Ignite Creation Date:
2025-12-25 @ 2:45 AM
Ignite Modification Date:
2025-12-31 @ 1:15 PM
Study NCT ID:
NCT01842633
Status:
TERMINATED
Last Update Posted:
2017-09-01
First Post:
2013-04-25
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Clinical Study to Evaluate Efficacy of New Paracetamol Formulation Compared to Ibuprofen in Headache
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000082', 'term': 'Acetaminophen'}, {'id': 'D002110', 'term': 'Caffeine'}, {'id': 'D007052', 'term': 'Ibuprofen'}], 'ancestors': [{'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'}, {'id': 'D014970', 'term': 'Xanthines'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011688', 'term': 'Purinones'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D010666', 'term': 'Phenylpropionates'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '866-435-7343', 'title': 'GSK Response Center', 'organization': 'GlaxoSmithKline'}, 'certainAgreement': {'otherDetails': 'GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'Enrollment into the trial was terminated after randomization of 62% of the plan resulting in a significant reduction in study power. The originally planned inferential statistics (p-values) were therefore not presented in tables summarizing results.'}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Paracetamol/ Caffeine Caplets', 'description': 'Participants were administered with two caplets of paracetamol/caffeine combination 500/65mg plus 2 placebo caplets orally with 8 ounce of water', 'otherNumAtRisk': 62, 'otherNumAffected': 4, 'seriousNumAtRisk': 62, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Ibuprofen Caplets', 'description': 'Participants were administered with two caplets of ibuprofen 200mg plus 2 placebo caplets orally with 8 ounce of water', 'otherNumAtRisk': 62, 'otherNumAffected': 3, 'seriousNumAtRisk': 62, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Placebo Caplets', 'description': 'Participants were administered with four placebo caplets orally with 8 ounce of water', 'otherNumAtRisk': 33, 'otherNumAffected': 1, 'seriousNumAtRisk': 33, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 33, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 33, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'VIRAL UPPER RESPIRATORY TRACT INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 33, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'UPPER RESPIRATORY TRACT INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 33, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'HYPOTHYROIDISM', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 33, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'FEELING JITTERY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 33, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'DEPRESSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 62, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 33, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'INSOMNIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 62, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 33, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'OROPHARYNGEAL PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 62, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 33, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'PARANASAL SINUS DISCOMFORT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 62, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 33, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'SINUS CONGESTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 62, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 33, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Sum of Pain Intensity Difference (SPID) of Treatment and Placebo at 4 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Paracetamol/ Caffeine Caplets', 'description': 'Participants were administered with two caplets of paracetamol/caffeine combination 500/65mg plus two placebo caplets orally with eight ounce of water'}, {'id': 'OG001', 'title': 'Ibuprofen Caplets', 'description': 'Participants were administered with two caplets of ibuprofen 200mg plus two placebo caplets orally with eight ounce of water'}, {'id': 'OG002', 'title': 'Placebo Caplets', 'description': 'Participants were administered with four placebo caplets orally with eight ounce of water'}], 'classes': [{'categories': [{'measurements': [{'value': '-6.13', 'spread': '2.164', 'groupId': 'OG000'}, {'value': '-5.78', 'spread': '2.098', 'groupId': 'OG001'}, {'value': '-5.86', 'spread': '2.339', 'groupId': 'OG002'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG002'], 'paramType': 'Treatment Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.47', 'ciLowerLimit': '-1.36', 'ciUpperLimit': '0.42', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Up to 4 hours post dose', 'description': 'SPID was calculated as the weighted sum of Pain (Headache) intensity differences at 4 hours post dose. The time-intervals used were 0-10, 10-15, 15-20, 20-25, 25-30, 30-40, 40-50, 50-60, 60-90, 90-120, 120-180, 180-240 minutes. The range of SPID at 4 hours post dose was from -12 to 4". PID was calculated as difference of pain intensity (PI) at baseline (prior to the first dose) with PI at a given time point. PI was assessed on a 4-point scale (0-no headache, 1-mild headache, 2-moderate headache, 3-severe headache).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention-to-treat (ITT) population defined as all participants who received treatment and who had at least one post-baseline efficacy assessment.'