Ignite Creation Date:
2025-12-24 @ 10:22 PM
Ignite Modification Date:
2025-12-30 @ 9:28 AM
Study NCT ID:
NCT04622735
Status:
COMPLETED
Last Update Posted:
2024-11-27
First Post:
2020-10-22
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Nefopam/Paracetamol Fixed Dose Combination in Acute Pain After Impacted Third Molar Extraction
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': 'D009340', 'term': 'Nefopam'}, {'id': 'D000082', 'term': 'Acetaminophen'}], 'ancestors': [{'id': 'D010079', 'term': 'Oxazocines'}, {'id': 'D001392', 'term': 'Azocines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D000083', 'term': 'Acetanilides'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicaltrials@unither-pharma.com', 'phone': '+33 (0)1 44 63 51 78', 'title': 'Non Clinical & Clinical Project Manager', 'organization': 'Unither Pharmaceuticals'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '10 days', 'eventGroups': [{'id': 'EG000', 'title': 'FDC Nefopam Hydrochloride 30 mg / Paracetamol 500 mg (X2)', 'description': 'Each dose: 2 tablets (included in masking capsule)\n\nnefopam hydrochloride 30mg / paracetamol 500mg X2: The first intake is taken right after randomization. Then on-demand period (5 days maximum) respecting a 6-hour interval between intakes, and up to 3 intakes per day.', 'otherNumAtRisk': 107, 'deathsNumAtRisk': 107, 'otherNumAffected': 39, 'seriousNumAtRisk': 107, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Paracetamol 500 mg (X2)', 'description': 'Each dose: 2 tablets (included in masking capsule)\n\nParacetamol 500 Mg Oral Tablet X2: The first intake is taken right after randomization. Then on-demand period (5 days maximum) respecting a 6-hour interval between intakes, and up to 3 intakes per day.', 'otherNumAtRisk': 108, 'deathsNumAtRisk': 108, 'otherNumAffected': 25, 'seriousNumAtRisk': 108, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Nefopam Hydrochloride 30 mg (X2)', 'description': 'Each dose: 2 tablets (included in masking capsule)\n\nNefopam HCl 30 MG Oral Tablet X2: The first intake is taken right after randomization. Then on-demand period (5 days maximum) respecting a 6-hour interval between intakes, and up to 3 intakes per day.', 'otherNumAtRisk': 106, 'deathsNumAtRisk': 106, 'otherNumAffected': 35, 'seriousNumAtRisk': 106, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'LYMPHADENOPATHY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 108, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 106, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'PALPITATIONS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 108, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 106, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'TACHYCARDIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 108, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 106, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'EAR PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 108, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 106, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'EAR DISCOMFORT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 108, 'numEvents': 0, 'numAffected': 0}, {'groupId': 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{'groupId': 'EG001', 'numAtRisk': 108, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 106, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'PRESYNCOPE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 108, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 106, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'DYSGEUSIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 108, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 106, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'HYPOAESTHESIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 108, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 106, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'LETHARGY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 108, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 106, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'PARAESTHESIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 108, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 106, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'SYNCOPE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 108, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 106, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'TREMOR', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 108, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 106, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'INSOMNIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 108, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 106, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'SLEEP DISORDER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 108, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 106, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'CHROMATURIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 108, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 106, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'DYSURIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 108, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 106, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'ERECTILE DYSFUNCTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 108, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 106, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'OROPHARYNGEAL PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 108, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 106, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'HYPERHIDROSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 108, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 106, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'NIGHT SWEATS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 108, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 106, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'RASH PRURITIC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 108, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 106, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'SKIN DISCOLOURATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 108, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 106, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'HOT FLUSH', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 108, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 106, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'FLUSHING', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 108, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 106, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Ranked Endpoints : 1. Sum of Pain Intensity Differences at 6 Hours (SPID0-6h)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}, {'value': '108', 'groupId': 'OG001'}, {'value': '106', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Fixed Dose Combination Nefopam Hydrochloride 30 mg / Paracetamol 500 mg (X2)', 'description': 'Each dose: 2 tablets (included in masking capsule)\n\nnefopam hydrochloride 30mg / paracetamol 500mg X2: The first intake is taken right after randomization. Then on-demand period (5 days maximum) respecting a 6-hour interval between intakes, and up to 3 intakes per day.'}, {'id': 'OG001', 'title': 'Paracetamol 500 mg (X2)', 'description': 'Each dose: 2 tablets (included in masking capsule)\n\nParacetamol 500 Mg Oral Tablet X2: The first intake is taken right after randomization. Then on-demand period (5 days maximum) respecting a 6-hour interval between intakes, and up to 3 intakes per day.'}, {'id': 'OG002', 'title': 'Nefopam Hydrochloride 30 mg (X2)', 'description': 'Each dose: 2 tablets (included in masking capsule)\n\nNefopam HCl 30 MG Oral Tablet X2: The first intake is taken right after randomization. Then on-demand period (5 days maximum) respecting a 6-hour interval between intakes, and up to 3 intakes per day.'