'}, {'id': 'OG003', 'title': 'PLACEBO', 'description': 'Drug: Placebo; Arm type: PLACEBO comparator; Placebo single oral dose during single dose phase (first 8 hours);'}], 'classes': [{'categories': [{'measurements': [{'value': '57.9', 'groupId': 'OG000'}, {'value': '56.5', 'groupId': 'OG001'}, {'value': '51.9', 'groupId': 'OG002'}, {'value': '37.9', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'over 8 hours after the first dose', 'description': 'Percentage of responders over 8 hours after first dose, according to the 50% maximum total pain relief rule: maximum TOTPAR calculated as the theoretical maximum weighted sum of PAR-VRS (Pain Relief - Verbal Rating Scale: pain relief 0=none, 4=complete) scores.\n\nThe analysis was performed combining all randomization arms including placebo into one group, which resulted in the following 4 analysis groups: DKP/TRAM, DEXKETOPROFEN, TRAMADOL, and Placebo.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'DKP/TRAM Followed by DKP/TRAM', 'description': 'Dexketoprofen/Tramadol-single dose followed by Dexketoprofen/Tramadol-multiple doses'}, {'id': 'FG001', 'title': 'DKP Followed by DKP', 'description': 'Dexketoprofen-single dose followed by Dexketoprofen-multiple doses'}, {'id': 'FG002', 'title': 'TRAM Followed by TRAM', 'description': 'Tramadol-single dose followed by Tramadol-multiple doses'}, {'id': 'FG003', 'title': 'Placebo Followed by DKP/TRAM', 'description': 'Placebo single dose followed by Dexketoprofen/Tramadol-multiple doses'}, {'id': 'FG004', 'title': 'Placebo Followed by DKP', 'description': 'Placebo single dose followed by Dexketoprofen-multiple doses Placebo followed by DKP'}, {'id': 'FG005', 'title': 'Placebo Followed by TRAM', 'description': 'Placebo single dose followed by Tramadol-multiple doses'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '159'}, {'groupId': 'FG001', 'numSubjects': '161'}, {'groupId': 'FG002', 'numSubjects': '160'}, {'groupId': 'FG003', 'numSubjects': '54'}, {'groupId': 'FG004', 'numSubjects': '53'}, {'groupId': 'FG005', 'numSubjects': '54'}]}, {'type': 'Single-dose Phase', 'achievements': [{'groupId': 'FG000', 'numSubjects': '159'}, {'groupId': 'FG001', 'numSubjects': '161'}, {'groupId': 'FG002', 'numSubjects': '160'}, {'groupId': 'FG003', 'numSubjects': '54'}, {'groupId': 'FG004', 'numSubjects': '53'}, {'groupId': 'FG005', 'numSubjects': '54'}]}, {'type': 'Multiple-dose Phase', 'achievements': [{'groupId': 'FG000', 'numSubjects': '159'}, {'groupId': 'FG001', 'numSubjects': '160'}, {'groupId': 'FG002', 'numSubjects': '160'}, {'groupId': 'FG003', 'numSubjects': '54'}, {'groupId': 'FG004', 'numSubjects': '53'}, {'groupId': 'FG005', 'numSubjects': '52'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '151'}, {'groupId': 'FG001', 'numSubjects': '150'}, {'groupId': 'FG002', 'numSubjects': '145'}, {'groupId': 'FG003', 'numSubjects': '52'}, {'groupId': 'FG004', 'numSubjects': '46'}, {'groupId': 'FG005', 'numSubjects': '45'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '11'}, {'groupId': 'FG002', 'numSubjects': '15'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '7'}, {'groupId': 'FG005', 'numSubjects': '9'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '3'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '9'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '5'}, {'groupId': 'FG005', 'numSubjects': '4'}]}, {'type': 'no compliance', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '159', 'groupId': 'BG000'}, {'value': '161', 'groupId': 'BG001'}, {'value': '160', 'groupId': 'BG002'}, {'value': '54', 'groupId': 'BG003'}, {'value': '53', 'groupId': 'BG004'}, {'value': '54', 'groupId': 'BG005'}, {'value': '641', 'groupId': 'BG006'}]}], 'groups': [{'id': 'BG000', 'title': 'DKP/TRAM Followed by DKP/TRAM', 'description': 'Dexketoprofen/Tramadol-single dose followed by Dexketoprofen/Tramadol-multiple doses'}, {'id': 