Ignite Creation Date:
2025-12-25 @ 4:03 AM
Ignite Modification Date:
2026-02-20 @ 6:39 PM
Study NCT ID:
NCT01755702
Status:
TERMINATED
Last Update Posted:
2015-03-27
First Post:
2011-06-23
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Paracetamol With Caffeine to Treat Episodic Tension Type Headache
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018781', 'term': 'Tension-Type Headache'}], 'ancestors': [{'id': 'D051270', 'term': 'Headache Disorders, Primary'}, {'id': 'D020773', 'term': 'Headache Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, '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}}, 'adverseEventsModule': {'timeFrame': 'All adverse events that occured in the time frame of start of the investigational product and until five days following last administration of the investigational product, were recorded.', 'eventGroups': [{'id': 'EG000', 'title': 'Paracetamol/Caffeine', 'description': 'Participants were administered with two paracetamol/ caffeine caplets (500/65 mg each) and two placebo caplets (matching ibuprofen) orally with approx. 250 mL of water.', 'otherNumAtRisk': 47, 'otherNumAffected': 2, 'seriousNumAtRisk': 47, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Ibuprofen', 'description': 'Participants were administered with two 200 mg Ibuprofen caplets and two placebo caplets (matching paracetamol/caffeine) orally with approx. 250 mL of water.', 'otherNumAtRisk': 50, 'otherNumAffected': 4, 'seriousNumAtRisk': 50, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Paracetamol', 'description': 'Participants were administered with two 500 mg paracetamol caplets and two placebo caplets (matching paracetamol/caffeine) orally with approx. 250 mL of water.', 'otherNumAtRisk': 45, 'otherNumAffected': 0, 'seriousNumAtRisk': 45, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Placebo', 'description': 'Participants were administered with four placebo caplets (two caplets matching paracetamol/caffeine and two caplets matching ibuprofen) orally with approx. 250 mL of water.', 'otherNumAtRisk': 45, 'otherNumAffected': 3, 'seriousNumAtRisk': 45, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Abdominal Pain Upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dry Mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 45, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Oral Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pharyngitis Streptococcal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 45, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Plantar Fascilitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 45, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Upper Respiratory Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Time to First Perceptible Headache Relief', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '45', 'groupId': 'OG002'}, {'value': '45', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Paracetamol/Caffeine', 'description': 'Participants were administered with two paracetamol/ caffeine caplets (500/65 mg each) and two placebo caplets (matching ibuprofen) orally with approx. 250 mL of water.'}, {'id': 'OG001', 'title': 'Ibuprofen', 'description': 'Participants were administered with two 200 mg Ibuprofen caplets and two placebo caplets (matching paracetamol/caffeine) orally with approx. 250 mL of water.'}, {'id': 'OG002', 'title': 'Paracetamol', 'description': 'Participants were administered with two 500 mg paracetamol caplets and two placebo caplets (matching paracetamol/caffeine) orally with approx. 250 mL of water.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Participants were administered with four placebo caplets (two caplets matching paracetamol/caffeine and two caplets matching ibuprofen) orally with approx. 250 mL of water.'}], 'classes': [{'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000', 'lowerLimit': '5', 'upperLimit': '240'}, {'value': '30', 'groupId': 'OG001', 'lowerLimit': '8', 'upperLimit': '120'}, {'value': '30', 'groupId': 'OG002', 'lowerLimit': '15', 'upperLimit': '240'}, {'value': '30', 'groupId': 'OG003', 'lowerLimit': '12', 'upperLimit': '240'}]}]}], 'analyses': [{'pValue': '0.2840', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.25', 'ciLowerLimit': '0.83', 'ciUpperLimit': '1.90', 'groupDescription': 'Null hypothesis considered no difference between the treatments in comparison.', 'statisticalMethod': 'Cox Proportional Hazard Model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.2008', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.32', 'ciLowerLimit': '0.86', 'ciUpperLimit': '2.01', 'groupDescription': 'Null hypothesis considered no difference between the treatments in comparison.', 'statisticalMethod': 'Cox Proportional Hazard Model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.4552', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.17', 'ciLowerLimit': '0.78', 'ciUpperLimit': '1.74', 'groupDescription': 'Null hypothesis considered no difference between the treatments in comparison.', 'statisticalMethod': 'Cox Proportional Hazard Model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.5579', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.13', 'ciLowerLimit': '0.75', 'ciUpperLimit': '1.71', 'statisticalMethod': 'Cox Proportional Hazard