}], 'classes': [{'categories': [{'measurements': [{'value': '8955.4', 'spread': '8751.8', 'groupId': 'OG000'}, {'value': '8458.0', 'spread': '8831.7', 'groupId': 'OG001'}, {'value': '5290.7', 'spread': '9109.3', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0031', 'groupIds': ['OG000', 'OG002'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.6787', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '6 hours post-dose', 'description': 'Pain intensity difference (PID) will be calculated using the score of pain intensity assessed by the patient at defined time points (T30, T45, T60, T90, T120, T150, T180, T240, T300, T360 min,) after the first Investigational Medicinal Product (IMP) intake and/or right before first intake of rescue medication using a 100-mm Visual Analogic Scale (VAS) compared to baseline.\n\nCalculation: Sum of Pain intensity difference (SPID) is the time-weighted summary measure of the total area under the pain intensity difference (PID) curve that integrates serial assessments of pain during x times after the first Investigational Medicinal Product\n\nSPID0-6h= SPID0-30min+SPID30min-45min+SPID45min-1h+SPID1h-1h30+SPID1h30-2h+SPID2h-2h30+SPID2h30-3h+SPID3h-4h+SPID4h-5h+SPID5h-6h With: SPIDTime1-Time2 = (PID Theoretical Time1 + PID Theoretical Time2) \\* (Theoretical Time2- Theoretical Time1) / 2 SPID min 0-6h = 0 SPID max 0-6h = 36000 The lower score mean a better score', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Total Pain Relief at 6 Hours (TOTPAR0-6h)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}, {'value': '108', 'groupId': 'OG001'}, {'value': '106', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Fixed Dose Combination Nefopam Hydrochloride 30 mg / Paracetamol 500 mg (X2)', 'description': 'Each dose: 2 tablets (included in masking capsule)\n\nnefopam hydrochloride 30mg / paracetamol 500mg X2: The first intake is taken right after randomization. Then on-demand period (5 days maximum) respecting a 6-hour interval between intakes, and up to 3 intakes per day.'}, {'id': 'OG001', 'title': 'Paracetamol 500 mg (X2)', 'description': 'Each dose: 2 tablets (included in masking capsule)\n\nParacetamol 500 Mg Oral Tablet X2: The first intake is taken right after randomization. Then on-demand period (5 days maximum) respecting a 6-hour interval between intakes, and up to 3 intakes per day.'}, {'id': 'OG002', 'title': 'Nefopam Hydrochloride 30 mg (X2)', 'description': 'Each dose: 2 tablets (included in masking capsule)\n\nNefopam HCl 30 MG Oral Tablet X2: The first intake is taken right after randomization. Then on-demand period (5 days maximum) respecting a 6-hour interval between intakes, and up to 3 intakes per day.'}], 'classes': [{'categories': [{'measurements': [{'value': '610.6', 'spread': '434.5', 'groupId': 'OG000'}, {'value': '602.2', 'spread': '383.6', 'groupId': 'OG001'}, {'value': '461.4', 'spread': '384.5', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 hours post-dose', 'description': 'Pain Relief will be assessed by the patient at defined time points (T30, T45, T60, T90, T120, T150, T180, T240, T300, T360 min) after the first IMP intake and/or right before first intake of rescue medication using a 5-point verbal rating scale (VRS).\n\nCalculation: TOTPAR is the time-weighted summary measure of the total area under the pain release difference curve that integrates serial assessments of pain release during x times after the first Investigational Medicinal Product TOTPAR0-6h=TOTPAR0-30min+TOTPAR30min-45min+TOTPAR45min-1h+TOTPAR1h-1h30+TOTPAR1h30-2h+TOTPAR2h-2h30+TOTPAR2h30-3h+ TOTPAR 3h-4h+ TOTPAR 4h-5h+ TOTPAR 5h-6h With: TOTPARTime1-Time2 = (PAR Time1 + PAR Time2) \\* (Time2-Time1) / 2 And with the score of pain relief at T0 = 0 ("none") TOTPAR min 0-6h = 0 TOTPAR max 0-6h = 1800 The higher score mean a better outcome', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Proportion of Responder Patients', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}, {'value': '108', 'groupId': 'OG001'}, {'value': '106', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'FDC Nefopam Hydrochloride 30 mg / Paracetamol 500 mg (X2)', 'description': 'Each dose: 2 tablets (included in masking capsule)\n\nnefopam hydrochloride 30mg / paracetamol 500mg X2: The first intake is taken right after randomization. Then on-demand period (5 days maximum) respecting a 6-hour interval between intakes, and up to 3 intakes per day.'}, {'id': 'OG001', 'title': 'Paracetamol 500 mg (X2)', 'description': 'Each dose: 2 tablets (included in masking capsule)\n\nParacetamol 500 Mg Oral Tablet X2: The first intake is taken right after randomization. Then on-demand period (5 days maximum) respecting a 6-hour interval between intakes, and up to 3 intakes per day.'}, {'id': 'OG002', 'title': 'Nefopam Hydrochloride 30 mg (X2)', 'description': 'Each dose: 2 tablets (included in masking capsule)\n\nNefopam HCl 30 MG Oral Tablet X2: The first intake is taken right after randomization. Then on-demand period (5 days maximum) respecting a 6-hour interval between intakes, and up to 3 intakes per day.'}], 'classes': [{'categories': [{'measurements': [{'value': '47', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 hours post-dose', 'description': 'A responder patient is a subject who achieves a reduction of 50% of pain intensity compared to baseline.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': "The Patient's Global Impression of Change (PGIC) Questionnaire", 'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}, {'value': '101', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'FDC Nefopam Hydrochloride 30 mg / Paracetamol 500 mg (X2)', 'description': 'Each dose: 2 tablets (included in masking capsule)\n\nnefopam hydrochloride 30mg / paracetamol 500mg X2: The first intake is taken right after randomization. Then on-demand period (5 days maximum) respecting a 6-hour interval between intakes, and up to 3 intakes per day.'}, {'id': 'OG001', 'title': 'Paracetamol 500 mg (X2)', 'description': 'Each dose: 2 tablets (included in masking capsule)\n\nParacetamol 500 Mg Oral Tablet X2: The first intake is taken right after randomization. Then on-demand period (5 days maximum) respecting a 6-hour interval between intakes, and up to 3 intakes per day.'}, {'id': 'OG002', 'title': 'Nefopam Hydrochloride 30 mg (X2)', 'description': 'Each dose: 2 tablets (included in masking capsule)\n\nNefopam HCl 30 MG Oral Tablet X2: The first intake is taken right after randomization. Then on-demand period (5 days maximum) respecting a 6-hour interval between intakes, and up to 3 intakes per day.'}], 'classes': [{'title': 'VERY MUCH IMPROVED', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}]}, {'title': 'MUCH IMPROVED', 'categories': [{'measurements': [{'value': '39', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}]}]}, {'title': 'MINIMALLY IMPROVED', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}]}]}, {'title': 'NO CHANGE', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}]}, {'title': 'MINIMALLY WORSE', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}]}, {'title': 'MUCH WORSE', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}]}, {'title': 'VERY MUCH WORSE', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 hours post-dose', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'The Onset of Pain Relief', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}, {'value': '108', 'groupId': 'OG001'}, {'value': '106', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'FDC Nefopam Hydrochloride 30 mg / Paracetamol 500 mg (X2)', 'description': 'Each dose: 2 tablets (included in masking capsule)\n\nnefopam hydrochloride 30mg / paracetamol 500mg X2: The first intake is taken right after randomization. Then on-demand period (5 days maximum) respecting a 6-hour interval between intakes, and up to 3 intakes per day.'}, {'id': 'OG001', 'title': 'Paracetamol 500 mg (X2)', 'description': 'Each dose: 2 tablets (included in masking capsule)\n\nParacetamol 500 Mg Oral Tablet X2: The first intake is taken right after randomization. Then on-demand period (5 days maximum) respecting a 6-hour interval between intakes, and up to 3 intakes per day.'