Ignite Creation Date:
2025-12-25 @ 4:25 AM
Ignite Modification Date:
2026-02-25 @ 9:45 PM
Study NCT ID:
NCT01307020
Status:
COMPLETED
Last Update Posted:
2013-08-12
First Post:
2011-02-28
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Analgesic Effect of Different Combinations of Dexketoprofen Trometamol With Tramadol Hydrochloride in a Model of Moderate to Severe Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D010149', 'term': 'Pain, Postoperative'}], 'ancestors': [{'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'}, {'id': 'D014147', 'term': 'Tramadol'}, {'id': 'D007052', 'term': 'Ibuprofen'}], 'ancestors': [{'id': 'D003511', 'term': 'Cyclohexanols'}, {'id': 'D000441', 'term': 'Hexanols'}, {'id': 'D005233', 'term': 'Fatty Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D004123', 'term': 'Dimethylamines'}, {'id': 'D008744', 'term': 'Methylamines'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D010666', 'term': 'Phenylpropionates'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'acapriati@menarini-ricerche.it', 'phone': '+39 055 5680 9933', 'title': 'Dr Angela Capriati, Corporate Clinical Research Director', 'organization': 'Menarini Ricerche S.p.A.'}, 'certainAgreement': {'otherDetails': 'Prior to submitting the results of this study for publication or presentation, the investigator will allow the Sponsor at least 60 days time to review and comment upon the publication manuscript. It is agreed, that the results of the study will not be submitted for presentation, abstract, poster exhibition, or publication by the investigator until the Sponsor has reviewed/commented and agreed to any publication.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '10 ± 3 days', 'description': 'Analyzed for the Safety population (all patients who received study treatment)', 'eventGroups': [{'id': 'EG000', 'title': 'DKP-TRIS 12.5mg - TRAM.HCl 37.5mg', 'description': 'DKP-TRIS 12.5mg - TRAM.HCl 37.5mg oral film-coated tablet, once', 'otherNumAtRisk': 61, 'otherNumAffected': 7, 'seriousNumAtRisk': 61, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'DKP-TRIS 12.5mg - TRAM.HCl 75mg', 'description': 'DKP-TRIS 12.5mg - TRAM.HCl 75mg oral film-coated tablet, once', 'otherNumAtRisk': 63, 'otherNumAffected': 9, 'seriousNumAtRisk': 63, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'DKP-TRIS 25mg - TRAM.HCl 37.5mg', 'description': 'DKP-TRIS 25mg - TRAM.HCl 37.5mg oral film-coated tablet, once', 'otherNumAtRisk': 63, 'otherNumAffected': 6, 'seriousNumAtRisk': 63, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'DKP-TRIS 25mg - TRAM.HCl 75mg', 'description': 'DKP-TRIS 25mg - TRAM.HCl 75mg oral film-coated tablet, once', 'otherNumAtRisk': 61, 'otherNumAffected': 10, 'seriousNumAtRisk': 61, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'DKP-TRIS 12.5mg', 'description': 'DKP-TRIS 12.5mg oral film-coated tablet, once', 'otherNumAtRisk': 60, 'otherNumAffected': 2, 'seriousNumAtRisk': 60, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'DKP-TRIS 25mg', 'description': 'DKP-TRIS 25mg oral film-coated tablet, once', 'otherNumAtRisk': 61, 'otherNumAffected': 4, 'seriousNumAtRisk': 61, 'seriousNumAffected': 0}, {'id': 'EG006', 'title': 'TRAM.HCl 37.5mg', 'description': 'TRAM.HCl 37.5mg oral film-coated tablet, once', 'otherNumAtRisk': 59, 'otherNumAffected': 5, 'seriousNumAtRisk': 59, 'seriousNumAffected': 0}, {'id': 'EG007', 'title': 'TRAM.HCl 75mg', 'description': 'TRAM.HCl 75mg oral film-coated tablet, once', 'otherNumAtRisk': 60, 'otherNumAffected': 14, 'seriousNumAtRisk': 60, 'seriousNumAffected': 1}, {'id': 'EG008', 'title': 'Ibuprofen 400mg', 'description': 'Ibuprofen 400mg oral film-coated tablet, once', 'otherNumAtRisk': 61, 'otherNumAffected': 5, 'seriousNumAtRisk': 61, 'seriousNumAffected': 0}, {'id': 'EG009', 'title': 'Placebo', 'description': 'Placebo oral film-coated tablet, once', 'otherNumAtRisk': 62, 'otherNumAffected': 1, 'seriousNumAtRisk': 62, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 63, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 63, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 61, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 60, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 61, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 59, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 60, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG008', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 13.