}, {'type': 'SECONDARY', 'title': 'Sum of Pain Intensity Difference (SPID) at 1, 2 and 3 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Paracetamol/ Caffeine Caplets', 'description': 'Participants were administered with two caplets of paracetamol/caffeine combination 500/65mg plus two placebo caplets orally with eight ounce of water'}, {'id': 'OG001', 'title': 'Ibuprofen Caplets', 'description': 'Participants were administered with two caplets of ibuprofen 200mg plus two placebo caplets orally with eight ounce of water'}, {'id': 'OG002', 'title': 'Placebo Caplets', 'description': 'Participants were administered with four placebo caplets orally with eight ounce of water'}], 'classes': [{'title': 'At 1 hour (n=62, 61, 33)', 'categories': [{'measurements': [{'value': '-0.64', 'spread': '0.488', 'groupId': 'OG000'}, {'value': '-0.56', 'spread': '0.418', 'groupId': 'OG001'}, {'value': '-0.57', 'spread': '0.505', 'groupId': 'OG002'}]}]}, {'title': 'At 2 hour (n=62, 61, 33)', 'categories': [{'measurements': [{'value': '-2.21', 'spread': '1.106', 'groupId': 'OG000'}, {'value': '-2.02', 'spread': '1.002', 'groupId': 'OG001'}, {'value': '-2.04', 'spread': '1.088', 'groupId': 'OG002'}]}]}, {'title': 'At 3 hour (n=61, 62, 32)', 'categories': [{'measurements': [{'value': '-4.09', 'spread': '1.524', 'groupId': 'OG000'}, {'value': '-3.86', 'spread': '1.342', 'groupId': 'OG001'}, {'value': '-3.97', 'spread': '1.528', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From (Baseline) 0 to 1 hour, 0 to 2 hours, and 0 to 3 hours post dose', 'description': 'SPID was calculated as the weighted sum of Pain (Headache) intensity differences at 1, 2 and 3 hours post dose.\n\nThe time-intervals used were 0-10, 10-15, 15-20, 20-25, 25-30, 30-40, 40-50, 50-60 minutes for SPID at 1 hour post dose. The range of SPID at 1 hour post dose was from -3 to 1. The time-intervals used were 0-10, 10-15, 15-20, 20-25, 25-30, 30-40, 40-50, 50-60, 60-90, 90-120 minutes for SPID at 2 hours post dose . The range of SPID at 2 hours post dose was from -6 to 2. The time-intervals used were 0-10, 10-15, 15-20, 20-25, 25-30, 30-40, 40-50, 50-60, 60-90, 90-120, 120-180 minutes for SPID at 3 hours post dose. The range of SPID at 3 hours post dose was from -9 to 3. PID was calculated as difference of pain intensity (PI) at baseline (prior to the first dose) with PI at a given time point. PI was assessed on a 4-point scale (0-no headache, 1-mild headache, 2-moderate headache, 3-severe headache).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population defined as all participants who received treatment and who had at least one post-baseline efficacy assessment.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Perceptible Pain Relief', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Paracetamol/ Caffeine Caplets', 'description': 'Participants were administered with two caplets of paracetamol/caffeine combination 500/65mg plus two placebo caplets orally with eight ounce of water'}, {'id': 'OG001', 'title': 'Ibuprofen Caplets', 'description': 'Participants were administered with two caplets of ibuprofen 200mg plus two placebo caplets orally with eight ounce of water'}, {'id': 'OG002', 'title': 'Placebo Caplets', 'description': 'Participants were administered with four placebo caplets orally with eight ounce of water'}], 'classes': [{'title': 'number of participants', 'categories': [{'measurements': [{'value': '62', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}]}]}, {'title': 'number of censored participants', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to 4 hours', 'unitOfMeasure': 'number of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population defined as all participants who received treatment and who had at least one post-baseline efficacy assessment.'}, {'type': 'SECONDARY', 'title': 'Time to Perceptible Headache Relief', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Paracetamol/ Caffeine Caplets', 'description': 'Participants were administered with two caplets of paracetamol/caffeine combination 500/65mg plus two placebo caplets orally with eight ounce of water'}, {'id': 'OG001', 'title': 'Ibuprofen Caplets', 'description': 'Participants were administered with two caplets of ibuprofen 200mg plus two placebo caplets orally with eight ounce of water'}, {'id': 'OG002', 'title': 'Placebo Caplets', 'description': 'Participants were administered with four placebo caplets orally with eight ounce of water'}], 'classes': [{'categories': [{'measurements': [{'value': '27.00', 'spread': '31.274', 'groupId': 'OG000', 'lowerLimit': '6.0', 'upperLimit': '140.3'}, {'value': '29.67', 'spread': '41.173', 'groupId': 'OG001', 'lowerLimit': '8.7', 'upperLimit': '240.0'}, {'value': '27.00', 'spread': '38.042', 'groupId': 'OG002', 'lowerLimit': '4.0', 'upperLimit': '156.7'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline up to 4 hours', 'description': 'Time to perceptible headache relief was assessed as the time when participants achieve pain relief scores (PRS) more than or equal to 1.', 'unitOfMeasure': 'minutes (min.)', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population defined as all participants who received treatment and who had at least one post-baseline efficacy assessment.