}, {'id': 'OG002', 'title': 'Nefopam Hydrochloride 30 mg (X2)', 'description': 'Each dose: 2 tablets (included in masking capsule)\n\nNefopam HCl 30 MG Oral Tablet X2: The first intake is taken right after randomization. Then on-demand period (5 days maximum) respecting a 6-hour interval between intakes, and up to 3 intakes per day.'}], 'classes': [{'categories': [{'measurements': [{'value': '76', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}, {'value': '58', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'during the first 6 hours', 'description': 'Score of pain intensity will be assessed by the patient at defined time points (T30, T45, T60, T90, T120, T150, T180, T240, T300, T360 min). The time point of the first assessment obtaining a score ≤ 30 mm will be retained as time score of onset of pain relief.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Total Pain Relief at 1 Hour (TOTPAR0-1h), 2 Hours (TOTPAR0-2h), 3 Hours (TOTPAR0-3h), and 4 Hours (TOTPAR0-4h)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}, {'value': '108', 'groupId': 'OG001'}, {'value': '106', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'FDC Nefopam Hydrochloride 30 mg / Paracetamol 500 mg (X2)', 'description': 'Each dose: 2 tablets (included in masking capsule)\n\nnefopam hydrochloride 30mg / paracetamol 500mg X2: The first intake is taken right after randomization. Then on-demand period (5 days maximum) respecting a 6-hour interval between intakes, and up to 3 intakes per day.'}, {'id': 'OG001', 'title': 'Paracetamol 500 mg (X2)', 'description': 'Each dose: 2 tablets (included in masking capsule)\n\nParacetamol 500 Mg Oral Tablet X2: The first intake is taken right after randomization. Then on-demand period (5 days maximum) respecting a 6-hour interval between intakes, and up to 3 intakes per day.'}, {'id': 'OG002', 'title': 'Nefopam Hydrochloride 30 mg (X2)', 'description': 'Each dose: 2 tablets (included in masking capsule)\n\nNefopam HCl 30 MG Oral Tablet X2: The first intake is taken right after randomization. Then on-demand period (5 days maximum) respecting a 6-hour interval between intakes, and up to 3 intakes per day.'}], 'classes': [{'title': 'TOTPAR0-1h', 'categories': [{'measurements': [{'value': '60.2', 'spread': '54.2', 'groupId': 'OG000'}, {'value': '69.4', 'spread': '49.5', 'groupId': 'OG001'}, {'value': '49.7', 'spread': '47.7', 'groupId': 'OG002'}]}]}, {'title': 'TOTPAR0-2h', 'categories': [{'measurements': [{'value': '170.0', 'spread': '130.6', 'groupId': 'OG000'}, {'value': '183.0', 'spread': '115.7', 'groupId': 'OG001'}, {'value': '133.2', 'spread': '116.9', 'groupId': 'OG002'}]}]}, {'title': 'TOTPAR0-3h', 'categories': [{'measurements': [{'value': '285.4', 'spread': '210.5', 'groupId': 'OG000'}, {'value': '300.8', 'spread': '184.7', 'groupId': 'OG001'}, {'value': '216.3', 'spread': '185.7', 'groupId': 'OG002'}]}]}, {'title': 'TOTPAR0-4h', 'categories': [{'measurements': [{'value': '399.7', 'spread': '288.4', 'groupId': 'OG000'}, {'value': '412.2', 'spread': '252.2', 'groupId': 'OG001'}, {'value': '298.4', 'spread': '254.4', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At 1 hour, 2 hours, 3 hours, and 4 hours', 'description': 'Pain relief (PAR) will be assessed by the patient at defined time points (T30, T45, T60, T90, T120, T150, T180, T240 min) after the first IMP intake and/or right before first intake of rescue medication using a 5-point verbal rating scale\n\nCalculation: TOTPAR is the time-weighted summary measure of the total area under the pain release difference curve that integrates serial assessments of pain release during x times after the first Investigational Medicinal Product TOTPAR0-6h=TOTPAR0-30min+TOTPAR30min-45min+TOTPAR45min-1h+TOTPAR1h-1h30+TOTPAR1h30-2h+TOTPAR2h-2h30+TOTPAR2h30-3h+ TOTPAR 3h-4h+ TOTPAR 4h-5h+ TOTPAR 5h-6h With: TOTPARTime1-Time2 = (PAR Time1 + PAR Time2) \\* (Time2-Time1) / 2 And with the score of pain relief at T0 = 0 ("none") TOTPAR min 0-any time = 0 TOTPAR max 0-1h = 300 ; TOTPAR max 0-2h = 600 ;TOTPAR max 0-3h = 900 ;TOTPAR max 0-4h = 1200 ; The higher score mean a better outcome', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Sum of Pain Intensity Differences at 1 Hour (SPID0-1h), 2 Hours (SPID0-2h), 3 Hours (SPID0-3h), and 4 Hours (SPID0-4h)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}, {'value': '108', 'groupId': 'OG001'}, {'value': '106', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'FDC Nefopam Hydrochloride 30 mg / Paracetamol 500 mg (X2)', 'description': 'Each dose: 2 tablets (included in masking capsule)\n\nnefopam hydrochloride 30mg / paracetamol 500mg X2: The first intake is taken right after randomization. Then on-demand period (5 days maximum) respecting a 6-hour interval between intakes, and up to 3 intakes per day.'}, {'id': 'OG001', 'title': 'Paracetamol 500 mg (X2)', 'description': 'Each dose: 2 tablets (included in masking capsule)\n\nParacetamol 500 Mg Oral Tablet X2: The first intake is taken right after randomization. Then on-demand period (5 days maximum) respecting a 6-hour interval between intakes, and up to 3 intakes per day.'}, {'id': 'OG002', 'title': 'Nefopam Hydrochloride 30 mg (X2)', 'description': 'Each dose: 2 tablets (included in masking capsule)\n\nNefopam HCl 30 MG Oral Tablet X2: The first intake is taken right after randomization. Then on-demand period (5 days maximum) respecting a 6-hour interval between intakes, and up to 3 intakes per day.'}], 'classes': [{'title': 'SPID0-1h', 'categories': [{'measurements': [{'value': '743.7', 'spread': '1075.2', 'groupId': 'OG000'}, {'value': '809.5', 'spread': '1017.3', 'groupId': 'OG001'}, {'value': '506.4', 'spread': '1042.5', 'groupId': 'OG002'}]}]}, {'title': 'SPID0-2h', 'categories': [{'measurements': [{'value': '2405.9', 'spread': '2553.0', 'groupId': 'OG000'}, {'value': '2418.4', 'spread': '2469.2', 'groupId': 'OG001'}, {'value': '1487.2', 'spread': '2723.5', 'groupId': 'OG002'}]}]}, {'title': 'SPID0-3h', 'categories': [{'measurements': [{'value': '4281.3', 'spread': '4071.1', 'groupId': 'OG000'}, {'value': '4128.8', 'spread': '4022.0', 'groupId': 'OG001'}, {'value': '2486.8', 'spread': '4425.5', 'groupId': 'OG002'}]}]}, {'title': 'SPID0-4h', 'categories': [{'measurements': [{'value': '6039.8', 'spread': '5636.4', 'groupId': 'OG000'}, {'value': '5786.0', 'spread': '5639.1', 'groupId': 'OG001'}, {'value': '3467.2', 'spread': '6054.1', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At 1 hour, 2 hours, 3 hours, and 4 hours', 'description': 'PID will be calculated using the score of pain intensity assessed by the patient at defined time points (T30, T45, T60, T90, T120, T150, T180, T240 min) after the first IMP intake and/or right before first intake of rescue medication using a 100-mm VAS compared to baseline.\n\nCalculation: SPID is the time-weighted summary measure of the total area under the pain intensity difference curve that integrates serial assessments of pain during x times after the first IMP\n\nSPID0-4h= SPID0-30min+SPID30min-45min+SPID45min-1h+SPID1h-1h30+SPID1h30-2h+SPID2h-2h30+SPID2h30-3h+SPID3h-4h With: SPIDTime1-Time2 = (PID Theoretical Time1 + PID Theoretical Time2) \\* (Theoretical Time2- Theoretical Time1) / 2 SPID min 0-any time = 0 SPID max 0-1h = 6000 ; SPID max 0-2h = 12000; SPID max 0-3h = 18000; SPID max 0-4h = 24000 The lower score mean a better score', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'The Pain Intensity Differences (PID) Assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}, {'value': '108', 'groupId': 'OG001'}, {'value': '106', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'FDC Nefopam Hydrochloride 30 mg / Paracetamol 500 mg (X2)', 'description': 'Each dose: 2 tablets (included in masking capsule)\n\nnefopam hydrochloride 30mg / paracetamol 500mg X2: The first intake is taken right after randomization. Then on-demand period (5 days maximum) respecting a 6-hour interval between intakes, and up to 3 intakes per day.'}, {'id': 'OG001', 'title': 'Paracetamol 500 mg (X2)', 'description': 'Each dose: 2 tablets (included in masking capsule)\n\nParacetamol 500 Mg Oral Tablet X2: The first intake is taken right after randomization. Then on-demand period (5 days maximum) respecting a 6-hour interval between intakes, and up to 3 intakes per day.'