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 63, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 63, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 61, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 61, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 59, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 60, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG008', 'numAtRisk': 61, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG009', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 13.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 63, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 63, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 61, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 59, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 60, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG008', 'numAtRisk': 61, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG009', 'numAtRisk': 62, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 13.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 63, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 63, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 59, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG007', 'numAtRisk': 60, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG008', 'numAtRisk': 61, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 13.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 61, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 61, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 59, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 60, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG008', 'numAtRisk': 61, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 13.1'}], 'seriousEvents': [{'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 59, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 60, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 13.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Patients Achieving at Least 50 % of the Theoretical Maximum Total Pain Relief Score at 6 Hours Post-dosing.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}, {'value': '63', 'groupId': 'OG002'}, {'value': '61', 'groupId': 'OG003'}, {'value': '60', 'groupId': 'OG004'}, {'value': '60', 'groupId': 'OG005'}, {'value': '59', 'groupId': 'OG006'}, {'value': '59', 'groupId': 'OG007'}, {'value': '60', 'groupId': 'OG008'}, {'value': '62', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'DKP-TRIS 12.5mg - TRAM.HCl 37.5mg', 'description': 'DKP-TRIS 12.5mg - TRAM.HCl 37.5mg oral film-coated tablet, once'}, {'id': 'OG001', 'title': 'DKP-TRIS 12.5mg - TRAM.HCl 75mg', 'description': 'DKP-TRIS 12.5mg - TRAM.HCl 75mg oral film-coated tablet, once'}, {'id': 'OG002', 'title': 'DKP-TRIS 25mg - TRAM.HCl 37.5mg', 'description': 'DKP-TRIS 25mg - TRAM.HCl 37.5mg oral film-coated tablet, once'}, {'id': 'OG003', 'title': 'DKP-TRIS 25mg - TRAM.HCl 75mg', 'description': 'DKP-TRIS 25mg - TRAM.HCl 75mg oral film-coated tablet, once'}, {'id': 'OG004', 'title': 'DKP-TRIS 12.5mg', 'description': 'DKP-TRIS 12.5mg oral film-coated tablet, once'}, {'id': 'OG005', 'title': 'DKP-TRIS 25mg', 'description': 'DKP-TRIS 25mg oral film-coated tablet, once'}, {'id': 'OG006', 'title': 'TRAM.HCl 37.5mg', 'description': 'TRAM.HCl 37.5mg oral film-coated tablet, once'}, {'id': 'OG007', 'title': 'TRAM.HCl 75mg', 'description': 'TRAM.HCl 75mg oral