'BG001', 'title': 'DKP Followed by DKP', 'description': 'Dexketoprofen-single dose followed by Dexketoprofen-multiple doses'}, {'id': 'BG002', 'title': 'TRAM Followed by TRAM', 'description': 'Tramadol-single dose followed by Tramadol-multiple doses'}, {'id': 'BG003', 'title': 'Placebo Followed by DKP/TRAM', 'description': 'Placebo single dose followed by Dexketoprofen/Tramadol-multiple doses'}, {'id': 'BG004', 'title': 'Placebo Followed by DKP', 'description': 'Placebo single dose followed by Dexketoprofen-multiple doses'}, {'id': 'BG005', 'title': 'Placebo Followed by TRAM', 'description': 'Placebo single dose followed by Tramadol-multiple doses'}, {'id': 'BG006', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '61.3', 'spread': '10.43', 'groupId': 'BG000'}, {'value': '63.3', 'spread': '9.01', 'groupId': 'BG001'}, {'value': '61.3', 'spread': '9.68', 'groupId': 'BG002'}, {'value': '63.9', 'spread': '9.0', 'groupId': 'BG003'}, {'value': '61.0', 'spread': '11.10', 'groupId': 'BG004'}, {'value': '59.8', 'spread': '11.30', 'groupId': 'BG005'}, {'value': '61.9', 'spread': '9.96', 'groupId': 'BG006'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '86', 'groupId': 'BG000'}, {'value': '86', 'groupId': 'BG001'}, {'value': '80', 'groupId': 'BG002'}, {'value': '37', 'groupId': 'BG003'}, {'value': '33', 'groupId': 'BG004'}, {'value': '24', 'groupId': 'BG005'}, {'value': '346', 'groupId': 'BG006'}]}, {'title': 'Male', 'measurements': [{'value': '73', 'groupId': 'BG000'}, {'value': '75', 'groupId': 'BG001'}, {'value': '80', 'groupId': 'BG002'}, {'value': '17', 'groupId': 'BG003'}, {'value': '20', 'groupId': 'BG004'}, {'value': '30', 'groupId': 'BG005'}, {'value': '295', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Asian', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '7', 'groupId': 'BG006'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '159', 'groupId': 'BG000'}, {'value': '159', 'groupId': 'BG001'}, {'value': '157', 'groupId': 'BG002'}, {'value': '54', 'groupId': 'BG003'}, {'value': '53', 'groupId': 'BG004'}, {'value': '52', 'groupId': 'BG005'}, {'value': '634', 'groupId': 'BG006'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Serbia', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}, {'value': '5', 'groupId': 'BG005'}, {'value': '62', 'groupId': 'BG006'}]}]}, {'title': 'Taiwan', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '7', 'groupId': 'BG006'}]}]}, {'title': 'Czech Republic', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '36', 'groupId': 'BG006'}]}]}, {'title': 'Hungary', 'categories': [{'measurements': [{'value': '49', 'groupId': 'BG000'}, {'value': '57', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}, {'value': '17', 'groupId': 'BG003'}, {'value': '16', 'groupId': 'BG004'}, {'value': '11', 'groupId': 'BG005'}, {'value': '204', 'groupId': 'BG006'}]}]}, {'title': 'Spain', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '2', 'groupId': 'BG006'}]}]}, {'title': 'Poland', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '33', 'groupId': 'BG006'}]}]}, {'title': 'Ukraine', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '56', 'groupId': 'BG006'}]}]}, {'title': 'Lithuania', 'categories': [{'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}, {'value': '11', 'groupId': 'BG005'}, {'value': '84', 'groupId': 'BG006'}]}]}, {'title': 'Germany', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '4', 'groupId': 'BG006'}]}]}, {'title': 'Latvia', 'categories': [{'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}, {'value': '16', 'groupId': 'BG003'}, {'value': '15', 'groupId': 'BG004'}, {'value': '16', 'groupId': 'BG005'}, {'value': '153', 'groupId': 'BG006'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Weight', 'classes': [{'categories': [{'measurements': [{'value': '83.3', 'spread': '15.37', 'groupId': 'BG000'}, {'value': '81.4', 'spread': '15.63', 'groupId': 