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Meaningful Pain Relief', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Paracetamol/ Caffeine Caplets', 'description': 'Participants were administered with two caplets of paracetamol/caffeine combination 500/65mg plus two placebo caplets orally with eight ounce of water'}, {'id': 'OG001', 'title': 'Ibuprofen Caplets', 'description': 'Participants were administered with two caplets of ibuprofen 200mg plus two placebo caplets orally with eight ounce of water'}, {'id': 'OG002', 'title': 'Placebo Caplets', 'description': 'Participants were administered with four placebo caplets orally with eight ounce of water'}], 'classes': [{'title': 'number of participants', 'categories': [{'measurements': [{'value': '61', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}]}]}, {'title': 'number of censored participants', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to 4 hours', 'unitOfMeasure': 'number of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population defined as all participants who received treatment and who had at least one post-baseline efficacy assessment.'}, {'type': 'SECONDARY', 'title': 'Time to Meaningful Headache Relief', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Paracetamol/ Caffeine Caplets', 'description': 'Participants were administered with two caplets of paracetamol/caffeine combination 500/65mg plus two placebo caplets orally with eight ounce of water'}, {'id': 'OG001', 'title': 'Ibuprofen Caplets', 'description': 'Participants were administered with two caplets of ibuprofen 200mg plus two placebo caplets orally with eight ounce of water'}, {'id': 'OG002', 'title': 'Placebo Caplets', 'description': 'Participants were administered with four placebo caplets orally with eight ounce of water'}], 'classes': [{'categories': [{'measurements': [{'value': '43.33', 'spread': '49.342', 'groupId': 'OG000', 'lowerLimit': '11.7', 'upperLimit': '240.0'}, {'value': '54.17', 'spread': '49.095', 'groupId': 'OG001', 'lowerLimit': '16.7', 'upperLimit': '240.0'}, {'value': '46.67', 'spread': '61.477', 'groupId': 'OG002', 'lowerLimit': '12.5', 'upperLimit': '240.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline up to 4 hours', 'description': 'Time to meaningful headache relief was assessed as time when participants reported a PRS ≥ 2.', 'unitOfMeasure': 'min.', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population defined as all participants who received treatment and who had at least one post-baseline efficacy assessment.'}, {'type': 'SECONDARY', 'title': 'Total Pain Relief (TOTPAR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Paracetamol/ Caffeine Caplets', 'description': 'Participants were administered with two caplets of paracetamol/caffeine combination 500/65mg plus two placebo caplets orally with eight ounce of water'}, {'id': 'OG001', 'title': 'Ibuprofen Caplets', 'description': 'Participants were administered with two caplets of ibuprofen 200mg plus two placebo caplets orally with eight ounce of water'}, {'id': 'OG002', 'title': 'Placebo Caplets', 'description': 'Participants were administered with four placebo caplets orally with eight ounce of water'}], 'classes': [{'title': 'Baseline-1 hour (62, 61, 33)', 'categories': [{'measurements': [{'value': '1.31', 'spread': '0.922', 'groupId': 'OG000'}, {'value': '1.17', 'spread': '0.801', 'groupId': 'OG001'}, {'value': '1.14', 'spread': '0.864', 'groupId': 'OG002'}]}]}, {'title': 'Baseline-2 hour (62, 61, 33)', 'categories': [{'measurements': [{'value': '4.28', 'spread': '1.818', 'groupId': 'OG000'}, {'value': '4.05', 'spread': '1.740', 'groupId': 'OG001'}, {'value': '3.82', 'spread': '1.886', 'groupId': 'OG002'}]}]}, {'title': 'Baseline-3 hour (61, 62, 33)', 'categories': [{'measurements': [{'value': '7.84', 'spread': '2.337', 'groupId': 'OG000'}, {'value': '7.51', 'spread': '2.250', 'groupId': 'OG001'}, {'value': '7.35', 'spread': '2.463', 'groupId': 'OG002'}]}]}, {'title': 'Baseline-4 hour (59, 59, 33)', 'categories': [{'measurements': [{'value': '11.57', 'spread': '3.373', 'groupId': 'OG000'}, {'value': '11.05', 'spread': '3.774', 'groupId': 'OG001'}, {'value': '10.47', 'spread': '4.053', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From (Baseline) 0 to 1, from 0 to 2, from 0 to 3 and from 0 to 4 hour post dose', 'description': 'TOTPAR was calculated as the weighted sum of pain relief scores (PRS) at each time point. PRS was assessed on a 5-point scale (0-no relief, 1-a little relief, 2-some relief, 3-a lot of relief, and 4-complete relief). The range for TOTPAR for different time points were as follows: from 0 to 4 for TOTPAR at 1 hour post dose, from 0 to 8 for TOTPAR at 2 hours post dose, from 0 to 12 for TOTPAR at 3 hours post dose, and from 0 to 16 for TOTPAR at 4 hours post dose.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population defined as all participants who received treatment and who had at least one post-baseline efficacy assessment.'