Ignite Creation Date:
2025-12-24 @ 4:19 PM
Ignite Modification Date:
2026-01-25 @ 4:08 AM
Study NCT ID:
NCT02246166
Status:
COMPLETED
Last Update Posted:
2016-09-14
First Post:
2014-09-18
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
The Effect of Paracetamol, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide and Chlorpheniramine Maleate Tablets Compared to Placebo in Subjects Suffering From the Common Cold or Influenza.
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003139', 'term': 'Common Cold'}], 'ancestors': [{'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D010850', 'term': 'Picornaviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract 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': 'AEs were collected from the start of the study until 5 days following last administration of the investigational product', 'eventGroups': [{'id': 'EG000', 'title': 'Test Tablet', 'description': 'Tablet containing Paracetamol, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide and Chlorpheniramine Maleate Tablets (II) (Paracetamol 500mg, pseudoephedrine 30mg, chlorpheniramine 2mg and dextromethorphan 15mg).', 'otherNumAtRisk': 25, 'otherNumAffected': 1, 'seriousNumAtRisk': 25, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Matching placebo tablet', 'otherNumAtRisk': 27, 'otherNumAffected': 3, 'seriousNumAtRisk': 27, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'GINGIVAL SWELLING', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'NAUSEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'DIZZINESS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'SOMNOLENCE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Symptom Severity Assessment at 15 Minutes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Test Tablet', 'description': 'Tablet containing Paracetamol, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide and Chlorpheniramine Maleate Tablets (II) (Paracetamol 500mg, pseudoephedrine 30mg, chlorpheniramine 2mg and dextromethorphan 15mg).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching placebo tablet'}], 'classes': [{'title': 'Observed value', 'categories': [{'measurements': [{'value': '10.66', 'spread': '0.309', 'groupId': 'OG000'}, {'value': '10.64', 'spread': '0.304', 'groupId': 'OG001'}]}]}, {'title': 'Change from baseline', 'categories': [{'measurements': [{'value': '-1.11', 'spread': '0.309', 'groupId': 'OG000'}, {'value': '-1.13', 'spread': '0.304', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.9473', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.03', 'ciLowerLimit': '-0.77', 'ciUpperLimit': '0.83', 'estimateComment': 'Difference is first named treatment minus the second named treatment such that a negative difference favors the first named treatment', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'From ANCOVA model with factors for treatment group and study site and baseline TSS score as a covariate', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '15 minutes', 'description': 'Symptom severity assessment was determined by Total Sum Score (TSS), TSS ranged from 0 to 21 with less severity score at the given time point represented a better outcome measure.\n\nTSS was calculated as the sum of the non missing scores (all on a 0-3 scale measuring worsening or severity) of the following common cold symptoms: sore throat, headache, extremities pain, nasal congestion, runny nose, sneezing, and cough post treatment administration.\n\nParticipants self assessed symptoms severity using 4 points (0 = absent, 1 = mild, 2 = moderate, and 3 = severe) categorical scale at 15 minutes post product use.', 'unitOfMeasure': 'Score on scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The primary population for assessment of efficacy was the intent to treat (ITT) population. The ITT population was defined as all participants who were randomized and received at least one dose of treatment during the study and provide at least one post baseline assessment of efficacy.'}, {'type': 'PRIMARY', 'title': 'Symptom Severity Assessment at 30 Minutes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Test Tablet', 'description': 'Tablet containing Paracetamol, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide and Chlorpheniramine Maleate Tablets (II) (Paracetamol 500mg, pseudoephedrine 30mg, chlorpheniramine 2mg and dextromethorphan 15mg).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching placebo tablet'}], 'classes': [{'title': 'Observed value', 'categories': [{'measurements': [{'value': '9.55', 'spread': '0.402', 'groupId': 'OG000'}, {'value': '9.74', 'spread': '0.396', 'groupId': 'OG001'}]}]}, {'title': 'Change from baseline', 'categories': [{'measurements': [{'value': '-2.22', 'spread': '0.402', 'groupId': 'OG000'}, {'value': '-2.03', 'spread': '0.396', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.7210', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.19', 'ciLowerLimit': '-1.23', 'ciUpperLimit': '0.86', 'estimateComment': 'Difference is first named treatment minus the second named treatment such that a negative difference favors the first named treatme', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'From ANCOVA model with factors for treatment group and study site and baseline TSS score as a covariate.', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '30 minutes', 'description': 'Symptom severity assessment was determined by TSS, TSS ranged from 0 to 21 with less severity score at the given time point represented a better outcome measure.