Model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.7214', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.08', 'ciLowerLimit': '0.72', 'ciUpperLimit': '1.61', 'groupDescription': 'Null hypothesis considered no difference between the treatments in comparison.', 'statisticalMethod': 'Cox Proportional Hazard Model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.8192', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.95', 'ciLowerLimit': '0.62', 'ciUpperLimit': '1.45', 'groupDescription': 'Null hypothesis considered no difference between the treatments in comparison.', 'statisticalMethod': 'Cox Proportional Hazard Model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline to 6 hours', 'description': "Time to first perceptible pain relief, calculated as time when partcipant selected 'a little' pain relief in the electronic pad minus the time of treatment. If this time was not available in the electronic pad then the earliest time corresponding to a pain relief score 1 or greater was recorded as time to 'a little' pain relief.", 'unitOfMeasure': 'minutes', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to treat (ITT) population: All randomized participants who received at least one study medication and who had at least one post-baseline efficacy assessment.'}, {'type': 'SECONDARY', 'title': 'Headache Relief Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '45', 'groupId': 'OG002'}, {'value': '45', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Paracetamol/Caffeine', 'description': 'Participants were administered with two paracetamol/ caffeine caplets (500/65 mg each) and two placebo caplets (matching ibuprofen) orally with approx. 250 mL of water.'}, {'id': 'OG001', 'title': 'Ibuprofen', 'description': 'Participants were administered with two 200 mg Ibuprofen caplets and two placebo caplets (matching paracetamol/caffeine) orally with approx. 250 mL of water.'}, {'id': 'OG002', 'title': 'Paracetamol', 'description': 'Participants were administered with two 500 mg paracetamol caplets and two placebo caplets (matching paracetamol/caffeine) orally with approx. 250 mL of water.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Participants were administered with four placebo caplets (two caplets matching paracetamol/caffeine and two caplets matching ibuprofen) orally with approx. 250 mL of water.'}], 'classes': [{'title': '15 minutes', 'categories': [{'measurements': [{'value': '0.15', 'spread': '0.427', 'groupId': 'OG000'}, {'value': '0.08', 'spread': '0.267', 'groupId': 'OG001'}, {'value': '0.29', 'spread': '0.622', 'groupId': 'OG002'}, {'value': '0.08', 'spread': '0.273', 'groupId': 'OG003'}]}]}, {'title': '30 minutes', 'categories': [{'measurements': [{'value': '1.09', 'spread': '1.095', 'groupId': 'OG000'}, {'value': '0.84', 'spread': '0.754', 'groupId': 'OG001'}, {'value': '0.81', 'spread': '0.877', 'groupId': 'OG002'}, {'value': '0.87', 'spread': '0.951', 'groupId': 'OG003'}]}]}, {'title': '45 minutes', 'categories': [{'measurements': [{'value': '1.87', 'spread': '0.894', 'groupId': 'OG000'}, {'value': '1.61', 'spread': '1.046', 'groupId': 'OG001'}, {'value': '1.46', 'spread': '0.969', 'groupId': 'OG002'}, {'value': '1.70', 'spread': '1.222', 'groupId': 'OG003'}]}]}, {'title': '60 minutes', 'categories': [{'measurements': [{'value': '2.79', 'spread': '1.143', 'groupId': 'OG000'}, {'value': '2.49', 'spread': '1.023', 'groupId': 'OG001'}, {'value': '2.05', 'spread': '1.161', 'groupId': 'OG002'}, {'value': '2.21', 'spread': '1.277', 'groupId': 'OG003'}]}]}, {'title': '90 minutes', 'categories': [{'measurements': [{'value': '3.36', 'spread': '0.903', 'groupId': 'OG000'}, {'value': '3.16', 'spread': '1.124', 'groupId': 'OG001'}, {'value': '2.95', 'spread': '1.280', 'groupId': 'OG002'}, {'value': '2.95', 'spread': '1.378', 'groupId': 'OG003'}]}]}, {'title': '120 minutes', 'categories': [{'measurements': [{'value': '3.50', 'spread': '0.985', 'groupId': 'OG000'}, {'value': '3.46', 'spread': '1.141', 'groupId': 'OG001'}, {'value': '3.35', 'spread': '1.169', 'groupId': 'OG002'}, {'value': '3.00', 'spread': '1.414', 'groupId': 'OG003'}]}]}, {'title': '240 minutes', 'categories': [{'measurements': [{'value': '3.50', 'spread': '1.012', 'groupId': 'OG000'}, {'value': '3.75', 'spread': '0.639', 'groupId': 'OG001'}, {'value': '3.24', 'spread': '1.179', 'groupId': 'OG002'}, {'value': '3.55', 'spread': '0.912', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 4 hours', 'description': 'Pain relief scores were measured on a scale from 0-4: 0- No pain relief; 1- Perceptible pain relief; 2- Meaningful pain relief; 3- A lot of relief and 4- Complete relief.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population: All randomized participants who received at least one study medication and who had at least one post-baseline efficacy assessment.'}, {'type': 'SECONDARY', 'title': 'Total Pain Relief (TOTPAR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '45', 'groupId': 'OG002'}, {'value': '45', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Paracetamol/Caffeine', 'description': 'Participants were administered with two paracetamol/ caffeine caplets (500/65 mg each) and two placebo caplets (matching ibuprofen) orally with approx. 250 mL of water.'}, {'id': 'OG001', 'title': 'Ibuprofen', 'description': 'Participants were administered with two 200 mg Ibuprofen caplets and two placebo caplets (matching paracetamol/caffeine) orally with approx. 