film-coated tablet, once'}, {'id': 'OG008', 'title': 'Ibuprofen 400mg', 'description': 'Ibuprofen 400mg oral film-coated tablet, once'}, {'id': 'OG009', 'title': 'Placebo', 'description': 'Placebo oral film-coated tablet, once'}], 'classes': [{'categories': [{'measurements': [{'value': '36.7', 'groupId': 'OG000'}, {'value': '59.7', 'groupId': 'OG001'}, {'value': '55.6', 'groupId': 'OG002'}, {'value': '72.1', 'groupId': 'OG003'}, {'value': '26.7', 'groupId': 'OG004'}, {'value': '55.0', 'groupId': 'OG005'}, {'value': '10.2', 'groupId': 'OG006'}, {'value': '25.4', 'groupId': 'OG007'}, {'value': '45.0', 'groupId': 'OG008'}, {'value': '9.7', 'groupId': 'OG009'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 hours', 'description': 'Pain relief is measured by a verbal rating scale (ranging from 0=none to 4=complete). Theoretical maximum TOTPAR at 6 hours is calculated by summing up the maximum score of analgesia which the patient can attribute at defined time points along 6 hour (maxTOTPAR6h= 24). Unit of measure is %', 'unitOfMeasure': 'percentage of patients', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT (intention to treat) population which was defined as all patients who have taken the study treatment and have at least 1 post-dose assessment'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients Achieving at Least 50 % of the Theoretical Maximum Total Pain Relief Score at 4, 8 and 12 Hours Post-dosing.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}, {'value': '63', 'groupId': 'OG002'}, {'value': '61', 'groupId': 'OG003'}, {'value': '60', 'groupId': 'OG004'}, {'value': '60', 'groupId': 'OG005'}, {'value': '59', 'groupId': 'OG006'}, {'value': '59', 'groupId': 'OG007'}, {'value': '60', 'groupId': 'OG008'}, {'value': '62', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'DKP-TRIS 12.5mg - TRAM.HCl 37.5mg', 'description': 'DKP-TRIS 12.5mg - TRAM.HCl 37.5mg oral film-coated tablet, once'}, {'id': 'OG001', 'title': 'DKP-TRIS 12.5mg - TRAM.HCl 75mg', 'description': 'DKP-TRIS 12.5mg - TRAM.HCl 75mg oral film-coated tablet, once'}, {'id': 'OG002', 'title': 'DKP-TRIS 25mg - TRAM.HCl 37.5mg', 'description': 'DKP-TRIS 25mg - TRAM.HCl 37.5mg oral film-coated tablet, once'}, {'id': 'OG003', 'title': 'DKP-TRIS 25mg - TRAM.HCl 75mg', 'description': 'DKP-TRIS 25mg - TRAM.HCl 75mg oral film-coated tablet, once'}, {'id': 'OG004', 'title': 'DKP-TRIS 12.5mg', 'description': 'DKP-TRIS 12.5mg oral film-coated tablet, once'}, {'id': 'OG005', 'title': 'DKP-TRIS 25mg', 'description': 'DKP-TRIS 25mg oral film-coated tablet, once'}, {'id': 'OG006', 'title': 'TRAM.HCl 37.5mg', 'description': 'TRAM.HCl 37.5mg oral film-coated tablet, once'}, {'id': 'OG007', 'title': 'TRAM.HCl 75mg', 'description': 'TRAM.HCl 75mg oral film-coated tablet, once'}, {'id': 'OG008', 'title': 'Ibuprofen 400mg', 'description': 'Ibuprofen 400mg oral film-coated tablet, once'}, {'id': 'OG009', 'title': 'Placebo', 'description': 'Placebo oral film-coated tablet, once'}], 'classes': [{'title': 'at 4 hours post-dose', 'categories': [{'measurements': [{'value': '63.3', 'groupId': 'OG000'}, {'value': '72.6', 'groupId': 'OG001'}, {'value': '65.1', 'groupId': 'OG002'}, {'value': '78.7', 'groupId': 'OG003'}, {'value': '40.0', 'groupId': 'OG004'}, {'value': '65.0', 'groupId': 'OG005'}, {'value': '11.9', 'groupId': 'OG006'}, {'value': '23.7', 'groupId': 'OG007'}, {'value': '56.7', 'groupId': 'OG008'}, {'value': '6.5', 'groupId': 'OG009'}]}]}, {'title': 'at 8 hours post-dose', 'categories': [{'measurements': [{'value': '21.7', 'groupId': 'OG000'}, {'value': '48.4', 'groupId': 'OG001'}, {'value': '44.4', 'groupId': 'OG002'}, {'value': '54.1', 'groupId': 'OG003'}, {'value': '16.7', 'groupId': 'OG004'}, {'value': '31.7', 'groupId': 'OG005'}, {'value': '6.8', 'groupId': 'OG006'}, {'value': '20.3', 'groupId': 'OG007'}, {'value': '33.3', 'groupId': 'OG008'}, {'value': '6.5', 'groupId': 'OG009'}]}]}, {'title': 'at 12 hours post-dose', 