\n\nTSS was calculated as the sum of the non missing scores (all on a 0-3 scale measuring worsening or severity) of the following common cold symptoms: sore throat, headache, extremities pain, nasal congestion, runny nose, sneezing, and cough post treatment administration.\n\nParticipants self assessed symptoms severity using 4 points (0 = absent, 1 = mild, 2 = moderate, and 3 = severe) categorical scale at 30 minutes post product use.', 'unitOfMeasure': 'Score on scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The primary population for assessment of efficacy was the intent to treat (ITT) population. The intent-to-treat (ITT) population was defined as all participants who were randomized and received at least one dose of treatment during the study and provide at least one post baseline assessment of efficacy.'}, {'type': 'PRIMARY', 'title': 'Symptom Severity Assessment at 1 Hour', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Test Tablet', 'description': 'Tablet containing Paracetamol, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide and Chlorpheniramine Maleate Tablets (II) (Paracetamol 500mg, pseudoephedrine 30mg, chlorpheniramine 2mg and dextromethorphan 15mg).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching placebo tablet'}], 'classes': [{'title': 'Observed value', 'categories': [{'measurements': [{'value': '8.73', 'spread': '0.495', 'groupId': 'OG000'}, {'value': '8.52', 'spread': '0.487', 'groupId': 'OG001'}]}]}, {'title': 'Change from baseline', 'categories': [{'measurements': [{'value': '-3.04', 'spread': '0.495', 'groupId': 'OG000'}, {'value': '-3.25', 'spread': '0.487', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.7445', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.21', 'ciLowerLimit': '-1.07', 'ciUpperLimit': '1.49', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'From ANCOVA model with factors for treatment group and study site and baseline TSS score as a covariate.', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '1 hour', 'description': 'Symptom severity assessment was determined by TSS, TSS ranged from 0 to 21 with less severity score at the given time point represented a better outcome measure.\n\nTSS was calculated as the sum of the non missing scores (all on a 0-3 scale measuring worsening or severity) of the following common cold symptoms: sore throat, headache, extremities pain, nasal congestion, runny nose, sneezing, and cough post treatment administration.\n\nParticipants self assessed symptoms severity using 4 points (0 = absent, 1 = mild, 2 = moderate, and 3 = severe) categorical scale at 1hour post product use.', 'unitOfMeasure': 'Score on scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The primary population for assessment of efficacy was the intent to treat (ITT) population. The intent-to-treat (ITT) population was defined as all participants who were randomized and received at least one dose of treatment during the study and provide at least one post baseline assessment of efficacy.'}, {'type': 'PRIMARY', 'title': 'Symptom Severity Assessment at 2 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Test Tablet', 'description': 'Tablet containing Paracetamol, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide and Chlorpheniramine Maleate Tablets (II) (Paracetamol 500mg, pseudoephedrine 30mg, chlorpheniramine 2mg and dextromethorphan 15mg).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching placebo tablet'}], 'classes': [{'title': 'Observed value', 'categories': [{'measurements': [{'value': '7.54', 'spread': '0.596', 'groupId': 'OG000'}, {'value': '7.31', 'spread': '0.587', 'groupId': 'OG001'}]}]}, {'title': 'Change from baseline', 'categories': [{'measurements': [{'value': '-4.23', 'spread': '0.596', 'groupId': 'OG000'}, {'value': '-4.46', 'spread': '0.587', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.7662', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.23', 'ciLowerLimit': '-1.32', 'ciUpperLimit': '1.78', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'From ANCOVA model with factors for treatment group and study site and baseline TSS score as a covariate', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '2 hours', 'description': 'Symptom severity assessment was determined by TSS, TSS ranged from 0 to 21 with less severity score at the given time point represented a better outcome measure.\n\nTSS was calculated as the sum of the non missing scores (all on a 0-3 scale measuring worsening or severity) of the following common cold symptoms: sore throat, headache, extremities pain, nasal congestion, runny nose, sneezing, and cough post treatment administration.