250 mL of water.'}, {'id': 'OG002', 'title': 'Paracetamol', 'description': 'Participants were administered with two 500 mg paracetamol caplets and two placebo caplets (matching paracetamol/caffeine) orally with approx. 250 mL of water.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Participants were administered with four placebo caplets (two caplets matching paracetamol/caffeine and two caplets matching ibuprofen) orally with approx. 250 mL of water.'}], 'classes': [{'title': 'TOTPAR (0-60 minutes)', 'categories': [{'measurements': [{'value': '1.57', 'spread': '0.75', 'groupId': 'OG000'}, {'value': '1.37', 'spread': '0.64', 'groupId': 'OG001'}, {'value': '1.14', 'spread': '0.68', 'groupId': 'OG002'}, {'value': '1.26', 'spread': '0.82', 'groupId': 'OG003'}]}]}, {'title': 'TOTPAR (0-90 minutes)', 'categories': [{'measurements': [{'value': '3.37', 'spread': '1.08', 'groupId': 'OG000'}, {'value': '2.96', 'spread': '1.18', 'groupId': 'OG001'}, {'value': '2.66', 'spread': '1.20', 'groupId': 'OG002'}, {'value': '2.79', 'spread': '1.40', 'groupId': 'OG003'}]}]}, {'title': 'TOTPAR (0-120 minutes)', 'categories': [{'measurements': [{'value': '5.08', 'spread': '1.65', 'groupId': 'OG000'}, {'value': '4.94', 'spread': '1.63', 'groupId': 'OG001'}, {'value': '4.62', 'spread': '1.81', 'groupId': 'OG002'}, {'value': '4.18', 'spread': '1.97', 'groupId': 'OG003'}]}]}, {'title': 'TOTPAR (0-240 minutes)', 'categories': [{'measurements': [{'value': '11.73', 'spread': '3.22', 'groupId': 'OG000'}, {'value': '12.08', 'spread': '2.48', 'groupId': 'OG001'}, {'value': '10.65', 'spread': '3.74', 'groupId': 'OG002'}, {'value': '11.19', 'spread': '3.48', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 4 hours', 'description': "TOTPAR was calculated as sum of the products of pain relief score at time interval at 0-60 minutes, 60-90 minutes, 90-120 minutes and 120-240 minutes. Participants were asked to choose a number on a scale of 0 to 4, where, 0- No pain relief; 1- A little or perceptible pain relief; 2- Meaningful pain relief; 3- A lot of relief; 4- Complete relief. The mean PRS scores were calculated on the basis of participant's response based on the above score.\n\nIt was calculated using the following formula.\n\nTOTPAR t = Σ(Rt x (time t - time t-1)), where Rt = pain relief score at time t; time t = time t in hours; time t-1 = time at previous time-point.", 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population: All randomized participants who received at least one study medication and who had at least one post-baseline efficacy assessment.'}, {'type': 'SECONDARY', 'title': 'Sum of Pain Intensity Difference (SPID)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '45', 'groupId': 'OG002'}, {'value': '45', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Paracetamol/Caffeine', 'description': 'Participants were administered with two paracetamol/ caffeine caplets (500/65 mg each) and two placebo caplets (matching ibuprofen) orally with approx. 250 mL of water.'}, {'id': 'OG001', 'title': 'Ibuprofen', 'description': 'Participants were administered with two 200 mg Ibuprofen caplets and two placebo caplets (matching paracetamol/caffeine) orally with approx. 250 mL of water.'}, {'id': 'OG002', 'title': 'Paracetamol', 'description': 'Participants were administered with two 500 mg paracetamol caplets and two placebo caplets (matching paracetamol/caffeine) orally with approx. 250 mL of water.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Participants were administered with four placebo caplets (two caplets matching paracetamol/caffeine and two caplets matching ibuprofen) orally with approx. 250 mL of water.'}], 'classes': [{'title': 'SPID (0-60 minutes)', 'categories': [{'measurements': [{'value': '1.49', 'spread': '0.81', 'groupId': 'OG000'}, {'value': '1.34', 'spread': '0.64', 'groupId': 'OG001'}, {'value': '1.15', 'spread': '0.61', 'groupId': 'OG002'}, {'value': '1.16', 'spread': '0.72', 'groupId': 'OG003'}]}]}, {'title': 'SPID (0-90 minutes)', 'categories': [{'measurements': [{'value': '3.06', 'spread': '1.25', 'groupId': 'OG000'}, {'value': '2.69', 'spread': '1.13', 'groupId': 'OG001'}, {'value': '2.48', 'spread': '1.18', 'groupId': 'OG002'}, {'value': '2.42', 'spread': '1.20', 'groupId': 'OG003'}]}]}, {'title': 'SPID (0-120 minutes)', 'categories': [{'measurements': [{'value': '4.42', 'spread': '1.88', 'groupId': 'OG000'}, {'value': '4.56', 'spread': '1.73', 'groupId': 'OG001'}, {'value': '4.32', 'spread': '1.98', 'groupId': 'OG002'}, {'value': '3.69', 'spread': '1.70', 'groupId': 'OG003'}]}]}, {'title': 'SPID (0-240 minutes)', 'categories': [{'measurements': [{'value': '9.43', 'spread': '3.62', 'groupId': 'OG000'}, {'value': '9.93', 'spread': '3.28', 'groupId': 'OG001'}, {'value': '8.69', 'spread': '2.77', 'groupId': 'OG002'}, {'value': '9.51', 'spread': '3.29', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 4 hours', 'description': 'Sum of pain intensity difference (SPID) at 60, 90, 120 and 240 minutes - calculated as the sum of headache intensity differences between the baseline pain intensity score and pain intensity score at each timepoint.\n\nPain intensity was measured by numerical rating scale which is horizontal line with a scale from 0-10, where 0 represents no pain and 10 represents the worst possible pain.