'categories': [{'measurements': [{'value': '11.7', 'groupId': 'OG000'}, {'value': '35.5', 'groupId': 'OG001'}, {'value': '28.6', 'groupId': 'OG002'}, {'value': '37.7', 'groupId': 'OG003'}, {'value': '10.0', 'groupId': 'OG004'}, {'value': '13.3', 'groupId': 'OG005'}, {'value': '5.1', 'groupId': 'OG006'}, {'value': '15.3', 'groupId': 'OG007'}, {'value': '25.0', 'groupId': 'OG008'}, {'value': '6.5', 'groupId': 'OG009'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '4, 8 and 12 hours', 'description': 'Pain relief is measured by a verbal rating scale (ranging from 0=none to 4=complete). Theoretical maximum TOTPAR at 6 hours is calculated by summing up the maximum score of analgesia which the patient can attribute at defined time points along 4, 8 and 12 hours(maxTOTPAR4h= 16, maxTOTPAR8h= 32 and maxTOTPAR12h= 48, respectively) Unit of measure is %', 'unitOfMeasure': 'percentage of patient', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT (intention to treat) population which was defined as all patients who have taken the study treatment and have at least 1 post-dose assessment'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients Using Rescue Medication at 6 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}, {'value': '63', 'groupId': 'OG002'}, {'value': '61', 'groupId': 'OG003'}, {'value': '60', 'groupId': 'OG004'}, {'value': '60', 'groupId': 'OG005'}, {'value': '59', 'groupId': 'OG006'}, {'value': '59', 'groupId': 'OG007'}, {'value': '60', 'groupId': 'OG008'}, {'value': '62', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'DKP-TRIS 12.5mg - TRAM.HCl 37.5mg', 'description': 'DKP-TRIS 12.5mg - TRAM.HCl 37.5mg oral film-coated tablet, once'}, {'id': 'OG001', 'title': 'DKP-TRIS 12.5mg - TRAM.HCl 75mg', 'description': 'DKP-TRIS 12.5mg - TRAM.HCl 75mg oral film-coated tablet, once'}, {'id': 'OG002', 'title': 'DKP-TRIS 25mg - TRAM.HCl 37.5mg', 'description': 'DKP-TRIS 25mg - TRAM.HCl 37.5mg oral film-coated tablet, once'}, {'id': 'OG003', 'title': 'DKP-TRIS 25mg - TRAM.HCl 75mg', 'description': 'DKP-TRIS 25mg - TRAM.HCl 75mg oral film-coated tablet, once'}, {'id': 'OG004', 'title': 'DKP-TRIS 12.5mg', 'description': 'DKP-TRIS 12.5mg oral film-coated tablet, once'}, {'id': 'OG005', 'title': 'DKP-TRIS 25mg', 'description': 'DKP-TRIS 25mg oral film-coated tablet, once'}, {'id': 'OG006', 'title': 'TRAM.HCl 37.5mg', 'description': 'TRAM.HCl 37.5mg oral film-coated tablet, once'}, {'id': 'OG007', 'title': 'TRAM.HCl 75mg', 'description': 'TRAM.HCl 75mg oral film-coated tablet, once'}, {'id': 'OG008', 'title': 'Ibuprofen 400mg', 'description': 'Ibuprofen 400mg oral film-coated tablet, once'}, {'id': 'OG009', 'title': 'Placebo', 'description': 'Placebo oral film-coated tablet, once'}], 'classes': [{'categories': [{'measurements': [{'value': '66.7', 'groupId': 'OG000'}, {'value': '46.8', 'groupId': 'OG001'}, {'value': '39.7', 'groupId': 'OG002'}, {'value': '37.7', 'groupId': 'OG003'}, {'value': '65.0', 'groupId': 'OG004'}, {'value': '53.3', 'groupId': 'OG005'}, {'value': '69.5', 'groupId': 'OG006'}, {'value': '64.4', 'groupId': 'OG007'}, {'value': '48.3', 'groupId': 'OG008'}, {'value': '72.6', 'groupId': 'OG009'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to 6 hours', 'description': 'Percentage of patients using rescue medication at 6 hours post-dosing.', 'unitOfMeasure': 'percentage of patients', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT (intention to treat) population which was defined as all patients who have taken the study treatment and have at least 1 post-dose assessment'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'DKP-TRIS 12.5mg - TRAM.HCl 37.5mg', 'description': 'DKP-TRIS 12.5mg - TRAM.HCl 37.5mg oral film-coated tablet, once'}, {'id': 'FG001', 'title': 'DKP-TRIS 12.5mg - TRAM.HCl 75mg', 'description': 'DKP-TRIS 12.5mg - TRAM.HCl 75mg oral film-coated tablet, once'}, {'id': 'FG002', 'title': 'DKP-TRIS 25mg - TRAM.HCl 37.5mg', 'description': 'DKP-TRIS 