}, {'type': 'SECONDARY', 'title': 'Area Under the Time-Response Curve for Change in Headache Intensity and Headache Relief (SPRID)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Paracetamol/ Caffeine Caplets', 'description': 'Participants were administered with two caplets of paracetamol/caffeine combination 500/65mg plus two placebo caplets orally with eight ounce of water'}, {'id': 'OG001', 'title': 'Ibuprofen Caplets', 'description': 'Participants were administered with two caplets of ibuprofen 200mg plus two placebo caplets orally with eight ounce of water'}, {'id': 'OG002', 'title': 'Placebo Caplets', 'description': 'Participants were administered with four placebo caplets orally with eight ounce of water'}], 'classes': [{'title': 'At 1 hour (n=62, 61, 33)', 'categories': [{'measurements': [{'value': '0.67', 'spread': '0.505', 'groupId': 'OG000'}, {'value': '0.61', 'spread': '0.424', 'groupId': 'OG001'}, {'value': '0.57', 'spread': '0.473', 'groupId': 'OG002'}]}]}, {'title': 'At 2 hour (n=62, 61, 33)', 'categories': [{'measurements': [{'value': '2.07', 'spread': '0.957', 'groupId': 'OG000'}, {'value': '2.03', 'spread': '0.933', 'groupId': 'OG001'}, {'value': '1.78', 'spread': '1.116', 'groupId': 'OG002'}]}]}, {'title': 'At 3 hour (n=61, 62, 32)', 'categories': [{'measurements': [{'value': '3.75', 'spread': '1.250', 'groupId': 'OG000'}, {'value': '3.64', 'spread': '1.285', 'groupId': 'OG001'}, {'value': '3.38', 'spread': '1.581', 'groupId': 'OG002'}]}]}, {'title': 'At 4 hour (n=59, 59, 33)', 'categories': [{'measurements': [{'value': '5.44', 'spread': '1.890', 'groupId': 'OG000'}, {'value': '5.28', 'spread': '2.126', 'groupId': 'OG001'}, {'value': '4.61', 'spread': '2.613', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From (Baseline) 0 to 1 hour, 0 to 2 hours, 0 to 3 hours and 0 to 4 hours post dose', 'description': 'SPRID was measured as sum of TOTPAR and SPID. SPID and TOTPAR were calculated as weighted sums of PID and PRS at each measurement time point, respectively. PID at each time point was calculated as difference of PI at baseline (prior to the first dose) with PI at a given time point. PI was assessed on a 4-point scale (0-no headache, 1-mild headache, 2-moderate headache, 3-severe headache). PRS was assessed on a 5-point scale (0-no relief, 1-a little relief, 2-some relief, 3-a lot of relief, and 4-complete relief). The range of SPRID for different time points were as follow: from-3 to 5 for SPRID at 1 hour post dose, from -6 to 10 for SPRID at 2 hours post dose, from -9 to 15 for SPRID at 3 hours post dose, and from -12 to 20 for SPRID at 4 hours post dose.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population defined as all participants who received treatment and who had at least one post-baseline efficacy assessment.'}, {'type': 'SECONDARY', 'title': 'Global Evaluation of Response to Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Paracetamol/ Caffeine Caplets', 'description': 'Participants were administered with two caplets of paracetamol/caffeine combination 500/65mg plus two placebo caplets orally with eight ounce of water'}, {'id': 'OG001', 'title': 'Ibuprofen Caplets', 'description': 'Participants were administered with two caplets of ibuprofen 200mg plus two placebo caplets orally with eight ounce of water'}, {'id': 'OG002', 'title': 'Placebo Caplets', 'description': 'Participants were administered with four placebo caplets orally with eight ounce of water'}], 'classes': [{'categories': [{'measurements': [{'value': '2.88', 'spread': '0.740', 'groupId': 'OG000'}, {'value': '2.81', 'spread': '0.834', 'groupId': 'OG001'}, {'value': '2.66', 'spread': '0.946', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 hours', 'description': 'Global evaluation of treatment response was measured by a score in a scale from: 0-very poor, 1-poor, 2-neutral \\[neither poor nor good\\], 3-good, or 4-very good).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population defined as all participants who received treatment and who had at least one post-baseline efficacy assessment.'}, {'type': 'SECONDARY', 'title': 'Rate of Rescue Medication', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Paracetamol/ Caffeine Caplets', 'description': 'Participants were administered with two caplets of paracetamol/caffeine combination 500/65mg plus two placebo caplets orally with eight ounce of water'}, {'id': 'OG001', 'title': 'Ibuprofen Caplets', 'description': 'Participants were administered with two caplets of ibuprofen 200mg plus two placebo caplets orally with eight ounce of water'}, {'id': 'OG002', 'title': 'Placebo Caplets', 'description': 'Participants were administered with four placebo caplets orally with eight ounce of water'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '4 hours', 'description': 'Number of participants that took rescue medication over the total number of participants for a given treatment group', 'unitOfMeasure': 'number of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population defined as all participants who received treatment, who took rescue medication and who had at least one post-baseline efficacy assessment.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Headache Pain Intensity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Paracetamol/ Caffeine Caplets', 'description': 'Participants were administered with two caplets of paracetamol/caffeine combination 500/65mg plus two placebo caplets orally with eight ounce of water'}, {'id': 'OG001', 'title': 'Ibuprofen Caplets', 'description': 'Participants were administered with two caplets of ibuprofen 200mg plus two placebo caplets orally with eight ounce of water'}, {'id': 'OG002', 'title': 'Placebo Caplets', 'description': 'Participants were administered with four placebo caplets orally with eight ounce of water'}], 'classes': [{'title': 'At 10 min.', 'categories': [{'measurements': [{'value': '-0.03', 'spread': '0.166', 'groupId': 'OG000'}, {'value': '-0.01', 'spread': '0.064', 'groupId': 'OG001'}, {'value': '-0.04', 'spread': '0.211', 'groupId': 'OG002'}]}]}, {'title': 'At 15 min.', 'categories': [{'measurements': [{'value': '-0.10', 'spread': '0.322', 'groupId': 'OG000'}, {'value': '-0.06', 'spread': '0.208', 'groupId': 'OG001'}, {'value': '-0.10', 'spread': '0.366', 'groupId': 'OG002'}]}]}, {'title': 