}, {'id': 'OG002', 'title': 'Nefopam Hydrochloride 30 mg (X2)', 'description': 'Each dose: 2 tablets (included in masking capsule)\n\nNefopam HCl 30 MG Oral Tablet X2: The first intake is taken right after randomization. Then on-demand period (5 days maximum) respecting a 6-hour interval between intakes, and up to 3 intakes per day.'}], 'classes': [{'title': '30 min', 'categories': [{'measurements': [{'value': '-11.4', 'spread': '22.6', 'groupId': 'OG000'}, {'value': '-14.8', 'spread': '22.3', 'groupId': 'OG001'}, {'value': '-8.6', 'spread': '20.8', 'groupId': 'OG002'}]}]}, {'title': '45 min', 'categories': [{'measurements': [{'value': '-20.1', 'spread': '27', 'groupId': 'OG000'}, {'value': '-19.6', 'spread': '24.6', 'groupId': 'OG001'}, {'value': '-12.7', 'spread': '25.9', 'groupId': 'OG002'}]}]}, {'title': '360 min', 'categories': [{'measurements': [{'value': '-20.2', 'spread': '30.2', 'groupId': 'OG000'}, {'value': '-18.0', 'spread': '31.1', 'groupId': 'OG001'}, {'value': '-14.6', 'spread': '29.2', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At each timepoint: 30min, At 45min, until at 360 min post-dose', 'description': 'PID will be calculated using the scores of pain intensity (VAS) at each time point compared to baseline.\n\nPID30min = VAS of pain intensity 30min - VAS of pain intensity baseline PID min = 0 / PID max = 100 A higher PID is a better outcome', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Proportion of Responder Patients.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}, {'value': '108', 'groupId': 'OG001'}, {'value': '106', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'FDC Nefopam Hydrochloride 30 mg / Paracetamol 500 mg (X2)', 'description': 'Each dose: 2 tablets (included in masking capsule)\n\nnefopam hydrochloride 30mg / paracetamol 500mg X2: The first intake is taken right after randomization. Then on-demand period (5 days maximum) respecting a 6-hour interval between intakes, and up to 3 intakes per day.'}, {'id': 'OG001', 'title': 'Paracetamol 500 mg (X2)', 'description': 'Each dose: 2 tablets (included in masking capsule)\n\nParacetamol 500 Mg Oral Tablet X2: The first intake is taken right after randomization. Then on-demand period (5 days maximum) respecting a 6-hour interval between intakes, and up to 3 intakes per day.'}, {'id': 'OG002', 'title': 'Nefopam Hydrochloride 30 mg (X2)', 'description': 'Each dose: 2 tablets (included in masking capsule)\n\nNefopam HCl 30 MG Oral Tablet X2: The first intake is taken right after randomization. Then on-demand period (5 days maximum) respecting a 6-hour interval between intakes, and up to 3 intakes per day.'}], 'classes': [{'title': 'RESPONDER AT 1 HOUR,', 'categories': [{'measurements': [{'value': '44', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}]}]}, {'title': 'RESPONDER AT 2 HOUR,', 'categories': [{'measurements': [{'value': '57', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}]}]}, {'title': 'RESPONDER AT 3 HOUR,', 'categories': [{'measurements': [{'value': '61', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}]}]}, {'title': 'RESPONDER AT 4 HOUR,', 'categories': [{'measurements': [{'value': '54', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At 1 hour, 2 hours, 3 hours and 4 hours.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Time to the Second Investigational Medicinal Product (IMP) Intake', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}, {'value': '108', 'groupId': 'OG001'}, {'value': '106', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Fixed Dose Combination Nefopam Hydrochloride 30 mg / Paracetamol 500 mg (X2)', 'description': 'Each dose: 2 tablets (included in masking capsule)\n\nnefopam hydrochloride 30mg / paracetamol 500mg X2: The first intake is taken right after randomization. Then on-demand period (5 days maximum) respecting a 6-hour interval between intakes, and up to 3 intakes per day.'}, {'id': 'OG001', 'title': 'Paracetamol 500 mg (X2)', 'description': 'Each dose: 2 tablets (included in masking capsule)\n\nParacetamol 500 Mg Oral Tablet X2: The first intake is taken right after randomization. Then on-demand period (5 days maximum) respecting a 6-hour interval between intakes, and up to 3 intakes per day.'}, {'id': 'OG002', 'title': 'Nefopam Hydrochloride 30 mg (X2)', 'description': 'Each dose: 2 tablets (included in masking capsule)\n\nNefopam HCl 30 MG Oral Tablet X2: The first intake is taken right after randomization. Then on-demand period (5 days maximum) respecting a 6-hour interval between intakes, and up to 3 intakes per day.'}], 'classes': [{'categories': [{'measurements': [{'value': '438.5', 'groupId': 'OG000', 'lowerLimit': '400.0', 'upperLimit': '495.0'}, {'value': '429.0', 'groupId': 'OG001', 'lowerLimit': '385.0', 'upperLimit': '480.0'}, {'value': '387.0', 'groupId': 'OG002', 'lowerLimit': '375.0', 'upperLimit': '435.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to 5 days after first dose', 'unitOfMeasure': 'minutes', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Participant Having Taken a Rescue Analgesic Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}, {'value': '108', 'groupId': 'OG001'}, {'value': '106', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'FDC Nefopam Hydrochloride 30 mg / Paracetamol 500 mg (X2)', 'description': 'Each dose: 2 tablets (included in masking capsule)\n\nnefopam hydrochloride 30mg / paracetamol 500mg X2: The first intake is taken right after randomization. Then on-demand period (5 days maximum) respecting a 6-hour interval between intakes, and up to 3 intakes per day.'}, {'id': 'OG001', 'title': 'Paracetamol 500 mg (X2)', 'description': 'Each dose: 2 tablets (included in masking capsule)\n\nParacetamol 500 Mg Oral Tablet X2: The first intake is taken right after randomization. Then on-demand period (5 days maximum) respecting a 6-hour interval between intakes, and up to 3 intakes per day.'}, {'id': 'OG002', 'title': 'Nefopam Hydrochloride 30 mg (X2)', 'description': 'Each dose: 2 tablets (included in masking capsule)\n\nNefopam HCl 30 MG Oral Tablet X2: The first intake is taken right after randomization. Then on-demand period (5 days maximum) respecting a 6-hour interval between intakes, and up to 3 intakes per day.'}], 'classes': [{'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 10 days after first dose', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Sum of Pain Intensity Differences', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}, {'value': '108', 'groupId': 'OG001'}, {'value': '106', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Fixed Dose Combination Nefopam Hydrochloride 30 mg / Paracetamol 500 mg (X2)', 'description': 'Each dose: 2 tablets (included in masking capsule)\n\nnefopam hydrochloride 30mg / paracetamol 500mg X2: The first intake is taken right after randomization. Then on-demand period (5 days maximum) respecting a 6-hour interval between intakes, and up to 3 intakes per day.'}, {'id': 'OG001', 'title': 'Paracetamol 500 mg (X2)', 'description': 'Each dose: 2 tablets (included in masking capsule)\n\nParacetamol 500 Mg Oral Tablet X2: The first intake is taken right after randomization. Then on-demand period (5 days maximum) respecting a 6-hour interval between intakes, and up to 3 intakes per day.'}, {'id': 'OG002', 'title': 'Nefopam Hydrochloride 30 mg (X2)', 'description': 'Each dose: 2 tablets (included in masking capsule)\n\nNefopam HCl 30 MG Oral Tablet X2: The first intake is taken right after randomization. Then on-demand period (5 days maximum) respecting a 6-hour interval between intakes, and up to 3 intakes per day.'