25mg - TRAM.HCl 37.5mg oral film-coated tablet, once'}, {'id': 'FG003', 'title': 'DKP-TRIS 25mg - TRAM.HCl 75mg', 'description': 'DKP-TRIS 25mg - TRAM.HCl 75mg oral film-coated tablet, once'}, {'id': 'FG004', 'title': 'DKP-TRIS 12.5mg', 'description': 'DKP-TRIS 12.5mg oral film-coated tablet, once'}, {'id': 'FG005', 'title': 'DKP-TRIS 25mg', 'description': 'DKP-TRIS 25mg oral film-coated tablet, once'}, {'id': 'FG006', 'title': 'TRAM.HCl 37.5mg', 'description': 'TRAM.HCl 37.5mg oral film-coated tablet, once'}, {'id': 'FG007', 'title': 'TRAM.HCl 75mg', 'description': 'TRAM.HCl 75mg oral film-coated tablet, once'}, {'id': 'FG008', 'title': 'Ibuprofen 400mg', 'description': 'Ibuprofen 400mg oral film-coated tablet, once'}, {'id': 'FG009', 'title': 'Placebo', 'description': 'Placebo oral film-coated tablet, once'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '61'}, {'groupId': 'FG001', 'numSubjects': '63'}, {'groupId': 'FG002', 'numSubjects': '63'}, {'groupId': 'FG003', 'numSubjects': '61'}, {'groupId': 'FG004', 'numSubjects': '60'}, {'groupId': 'FG005', 'numSubjects': '61'}, {'groupId': 'FG006', 'numSubjects': '59'}, {'groupId': 'FG007', 'numSubjects': '60'}, {'groupId': 'FG008', 'numSubjects': '61'}, {'groupId': 'FG009', 'numSubjects': '62'}]}, {'type': 'Safety Population', 'achievements': [{'groupId': 'FG000', 'numSubjects': '61'}, {'groupId': 'FG001', 'numSubjects': '63'}, {'groupId': 'FG002', 'numSubjects': '63'}, {'groupId': 'FG003', 'numSubjects': '61'}, {'groupId': 'FG004', 'numSubjects': '60'}, {'groupId': 'FG005', 'numSubjects': '61'}, {'groupId': 'FG006', 'numSubjects': '59'}, {'groupId': 'FG007', 'numSubjects': '60'}, {'groupId': 'FG008', 'numSubjects': '61'}, {'groupId': 'FG009', 'numSubjects': '62'}]}, {'type': 'ITT (>= 1 Assessment Post Randomization)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '60'}, {'groupId': 'FG001', 'numSubjects': '62'}, {'groupId': 'FG002', 'numSubjects': '63'}, {'groupId': 'FG003', 'numSubjects': '61'}, {'groupId': 'FG004', 'numSubjects': '60'}, {'groupId': 'FG005', 'numSubjects': '60'}, {'groupId': 'FG006', 'numSubjects': '59'}, {'groupId': 'FG007', 'numSubjects': '59'}, {'groupId': 'FG008', 'numSubjects': '60'}, {'groupId': 'FG009', 'numSubjects': '62'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '61'}, {'groupId': 'FG001', 'numSubjects': '62'}, {'groupId': 'FG002', 'numSubjects': '62'}, {'groupId': 'FG003', 'numSubjects': '60'}, {'groupId': 'FG004', 'numSubjects': '60'}, {'groupId': 'FG005', 'numSubjects': '61'}, {'groupId': 'FG006', 'numSubjects': '58'}, {'groupId': 'FG007', 'numSubjects': '60'}, {'groupId': 'FG008', 'numSubjects': '61'}, {'groupId': 'FG009', 'numSubjects': '62'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '1'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '1'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}]}, {'type': 'Electronic data capture failure', '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'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'First patient in (screening) 23 Feb 2011, last patient out 14 Oct 2011. At 16 study centres in 6 European countries (Germany, Italy, Hungary, Poland, Spain and United Kingdom).', 'preAssignmentDetails': 'The trial encompassed 3 visits: 1-Screening; 2-Dental surgery (patients who have moderate to severe pain afterwards were randomised and received study drug); 3-End of study. Overall, 745 patients were enrolled (screened), of them 611 were randomized to receive the study drug and therefore considered as started.