'BG001'}, {'value': '83.5', 'spread': '17.25', 'groupId': 'BG002'}, {'value': '82.4', 'spread': '15.91', 'groupId': 'BG003'}, {'value': '81.7', 'spread': '13.77', 'groupId': 'BG004'}, {'value': '82.1', 'spread': '15.27', 'groupId': 'BG005'}, {'value': '82.6', 'spread': '15.80', 'groupId': 'BG006'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Height', 'classes': [{'categories': [{'measurements': [{'value': '168.8', 'spread': '8.99', 'groupId': 'BG000'}, {'value': '167.9', 'spread': '9.14', 'groupId': 'BG001'}, {'value': '169.1', 'spread': '9.20', 'groupId': 'BG002'}, {'value': '166.1', 'spread': '8.47', 'groupId': 'BG003'}, {'value': '168.0', 'spread': '9.49', 'groupId': 'BG004'}, {'value': '169.9', 'spread': '7.94', 'groupId': 'BG005'}, {'value': '168.5', 'spread': '9.01', 'groupId': 'BG006'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'cm', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'Intention-to-treat (ITT) population (which includes all patients randomized).'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 641}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-02', 'completionDateStruct': {'date': '2014-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-02-04', 'studyFirstSubmitDate': '2013-07-15', 'resultsFirstSubmitDate': '2015-02-06', 'studyFirstSubmitQcDate': '2013-07-15', 'lastUpdatePostDateStruct': {'date': '2016-03-07', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-03-17', 'studyFirstPostDateStruct': {'date': '2013-07-18', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-04-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'SPID8 (Sum of Pain Intensity Differences Over 8 Hours)', 'timeFrame': 'over 8 hours after the first dose', 'description': 'Sum of Pain Intensity Differences calculated as the weighted sum of the PI-VAS differences over 8 hour period. PI-VAS corresponds to the pain intensity measured by a 0-100 visual analogue scale (0=no pain to 100=worst pain imaginable) which was measured at 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, and 8h after the first dose. A higher value in SPID indicates greater pain relief.\n\nThe analysis was performed combining all randomization arms including placebo into one group, which resulted in the following 4 analysis groups: DKP/TRAM, DEXKETOPROFEN, TRAMADOL, and Placebo.'}], 'secondaryOutcomes': [{'measure': 'SPID48 (Sum of Pain Intensity Differences Over First 48 Hours of the Multiple-dose Phase)', 'timeFrame': 'over 48 hours of the multiple-dose phase', 'description': 'Sum of Pain Intensity Differences calculated as the weighted sum of the PI-VAS differences over 48 hours of the multiple-dose phase.\n\nPI-VAS corresponds to the pain intensity measured by a 0-100 visual analogue scale (0=no pain to 100=worst pain imaginable) which was measured every two hours over the first 48 hours of the multiple-dose phase. A higher value in SPID indicates greater pain relief.\n\nThe analysis was performed combining all randomization arms including the same active treatment, which resulted in the following 3 analysis groups: DKP/TRAM, DEXKETOPROFEN, and TRAMADOL.'}, {'measure': 'Percentage of Responders According to PI-VAS (Pain Intensity - Visual Analogue Scale)', 'timeFrame': 'over 48 hours of the multiple-dose phase', 'description': 'Percentage of responders; response defined as achievement a mean pain intensity, PI-VAS \\< 40 mm (PI-VAS corresponds to the pain intensity measured by a 0-100 visual analogue scale, 0=no pain to 100=worst pain imaginable),over 48 hours of the multiple-dose phase.\n\nThe analysis was performed combining all randomization arms including the same active treatment, which resulted in the following 3 analysis groups: DKP/TRAM, DEXKETOPROFEN, and TRAMADOL.'