}], 'classes': [{'title': 'SPID Day 1', 'categories': [{'measurements': [{'value': '23306.5', 'spread': '23707.8', 'groupId': 'OG000'}, {'value': '22173.7', 'spread': '25105.0', 'groupId': 'OG001'}, {'value': '19910.3', 'spread': '28416.2', 'groupId': 'OG002'}]}]}, {'title': 'SPID Day 2', 'categories': [{'measurements': [{'value': '48792.4', 'spread': '48167.2', 'groupId': 'OG000'}, {'value': '44604.7', 'spread': '48227.7', 'groupId': 'OG001'}, {'value': '42972.1', 'spread': '52821.9', 'groupId': 'OG002'}]}]}, {'title': 'SPID Day 3', 'categories': [{'measurements': [{'value': '70094.2', 'spread': '70059.9', 'groupId': 'OG000'}, {'value': '68351.5', 'spread': '71111.0', 'groupId': 'OG001'}, {'value': '61347.0', 'spread': '75669.6', 'groupId': 'OG002'}]}]}, {'title': 'SPID Day 4', 'categories': [{'measurements': [{'value': '84261.6', 'spread': '84118.3', 'groupId': 'OG000'}, {'value': '84781.0', 'spread': '90576.9', 'groupId': 'OG001'}, {'value': '73960.7', 'spread': '96674.9', 'groupId': 'OG002'}]}]}, {'title': 'SPID Day 5', 'categories': [{'measurements': [{'value': '92644.0', 'spread': '96128.8', 'groupId': 'OG000'}, {'value': '96134.2', 'spread': '107774.7', 'groupId': 'OG001'}, {'value': '78299.5', 'spread': '106041.1', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At days 1, 2, 3, 4 and 5', 'description': 'Pain Intensity Difference (PID) will be calculated using the score of pain intensity assessed by the patient at defined time points using a 100-mm visual Analog Scale (VAS) compared to baseline.\n\nCalculation: Sum of Pain Intensity Difference (SPID) is the time-weighted summary measure of the total area under the pain intensity difference curve that integrates serial assessments of pain during x times after the first Investigational Medicinal Product\n\nWith: SPIDTime1-Time2 = (VAS Theoretical Time1 + VAS Theoretical Time2) \\* (Theoretical Time2- Theoretical Time1) / 2 SPID min 0-any time = 0 SPID max 0-day 1 = 144000 ; SPID max 0-day 2 = 288000 ; SPID max 0-day 3 = 432000 ; SPID max 0-day 4 = 576000 ; SPID max 0-day 5 = 720000 ; The lower score means a better outcome', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Proportion of Patients Having Taken a Rescue Analgesic Treatment Throughout the Study.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}, {'value': '108', 'groupId': 'OG001'}, {'value': '106', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'FDC Nefopam Hydrochloride 30 mg / Paracetamol 500 mg (X2)', 'description': 'Each dose: 2 tablets (included in masking capsule)\n\nnefopam hydrochloride 30mg / paracetamol 500mg X2: The first intake is taken right after randomization. Then on-demand period (5 days maximum) respecting a 6-hour interval between intakes, and up to 3 intakes per day.'}, {'id': 'OG001', 'title': 'Paracetamol 500 mg (X2)', 'description': 'Each dose: 2 tablets (included in masking capsule)\n\nParacetamol 500 Mg Oral Tablet X2: The first intake is taken right after randomization. Then on-demand period (5 days maximum) respecting a 6-hour interval between intakes, and up to 3 intakes per day.'}, {'id': 'OG002', 'title': 'Nefopam Hydrochloride 30 mg (X2)', 'description': 'Each dose: 2 tablets (included in masking capsule)\n\nNefopam HCl 30 MG Oral Tablet X2: The first intake is taken right after randomization. Then on-demand period (5 days maximum) respecting a 6-hour interval between intakes, and up to 3 intakes per day.'}], 'classes': [{'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 10 days after first dose', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'The Total Dose of Rescue Medication Taken.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'FDC Nefopam Hydrochloride 30 mg / Paracetamol 500 mg (X2)', 'description': 'Each dose: 2 tablets (included in masking capsule)\n\nnefopam hydrochloride 30mg / paracetamol 500mg X2: The first intake is taken right after randomization. Then on-demand period (5 days maximum) respecting a 6-hour interval between intakes, and up to 3 intakes per day.'}, {'id': 'OG001', 'title': 'Paracetamol 500 mg (X2)', 'description': 'Each dose: 2 tablets (included in masking capsule)\n\nParacetamol 500 Mg Oral Tablet X2: The first intake is taken right after randomization. Then on-demand period (5 days maximum) respecting a 6-hour interval between intakes, and up to 3 intakes per day.'}, {'id': 'OG002', 'title': 'Nefopam Hydrochloride 30 mg (X2)', 'description': 'Each dose: 2 tablets (included in masking capsule)\n\nNefopam HCl 30 MG Oral Tablet X2: The first intake is taken right after randomization. Then on-demand period (5 days maximum) respecting a 6-hour interval between intakes, and up to 3 intakes per day.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.1', 'spread': '5.2', 'groupId': 'OG000'}, {'value': '7.3', 'spread': '4.5', 'groupId': 'OG001'}, {'value': '6.0', 'spread': '4.0', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 10 days after first dose', 'unitOfMeasure': 'mg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Mean Duration Under Rescue Medication Over the 5 Days.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'FDC Nefopam Hydrochloride 30 mg / Paracetamol 500 mg (X2)', 'description': 'Each dose: 2 tablets (included in masking capsule)\n\nnefopam hydrochloride 30mg / paracetamol 500mg X2: The first intake is taken right after randomization. Then on-demand period (5 days maximum) respecting a 6-hour interval between intakes, and up to 3 intakes per day.'}, {'id': 'OG001', 'title': 'Paracetamol 500 mg (X2)', 'description': 'Each dose: 2 tablets (included in masking capsule)\n\nParacetamol 500 Mg Oral Tablet X2: The first intake is taken right after randomization. Then on-demand period (5 days maximum) respecting a 6-hour interval between intakes, and up to 3 intakes per day.'}, {'id': 'OG002', 'title': 'Nefopam Hydrochloride 30 mg (X2)', 'description': 'Each dose: 2 tablets (included in masking capsule)\n\nNefopam HCl 30 MG Oral Tablet X2: The first intake is taken right after randomization. Then on-demand period (5 days maximum) respecting a 6-hour interval between intakes, and up to 3 intakes per day.'}], 'classes': [{'categories': [{'measurements': [{'value': '57.9', 'spread': '51.5', 'groupId': 'OG000'}, {'value': '99.4', 'spread': '144.5', 'groupId': 'OG001'}, {'value': '61.9', 'spread': '42.2', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 5 days after first dose', 'unitOfMeasure': 'hours', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Investigational Medicinal Product (IMP) Intakes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}, {'value': '108', 'groupId': 'OG001'}, {'value': '106', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Fixed Dose Combination (FDC) Nefopam Hydrochloride 30 mg / Paracetamol 500 mg (X2)', 'description': 'Each dose: 2 tablets (included in masking capsule)\n\nnefopam hydrochloride 30mg / paracetamol 500mg X2: The first intake is taken right after randomization. Then on-demand period (5 days maximum) respecting a 6-hour interval between intakes, and up to 3 intakes per day.'}, {'id': 'OG001', 'title': 'Paracetamol 500 mg (X2)', 'description': 'Each dose: 2 tablets (included in masking capsule)\n\nParacetamol 500 Mg Oral Tablet X2: The first intake is taken right after randomization. Then on-demand period (5 days maximum) respecting a 6-hour interval between intakes, and up to 3 intakes per day.'}, {'id': 'OG002', 'title': 'Nefopam Hydrochloride 30 mg (X2)', 'description': 'Each dose: 2 tablets (included in masking capsule)\n\nNefopam HCl 30 MG Oral Tablet X2: The first intake is taken right after randomization. Then on-demand period (5 days maximum) respecting a 6-hour interval between intakes, and up to 3 intakes per day.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.4', 'spread': '4.5', 'groupId': 'OG000'}, {'value': '5.8', 'spread': '4.2', 'groupId': 'OG001'}, {'value': '5.1', 'spread': '3.6', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 5 days after first dose', 'unitOfMeasure': 'intake', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': "Patient's Global Impression of Change (PGIC) Score", 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}, {'value': '108', 'groupId': 'OG001'}, {'value': '106', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'FDC Nefopam Hydrochloride 30 mg / Paracetamol 500 mg (X2)', 'description': 'Each dose: 2 tablets (included in masking capsule)\n\nnefopam hydrochloride 30mg / paracetamol 500mg X2: The first intake is taken right after randomization. Then on-demand period (5 days maximum) respecting a 6-hour interval between intakes, and up to 3 intakes per day.'