\n\nParticipants self assessed symptoms severity using 4 points (0 = absent, 1 = mild, 2 = moderate, and 3 = severe) categorical scale at 2 hours post product use.', 'unitOfMeasure': 'Score on scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The primary population for assessment of efficacy was the intent to treat (ITT) population. The ITT population was defined as all participants who were randomized and received at least one dose of treatment during the study and provide at least one post baseline assessment of efficacy.'}, {'type': 'PRIMARY', 'title': 'Symptom Severity Assessment at 3 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Test Tablet', 'description': 'Tablet containing Paracetamol, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide and Chlorpheniramine Maleate Tablets (II) (Paracetamol 500mg, pseudoephedrine 30mg, chlorpheniramine 2mg and dextromethorphan 15mg).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching placebo tablet'}], 'classes': [{'title': 'Observed value', 'categories': [{'measurements': [{'value': '6.80', 'spread': '0.669', 'groupId': 'OG000'}, {'value': '6.25', 'spread': '0.659', 'groupId': 'OG001'}]}]}, {'title': 'Change from baseline', 'categories': [{'measurements': [{'value': '-4.97', 'spread': '0.669', 'groupId': 'OG000'}, {'value': '-5.52', 'spread': '0.659', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.5208', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.56', 'ciLowerLimit': '-1.18', 'ciUpperLimit': '2.29', 'estimateComment': 'Difference is first named treatment minus the second named treatment such that a negative difference favors the first named treatment', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'From ANCOVA model with factors for treatment group and study site and baseline TSS score as a covariate.', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '3 hours', 'description': 'Symptom severity assessment was determined by TSS, TSS ranged from 0 to 21 with less severity score at the given time point represented a better outcome measure.\n\nTSS was calculated as the sum of the non missing scores (all on a 0-3 scale measuring worsening or severity) of the following common cold symptoms: sore throat, headache, extremities pain, nasal congestion, runny nose, sneezing, and cough post treatment administration.\n\nParticipants self assessed symptoms severity using 4 points (0 = absent, 1 = mild, 2 = moderate, and 3 = severe) categorical scale at 3 hours post product use.', 'unitOfMeasure': 'Score on scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The primary population for assessment of efficacy was the intent to treat (ITT) population. The ITT population was defined as all participants who were randomized and received at least one dose of treatment during the study and provide at least one post baseline assessment of efficacy.'}, {'type': 'PRIMARY', 'title': 'Symptom Severity Assessment at 4 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Test Tablet', 'description': 'Tablet containing Paracetamol, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide and Chlorpheniramine Maleate Tablets (II) (Paracetamol 500mg, pseudoephedrine 30mg, chlorpheniramine 2mg and dextromethorphan 15mg).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching placebo tablet'}], 'classes': [{'title': 'Observed value', 'categories': [{'measurements': [{'value': '5.94', 'spread': '0.702', 'groupId': 'OG000'}, {'value': '5.82', 'spread': '0.692', 'groupId': 'OG001'}]}]}, {'title': 'Change from baseline', 'categories': [{'measurements': [{'value': '-5.83', 'spread': '0.702', 'groupId': 'OG000'}, {'value': '-5.95', 'spread': '0.692', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.8993', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.12', 'ciLowerLimit': '-1.71', 'ciUpperLimit': '1.94', 'estimateComment': 'Difference is first named treatment minus the second named treatment such that a negative difference favors the first named treatment', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'From ANCOVA model with factors for treatment group and study site and baseline TSS score as a covariate.', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '4 hours', 'description': 'Symptom severity assessment was determined by TSS, TSS ranged from 0 to 21 with less severity score at the given time point represented a better outcome measure.\n\nTSS was calculated as the sum of the non missing scores (all on a 0-3 scale measuring worsening or severity) of the following common cold symptoms: sore throat, headache, extremities pain, nasal congestion, runny nose, sneezing, and cough post treatment administration.\n\nParticipants self assessed symptoms severity using 4 points (0 = absent, 1 = mild, 2 = moderate, and 3 = severe) categorical scale at 4 hours post product use.', 'unitOfMeasure': 'Score on scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The primary population for assessment of efficacy was the intent to treat (ITT) population. The ITT population was defined as all participants who were randomized and received at least one dose of treatment during the study and provide at least one post baseline assessment of efficacy.'