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'BG000'}, {'value': '63', 'groupId': 'BG001'}, {'value': '63', 'groupId': 'BG002'}, {'value': '61', 'groupId': 'BG003'}, {'value': '60', 'groupId': 'BG004'}, {'value': '61', 'groupId': 'BG005'}, {'value': '59', 'groupId': 'BG006'}, {'value': '60', 'groupId': 'BG007'}, {'value': '61', 'groupId': 'BG008'}, {'value': '62', 'groupId': 'BG009'}, {'value': '611', 'groupId': 'BG010'}]}], 'groups': [{'id': 'BG000', 'title': 'DKP-TRIS 12.5mg - TRAM.HCl 37.5mg', 'description': 'DKP-TRIS 12.5mg - TRAM.HCl 37.5mg oral film-coated tablet, once'}, {'id': 'BG001', 'title': 'DKP-TRIS 12.5mg - TRAM.HCl 75mg', 'description': 'DKP-TRIS 12.5mg - TRAM.HCl 75mg oral film-coated tablet, once'}, {'id': 'BG002', 'title': 'DKP-TRIS 25mg - TRAM.HCl 37.5mg', 'description': 'DKP-TRIS 25mg - TRAM.HCl 37.5mg oral film-coated tablet, once'}, {'id': 'BG003', 'title': 'DKP-TRIS 25mg - TRAM.HCl 75mg', 'description': 'DKP-TRIS 25mg - TRAM.HCl 75mg oral film-coated tablet, once'}, {'id': 'BG004', 'title': 'DKP-TRIS 12.5mg', 'description': 'DKP-TRIS 12.5mg oral film-coated tablet, once'}, {'id': 'BG005', 'title': 'DKP-TRIS 25mg', 'description': 'DKP-TRIS 25mg oral film-coated tablet, once'}, {'id': 'BG006', 'title': 'TRAM.HCl 37.5mg', 'description': 'TRAM.HCl 37.5mg oral film-coated tablet, once'}, {'id': 'BG007', 'title': 'TRAM.HCl 75mg', 'description': 'TRAM.HCl 75mg oral film-coated tablet, once'}, {'id': 'BG008', 'title': 'Ibuprofen 400mg', 'description': 'Ibuprofen 400mg oral film-coated tablet, once'}, {'id': 'BG009', 'title': 'Placebo', 'description': 'Placebo oral film-coated tablet, once'}, {'id': 'BG010', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '28.6', 'spread': '7.64', 'groupId': 'BG000'}, {'value': '26.9', 'spread': '7.62', 'groupId': 'BG001'}, {'value': '26.3', 'spread': '7.33', 'groupId': 'BG002'}, {'value': '27.3', 'spread': '7.55', 'groupId': 'BG003'}, {'value': '27.0', 'spread': '9.85', 'groupId': 'BG004'}, {'value': '26.9', 'spread': '6.94', 'groupId': 'BG005'}, {'value': '25.5', 'spread': '7.15', 'groupId': 'BG006'}, {'value': '27.8', 'spread': '7.99', 'groupId': 'BG007'}, {'value': '26.6', 'spread': '6.48', 'groupId': 'BG008'}, {'value': '26.1', 'spread': '6.64', 'groupId': 'BG009'}, {'value': '26.9', 'spread': '7.56', 'groupId': 'BG010'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}, {'value': '34', 'groupId': 'BG003'}, {'value': '36', 'groupId': 'BG004'}, {'value': '44', 'groupId': 'BG005'}, {'value': '38', 'groupId': 'BG006'}, {'value': '28', 'groupId': 'BG007'}, {'value': '41', 'groupId': 'BG008'}, {'value': '33', 'groupId': 'BG009'}, {'value': '364', 'groupId': 'BG010'}]}, {'title': 'Male', 'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}, {'value': '27', 'groupId': 'BG003'}, {'value': '24', 'groupId': 'BG004'}, {'value': '17', 'groupId': 'BG005'}, {'value': '21', 'groupId': 'BG006'}, {'value': '32', 'groupId': 'BG007'}, {'value': '20', 'groupId': 'BG008'}, {'value': '29', 'groupId': 'BG009'}, {'value': '247', 'groupId': 'BG010'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'BMI', 'classes': [{'categories': [{'measurements': [{'value': '23.7', 'spread': '3.39', 'groupId': 'BG000'}, {'value': '24.1', 'spread': '3.69', 'groupId': 'BG001'}, {'value': '23.0', 'spread': '2.87', 'groupId': 'BG002'}, {'value': '23.2', 'spread': '3.19', 'groupId': 'BG003'}, {'value': '23.6', 'spread': '3.20', 'groupId': 'BG004'}, {'value': '23.5', 'spread': '3.30', 'groupId': 'BG005'}, {'value': '23.0', 'spread': '3.19', 'groupId': 'BG006'}, {'value': '24.2', 'spread': '3.08', 'groupId': 'BG007'}, {'value': '22.4', 'spread': '3.04', 'groupId': 'BG008'}, {'value': '22.7', 'spread': '2.80', 'groupId': 'BG009'}, {'value': '23.3', 'spread': '3.21', 'groupId': 'BG010'}]}]}], 'paramType': 'MEAN', 'description': 'Body Mass Index (measured in kg/m\\^2)', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 745}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-07', 'completionDateStruct': {'date': '2011-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-07-31', 'studyFirstSubmitDate': '2011-02-28', 'resultsFirstSubmitDate': '2012-10-11', 'studyFirstSubmitQcDate': '2011-03-01', 'lastUpdatePostDateStruct': {'date': '2013-08-12', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-11-12', 