}, {'measure': 'Percentage of Responders According to 50% Max TOTPAR (Total Pain Relief)', 'timeFrame': 'over 8 hours after the first dose', 'description': 'Percentage of responders over 8 hours after first dose, according to the 50% maximum total pain relief rule: maximum TOTPAR calculated as the theoretical maximum weighted sum of PAR-VRS (Pain Relief - Verbal Rating Scale: pain relief 0=none, 4=complete) scores.\n\nThe analysis was performed combining all randomization arms including placebo into one group, which resulted in the following 4 analysis groups: DKP/TRAM, DEXKETOPROFEN, TRAMADOL, and Placebo.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Moderate to severe acute pain', 'Postoperative pain', 'Hip arthroplasty', 'Analgesics', 'Dexketoprofen', 'Tramadol'], 'conditions': ['Acute Pain']}, 'referencesModule': {'references': [{'pmid': '26787797', 'type': 'RESULT', 'citation': 'McQuay HJ, Moore RA, Berta A, Gainutdinovs O, Fulesdi B, Porvaneckas N, Petronis S, Mitkovic M, Bucsi L, Samson L, Zegunis V, Ankin ML, Bertolotti M, Piza-Vallespir B, Cuadripani S, Contini MP, Nizzardo A. Randomized clinical trial of dexketoprofen/tramadol 25 mg/75 mg in moderate-to-severe pain after total hip arthroplasty. Br J Anaesth. 2016 Feb;116(2):269-76. doi: 10.1093/bja/aev457.'}]}, 'descriptionModule': {'briefSummary': 'This study aims to evaluate the analgesic efficacy of single and repeated doses of fixed combination of dexketoprofen trometamol (DKP) and tramadol hydrochloride (TRAM) in comparison to the single agents (and placebo for the single dose phase only) Approximately 600 male and female patients presenting moderate to severe pain after an elective primary hip arthroplasty are eligible to be randomised provided that they experience moderate to severe pain on the day after surgery.', 'detailedDescription': 'In this clinical trial patients were randomized to the described 6 treatment arms, where each arm define the treatment to be received in the first single dose phase (lasting 8 hours after the 1st treatment intake) and in the subsequent multiple-dose phase (lasting from the second treatment intake up to the 8 hours after the last intake). Namely:\n\n* DKP/TRAM followed by DKP/TRAM;\n* DKP followed by DKP;\n* TRAM followed by TRAM;\n* placebo followed by DKP;\n* placebo followed by TRAM;\n* placebo followed by DKP/TRAM;\n\nThe analyses of endpoints pertinent to the single dose phase were performed combining all the 3 treatment arms including placebo into one group, which resulted in the following 4 analysis groups: DKP/TRAM, DEXKETOPROFEN, TRAMADOL, and Placebo.\n\nThe analysis of endpoints pertinent to the multiple dose phase were performed combining the treatment arms including the same active treatment, which resulted in the following 3 analysis groups: DKP/TRAM, DEXKETOPROFEN, and TRAMADOL.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female patients aged 18 to 80 years. Females participating in the study must be either of non-childbearing potential, or willing to use a highly effective contraceptive method.\n* Scheduled to undergo standard primary (first-time) one-sided total hip replacement surgery due to primary osteoarthritis.\n* Patients experiencing pain at rest of at least moderate intensity the day after surgery.\n\nExclusion Criteria:\n\n* Patients not suitable for study treatments and rescue medication (RM) or those for whom non-steroidal anti-inflammatory drugs (NSAIDs), opioids, acetyl salicylic acid, pyrazolones or pyrazolidines are contraindicated.\n* Patients with clinically significant abnormalities in vital signs, safety laboratory tests and 12-lead ECG at screening.\n* Patients with history of any illness or condition that might pose a risk to the patient or confound the efficacy and safety study results.\n* Patients using and not suitable to withdraw analgesics other than those specified in the protocol.\n* Patients using and not suitable for withdrawing any of the prohibited medication specified in the protocol.