\n\nIt was calculated using the following formula; SPID t = ΣPID x (time t - time t-1), where PID = PI (baseline) - PI t and PI = pain intensity.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population: All randomized participants who received at least one study medication and who had at least one post-baseline efficacy assessment.'}, {'type': 'SECONDARY', 'title': 'Sum of TOTPAR and SPID (SPRID)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '45', 'groupId': 'OG002'}, {'value': '45', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Paracetamol/Caffeine', 'description': 'Participants were administered with two paracetamol/ caffeine caplets (500/65 mg each) and two placebo caplets (matching ibuprofen) orally with approx. 250 mL of water.'}, {'id': 'OG001', 'title': 'Ibuprofen', 'description': 'Participants were administered with two 200 mg Ibuprofen caplets and two placebo caplets (matching paracetamol/caffeine) orally with approx. 250 mL of water.'}, {'id': 'OG002', 'title': 'Paracetamol', 'description': 'Participants were administered with two 500 mg paracetamol caplets and two placebo caplets (matching paracetamol/caffeine) orally with approx. 250 mL of water.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Participants were administered with four placebo caplets (two caplets matching paracetamol/caffeine and two caplets matching ibuprofen) orally with approx. 250 mL of water.'}], 'classes': [{'title': 'SPRID (0-60 minutes)', 'categories': [{'measurements': [{'value': '3.05', 'spread': '1.43', 'groupId': 'OG000'}, {'value': '2.71', 'spread': '1.19', 'groupId': 'OG001'}, {'value': '2.28', 'spread': '1.17', 'groupId': 'OG002'}, {'value': '2.42', 'spread': '1.47', 'groupId': 'OG003'}]}]}, {'title': 'SPRID (0-90 minutes)', 'categories': [{'measurements': [{'value': '6.43', 'spread': '2.17', 'groupId': 'OG000'}, {'value': '5.66', 'spread': '2.13', 'groupId': 'OG001'}, {'value': '5.14', 'spread': '2.26', 'groupId': 'OG002'}, {'value': '5.22', 'spread': '2.43', 'groupId': 'OG003'}]}]}, {'title': 'SPRID (0-120 minutes)', 'categories': [{'measurements': [{'value': '9.50', 'spread': '3.39', 'groupId': 'OG000'}, {'value': '9.50', 'spread': '3.08', 'groupId': 'OG001'}, {'value': '8.94', 'spread': '3.65', 'groupId': 'OG002'}, {'value': '7.87', 'spread': '3.34', 'groupId': 'OG003'}]}]}, {'title': 'SPRID (0-240 minutes)', 'categories': [{'measurements': [{'value': '21.16', 'spread': '6.18', 'groupId': 'OG000'}, {'value': '22.00', 'spread': '5.46', 'groupId': 'OG001'}, {'value': '19.35', 'spread': '5.72', 'groupId': 'OG002'}, {'value': '20.70', 'spread': '6.35', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 4 hours', 'description': "Area under the time-response curve for change in headache intensity and headache relief (SPRID) at 60, 90, 120 and 240 minutes, was calculated as sum of TOTPAR and SPID:\n\nSPRIDt = TOTPARt + SPIDt\n\nTOTPAR was calculated as sum of the products of pain relief score. Participants were asked to choose a number on a scale of 0 to 4, where, 0- No pain relief; 1- A little or perceptible pain relief; 2- Meaningful pain relief; 3- A lot of relief; 4- Complete relief. The mean PRS scores were calculated on the basis of participant's response based on the above score.\n\nSPID was calculated as the sum of headache intensity differences between baseline and at each time point. It was measured by numerical rating scale which is horizontal line with a scale from 0-10, where 0 represents no pain and 10 represents the worst possible pain.", 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population: All randomized participants who received at least one study medication and who had at least one post-baseline efficacy assessment.'}, {'type': 'SECONDARY', 'title': 'Time to Rescue Medication', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '45', 'groupId': 'OG002'}, {'value': '45', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Paracetamol/Caffeine', 'description': 'Participants were administered with two paracetamol/ caffeine caplets (500/65 mg each) and two placebo caplets (matching ibuprofen) orally with approx. 250 mL of water.'}, {'id': 'OG001', 'title': 'Ibuprofen', 'description': 'Participants were administered with two 200 mg Ibuprofen caplets and two placebo caplets (matching paracetamol/caffeine) orally with approx. 250 mL of water.'}, {'id': 'OG002', 'title': 'Paracetamol', 'description': 'Participants were administered with two 500 mg paracetamol caplets and two placebo caplets (matching paracetamol/caffeine) orally with approx. 250 mL of water.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Participants were administered with four placebo caplets (two caplets matching paracetamol/caffeine and two caplets matching ibuprofen) orally with approx. 250 mL of water.'}], 'classes': [{'categories': [{'measurements': [{'value': '119.0', 'groupId': 'OG000', 'lowerLimit': '119', 'upperLimit': '119'}, {'value': '150.0', 'groupId': 'OG001', 'lowerLimit': '126', 'upperLimit': '211'}, {'value': '129.5', 'groupId': 'OG002', 'lowerLimit': '129', 'upperLimit': '130'}, {'value': '62.0', 'groupId': 'OG003', 'lowerLimit': '62', 'upperLimit': '149'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline to 6 hours post dose', 'description': 'Time to rescue medication was evaluated.', 'unitOfMeasure': 'minutes', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population: All randomized participants who received at least one study medication and who had at least one post-baseline efficacy assessment.