}, {'type': 'SECONDARY', 'title': 'Global Assessment of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Test Tablet', 'description': 'Tablet containing Paracetamol, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide and Chlorpheniramine Maleate Tablets (II) (Paracetamol 500mg, pseudoephedrine 30mg, chlorpheniramine 2mg and dextromethorphan 15mg).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching placebo tablet'}], 'classes': [{'title': 'Ineffective (0)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Poor (1)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Fair (2)', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Good (3)', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}]}, {'title': 'Excellent (4)', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '4 hours', 'description': 'After completing the 4 hours symptom severity assessments, participants evaluated their treatment response on a 5-point scale by answering the question: "How well did the test medication control your symptoms?" (0-ineffective, 1-poor, 2-fair, 3-good, or 4-excellent).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The primary population for assessment of efficacy was the intent to treat (ITT) population. The ITT population was defined as all participants who were randomized and received at least one dose of treatment during the study and provide at least one post baseline assessment of efficacy.'}, {'type': 'SECONDARY', 'title': 'Sore Throat Severity Assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Test Tablet', 'description': 'Tablet containing Paracetamol, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide and Chlorpheniramine Maleate Tablets (II) (Paracetamol 500mg, pseudoephedrine 30mg, chlorpheniramine 2mg and dextromethorphan 15mg).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching placebo tablet'}], 'classes': [{'title': 'Change from baseline in 15 minutes', 'categories': [{'measurements': [{'value': '-0.12', 'spread': '0.076', 'groupId': 'OG000'}, {'value': '-0.28', 'spread': '0.073', 'groupId': 'OG001'}]}]}, {'title': 'Change from baseline in 30 minutes', 'categories': [{'measurements': [{'value': '-0.21', 'spread': '0.082', 'groupId': 'OG000'}, {'value': '-0.29', 'spread': '0.080', 'groupId': 'OG001'}]}]}, {'title': 'Change from baseline in 60 minutes', 'categories': [{'measurements': [{'value': '-0.27', 'spread': '0.099', 'groupId': 'OG000'}, {'value': '-0.29', 'spread': '0.096', 'groupId': 'OG001'}]}]}, {'title': 'Change from baseline in 120 minutes', 'categories': [{'measurements': [{'value': '-0.33', 'spread': '0.124', 'groupId': 'OG000'}, {'value': '-0.49', 'spread': '0.120', 'groupId': 'OG001'}]}]}, {'title': 'Change from baseline in 180 minutes', 'categories': [{'measurements': [{'value': '-0.33', 'spread': '0.132', 'groupId': 'OG000'}, {'value': '-0.53', 'spread': '0.128', 'groupId': 'OG001'}]}]}, {'title': 'Change from baseline in 240 minutes', 'categories': [{'measurements': [{'value': '-0.46', 'spread': '0.137', 'groupId': 'OG000'}, {'value': '-0.71', 'spread': '0.133', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Change from baseline in 15, 30, 60,120, 180, and 240 minutes', 'description': 'Participants self-assessed sore throat severity using 4 points (0 = absent, 1 = mild, 2 = moderate, and 3 = severe) categorical scale at baseline and at 15, 30, 60, 120,180 and 240 minutes post product administration. All sore throat severity assessment values were recorded in questionnaire and tabulated. A reduction in severity score from baseline represented a better outcome measure.', 'unitOfMeasure': 'Score on scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The primary population for assessment of efficacy was the intent to treat (ITT) population. The ITT population was defined as all participants who were randomized and received at least one dose of treatment during the study and provide at least one post baseline assessment of efficacy.'}, {'type': 'SECONDARY', 'title': 'Headache Severity Assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Test Tablet', 'description': 'Tablet containing Paracetamol, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide and Chlorpheniramine Maleate Tablets (II) (Paracetamol 500mg, pseudoephedrine 30mg, chlorpheniramine 2mg and dextromethorphan 15mg).