'At 20 min.', 'categories': [{'measurements': [{'value': '-0.27', 'spread': '0.439', 'groupId': 'OG000'}, {'value': '-0.21', 'spread': '0.359', 'groupId': 'OG001'}, {'value': '-0.21', 'spread': '0.464', 'groupId': 'OG002'}]}]}, {'title': 'At 25 min.', 'categories': [{'measurements': [{'value': '-0.45', 'spread': '0.501', 'groupId': 'OG000'}, {'value': '-0.34', 'spread': '0.438', 'groupId': 'OG001'}, {'value': '-0.36', 'spread': '0.582', 'groupId': 'OG002'}]}]}, {'title': 'At 30 min.', 'categories': [{'measurements': [{'value': '-0.66', 'spread': '0.625', 'groupId': 'OG000'}, {'value': '-0.51', 'spread': '0.531', 'groupId': 'OG001'}, {'value': '-0.55', 'spread': '0.697', 'groupId': 'OG002'}]}]}, {'title': 'At 40 min.', 'categories': [{'measurements': [{'value': '-0.92', 'spread': '0.727', 'groupId': 'OG000'}, {'value': '-0.75', 'spread': '0.618', 'groupId': 'OG001'}, {'value': '-0.75', 'spread': '0.729', 'groupId': 'OG002'}]}]}, {'title': 'At 50 min.', 'categories': [{'measurements': [{'value': '-1.07', 'spread': '0.769', 'groupId': 'OG000'}, {'value': '-0.93', 'spread': '0.736', 'groupId': 'OG001'}, {'value': '-0.96', 'spread': '0.725', 'groupId': 'OG002'}]}]}, {'title': 'At 60 min.', 'categories': [{'measurements': [{'value': '-1.26', 'spread': '0.831', 'groupId': 'OG000'}, {'value': '-1.17', 'spread': '0.751', 'groupId': 'OG001'}, {'value': '-1.14', 'spread': '0.706', 'groupId': 'OG002'}]}]}, {'title': 'At 90 min.', 'categories': [{'measurements': [{'value': '-1.51', 'spread': '0.748', 'groupId': 'OG000'}, {'value': '-1.48', 'spread': '0.708', 'groupId': 'OG001'}, {'value': '-1.39', 'spread': '0.733', 'groupId': 'OG002'}]}]}, {'title': 'At 120 min.', 'categories': [{'measurements': [{'value': '-1.76', 'spread': '0.704', 'groupId': 'OG000'}, {'value': '-1.73', 'spread': '0.727', 'groupId': 'OG001'}, {'value': '-1.69', 'spread': '0.725', 'groupId': 'OG002'}]}]}, {'title': 'At 180 min.', 'categories': [{'measurements': [{'value': '-1.95', 'spread': '0.529', 'groupId': 'OG000'}, {'value': '-1.90', 'spread': '0.530', 'groupId': 'OG001'}, {'value': '-1.93', 'spread': '0.561', 'groupId': 'OG002'}]}]}, {'title': 'At 240 min.', 'categories': [{'measurements': [{'value': '-2.01', 'spread': '0.575', 'groupId': 'OG000'}, {'value': '-1.91', 'spread': '0.609', 'groupId': 'OG001'}, {'value': '-1.95', 'spread': '0.591', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At 10, 15, 20, 25, 30, 40, 50, 60, 90, 120, 180, and 240 min.', 'description': 'Change from baseline in headache pain intensity was calculated as the change (difference) from baseline PI with PI at each time-point. PI was assessed on a 4-point scale (0-no headache, 1-mild headache, 2-moderate headache, 3-severe headache).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population defined as all participants who received treatment and who had at least one post-baseline efficacy assessment.'}, {'type': 'SECONDARY', 'title': 'Headache Relief', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Paracetamol/ Caffiene Caplets', 'description': 'Participants were administered with two caplets of paracetamol/caffeine combination 500/65mg plus two placebo caplets orally with eight ounce of water'}, {'id': 'OG001', 'title': 'Ibuprofen Caplets', 'description': 'Participants were administered with two caplets of ibuprofen 200mg plus two placebo caplets orally with eight ounce of water'}, {'id': 'OG002', 'title': 'Placebo Caplets', 'description': 'Participants were administered with four placebo caplets orally with eight ounce of water'}], 'classes': [{'title': '10 min.', 'categories': [{'measurements': [{'value': '0.07', 'spread': '0.301', 'groupId': 'OG000'}, {'value': '0.03', 'spread': '0.140', 'groupId': 'OG001'}, {'value': '0.11', 'spread': '0.379', 'groupId': 'OG002'}]}]}, {'title': '15 min.', 'categories': [{'measurements': [{'value': '0.33', 'spread': '0.660', 'groupId': 'OG000'}, {'value': '0.16', 'spread': '0.374', 'groupId': 'OG001'}, {'value': '0.27', 'spread': '0.635', 'groupId': 'OG002'}]}]}, {'title': '20 min.', 'categories': [{'measurements': [{'value': '0.68', 'spread': '0.870', 'groupId': 'OG000'}, {'value': '0.49', 'spread': '0.670', 'groupId': 'OG001'}, {'value': '0.60', 'spread': '0.876', 'groupId': 'OG002'}]}]}, {'title': '25 min.', 'categories': [{'measurements': [{'value': '1.06', 'spread': '1.059', 'groupId': 'OG000'}, {'value': '0.77', 'spread': '0.870', 'groupId': 'OG001'}, {'value': '0.88', 'spread': '0.986', 'groupId': 'OG002'}]}]}, {'title': '30 min.', 'categories': [{'measurements': [{'value': '1.37', 'spread': '1.158', 'groupId': 'OG000'}, {'value': '1.17', 'spread': '1.072', 'groupId': 'OG001'}, {'value': '1.22', 'spread': '1.107', 'groupId': 'OG002'}]}]}, {'title': '40 min.', 'categories': [{'measurements': [{'value': '1.86', 'spread': '1.341', 'groupId': 'OG000'}, {'value': '1.62', 'spread': '1.195', 'groupId': 'OG001'}, {'value': '1.49', 'spread': '1.182', 'groupId': 'OG002'}]}]}, {'title': '50 min.', 'categories': [{'measurements': [{'value': '2.15', 'spread': '1.404', 'groupId': 'OG000'}, {'value': '1.91', 'spread': '1.356', 'groupId': 'OG001'}, {'value': '1.82', 'spread': '1.218', 'groupId': 'OG002'}]}]}, {'title': '60 min.', 'categories': [{'measurements': [{'value': '2.42', 'spread': '1.380', 'groupId': 'OG000'}, {'value': '2.34', 'spread': '1.255', 'groupId': 'OG001'}, {'value': '2.14', 'spread': '1.213', 'groupId': 'OG002'}]}]}, {'title': '90 min.', 'categories': [{'measurements': [{'value': '2.85', 'spread': '1.249', 'groupId': 'OG000'}, {'value': '2.91', 