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Complete Headache Relief', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '45', 'groupId': 'OG002'}, {'value': '45', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Paracetamol/Caffeine', 'description': 'Participants were administered with two paracetamol/ caffeine caplets (500/65 mg each) and two placebo caplets (matching ibuprofen) orally with approx. 250 mL of water.'}, {'id': 'OG001', 'title': 'Ibuprofen', 'description': 'Participants were administered with two 200 mg Ibuprofen caplets and two placebo caplets (matching paracetamol/caffeine) orally with approx. 250 mL of water.'}, {'id': 'OG002', 'title': 'Paracetamol', 'description': 'Participants were administered with two 500 mg paracetamol caplets and two placebo caplets (matching paracetamol/caffeine) orally with approx. 250 mL of water.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Participants were administered with four placebo caplets (two caplets matching paracetamol/caffeine and two caplets matching ibuprofen) orally with approx. 250 mL of water.'}], 'classes': [{'title': 'Headache resolved within 1 hour', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}]}, {'title': 'Headache resolved within 2 hour', 'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}, {'value': '24', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to 2 hours', 'description': "Number of headaches resolved at 1 and 2 hours before any rescue medication was calculated as number of participants with complete pain relief and headache severity of 'no headache' over total number of participants. These calculations were based on one headache per treatment per subject.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population: All randomized participants who received at least one study medication and who had at least one post-baseline efficacy assessment.'}, {'type': 'SECONDARY', 'title': 'Headache Severity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '45', 'groupId': 'OG002'}, {'value': '45', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Paracetamol/Caffeine', 'description': 'Participants were administered with two paracetamol/ caffeine caplets (500/65 mg each) and two placebo caplets (matching ibuprofen) orally with approx. 250 mL of water.'}, {'id': 'OG001', 'title': 'Ibuprofen', 'description': 'Participants were administered with two 200 mg Ibuprofen caplets and two placebo caplets (matching paracetamol/caffeine) orally with approx. 250 mL of water.'}, {'id': 'OG002', 'title': 'Paracetamol', 'description': 'Participants were administered with two 500 mg paracetamol caplets and two placebo caplets (matching paracetamol/caffeine) orally with approx. 250 mL of water.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Participants were administered with four placebo caplets (two caplets matching paracetamol/caffeine and two caplets matching ibuprofen) orally with approx. 250 mL of water.'}], 'classes': [{'title': '15 minutes', 'categories': [{'measurements': [{'value': '0.35', 'spread': '0.802', 'groupId': 'OG000'}, {'value': '0.20', 'spread': '0.464', 'groupId': 'OG001'}, {'value': '0.20', 'spread': '0.406', 'groupId': 'OG002'}, {'value': '0.18', 'spread': '0.692', 'groupId': 'OG003'}]}]}, {'title': '30 minutes', 'categories': [{'measurements': [{'value': '1.03', 'spread': '0.923', 'groupId': 'OG000'}, {'value': '0.77', 'spread': '0.649', 'groupId': 'OG001'}, {'value': '0.78', 'spread': '0.584', 'groupId': 'OG002'}, {'value': '0.85', 'spread': '0.779', 'groupId': 'OG003'}]}]}, {'title': '45 minutes', 'categories': [{'measurements': [{'value': '1.77', 'spread': '0.986', 'groupId': 'OG000'}, {'value': '1.61', 'spread': '0.919', 'groupId': 'OG001'}, {'value': '1.51', 'spread': '0.823', 'groupId': 'OG002'}, {'value': '1.38', 'spread': '0.924', 'groupId': 'OG003'}]}]}, {'title': '60 minutes', 'categories': [{'measurements': [{'value': '2.50', 'spread': '1.133', 'groupId': 'OG000'}, {'value': '2.36', 'spread': '1.013', 'groupId': 'OG001'}, {'value': '2.00', 'spread': '1.065', 'groupId': 'OG002'}, {'value': '2.03', 'spread': '1.102', 'groupId': 'OG003'}]}]}, {'title': '90 minutes', 'categories': [{'measurements': [{'value': '2.97', 'spread': '1.063', 'groupId': 'OG000'}, {'value': '2.76', 'spread': '1.128', 'groupId': 'OG001'}, {'value': '2.60', 'spread': '1.172', 'groupId': 'OG002'}, {'value': '2.57', 'spread': '1.192', 'groupId': 'OG003'}]}]}, {'title': '120 minutes', 'categories': [{'measurements': [{'value': '2.94', 'spread': '1.110', 'groupId': 'OG000'}, {'value': '3.08', 'spread': '1.100', 'groupId': 'OG001'}, {'value': '2.94', 'spread': '1.197', 'groupId': 'OG002'}, {'value': '2.67', 'spread': '1.238', 'groupId': 'OG003'}]}]}, {'title': '240 minutes', 'categories': [{'measurements': [{'value': '2.82', 'spread': '0.958', 'groupId': 'OG000'}, {'value': '3.05', 'spread': '0.887', 'groupId': 'OG001'}, {'value': '2.67', 'spread': '0.856', 'groupId': 'OG002'}, {'value': '3.00', 'spread': '0.926', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 4 hours', 'description': 'Headache severity (scores) at 15, 30, 45, 60, 90, 120, and 240 minutes were calculated as change (difference) from baseline of pain intensity at each time point.