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching placebo tablet'}], 'classes': [{'title': 'Change from baseline in 15 minutes', 'categories': [{'measurements': [{'value': '-0.17', 'spread': '0.094', 'groupId': 'OG000'}, {'value': '-0.14', 'spread': '0.090', 'groupId': 'OG001'}]}]}, {'title': 'Change from baseline in 30 minutes', 'categories': [{'measurements': [{'value': '-0.31', 'spread': '0.113', 'groupId': 'OG000'}, {'value': '-0.16', 'spread': '0.108', 'groupId': 'OG001'}]}]}, {'title': 'Change from baseline in 60 minutes', 'categories': [{'measurements': [{'value': '-0.47', 'spread': '0.130', 'groupId': 'OG000'}, {'value': '-0.51', 'spread': '0.123', 'groupId': 'OG001'}]}]}, {'title': 'Change from baseline in 120 minutes', 'categories': [{'measurements': [{'value': '-0.72', 'spread': '0.123', 'groupId': 'OG000'}, {'value': '-0.71', 'spread': '0.117', 'groupId': 'OG001'}]}]}, {'title': 'Change from baseline in 180 minutes', 'categories': [{'measurements': [{'value': '-0.89', 'spread': '0.130', 'groupId': 'OG000'}, {'value': '-0.88', 'spread': '0.123', 'groupId': 'OG001'}]}]}, {'title': 'Change from baseline in 240 minutes', 'categories': [{'measurements': [{'value': '-0.99', 'spread': '0.125', 'groupId': 'OG000'}, {'value': '-0.96', 'spread': '0.118', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Change from baseline in 15, 30, 60,120, 180, and 240 minutes', 'description': 'Participants self-assessed headache severity using 4 points (0 = absent, 1 = mild, 2 = moderate, and 3 = severe) categorical scale at baseline and at 15, 30, 60, 120,180 and 240 minutes post product administration. All headache severity assessment values were recorded in questionnaire and tabulated. A reduction in severity score from baseline represented a better outcome measure.', 'unitOfMeasure': 'Score on scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The primary population for assessment of efficacy was the intent to treat (ITT) population. The ITT population was defined as all participants who were randomized and received at least one dose of treatment during the study and provide at least one post baseline assessment of efficacy.'}, {'type': 'SECONDARY', 'title': 'Extremities Pain Severity Assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Test Tablet', 'description': 'Tablet containing Paracetamol, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide and Chlorpheniramine Maleate Tablets (II) (Paracetamol 500mg, pseudoephedrine 30mg, chlorpheniramine 2mg and dextromethorphan 15mg).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching placebo tablet'}], 'classes': [{'title': 'Change from baseline in 15 minutes', 'categories': [{'measurements': [{'value': '-0.21', 'spread': '0.101', 'groupId': 'OG000'}, {'value': '-0.10', 'spread': '0.099', 'groupId': 'OG001'}]}]}, {'title': 'Change from baseline in 30 minutes', 'categories': [{'measurements': [{'value': '-0.22', 'spread': '0.100', 'groupId': 'OG000'}, {'value': '-0.19', 'spread': '0.099', 'groupId': 'OG001'}]}]}, {'title': 'Change from baseline in 60 minutes', 'categories': [{'measurements': [{'value': '-0.32', 'spread': '0.104', 'groupId': 'OG000'}, {'value': '-0.32', 'spread': '0.102', 'groupId': 'OG001'}]}]}, {'title': 'Change from baseline in 120 minutes', 'categories': [{'measurements': [{'value': '-0.47', 'spread': '0.110', 'groupId': 'OG000'}, {'value': '-0.46', 'spread': '0.108', 'groupId': 'OG001'}]}]}, {'title': 'Change from baseline in 180 minutes', 'categories': [{'measurements': [{'value': '-0.58', 'spread': '0.126', 'groupId': 'OG000'}, {'value': '-0.57', 'spread': '0.124', 'groupId': 'OG001'}]}]}, {'title': 'Change from baseline in 240 minutes', 'categories': [{'measurements': [{'value': '-0.64', 'spread': '0.126', 'groupId': 'OG000'}, {'value': '-0.60', 'spread': '0.124', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Change from baseline in 15, 30, 60,120, 180, and 240 minutes', 'description': 'Participants self-assessed extremities pain severity using 4 points (0 = absent, 1 = mild, 2 = moderate, and 3 = severe) categorical scale at baseline and at 15, 30, 60, 120,180 and 240 minutes post product administration. All extremities pain severity assessment values were recorded in a questionnaire and tabulated. A reduction in severity score from baseline represented a better outcome measure.', 'unitOfMeasure': 'Score on scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The primary population for assessment of efficacy was the intent to treat (ITT) population. The ITT population was defined as all participants who were randomized and received at least one dose of treatment during the study and provide at least one post baseline assessment of efficacy.'}, {'type': 'SECONDARY', 'title': 'Nasal Congestion Severity Assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Test Tablet', 'description': 'Tablet containing Paracetamol, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide and Chlorpheniramine Maleate Tablets (II) (Paracetamol 500mg, pseudoephedrine 30mg, chlorpheniramine 2mg and dextromethorphan 15mg).