'spread': '1.162', 'groupId': 'OG001'}, {'value': '2.68', 'spread': '1.196', 'groupId': 'OG002'}]}]}, {'title': '120 min.', 'categories': [{'measurements': [{'value': '3.35', 'spread': '0.962', 'groupId': 'OG000'}, {'value': '3.37', 'spread': '1.113', 'groupId': 'OG001'}, {'value': '3.03', 'spread': '1.206', 'groupId': 'OG002'}]}]}, {'title': '180 min.', 'categories': [{'measurements': [{'value': '3.69', 'spread': '0.749', 'groupId': 'OG000'}, {'value': '3.59', 'spread': '0.907', 'groupId': 'OG001'}, {'value': '3.44', 'spread': '0.978', 'groupId': 'OG002'}]}]}, {'title': '240 min.', 'categories': [{'measurements': [{'value': '3.72', 'spread': '0.795', 'groupId': 'OG000'}, {'value': '3.55', 'spread': '1.138', 'groupId': 'OG001'}, {'value': '3.32', 'spread': '1.155', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At 10 min. 15 min., 20 min., 25 min., 30 min., 40 min., 50 min., 60 min., 90 min., 120 min., 180 min., 240 min.,', 'description': 'The participant assessed headache relief of each treated qualifying headache at 10, 15, 20, 25, 30, 40, 50, 60, 90, 120, 180, and 240 minutes post treatment on a 5-point scale (0-no relief, 1-a little relief, 2-some relief, 3-a lot of relief, and 4-complete relief). higher headache relief score indicates better outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population defined as all participants who received treatment and who had at least one post-baseline efficacy assessment.'}, {'type': 'SECONDARY', 'title': 'Number of Pain Free Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Paracetamol/Caffeine Caplets', 'description': 'Participants were administered with two caplets of paracetamol/caffeine combination 500/65mg plus two placebo caplets orally with eight ounce of water'}, {'id': 'OG001', 'title': 'Ibuprofen Caplets', 'description': 'Participants were administered with two caplets of ibuprofen 200mg plus two placebo caplets orally with eight ounce of water'}, {'id': 'OG002', 'title': 'Placebo Caplets', 'description': 'Participants were administered with four placebo caplets orally with eight ounce of water'}], 'classes': [{'title': 'At 1 hour', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}]}, {'title': 'At 2 hour', 'categories': [{'measurements': [{'value': '38', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 hour and 2 hour post dose', 'description': 'Number of participants with complete relief was calculated as the number of participants who reported PRS = 4-complete relief at 1 hour and 2 hours post dose.', 'unitOfMeasure': 'number of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population defined as all participants who received treatment and who had at least one post-baseline efficacy assessment.'}, {'type': 'SECONDARY', 'title': 'Time to the Use of Rescue Medication.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Paracetamol/ Caffeine Caplets', 'description': 'Participants were administered with two caplets of paracetamol/caffeine combination 500/65mg plus two placebo caplets orally with eight ounce of water'}, {'id': 'OG001', 'title': 'Ibuprofen Caplets', 'description': 'Participants were administered with two caplets of ibuprofen 200mg plus two placebo caplets orally with eight ounce of water'}, {'id': 'OG002', 'title': 'Placebo Caplets', 'description': 'Participants were administered with four placebo caplets orally with eight ounce of water'}], 'classes': [{'categories': [{'measurements': [{'value': '239.00', 'spread': '6.86', 'groupId': 'OG000'}, {'value': '235.14', 'spread': '24.06', 'groupId': 'OG001'}, {'value': '235.55', 'spread': '12.8', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 4 hours', 'description': 'Time taken by the participants to use the rescue medication', 'unitOfMeasure': 'Minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population defined as all participants who received treatment and who had at least one post-baseline efficacy assessment'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Paracetamol/ Caffeine Caplets', 'description': 'Participants were administered with two caplets of paracetamol/caffeine combination 500/65milligram (mg) plus 2 placebo caplets orally with 8 ounces of water'}, {'id': 'FG001', 'title': 'Ibuprofen Caplets', 'description': 'Participants were administered with two caplets of ibuprofen 200mg plus 2 placebo caplets orally with 8 ounces of water'}, {'id': 'FG002', 'title': 'Placebo Caplets', 'description': 'Participants were administered with four placebo caplets with 8 ounces of water'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '65'}, {'groupId': 'FG001', 'numSubjects': '66'}, {'groupId': 'FG002', 'numSubjects': '34'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '62'}, {'groupId': 'FG001', 'numSubjects': '64'}, {'groupId': 'FG002', 'numSubjects': '34'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Screen Failure', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Technical issues', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Participants were recruited at clinical sites in the United States.', 'preAssignmentDetails': '365 participants were enrolled in the study out of which 165 participants were randomized in the study. 200 participants were not randomized for the following reasons: 165 were screening failure, 3 due to Adverse Events (AEs), 7 were lost to follow-up, 19 withdrawals by participant, and 6 due to other reasons.