}, {'id': 'OG001', 'title': 'Paracetamol 500 mg (X2)', 'description': 'Each dose: 2 tablets (included in masking capsule)\n\nParacetamol 500 Mg Oral Tablet X2: The first intake is taken right after randomization. Then on-demand period (5 days maximum) respecting a 6-hour interval between intakes, and up to 3 intakes per day.'}, {'id': 'OG002', 'title': 'Nefopam Hydrochloride 30 mg (X2)', 'description': 'Each dose: 2 tablets (included in masking capsule)\n\nNefopam HCl 30 MG Oral Tablet X2: The first intake is taken right after randomization. Then on-demand period (5 days maximum) respecting a 6-hour interval between intakes, and up to 3 intakes per day.'}], 'classes': [{'title': 'VERY MUCH IMPROVED', 'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}]}]}, {'title': 'MUCH IMPROVED', 'categories': [{'measurements': [{'value': '40', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}]}]}, {'title': 'MINIMALLY IMPROVED', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}]}]}, {'title': 'NO CHANGE', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}]}, {'title': 'MINIMALLY WORSE', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'MUCH WORSE', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'VERY MUCH WORSE', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Missing', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 10 days after first dose', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Occurrence of Adverse Events (Serious and Non-serious Adverse Events).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}, {'value': '108', 'groupId': 'OG001'}, {'value': '106', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Fixed Dose Combination (FDC) Nefopam Hydrochloride 30 mg / Paracetamol 500 mg (X2)', 'description': 'Each dose: 2 tablets (included in masking capsule)\n\nnefopam hydrochloride 30mg / paracetamol 500mg X2: The first intake is taken right after randomization. Then on-demand period (5 days maximum) respecting a 6-hour interval between intakes, and up to 3 intakes per day.'}, {'id': 'OG001', 'title': 'Paracetamol 500 mg (X2)', 'description': 'Each dose: 2 tablets (included in masking capsule)\n\nParacetamol 500 Mg Oral Tablet X2: The first intake is taken right after randomization. Then on-demand period (5 days maximum) respecting a 6-hour interval between intakes, and up to 3 intakes per day.'}, {'id': 'OG002', 'title': 'Nefopam Hydrochloride 30 mg (X2)', 'description': 'Each dose: 2 tablets (included in masking capsule)\n\nNefopam HCl 30 MG Oral Tablet X2: The first intake is taken right after randomization. Then on-demand period (5 days maximum) respecting a 6-hour interval between intakes, and up to 3 intakes per day.'}], 'classes': [{'categories': [{'measurements': [{'value': '39', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 10 days after first dose', 'description': '= Number of Events', 'unitOfMeasure': 'Adverse Event', 'reportingStatus': 'POSTED', 'populationDescription': 'All population has been analysed'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'FDC Nefopam Hydrochloride 30 mg / Paracetamol 500 mg (X2)', 'description': 'Each dose: 2 tablets (included in masking capsule)\n\nnefopam hydrochloride 30mg / paracetamol 500mg X2: The first intake is taken right after randomization. Then on-demand period (5 days maximum) respecting a 6-hour interval between intakes, and up to 3 intakes per day.'}, {'id': 'FG001', 'title': 'Paracetamol 500 mg (X2)', 'description': 'Each dose: 2 tablets (included in masking capsule)\n\nParacetamol 500 Mg Oral Tablet X2: The first intake is taken right after randomization. Then on-demand period (5 days maximum) respecting a 6-hour interval between intakes, and up to 3 intakes per day.'}, {'id': 'FG002', 'title': 'Nefopam Hydrochloride 30 mg (X2)', 'description': 'Each dose: 2 tablets (included in masking capsule)\n\nNefopam HCl 30 MG Oral Tablet X2: The first intake is taken right after randomization. Then on-demand period (5 days maximum) respecting a 6-hour interval between intakes, and up to 3 intakes per day.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '107'}, {'groupId': 'FG001', 'numSubjects': '108'}, {'groupId': 'FG002', 'numSubjects': '106'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '105'}, {'groupId': 'FG001', 'numSubjects': '106'}, {'groupId': 'FG002', 'numSubjects': '104'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'BG000'}, {'value': '108', 'groupId': 'BG001'}, {'value': '106', 'groupId': 'BG002'}, {'value': '321', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'FDC Nefopam Hydrochloride 30 mg / Paracetamol 500 mg (X2)', 'description': 'Each dose: 2 tablets (included in masking capsule)\n\nnefopam hydrochloride 30mg / paracetamol 500mg X2: The first intake is taken right after randomization. Then on-demand period (5 days maximum) respecting a 6-hour interval between intakes, and up to 3 intakes per day.'}, {'id': 'BG001', 'title': 'Paracetamol 500 mg (X2)', 'description': 'Each dose: 2 tablets (included in masking capsule)\n\nParacetamol 500 Mg Oral Tablet X2: The first intake is taken right after randomization. Then on-demand period (5 days maximum) respecting a 6-hour interval between intakes, and up to 3 intakes per day.'}, {'id': 'BG002', 'title': 'Nefopam Hydrochloride 30 mg (X2)', 'description': 'Each dose: 2 tablets (included in masking capsule)\n\nNefopam HCl 30 MG Oral Tablet X2: The first intake is taken right after randomization. Then on-demand period (5 days maximum) respecting a 6-hour interval between intakes, and up to 3 intakes per day.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'BG000'}, {'value': '108', 'groupId': 'BG001'}, {'value': '106', 'groupId': 'BG002'}, {'value': '321', 'groupId': 'BG003'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '107', 'groupId': 'BG000'}, {'value': '108', 'groupId': 'BG001'}, {'value': '106', 'groupId': 'BG002'}, {'value': '321', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'BG000'}, {'value': '108', 'groupId': 'BG001'}, {'value': '106', 'groupId': 'BG002'}, {'value': '321', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '27.8', 'spread': '7.8', 'groupId': 'BG000'}, {'value': '28.3', 'spread': '7.9', 'groupId': 'BG001'}, {'value': '28.3', 'spread': '7.8', 'groupId': 'BG002'}, {'value': '28.1', 'spread': '7.8', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'BG000'}, {'value': '108', 'groupId': 'BG001'}, {'value': '106', 'groupId': 'BG002'}, {'value': '321', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '62', 'groupId': 'BG000'}, {'value': '61', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}, {'value': '184', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '45', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}, {'value': '137', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Belgium', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'BG000'}, {'value': '108', 'groupId': 'BG001'}, {'value': '106', 'groupId': 'BG002'}, {'value': '321', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '24', 'groupId': 'BG003'}]}]}, {'title': 'Hungary', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'BG000'}, {'value': '108', 'groupId': 'BG001'}, {'value': '106', 'groupId': 'BG002'}, {'value': '321', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}, {'value': '97', 'groupId': 'BG003'}]}]}, {'title': 'United Kingdom', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'BG000'}, {'value': '108', 'groupId': 'BG001'}, {'value': '106', 'groupId': 'BG002'}, {'value': '321', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}, {'value': '91', 'groupId': 'BG003'}]}]}, {'title': 'France', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'BG000'}, {'value': '108', 'groupId': 'BG001'}, {'value': '106', 'groupId': 'BG002'}, {'value': '321', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}, {'value': '56', 'groupId': 'BG003'}]}]}, {'title': 'Russia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'BG000'}, {'value': '108', 'groupId': 'BG001'}, {'value': '106', 'groupId': 'BG002'}, {'value': '321', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}, {'value': '53', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-07-23', 'size': 1972189, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-02-29T08:56', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': "Double-blind. Participants, investigators, and all persons involved in the conduct, data management, and analysis of the study will be fully blinded to the participant's treatment."