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching placebo tablet'}], 'classes': [{'title': 'Change from baseline in 15 minutes', 'categories': [{'measurements': [{'value': '-0.32', 'spread': '0.086', 'groupId': 'OG000'}, {'value': '-0.31', 'spread': '0.084', 'groupId': 'OG001'}]}]}, {'title': 'Change from baseline in 30 minutes', 'categories': [{'measurements': [{'value': '-0.59', 'spread': '0.119', 'groupId': 'OG000'}, {'value': '-0.60', 'spread': '0.115', 'groupId': 'OG001'}]}]}, {'title': 'Change from baseline in 60 minutes', 'categories': [{'measurements': [{'value': '-0.61', 'spread': '0.127', 'groupId': 'OG000'}, {'value': '-0.68', 'spread': '0.124', 'groupId': 'OG001'}]}]}, {'title': 'Change from baseline in 120 minutes', 'categories': [{'measurements': [{'value': '-0.91', 'spread': '0.138', 'groupId': 'OG000'}, {'value': '-1.02', 'spread': '0.134', 'groupId': 'OG001'}]}]}, {'title': 'Change from baseline in 180 minutes', 'categories': [{'measurements': [{'value': '-1.04', 'spread': '0.156', 'groupId': 'OG000'}, {'value': '-1.14', 'spread': '0.152', 'groupId': 'OG001'}]}]}, {'title': 'Change from baseline in 240 minutes', 'categories': [{'measurements': [{'value': '-1.19', 'spread': '0.162', 'groupId': 'OG000'}, {'value': '-1.20', 'spread': '0.157', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Change from baseline in 15, 30, 60,120, 180, and 240 minutes', 'description': 'Participants self-assessed nasal congestion severity using 4 points (0 = absent, 1 = mild, 2 = moderate, and 3 = severe) categorical scale at baseline and at 15, 30, 60, 120,180 and 240 minutes post product administration. All nasal congestion severity assessment values were recorded in a questionnaire and tabulated. A reduction in severity score from baseline represented a better outcome measure.', 'unitOfMeasure': 'Score on scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The primary population for assessment of efficacy was the intent to treat (ITT) population. The ITT population was defined as all participants who were randomized and received at least one dose of treatment during the study and provide at least one post baseline assessment of efficacy.'}, {'type': 'SECONDARY', 'title': 'Runny Nose Severity Assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Test Tablet', 'description': 'Tablet containing Paracetamol, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide and Chlorpheniramine Maleate Tablets (II) (Paracetamol 500mg, pseudoephedrine 30mg, chlorpheniramine 2mg and dextromethorphan 15mg).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching placebo tablet'}], 'classes': [{'title': 'Change from baseline in 15 minutes', 'categories': [{'measurements': [{'value': '-0.20', 'spread': '0.081', 'groupId': 'OG000'}, {'value': '-0.18', 'spread': '0.080', 'groupId': 'OG001'}]}]}, {'title': 'Change from baseline in 30 minutes', 'categories': [{'measurements': [{'value': '-0.48', 'spread': '0.116', 'groupId': 'OG000'}, {'value': '-0.32', 'spread': '0.114', 'groupId': 'OG001'}]}]}, {'title': 'Change from baseline in 60 minutes', 'categories': [{'measurements': [{'value': '-0.54', 'spread': '0.145', 'groupId': 'OG000'}, {'value': '-0.61', 'spread': '0.143', 'groupId': 'OG001'}]}]}, {'title': 'Change from baseline in 120 minutes', 'categories': [{'measurements': [{'value': '-0.78', 'spread': '0.148', 'groupId': 'OG000'}, {'value': '-0.65', 'spread': '0.146', 'groupId': 'OG001'}]}]}, {'title': 'Change from baseline in 180 minutes', 'categories': [{'measurements': [{'value': '-0.89', 'spread': '0.161', 'groupId': 'OG000'}, {'value': '-0.98', 'spread': '0.159', 'groupId': 'OG001'}]}]}, {'title': 'Change from baseline in 240 minutes', 'categories': [{'measurements': [{'value': '-1.12', 'spread': '0.149', 'groupId': 'OG000'}, {'value': '-0.97', 'spread': '0.147', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Change from baseline in 15, 30, 60,120, 180, and 240 minutes', 'description': 'Participants self-assessed runny nose severity using 4 points (0 = absent, 1 = mild, 2 = moderate, and 3 = severe) categorical scale at baseline and at 15, 30, 60, 120,180 and 240 minutes post product administration. All runny nose severity assessment values were recorded in questionnaire and tabulated. A reduction in severity score from baseline represented a better outcome measure.', 'unitOfMeasure': 'Score on scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The primary population for assessment of efficacy was the intent to treat (ITT) population. The ITT population was defined as all participants who were randomized and received at least one dose of treatment during the study and provide at least one post baseline assessment of efficacy.'}, {'type': 'SECONDARY', 'title': 'Sneezing Severity Assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Test Tablet', 'description': 'Tablet containing Paracetamol, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide and Chlorpheniramine Maleate Tablets (II) (Paracetamol 500mg, pseudoephedrine 30mg, chlorpheniramine 2mg and dextromethorphan 15mg).