\n\nPain intensity was measured by numerical rating scale which is a horizontal line with a scale from 0-10, where 0 represents no pain and 10 represents the worst possible pain.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population: All randomized participants who received at least one study medication and who had at least one post-baseline efficacy assessment.'}, {'type': 'SECONDARY', 'title': 'Patients Global Assessment in Response to Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '45', 'groupId': 'OG002'}, {'value': '45', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Paracetamol/Caffeine', 'description': 'Participants were administered with two paracetamol/ caffeine caplets (500/65 mg each) and two placebo caplets (matching ibuprofen) orally with approx. 250 mL of water.'}, {'id': 'OG001', 'title': 'Ibuprofen', 'description': 'Participants were administered with two 200 mg Ibuprofen caplets and two placebo caplets (matching paracetamol/caffeine) orally with approx. 250 mL of water.'}, {'id': 'OG002', 'title': 'Paracetamol', 'description': 'Participants were administered with two 500 mg paracetamol caplets and two placebo caplets (matching paracetamol/caffeine) orally with approx. 250 mL of water.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Participants were administered with four placebo caplets (two caplets matching paracetamol/caffeine and two caplets matching ibuprofen) orally with approx. 250 mL of water.'}], 'classes': [{'title': 'Score 0 (Very poor)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}, {'title': 'Score 1 (Poor)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}]}, {'title': 'Score 2 (Neutral)', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}]}, {'title': 'Score 3 (Good)', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '17', 'groupId': 'OG003'}]}]}, {'title': 'Score 4 (Very Good)', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to 8 weeks', 'description': 'Patients Global Assessment in Response to Treatment was assessed by a score in a scale from 0-4: 0- Poor; 1- Fair; 2- Good; 3- Very Good and 4- Excellent.', 'unitOfMeasure': 'Score on a scale', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population: All randomized participants who received at least one study medication and who had at least one post-baseline efficacy assessment.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Overall', 'description': 'In this cross-over study, participants were randomly-assigned to a blinded treatment sequence. Each participant was expected to complete 1, 2, or 3 periods depending on number of headache episodes.\n\nThe following treatments were administered during the study.\n\n1. 1000/130mg paracetamol/caffeine (two 500/65mg caplets) plus placebo ibuprofen (two caplets) for a total of four caplets taken orally with approximately (approx.) 250 ml of water.\n2. 1000mg paracetamol (two 500mg caplets) plus placebo paracetamol/caffeine (two caplets) taken orally with approx. 250 ml of water.\n3. 400mg ibuprofen (two 200mg caplets) plus placebo paracetamol/caffeine (two caplets) for a total of four caplets taken orally with approx. 250 ml of water.\n4. placebo paracetamol/caffeine (two caplets) plus placebo ibuprofen (two caplets) for a total of four caplets taken orally with approx. 250 ml of water.'}], 'periods': [{'title': 'Period I', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '66'}]}, {'type': 'Received Paracetamol', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}]}, {'type': 'Received Placebo', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}]}, {'type': 'Received Ibuprofen', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}]}, {'type': 'Received Paracetamol/Caffeine', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '66'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}, {'title': 'Wash Out Period I', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '66'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '63'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Other Reason', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}]}, {'title': 'Period II', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '63'}]}, {'type': 'Received Ibuprofen', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}]}, {'type': 'Received Placebo', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}]}, {'type': 'Received Paracetamol/Caffeine', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}]}, {'type': 'Received Paracetamol', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '63'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}, {'title': 'Washout Period II', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '63'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '58'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}]}], 'dropWithdraws': [{'type': 'Other Reason', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}]}]}, {'title': 'Period III', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '58'}]}, {'type': 'Received Paracetamol', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}]}, {'type': 'Received Placebo', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}]}, {'type': 'Received Paracetamol/Caffeine', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}]}, {'type': 'Received Ibuprofen', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '58'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'This was a multi-center study conducted at 7 centers.', 'preAssignmentDetails': '66 participants were randomized. Each participant was expected to complete 1, 2, or 3 periods depending on number of headache episodes, for example participants experiencing 2 episodes would take the first 2 treatments, but would not get the 3rd treatment. Such participants would be considered as completer, not a withdrawal.