'studyFirstPostDateStruct': {'date': '2011-03-02', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-12-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Patients Achieving at Least 50 % of the Theoretical Maximum Total Pain Relief Score at 6 Hours Post-dosing.', 'timeFrame': '6 hours', 'description': 'Pain relief is measured by a verbal rating scale (ranging from 0=none to 4=complete). Theoretical maximum TOTPAR at 6 hours is calculated by summing up the maximum score of analgesia which the patient can attribute at defined time points along 6 hour (maxTOTPAR6h= 24). Unit of measure is %'}], 'secondaryOutcomes': [{'measure': 'Percentage of Patients Achieving at Least 50 % of the Theoretical Maximum Total Pain Relief Score at 4, 8 and 12 Hours Post-dosing.', 'timeFrame': '4, 8 and 12 hours', 'description': 'Pain relief is measured by a verbal rating scale (ranging from 0=none to 4=complete). Theoretical maximum TOTPAR at 6 hours is calculated by summing up the maximum score of analgesia which the patient can attribute at defined time points along 4, 8 and 12 hours(maxTOTPAR4h= 16, maxTOTPAR8h= 32 and maxTOTPAR12h= 48, respectively) Unit of measure is %'}, {'measure': 'Percentage of Patients Using Rescue Medication at 6 Hours', 'timeFrame': 'Baseline to 6 hours', 'description': 'Percentage of patients using rescue medication at 6 hours post-dosing.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Moderate to severe pain', 'Postoperative pain', 'Analgesics', 'Dexketoprofen', 'Tramadol'], 'conditions': ['Pain']}, 'referencesModule': {'references': [{'pmid': '26123824', 'type': 'DERIVED', 'citation': 'Moore RA, Gay-Escoda C, Figueiredo R, Toth-Bagi Z, Dietrich T, Milleri S, Torres-Lagares D, Hill CM, Garcia-Garcia A, Coulthard P, Wojtowicz A, Matenko D, Penarrocha-Diago M, Cuadripani S, Piza-Vallespir B, Guerrero-Bayon C, Bertolotti M, Contini MP, Scartoni S, Nizzardo A, Capriati A, Maggi CA. Dexketoprofen/tramadol: randomised double-blind trial and confirmation of empirical theory of combination analgesics in acute pain. J Headache Pain. 2015;16:541. doi: 10.1186/s10194-015-0541-5. Epub 2015 Jun 27.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the analgesic efficacy of Dexketoprofen Trometamol and Tramadol Hydrochloride given in combinations and the analgesic efficacy of each single component in comparison to placebo on moderate to severe pain following impacted third mandibular molar tooth extraction. Ibuprofen will be used as an active control to validate the pain model.', 'detailedDescription': 'The aim of this study is to develop a combination of Dexketoprofen Trometamol (DKP.TRIS) and Tramadol Hydrochloride (TRAM.HCl) for the treatment of acute moderate to severe pain, based on the rationale that more than one drug is necessary in most patients suffering of acute and chronic pain, particularly of moderate to severe intensity.\n\nDKP.TRIS and TRAM.HCl have different mechanisms of action, therefore their combination is expect to result in an additive or synergistic analgesia, thus allowing a decrease in the required doses of the individual agents, and consequently a reduced risk of adverse events In this study, patients who present moderate to severe pain after impacted third mandibular molar tooth extraction will be randomised to a total of 10 treatment arms including 4 combinations of DKP.TRIS + TRAM.HCl, the four corresponding single treatments, placebo and ibuprofen. Treatment administration will be followed by a 24-hour pain and analgesic effect assessment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatients meeting ALL the following criteria will be eligible for entry into the study:\n\n* Male or female patients aged 18 to 70 years old. Females participating in the study must be either: of non-childbearing potential, or willing to use a highly effective contraceptive method.\n* Scheduled for outpatient surgical extraction -under local anaesthesia- of third mandibular molar teeth, with at least one of which is fully or partially impacted in the mandible requiring bone manipulation.