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching placebo tablet'}], 'classes': [{'title': 'Change from baseline in 15 minutes', 'categories': [{'measurements': [{'value': '-0.10', 'spread': '0.089', 'groupId': 'OG000'}, {'value': '-0.24', 'spread': '0.088', 'groupId': 'OG001'}]}]}, {'title': 'Change from baseline in 30 minutes', 'categories': [{'measurements': [{'value': '-0.25', 'spread': '0.103', 'groupId': 'OG000'}, {'value': '-0.42', 'spread': '0.102', 'groupId': 'OG001'}]}]}, {'title': 'Change from baseline in 60 minutes', 'categories': [{'measurements': [{'value': '-0.50', 'spread': '0.126', 'groupId': 'OG000'}, {'value': '-0.80', 'spread': '0.124', 'groupId': 'OG001'}]}]}, {'title': 'Change from baseline in 120 minutes', 'categories': [{'measurements': [{'value': '-0.67', 'spread': '0.138', 'groupId': 'OG000'}, {'value': '-0.86', 'spread': '0.136', 'groupId': 'OG001'}]}]}, {'title': 'Change from baseline in 180 minutes', 'categories': [{'measurements': [{'value': '-0.83', 'spread': '0.138', 'groupId': 'OG000'}, {'value': '-1.03', 'spread': '0.136', 'groupId': 'OG001'}]}]}, {'title': 'Change from baseline in 240 minutes', 'categories': [{'measurements': [{'value': '-0.88', 'spread': '0.135', 'groupId': 'OG000'}, {'value': '-1.11', 'spread': '0.133', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Change from baseline in 15, 30, 60,120, 180, and 240 minutes', 'description': 'Participants self-assessed sneezing severity using 4 points (0 = absent, 1 = mild, 2 = moderate, and 3 = severe) categorical scale at baseline and at 15, 30, 60, 120,180 and 240 minutes post product administration. All sneezing severity assessment values were recorded in a questionnaire and tabulated. A reduction in severity score from baseline represented a better outcome measure.', 'unitOfMeasure': 'Score on scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The primary population for assessment of efficacy was the intent to treat (ITT) population. The ITT population was defined as all participants who were randomized and received at least one dose of treatment during the study and provide at least one post baseline assessment of efficacy.'}, {'type': 'SECONDARY', 'title': 'Cough Severity Assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Test Tablet', 'description': 'Tablet containing Paracetamol, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide and Chlorpheniramine Maleate Tablets (II) (Paracetamol 500mg, pseudoephedrine 30mg, chlorpheniramine 2mg and dextromethorphan 15mg).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching placebo tablet'}], 'classes': [{'title': 'Change from baseline in 15 minutes', 'categories': [{'measurements': [{'value': '-0.11', 'spread': '0.071', 'groupId': 'OG000'}, {'value': '-0.06', 'spread': '0.078', 'groupId': 'OG001'}]}]}, {'title': 'Change from baseline in 30 minutes', 'categories': [{'measurements': [{'value': '-0.28', 'spread': '0.077', 'groupId': 'OG000'}, {'value': '-0.25', 'spread': '0.084', 'groupId': 'OG001'}]}]}, {'title': 'Change from baseline in 60 minutes', 'categories': [{'measurements': [{'value': '-0.49', 'spread': '0.116', 'groupId': 'OG000'}, {'value': '-0.33', 'spread': '0.126', 'groupId': 'OG001'}]}]}, {'title': 'Change from baseline in 120 minutes', 'categories': [{'measurements': [{'value': '-0.51', 'spread': '0.109', 'groupId': 'OG000'}, {'value': '-0.45', 'spread': '0.119', 'groupId': 'OG001'}]}]}, {'title': 'Change from baseline in 180 minutes', 'categories': [{'measurements': [{'value': '-0.53', 'spread': '0.116', 'groupId': 'OG000'}, {'value': '-0.53', 'spread': '0.127', 'groupId': 'OG001'}]}]}, {'title': 'Change from baseline in 240 minutes', 'categories': [{'measurements': [{'value': '-0.72', 'spread': '0.131', 'groupId': 'OG000'}, {'value': '-0.59', 'spread': '0.143', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Change from baseline in 15, 30, 60,120, 180, and 240 minutes', 'description': 'Participants self-assessed cough severity using 4 points (0 = absent, 1 = mild, 2 = moderate, and 3 = severe) categorical scale at baseline and at 15, 30, 60, 120,180 and 240 minutes post product administration. All cough severity assessment values were recorded in a questionnaire and tabulated. A reduction in severity score from baseline represented a better outcome measure.', 'unitOfMeasure': 'Score on scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The primary population for assessment of efficacy was the intent to treat (ITT) population. The ITT population was defined as all participants who were randomized and received at least one dose of treatment during the study and provide at least one post baseline assessment of efficacy.'}, {'type': 'SECONDARY', 'title': 'Body Temperature Reduction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Test Tablet', 'description': 'Tablet containing Paracetamol, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide and Chlorpheniramine Maleate Tablets (II) (Paracetamol 500mg, pseudoephedrine 30mg, chlorpheniramine 2mg and dextromethorphan 15mg).