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'All Randomized Participants', 'description': 'All randomized participants were evaluated for baseline measures.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '42.0', 'spread': '12.46', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '44', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '22', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 66}}, 'statusModule': {'whyStopped': 'Study was terminated due to unforeseen difficulties with subject recruitment. No safety issues were identified in the study with this new formulation.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2009-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-11', 'completionDateStruct': {'date': '2010-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-03-12', 'studyFirstSubmitDate': '2011-06-23', 'resultsFirstSubmitDate': '2014-01-16', 'studyFirstSubmitQcDate': '2012-12-19', 'lastUpdatePostDateStruct': {'date': '2015-03-27', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-03-12', 'studyFirstPostDateStruct': {'date': '2012-12-24', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-03-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to First Perceptible Headache Relief', 'timeFrame': 'Baseline to 6 hours', 'description': "Time to first perceptible pain relief, calculated as time when partcipant selected 'a little' pain relief in the electronic pad minus the time of treatment. If this time was not available in the electronic pad then the earliest time corresponding to a pain relief score 1 or greater was recorded as time to 'a little' pain relief."}], 'secondaryOutcomes': [{'measure': 'Headache Relief Scores', 'timeFrame': 'Baseline to 4 hours', 'description': 'Pain relief scores were measured on a scale from 0-4: 0- No pain relief; 1- Perceptible pain relief; 2- Meaningful pain relief; 3- A lot of relief and 4- Complete relief.'}, {'measure': 'Total Pain Relief (TOTPAR)', 'timeFrame': 'Baseline to 4 hours', 'description': "TOTPAR was calculated as sum of the products of pain relief score at time interval at 0-60 minutes, 60-90 minutes, 90-120 minutes and 120-240 minutes. Participants were asked to choose a number on a scale of 0 to 4, where, 0- No pain relief; 1- A little or perceptible pain relief; 2- Meaningful pain relief; 3- A lot of relief; 4- Complete relief. The mean PRS scores were calculated on the basis of participant's response based on the above score.\n\nIt was calculated using the following formula.\n\nTOTPAR t = Σ(Rt x (time t - time t-1)), where Rt = pain relief score at time t; time t = time t in hours; time t-1 = time at previous time-point."}, {'measure': 'Sum of Pain Intensity Difference (SPID)', 'timeFrame': 'Baseline to 4 hours', 'description': 'Sum of pain intensity difference (SPID) at 60, 90, 120 and 240 minutes - calculated as the sum of headache intensity differences between the baseline pain intensity score and pain intensity score at each timepoint.\n\nPain intensity was measured by numerical rating scale which is horizontal line with a scale from 0-10, where 0 represents no pain and 10 represents the worst possible pain.\n\nIt was calculated using the following formula; SPID t = ΣPID x (time t - time t-1), where PID = PI (baseline) - PI t and PI = pain intensity.'}, {'measure': 'Sum of TOTPAR and SPID (SPRID)', 'timeFrame': 'Baseline to 4 hours', 'description': "Area under the time-response curve for change in headache intensity and headache relief (SPRID) at 60, 90, 120 and 240 minutes, was calculated as sum of TOTPAR and SPID:\n\nSPRIDt = TOTPARt + SPIDt\n\nTOTPAR was calculated as sum of the products of pain relief score. Participants were asked to choose a number on a scale of 0 to 4, where, 0- No pain relief; 1- A little or perceptible pain relief; 2- Meaningful pain relief; 3- A lot of relief; 4- Complete relief. The mean PRS scores were calculated on the basis of participant's response based on the above score.\n\nSPID was calculated as the sum of headache intensity differences between baseline and at each time point. It was measured by numerical rating scale which is horizontal line with a scale from 0-10, where 0 represents no pain and 10 represents the worst possible pain."}, {'measure': 'Time to Rescue Medication', 'timeFrame': 'Baseline to 6 hours post dose', 'description': 'Time to rescue medication was evaluated.'}, {'measure': 'Number of Participants With Complete Headache Relief', 'timeFrame': 'Baseline to 2 hours', 'description': "Number of headaches resolved at 1 and 2 hours before any rescue medication was calculated as number of participants with complete pain relief and headache severity of 'no headache' over total number of participants. These calculations were based on one headache per treatment per subject."