}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 321}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-02-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2022-10-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-11-20', 'studyFirstSubmitDate': '2020-10-22', 'resultsFirstSubmitDate': '2024-02-29', 'studyFirstSubmitQcDate': '2020-11-03', 'lastUpdatePostDateStruct': {'date': '2024-11-27', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-11-20', 'studyFirstPostDateStruct': {'date': '2020-11-10', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-11-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-10-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Occurrence of Adverse Events (Serious and Non-serious Adverse Events).', 'timeFrame': 'Up to 10 days after first dose', 'description': '= Number of Events'}], 'primaryOutcomes': [{'measure': 'Ranked Endpoints : 1. Sum of Pain Intensity Differences at 6 Hours (SPID0-6h)', 'timeFrame': '6 hours post-dose', 'description': 'Pain intensity difference (PID) will be calculated using the score of pain intensity assessed by the patient at defined time points (T30, T45, T60, T90, T120, T150, T180, T240, T300, T360 min,) after the first Investigational Medicinal Product (IMP) intake and/or right before first intake of rescue medication using a 100-mm Visual Analogic Scale (VAS) compared to baseline.\n\nCalculation: Sum of Pain intensity difference (SPID) is the time-weighted summary measure of the total area under the pain intensity difference (PID) curve that integrates serial assessments of pain during x times after the first Investigational Medicinal Product\n\nSPID0-6h= SPID0-30min+SPID30min-45min+SPID45min-1h+SPID1h-1h30+SPID1h30-2h+SPID2h-2h30+SPID2h30-3h+SPID3h-4h+SPID4h-5h+SPID5h-6h With: SPIDTime1-Time2 = (PID Theoretical Time1 + PID Theoretical Time2) \\* (Theoretical Time2- Theoretical Time1) / 2 SPID min 0-6h = 0 SPID max 0-6h = 36000 The lower score mean a better score'}, {'measure': 'Total Pain Relief at 6 Hours (TOTPAR0-6h)', 'timeFrame': '6 hours post-dose', 'description': 'Pain Relief will be assessed by the patient at defined time points (T30, T45, T60, T90, T120, T150, T180, T240, T300, T360 min) after the first IMP intake and/or right before first intake of rescue medication using a 5-point verbal rating scale (VRS).\n\nCalculation: TOTPAR is the time-weighted summary measure of the total area under the pain release difference curve that integrates serial assessments of pain release during x times after the first Investigational Medicinal Product TOTPAR0-6h=TOTPAR0-30min+TOTPAR30min-45min+TOTPAR45min-1h+TOTPAR1h-1h30+TOTPAR1h30-2h+TOTPAR2h-2h30+TOTPAR2h30-3h+ TOTPAR 3h-4h+ TOTPAR 4h-5h+ TOTPAR 5h-6h With: TOTPARTime1-Time2 = (PAR Time1 + PAR Time2) \\* (Time2-Time1) / 2 And with the score of pain relief at T0 = 0 ("none") TOTPAR min 0-6h = 0 TOTPAR max 0-6h = 1800 The higher score mean a better outcome'}, {'measure': 'Proportion of Responder Patients', 'timeFrame': '6 hours post-dose', 'description': 'A responder patient is a subject who achieves a reduction of 50% of pain intensity compared to baseline.'}, {'measure': "The Patient's Global Impression of Change (PGIC) Questionnaire", 'timeFrame': '6 hours post-dose'}, {'measure': 'The Onset of Pain Relief', 'timeFrame': 'during the first 6 hours', 'description': 'Score of pain intensity will be assessed by the patient at defined time points (T30, T45, T60, T90, T120, T150, T180, T240, T300, T360 min). The time point of the first assessment obtaining a score ≤ 30 mm will be retained as time score of onset of pain relief.'}], 'secondaryOutcomes': [{'measure': 'Total Pain Relief at 1 Hour (TOTPAR0-1h), 2 Hours (TOTPAR0-2h), 3 Hours (TOTPAR0-3h), and 4 Hours (TOTPAR0-4h)', 'timeFrame': 'At 1 hour, 2 hours, 3 hours, and 4 hours', 'description': 'Pain relief (PAR) will be assessed by the patient at defined time points (T30, T45, T60, T90, T120, T150, T180, T240 min) after the first IMP intake and/or right before first intake of rescue medication using a 5-point verbal rating scale\n\nCalculation: TOTPAR is the time-weighted summary measure of the total area under the pain release difference curve that integrates serial assessments of pain release during x times after the first Investigational Medicinal Product TOTPAR0-6h=TOTPAR0-30min+TOTPAR30min-45min+TOTPAR45min-1h+TOTPAR1h-1h30+TOTPAR1h30-2h+TOTPAR2h-2h30+TOTPAR2h30-3h+ TOTPAR 3h-4h+ TOTPAR 4h-5h+ TOTPAR 5h-6h With: TOTPARTime1-Time2 = (PAR Time1 + PAR Time2) \\* (Time2-Time1) / 2 And with the score of pain relief at T0 = 0 ("none") TOTPAR min 0-any time = 0 TOTPAR max 0-1h = 300 ; TOTPAR max 0-2h = 600 ;TOTPAR max 0-3h = 900 ;TOTPAR max 0-4h = 1200 ; The higher score mean a better outcome'}, {'measure': 'Sum of Pain Intensity Differences at 1 Hour (SPID0-1h), 2 Hours (SPID0-2h), 3 Hours (SPID0-3h), and 4 Hours (SPID0-4h)', 'timeFrame': 'At 1 hour, 2 hours, 3 hours, and 4 hours', 'description': 'PID will be calculated using the score of pain intensity assessed by the patient at defined time points (T30, T45, T60, T90, T120, T150, T180, T240 min) after the first IMP intake and/or right before first intake of rescue medication using a 100-mm VAS compared to baseline.\n\nCalculation: SPID is the time-weighted summary measure of the total area under the pain intensity difference curve that integrates serial assessments of pain during x times after the first IMP\n\nSPID0-4h= SPID0-30min+SPID30min-45min+SPID45min-1h+SPID1h-1h30+SPID1h30-2h+SPID2h-2h30+SPID2h30-3h+SPID3h-4h With: SPIDTime1-Time2 = (PID Theoretical Time1 + PID Theoretical Time2) \\* (Theoretical Time2- Theoretical Time1) / 2 SPID min 0-any time = 0 SPID max 0-1h = 6000 ; SPID max 0-2h = 12000; SPID max 0-3h = 18000; SPID max 0-4h = 24000 The lower score mean a better score'}, {'measure': 'The Pain Intensity Differences (PID) Assessment', 'timeFrame': 'At each timepoint: 30min, At 45min, until at 360 min post-dose', 'description': 'PID will be calculated using the scores of pain intensity (VAS) at each time point compared to baseline.\n\nPID30min = VAS of pain intensity 30min - VAS of pain intensity baseline PID min = 0 / PID max = 100 A higher PID is a better outcome'}, {'measure': 'Proportion of Responder Patients.', 'timeFrame': 'At 1 hour, 2 hours, 3 hours and 4 hours.'}, {'measure': 'Time to the Second Investigational Medicinal Product (IMP) Intake', 'timeFrame': 'Up to 5 days after first dose'}, {'measure': 'Participant Having Taken a Rescue Analgesic Treatment', 'timeFrame': 'Up to 10 days after first dose'}, {'measure': 'Sum of Pain Intensity Differences', 'timeFrame': 'At days 1, 2, 3, 4 and 5', 'description': 'Pain Intensity Difference (PID) will be calculated using the score of pain intensity assessed by the patient at defined time points using a 100-mm visual Analog Scale (VAS) compared to baseline.\n\nCalculation: Sum of Pain Intensity Difference (SPID) is the time-weighted summary measure of the total area under the pain intensity difference curve that integrates serial assessments of pain during x times after the first Investigational Medicinal Product\n\nWith: SPIDTime1-Time2 = (VAS Theoretical Time1 + VAS Theoretical Time2) \\* (Theoretical Time2- Theoretical Time1) / 2 SPID min 0-any time = 0 SPID max 0-day 1 = 144000 ; SPID max 0-day 2 = 288000 ; SPID max 0-day 3 = 432000 ; SPID max 0-day 4 = 576000 ; SPID max 0-day 5 = 720000 ; The lower score means a better outcome'}, {'measure': 'Proportion of Patients Having Taken a Rescue Analgesic Treatment Throughout the Study.', 'timeFrame': 'Up to 10 days after first dose'}, {'measure': 'The Total Dose of Rescue Medication Taken.', 'timeFrame': 'Up to 10 days after first dose'}, {'measure': 'Mean Duration Under Rescue Medication Over the 5 Days.', 'timeFrame': 'Up to 5 days after first dose'}, {'measure': 'Number of Investigational Medicinal Product (IMP) Intakes', 'timeFrame': 'Up to 5 days after first dose'}, {'measure': "Patient's Global Impression of Change (PGIC) Score", 'timeFrame': 'Up to 10 days after first dose'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Moderate to severe acute pain', 'Postoperative pain', 'Third molar extraction', 'Analgesics', 'Nefopam', 'Paracetamol', 'Multimodal analgesia', 'Fixed drug combination'], 'conditions': ['Acute Pain']}, 'descriptionModule': {'briefSummary': 'This study aims to evaluate the analgesic efficacy of single and multiple doses of a new fixed dose combination of nefopam hydrochloride 30 mg and paracetamol 500mg taken orally in comparison to each single component.