\n* Pregnant and breastfeeding women.'}, 'identificationModule': {'nctId': 'NCT01902134', 'acronym': 'DAVID-art', 'briefTitle': 'Oral Treatment for Orthopaedic Post-operative Pain With Dexketoprofen Trometamol and Tramadol Hydrochloride', 'organization': {'class': 'INDUSTRY', 'fullName': 'Menarini Group'}, 'officialTitle': 'A Randomized, Double-blind, Placebo and Active-controlled, Parallel-group Study to Evaluate the Analgesic Efficacy and Safety of Dexketoprofen Trometamol and Tramadol Hydrochloride Oral Fixed Combination on Moderate to Severe Acute Pain After Elective Unilateral Total Hip Arthroplasty', 'orgStudyIdInfo': {'id': 'DEX-TRA-05'}, 'secondaryIdInfos': [{'id': '2012-004548-31', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'DKP/TRAM followed by DKP/TRAM', 'description': 'Dexketoprofen/Tramadol-single dose followed by Dexketoprofen/Tramadol-multiple doses', 'interventionNames': ['Drug: Dexketoprofen/Tramadol-single dose', 'Drug: Dexketoprofen/Tramadol-multiple doses']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'DKP followed by DKP', 'description': 'Dexketoprofen-single dose followed by Dexketoprofen-multiple doses', 'interventionNames': ['Drug: Dexketoprofen-single dose', 'Drug: Dexketoprofen-multiple doses']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'TRAM followed by TRAM', 'description': 'Tramadol-single dose followed by Tramadol-multiple doses', 'interventionNames': ['Drug: Tramadol-single dose', 'Drug: Tramadol-multiple doses']}, {'type': 'OTHER', 'label': 'Placebo followed by DKP/TRAM', 'description': 'Placebo single dose followed by Dexketoprofen/Tramadol-multiple doses', 'interventionNames': ['Drug: Placebo', 'Drug: Dexketoprofen/Tramadol-multiple doses']}, {'type': 'OTHER', 'label': 'Placebo followed by DKP', 'description': 'Placebo single dose followed by Dexketoprofen-multiple doses', 'interventionNames': ['Drug: Placebo', 'Drug: Dexketoprofen-multiple doses']}, {'type': 'OTHER', 'label': 'Placebo followed by TRAM', 'description': 'Placebo single dose followed by Tramadol-multiple doses', 'interventionNames': ['Drug: Placebo', 'Drug: Tramadol-multiple doses']}], 'interventions': [{'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo single oral dose (first 8 hours)', 'armGroupLabels': ['Placebo followed by DKP', 'Placebo followed by DKP/TRAM', 'Placebo followed by TRAM']}, {'name': 'Tramadol-single dose', 'type': 'DRUG', 'description': 'Tramadol single oral dose (first 8 hours)', 'armGroupLabels': ['TRAM followed by TRAM']}, {'name': 'Dexketoprofen-single dose', 'type': 'DRUG', 'description': 'Dexketoprofen single oral dose (first 8 hours)', 'armGroupLabels': ['DKP followed by DKP']}, {'name': 'Dexketoprofen/Tramadol-single dose', 'type': 'DRUG', 'description': 'Dexketoprofen/Tramadol oral single dose (first 8 hours)', 'armGroupLabels': ['DKP/TRAM followed by DKP/TRAM']}, {'name': 'Tramadol-multiple doses', 'type': 'DRUG', 'description': 'Tramadol multiple oral doses t.i.d. for 5 days (total 12 doses)', 'armGroupLabels': ['Placebo followed by TRAM', 'TRAM followed by TRAM']}, {'name': 'Dexketoprofen-multiple doses', 'type': 'DRUG', 'description': 'Dexketoprofen multiple oral doses t.i.d. for 5 days (total 12 doses)', 'armGroupLabels': ['DKP followed by DKP', 'Placebo followed by DKP']}, {'name': 'Dexketoprofen/Tramadol-multiple doses', 'type': 'DRUG', 'description': 'Dexketoprofen/Tramadol multiple oral doses t.i.d. for 5 days (total 12 doses)', 'armGroupLabels': ['DKP/TRAM followed by DKP/TRAM', 'Placebo followed by DKP/TRAM']}]}, 'contactsLocationsModule': {'locations': [{'zip': '625 00', 'city': 'Brno', 'country': 'Czechia', 'facility': 'Fakultni nemocnice Brno', 'geoPoint': {'lat': 49.19522, 'lon': 16.60796}}, {'zip': '662 50', 'city': 'Brno', 'country': 'Czechia', 'facility': 'Urazova nemocnice v Brne', 'geoPoint': {'lat': 49.19522, 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