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'BG000'}, {'value': '62', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}, {'value': '157', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Paracetamol/ Caffeine Caplets', 'description': 'Participants were administered with two caplets of paracetamol/caffeine combination 500/65mg plus 2 placebo caplets orally with 8 ounces of water'}, {'id': 'BG001', 'title': 'Ibuprofen Caplets', 'description': 'Participants were administered with two caplets of ibuprofen 200mg plus 2 placebo caplets orally with 8 ounces of water'}, {'id': 'BG002', 'title': 'Placebo Caplets', 'description': 'Participants were administered with four placebo caplets orally with 8 ounces of water'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '39.9', 'spread': '11.39', 'groupId': 'BG000'}, {'value': '38.1', 'spread': '13.13', 'groupId': 'BG001'}, {'value': '38.5', 'spread': '12.65', 'groupId': 'BG002'}, {'value': '38.9', 'spread': '12.32', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '46', 'groupId': 'BG000'}, {'value': '44', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}, {'value': '113', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '44', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '14', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '56', 'groupId': 'BG000'}, {'value': '55', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}, {'value': '139', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Demography data is available for 157 Participants only (safety Population).'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 365}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2013-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-08', 'completionDateStruct': {'date': '2015-03-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-08-02', 'studyFirstSubmitDate': '2013-04-25', 'resultsFirstSubmitDate': '2016-06-02', 'studyFirstSubmitQcDate': '2013-04-25', 'lastUpdatePostDateStruct': {'date': '2017-09-01', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-06-28', 'studyFirstPostDateStruct': {'date': '2013-04-29', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-07-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-03-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sum of Pain Intensity Difference (SPID) of Treatment and Placebo at 4 Hours', 'timeFrame': 'Up to 4 hours post dose', 'description': 'SPID was calculated as the weighted sum of Pain (Headache) intensity differences at 4 hours post dose. The time-intervals used were 0-10, 10-15, 15-20, 20-25, 25-30, 30-40, 40-50, 50-60, 60-90, 90-120, 120-180, 180-240 minutes. The range of SPID at 4 hours post dose was from -12 to 4". PID was calculated as difference of pain intensity (PI) at baseline (prior to the first dose) with PI at a given time point. PI was assessed on a 4-point scale (0-no headache, 1-mild headache, 2-moderate headache, 3-severe headache).'}], 'secondaryOutcomes': [{'measure': 'Sum of Pain Intensity Difference (SPID) at 1, 2 and 3 Hours', 'timeFrame': 'From (Baseline) 0 to 1 hour, 0 to 2 hours, and 0 to 3 hours post dose', 'description': 'SPID was calculated as the weighted sum of Pain (Headache) intensity differences at 1, 2 and 3 hours post dose.\n\nThe time-intervals used were 0-10, 10-15, 15-20, 20-25, 25-30, 30-40, 40-50, 50-60 minutes for SPID at 1 hour post dose. The range of SPID at 1 hour post dose was from -3 to 1. The time-intervals used were 0-10, 10-15, 15-20, 20-25, 25-30, 30-40, 40-50, 50-60, 60-90, 90-120 minutes for SPID at 2 hours post dose . The range of SPID at 2 hours post dose was from -6 to 2. The time-intervals used were 0-10, 10-15, 15-20, 20-25, 25-30, 30-40, 40-50, 50-60, 60-90, 90-120, 120-180 minutes for SPID at 3 hours post dose. The range of SPID at 3 hours post dose was from -9 to 3. PID was calculated as difference of pain intensity (PI) at baseline (prior to the first dose) with PI at a given time point. PI was assessed on a 4-point scale (0-no headache, 1-mild headache, 2-moderate headache, 3-severe headache).'}, {'measure': 'Number of Participants With Perceptible Pain Relief', 'timeFrame': 'Baseline up to 4 hours'}, {'measure': 'Time to Perceptible Headache Relief', 'timeFrame': 'Baseline up to 4 hours', 'description': 'Time to perceptible headache relief was assessed as the time when participants achieve pain relief scores (PRS) more than or equal to 1.'}, {'measure': 'Number of Participants With Meaningful Pain Relief', 'timeFrame': 'Baseline up to 4 hours'}, {'measure': 'Time to Meaningful Headache Relief', 'timeFrame': 'Baseline up to 4 hours', 'description': 'Time to meaningful headache relief was assessed as time when participants reported a PRS ≥ 2.'}, {'measure': 'Total Pain Relief (TOTPAR)', 'timeFrame': 'From (Baseline) 0 to 1, from 0 to 2, from 0 to 3 and from 0 to 4 hour post dose', 'description': 'TOTPAR was calculated as the weighted sum of pain relief scores (PRS) at each time point. PRS was assessed on a 5-point scale (0-no relief, 1-a little relief, 2-some relief, 3-a lot of relief, and 4-complete relief). The range for TOTPAR for different time points were as follows: from 0 to 4 for TOTPAR at 1 hour post dose, from 0 to 8 for TOTPAR at 2 hours post dose, from 0 to 12 for TOTPAR at 3 hours post dose, and from 0 to 16 for TOTPAR at 4 hours post dose.'