}, {'measure': 'Headache Severity', 'timeFrame': 'Baseline to 4 hours', 'description': 'Headache severity (scores) at 15, 30, 45, 60, 90, 120, and 240 minutes were calculated as change (difference) from baseline of pain intensity at each time point.\n\nPain intensity was measured by numerical rating scale which is a horizontal line with a scale from 0-10, where 0 represents no pain and 10 represents the worst possible pain.'}, {'measure': 'Patients Global Assessment in Response to Treatment', 'timeFrame': 'Baseline to 8 weeks', 'description': 'Patients Global Assessment in Response to Treatment was assessed by a score in a scale from 0-4: 0- Poor; 1- Fair; 2- Good; 3- Very Good and 4- Excellent.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['caffeine', 'paracetamol', 'tension headache'], 'conditions': ['Headache, Tension-Type']}, 'descriptionModule': {'briefSummary': 'This study will compare a fast-absorbing paracetamol plus caffeine formula with placebo and an over-the-counter dose of paracetamol and ibuprofen to treat episodic tension headache.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of episodic tension-type headache consistent with all of the following:\n\n 1. number of days with the condition is historically greater than or equal to two per month\n 2. onset of condition was greater than or equal to 12 months from Visit 1\n 3. age of onset was \\< 50 years\n 4. severity of headaches is historically at least moderate\n 5. duration of headaches is historically greater than or equal to four hours, if untreated\n 6. number of headache episodes was greater than or equal to 4 and less than or equal to 10 during each of the three months immediately prior to Visit 1\n 7. treatment of headache episodes with OTC analgesics has historically provided pain relief in less than or equal to 2 hours\n\nExclusion Criteria:\n\n* Subject has chronic tension type headache, which is defined as headache on more than 15 days per month for 3 months.\n* If a migraine sufferer,subject averages more than one episode per month, is incapable of differentiating between tension-type headaches and migraine headaches, and/or requires regular or prophylactic use of migraine medications'}, 'identificationModule': {'nctId': 'NCT01755702', 'briefTitle': 'Paracetamol With Caffeine to Treat Episodic Tension Type Headache', 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': 'A Study to Assess the Efficacy of Paracetamol Taken in Combination With Caffeine for the Treatment of Episodic Tension Type Headache', 'orgStudyIdInfo': {'id': 'A2260597'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Arm 1', 'description': 'Placebo', 'interventionNames': ['Drug: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Arm 2', 'description': 'paracetamol marketed forumulation', 'interventionNames': ['Drug: Paracetamol marketed formulation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Arm 3', 'description': 'ibuprofen marketed formulation', 'interventionNames': ['Drug: ibuprofen marketed formulation']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 4', 'description': 'experimental paracetamol + caffeine formulation', 'interventionNames': ['Drug: Experimental paracetamol + caffeine formulation']}], 'interventions': [{'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo', 'armGroupLabels': ['Arm 1']}, {'name': 'Experimental paracetamol + caffeine formulation', 'type': 'DRUG', 'description': 'experimental paracetamol + caffeine formulation', 'armGroupLabels': ['Arm 4']}, {'name': 'ibuprofen marketed formulation', 'type': 'DRUG', 'description': 'ibuprofen marketed formulation', 'armGroupLabels': ['Arm 3']}, {'name': 'Paracetamol marketed formulation', 'type': 'DRUG', 'description': 'Paracetamol marketed formulation', 'armGroupLabels': ['Arm 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33024', 'city': 'Pembroke Pines', 'state': 'Florida', 'country': 'United States', 'facility': 'University Clinical Research, Inc.', 'geoPoint': {'lat': 26.00315, 'lon': -80.22394}}, {'zip': '01104', 'city': 'Springfield', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Springfield Neurology Associates', 'geoPoint': {'lat': 42.10148, 'lon': -72.58981}}, {'zip': '02481', 'city': 'Wellesley Hills', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'MedVadis Research Corporation', 'geoPoint': {'lat': 42.30843, 'lon': -71.27867}}, {'zip': '11042', 'city': 'Lake Success', 'state': 'New York', 'country': 'United States', 'facility': 'Biomedical Research Alliance of New York LLC', 'geoPoint': {'lat': 40.77066, 'lon': -73.71763}}, {'zip': '10550', 'city': 'Mount Vernon', 'state': 'New York', 'country': 'United States', 'facility': 'Elkind Headache Center', 'geoPoint': {'lat': 40.9126, 'lon': -73.83708}}, {'zip': '10573', 'city': 'Port Chester', 'state': 'New York', 'country': 'United States', 'facility': 'International Research Service, Inc.', 'geoPoint': {'lat': 41.00176, 'lon': -73.66568}}, {'zip': '19107', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Jefferson Headache Center', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'overallOfficials': [{'name': 'GSK Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'GlaxoSmithKline'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}