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Main Inclusion Criteria:\n\n* Male and female patient aged from 18 years up to 65 years,\n* Patient scheduled to undergo the surgical removal of at least one fully or partially impacted third mandibular molar requiring bone removal under short-acting local anaesthetic (mepivacaine or lidocaine) with or without vasoconstrictor,\n* Patient weighing \\> 50 kg,\n* Patient who has signed a written informed consent prior to any study-related procedures.\n\nAdditional inclusion criteria after surgery (randomization):\n\n1. Patient experiencing moderate to severe pain within 4 hours after the dental extraction, defined by a baseline pain intensity Visual Analogic Scale (VAS) score ≥ 50 mm,\n2. Third molar extraction(s) completed without any immediate complication, that in the opinion of the investigator, would interfere with the study conduct and/or assessments (e.g., suspected neurosensory complication, incomplete removal of tooth)\n\nMain Exclusion Criteria:\n\n* Patient treated by analgesics or nonsteroidal anti-inflammatory drugs (NSAIDs) within 3 days preceding the day of randomization or within 5 times the elimination half-life whichever the longest,\n* Woman with positive results on a urine pregnancy test or breastfeeding woman or woman of childbearing potential without an effective contraception,\n* Patient with a history of convulsive disorders,\n* Patient taking mono-amine-oxidase (MAO) inhibitors (including but not limited to selegiline, isocarboxazid, tranylcypromine, phenelzine…),\n* Patient with an abnormal cardiac condition: medically significant disorders of cardiac rate and/or rhythm,\n* Patient with known anaemia,\n* Patient with known pulmonary disease,\n* Patient with known active gastric or duodenal ulcer or a history of recurrent gastrointestinal ulcer/bleeding,\n* Patient with known glaucoma,\n* Patients with a prostatic hyperplasia or urinary retention,\n* Patient with current or chronic history of liver disease, or known hepatic or biliary abnormalities,\n* Patient with a current or chronic history of severe renal impairment (glomerular filtration below 30 mL/min),'}, 'identificationModule': {'nctId': 'NCT04622735', 'briefTitle': 'Nefopam/Paracetamol Fixed Dose Combination in Acute Pain After Impacted Third Molar Extraction', 'organization': {'class': 'INDUSTRY', 'fullName': 'Unither Pharmaceuticals, France'}, 'officialTitle': 'A Comparative, Randomized, Double-blind, 3-arm Parallel, Phase III Study to Evaluate the Efficacy and Safety of a Fixed Dose Combination of Nefopam/Paracetamol Taken Orally in Moderate to Severe Pain After Impacted Third Molar Extraction', 'orgStudyIdInfo': {'id': 'UP-CLI-2019-002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'FDC nefopam hydrochloride 30 mg / paracetamol 500 mg (X2)', 'description': 'Each dose: 2 tablets (included in masking capsule)', 'interventionNames': ['Combination Product: nefopam hydrochloride 30mg / paracetamol 500mg X2']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Paracetamol 500 mg (X2)', 'description': 'Each dose: 2 tablets (included in masking capsule)', 'interventionNames': ['Drug: Paracetamol 500 Mg Oral Tablet X2']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Nefopam hydrochloride 30 mg (X2)', 'description': 'Each dose: 2 tablets (included in masking capsule)', 'interventionNames': ['Drug: Nefopam HCl 30 MG Oral Tablet X2']}], 'interventions': [{'name': 'nefopam hydrochloride 30mg / paracetamol 500mg X2', 'type': 'COMBINATION_PRODUCT', 'description': 'The first intake is taken right after randomization. Then on-demand period (5 days maximum) respecting a 6-hour interval between intakes, and up to 3 intakes per day.', 'armGroupLabels': ['FDC nefopam hydrochloride 30 mg / paracetamol 500 mg (X2)']}, {'name': 'Paracetamol 500 Mg Oral Tablet X2', 'type': 'DRUG', 'otherNames': ['Acetaminophen'], 'description': 'The first intake is taken right after randomization. Then on-demand period (5 days maximum) respecting a 6-hour interval between intakes, and up to 3 intakes per day.', 'armGroupLabels': ['Paracetamol 500 mg (X2)']}, {'name': 'Nefopam HCl 30 MG Oral Tablet X2', 'type': 'DRUG', 'description': 'The first intake is taken right after randomization. Then on-demand period (5 days maximum) respecting a 6-hour interval between intakes, and up to 3 intakes per day.', 'armGroupLabels': ['Nefopam hydrochloride 30 mg (X2)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Leuven', 'country': 'Belgium', 'facility': 'Hôpital Leuven', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}, {'zip': '49933', 'city': 'Angers', 'country': 'France', 'facility': 'CHU Angers', 'geoPoint': {'lat': 47.47156, 'lon': -0.55202}}, {'zip': '13385', 'city': 'Marseille', 'country': 'France', 'facility': 'CHU Marseille', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'zip': '95300', 'city': 'Pontoise', 'country': 'France', 'facility': 'Centre Hospitalier de Pontoise', 'geoPoint': {'lat': 49.05, 'lon': 2.1}}, {'zip': '83800', 'city': 'Toulon', 'country': 'France', 'facility': 'HIA Toulon', 'geoPoint': {'lat': 43.12442, 'lon': 5.92836}}, {'zip': '37170', 'city': 'Tours', 'country': 'France', 'facility': 'CHU de tours', 'geoPoint': {'lat': 47.39484, 'lon': 0.70398}}, {'city': 'Budapest', 'country': 'Hungary', 'facility': 'Clinexpert Kft.', 'geoPoint': {'lat': 47.49835, 'lon': 19.04045}}, {'city': 'Budapest', 'country': 'Hungary', 'facility': 'Óbudai Egészségügyi Centrum', 'geoPoint': {'lat': 47.49835, 'lon': 19.04045}}, {'city': 'Létavértes', 'country': 'Hungary', 'facility': 'Swan-Med Kft.', 'geoPoint': {'lat': 47.38333, 'lon': 21.9}}, {'city': 'Nyíregyháza', 'country': 'Hungary', 'facility': 'Szabolcs-Szatmár-Bereg Megyei Kórházak és Egyetemi Oktatókórház,', 'geoPoint': {'lat': 47.95539, 'lon': 21.71671}}, {'city': 'Tatabánya', 'country': 'Hungary', 'facility': 'Szent Borbála Kórház,', 'geoPoint': {'lat': 47.59247, 'lon': 18.38099}}, {'city': 'Zalaegerszeg', 'country': 'Hungary', 'facility': 'Óbudai Egészségügyi Centrum', 'geoPoint': {'lat': 46.83695, 'lon': 16.84401}}, {'zip': '141207', 'city': 'Moscow', 'country': 'Russia', 'facility': 'LLC Center for interdisciplinary dentistry & neuro', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'city': 'Moscow', 'country': 'Russia', 'facility': 'State Medico-stomato Univ., by A.I. Evdokimov', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'zip': '150062', 'city': 'Yaroslavl', 'country': 'Russia', 'facility': 'Regional clinical hospital', 'geoPoint': {'lat': 57.62987, 'lon': 39.87368}}, {'zip': 'B5 7EG', 'city': 'Birmingham', 'country': 'United Kingdom', 'facility': 'Birmingham School of Dentistry', 'geoPoint': {'lat': 52.48142, 'lon': -1.89983}}, {'zip': 'CF14 4XY', 'city': 'Cardiff', 'country': 'United Kingdom', 'facility': 'University Dental Hospital', 'geoPoint': {'lat': 51.48, 'lon': -3.18}}, {'zip': 'EH3 9HX', 'city': 'Edinburgh', 'country': 'United Kingdom', 'facility': 'Edinburgh Dental Institute', 'geoPoint': {'lat': 55.95206, 'lon': -3.19648}}, {'zip': 'E1 1FR', 'city': 'London', 'country': 'United Kingdom', 'facility': 'BARTS HEALTH NHS TRUST Royal London Hospital', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'International Study Coordinator', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Birmingham School of Dentistry'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Unither Pharmaceuticals, France', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Excelya', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}