}, {'measure': 'Area Under the Time-Response Curve for Change in Headache Intensity and Headache Relief (SPRID)', 'timeFrame': 'From (Baseline) 0 to 1 hour, 0 to 2 hours, 0 to 3 hours and 0 to 4 hours post dose', 'description': 'SPRID was measured as sum of TOTPAR and SPID. SPID and TOTPAR were calculated as weighted sums of PID and PRS at each measurement time point, respectively. PID at each time point was calculated as difference of PI at baseline (prior to the first dose) with PI at a given time point. PI was assessed on a 4-point scale (0-no headache, 1-mild headache, 2-moderate headache, 3-severe headache). PRS was assessed on a 5-point scale (0-no relief, 1-a little relief, 2-some relief, 3-a lot of relief, and 4-complete relief). The range of SPRID for different time points were as follow: from-3 to 5 for SPRID at 1 hour post dose, from -6 to 10 for SPRID at 2 hours post dose, from -9 to 15 for SPRID at 3 hours post dose, and from -12 to 20 for SPRID at 4 hours post dose.'}, {'measure': 'Global Evaluation of Response to Treatment', 'timeFrame': '4 hours', 'description': 'Global evaluation of treatment response was measured by a score in a scale from: 0-very poor, 1-poor, 2-neutral \\[neither poor nor good\\], 3-good, or 4-very good).'}, {'measure': 'Rate of Rescue Medication', 'timeFrame': '4 hours', 'description': 'Number of participants that took rescue medication over the total number of participants for a given treatment group'}, {'measure': 'Change From Baseline in Headache Pain Intensity', 'timeFrame': 'At 10, 15, 20, 25, 30, 40, 50, 60, 90, 120, 180, and 240 min.', 'description': 'Change from baseline in headache pain intensity was calculated as the change (difference) from baseline PI with PI at each time-point. PI was assessed on a 4-point scale (0-no headache, 1-mild headache, 2-moderate headache, 3-severe headache).'}, {'measure': 'Headache Relief', 'timeFrame': 'At 10 min. 15 min., 20 min., 25 min., 30 min., 40 min., 50 min., 60 min., 90 min., 120 min., 180 min., 240 min.,', 'description': 'The participant assessed headache relief of each treated qualifying headache at 10, 15, 20, 25, 30, 40, 50, 60, 90, 120, 180, and 240 minutes post treatment on a 5-point scale (0-no relief, 1-a little relief, 2-some relief, 3-a lot of relief, and 4-complete relief). higher headache relief score indicates better outcome.'}, {'measure': 'Number of Pain Free Participants', 'timeFrame': '1 hour and 2 hour post dose', 'description': 'Number of participants with complete relief was calculated as the number of participants who reported PRS = 4-complete relief at 1 hour and 2 hours post dose.'}, {'measure': 'Time to the Use of Rescue Medication.', 'timeFrame': 'Up to 4 hours', 'description': 'Time taken by the participants to use the rescue medication'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Pain']}, 'descriptionModule': {'briefSummary': 'The purpose of this multi-center study is to assess the efficacy of headache relief of new paracetamol/caffeine formulation compared to placebo and ibuprofen in episodic tension-type headache (ETTH).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participants in good general health, and with diagnosis of ETTH with following conditions:\n\n 1. number of days with the condition is historically greater than or equal to two per month;\n 2. severity of headaches is historically at least moderate;\n 3. duration of headaches is historically more than or equal to 4 hours, if untreated.\n\n Exclusion Criteria:\n* Participant with known or suspected hypersensitivity, allergy, intolerance or contraindication to the use of any of the study medications\n* Participant has chronic tension type headache, psychiatric disease or a significant cognitive disorder, or any chronic pain disorder.\n* Participant currently taking or has taken medications or herbal supplements within the three months that are likely to interfere with the validity of subject-rated assessments.'}, 'identificationModule': {'nctId': 'NCT01842633', 'briefTitle': 'Clinical Study to Evaluate Efficacy of New Paracetamol Formulation Compared to Ibuprofen in Headache', 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': 'A Study to Assess Efficacy Over Placebo and Speed of Onset of Pain Relief of New Paracetamol and Caffeine Tablets as Compared to Ibuprofen in Episodic Tension Type Headache', 'orgStudyIdInfo': {'id': '202172'}, 'secondaryIdInfos': [{'id': 'RH01649', 'type': 'OTHER', 'domain': 'GSK'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Paracetamol/ Caffeine Caplets', 'description': 'Two caplets of paracetamol/caffeine combination plus 2 placebo caplets to be administered', 'interventionNames': ['Drug: Paracetamol and Caffeine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Ibuprofen Caplets', 'description': 'Two ibuprofen caplets plus two placebo caplets to be administered', 'interventionNames': ['Drug: Ibuprofen']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Caplets', 'description': 'Four placebo caplets to be administered', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Paracetamol and Caffeine', 'type': 'DRUG', 'description': 'Caplets containing 500 milligrams (mg) of paracetamol and 65 mg of caffeine', 'armGroupLabels': ['Paracetamol/ Caffeine Caplets']}, {'name': 'Ibuprofen', 'type': 'DRUG', 'description': 'Caplets containing 200 mg of ibuprofen', 'armGroupLabels': ['Ibuprofen Caplets']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Matching placebo caplets', 'armGroupLabels': ['Placebo Caplets']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02451', 'city': 'Waltham', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'PAREXEL International, LLC', 'geoPoint': {'lat': 42.37649, 'lon': -71.23561}}], 'overallOfficials': [{'name': 'GSK Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'GlaxoSmithKline'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}