\n* Normal physical examination or without clinically relevant abnormalities.\n\nAt randomisation (after surgery):\n\nNo intake of analgesics (including prescription and over the counter drugs) within 24h prior to the surgery.\n\n* No complication during the surgery, duration of surgery \\< 1 hour and not requiring re-anaesthesia.\n* Patients experiencing pain of moderate or higher intensity in the first four hours after the end of surgery.\n\nExclusion Criteria:\n\n* History of allergy or hypersensitivity to NSAIDs, opioids or acetyl salicylic acid.\n* History of asthma, bronchospasm, acute rhinitis, nasal polyps, urticaria or angioneurotic oedema.\n* History of peptic ulcer, gastrointestinal disorders by NSAIDs, gastrointestinal bleeding or other active bleedings.'}, 'identificationModule': {'nctId': 'NCT01307020', 'acronym': 'DEX-TRA 02', 'briefTitle': 'Analgesic Effect of Different Combinations of Dexketoprofen Trometamol With Tramadol Hydrochloride in a Model of Moderate to Severe Pain', 'organization': {'class': 'INDUSTRY', 'fullName': 'Menarini Group'}, 'officialTitle': 'Double-blind, Randomised, Placebo and Active Controlled, Parallel Group Study to Evaluate the Analgesic Effect of a Single Oral Administration of Four Different Combination Doses of DKP.TRIS With TRAM.HCL in Comparison With the Single Agents, on Moderate to Severe Pain Following Impacted Third Mandibular Molar Tooth Extraction', 'orgStudyIdInfo': {'id': 'DEX-TRA 02'}, 'secondaryIdInfos': [{'id': '2010-022798-32', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Ibuprofen', 'interventionNames': ['Drug: Ibuprofen']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'TRAM.HCl high dose', 'interventionNames': ['Drug: Tramadol Hydrochloride']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'TRAM.HCl low dose', 'interventionNames': ['Drug: Tramadol Hydrochloride']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'DKP-TRIS high dose', 'interventionNames': ['Drug: Dexketoprofen Trometamol']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'DKP-TRIS low dose', 'interventionNames': ['Drug: Dexketoprofen Trometamol']}, {'type': 'EXPERIMENTAL', 'label': 'DKP-TRIS low dose - TRAM.HCl low dose', 'interventionNames': ['Drug: Dexketoprofen Trometamol + Tramadol Hydrochloride']}, {'type': 'EXPERIMENTAL', 'label': 'DKP-TRIS low dose - TRAM.HCl high dose', 'interventionNames': ['Drug: Dexketoprofen Trometamol + Tramadol Hydrochloride']}, {'type': 'EXPERIMENTAL', 'label': 'DKP-TRIS high dose - TRAM.HCl low dose', 'interventionNames': ['Drug: Dexketoprofen Trometamol + Tramadol Hydrochloride']}, {'type': 'EXPERIMENTAL', 'label': 'DKP-TRIS high dose - TRAM.HCl high dose', 'interventionNames': ['Drug: Dexketoprofen Trometamol + Tramadol Hydrochloride']}], 'interventions': [{'name': 'Dexketoprofen Trometamol', 'type': 'DRUG', 'description': 'Dexketoprofen Trometamol low dose, oral film-coated table, once', 'armGroupLabels': ['DKP-TRIS low dose']}, {'name': 'Dexketoprofen Trometamol', 'type': 'DRUG', 'description': 'Dexketoprofen Trometamol high dose, oral film-coated table, once', 'armGroupLabels': ['DKP-TRIS high dose']}, {'name': 'Tramadol Hydrochloride', 'type': 'DRUG', 'description': 'Tramadol Hydrochloride low dose, oral film-coated table, once', 'armGroupLabels': ['TRAM.HCl low dose']}, {'name': 'Tramadol Hydrochloride', 'type': 'DRUG', 'description': 'Tramadol Hydrochloride high dose, oral film-coated table, once', 'armGroupLabels': ['TRAM.HCl high dose']}, {'name': 'Ibuprofen', 'type': 'DRUG', 'description': 'Ibuprofen 400 mg, oral film-coated table, once', 'armGroupLabels': ['Ibuprofen']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo, oral film-coated table, once', 'armGroupLabels': ['Placebo']}, {'name': 'Dexketoprofen Trometamol + Tramadol Hydrochloride', 'type': 'DRUG', 'description': 'DKP-TRIS low dose - 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