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching placebo tablet'}], 'classes': [{'title': 'Change from baseline to 15 minutes', 'categories': [{'measurements': [{'value': '-0.02', 'spread': '0.070', 'groupId': 'OG000'}, {'value': '0.01', 'spread': '0.047', 'groupId': 'OG001'}]}]}, {'title': 'Change from baseline to 30 minutes', 'categories': [{'measurements': [{'value': '-0.03', 'spread': '0.080', 'groupId': 'OG000'}, {'value': '-0.01', 'spread': '0.071', 'groupId': 'OG001'}]}]}, {'title': 'Change from baseline to 60 minutes', 'categories': [{'measurements': [{'value': '-0.04', 'spread': '0.081', 'groupId': 'OG000'}, {'value': '0.01', 'spread': '0.049', 'groupId': 'OG001'}]}]}, {'title': 'Change from baseline to 120 minutes', 'categories': [{'measurements': [{'value': '-0.09', 'spread': '0.079', 'groupId': 'OG000'}, {'value': '-0.04', 'spread': '0.065', 'groupId': 'OG001'}]}]}, {'title': 'Change from baseline to 180 minutes', 'categories': [{'measurements': [{'value': '-0.14', 'spread': '0.060', 'groupId': 'OG000'}, {'value': '-0.09', 'spread': '0.067', 'groupId': 'OG001'}]}]}, {'title': 'Change from baseline to 240 minutes', 'categories': [{'measurements': [{'value': '-0.08', 'spread': '0.058', 'groupId': 'OG000'}, {'value': '-0.11', 'spread': '0.066', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Change from baseline in 15, 30, 60,120, 180, and 240 minutes', 'description': 'Summary statistics for body temperature was presented at baseline and at 15, 30, 60, 120,180 and 240 minutes post treatment. Wilcoxon Rank Sum test was used to investigate if there are any significant treatment differences.', 'unitOfMeasure': '°C (degree Celsius)', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The primary population for assessment of efficacy was the intent to treat (ITT) population. The ITT population was defined as all participants who were randomized and received at least one dose of treatment during the study and provide at least one post baseline assessment of efficacy.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Test Tablet', 'description': 'Tablet containing Paracetamol, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide and Chlorpheniramine Maleate Tablets (II) (Paracetamol 500mg, pseudoephedrine 30mg, chlorpheniramine 2mg and dextromethorphan 15mg).'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Matching placebo tablet'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '26'}, {'groupId': 'FG001', 'numSubjects': '27'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '27'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'The participants were recruited at 2 clinical sites in China'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Test Tablet', 'description': 'Tablet containing Paracetamol, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide and Chlorpheniramine Maleate Tablets (II) (Paracetamol 500mg, pseudoephedrine 30mg, chlorpheniramine 2mg and dextromethorphan 15mg).'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Matching placebo tablet'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '37.8', 'spread': '11.97', 'groupId': 'BG000'}, {'value': '38.5', 'spread': '11.06', 'groupId': 'BG001'}, {'value': '38.2', 'spread': '11.40', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Overall participants in the test arm were 25 as 1 participant data was not included in the baseline measure as he did not completed the study (Due to protocol deviation).'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 53}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-05', 'completionDateStruct': {'date': '2015-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-08-02', 'studyFirstSubmitDate': '2014-09-18', 'resultsFirstSubmitDate': '2015-10-08', 'studyFirstSubmitQcDate': '2014-09-18', 'lastUpdatePostDateStruct': {'date': '2016-09-14', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-05-12', 'studyFirstPostDateStruct': {'date': '2014-09-22', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-06-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Symptom Severity Assessment at 15 Minutes', 'timeFrame': '15 minutes', 'description': 'Symptom severity assessment was determined by Total Sum Score (TSS), TSS ranged from 0 to 21 with less severity score at the given time point represented a better outcome measure.\n\nTSS was calculated as the sum of the non missing scores (all on a 0-3 scale measuring worsening or severity) of the following common cold symptoms: sore throat, headache, extremities pain, nasal congestion, runny nose, sneezing, and cough post treatment administration.\n\nParticipants self assessed symptoms severity using 4 points (0 = absent, 1 = mild, 2 = moderate, and 3 = severe) categorical scale at 15 minutes post product use.'}, {'measure': 'Symptom Severity Assessment at 30 Minutes', 'timeFrame': '30 minutes', 'description': 'Symptom severity assessment was determined by TSS, TSS ranged from 0 to 21 with less severity score at the given time point represented a better outcome measure.\n\nTSS was calculated as the sum of the non missing scores (all on a 0-3 scale measuring worsening or severity) of the following common cold symptoms: sore throat, headache, extremities pain, nasal congestion, runny nose, sneezing, and cough post treatment administration.\n\nParticipants self assessed symptoms severity using 4 points (0 = absent, 1 = mild, 2 = moderate, and 3 = severe) categorical scale at 30 minutes post product use.'}, {'measure': 'Symptom Severity Assessment at 1 Hour', 'timeFrame': '1 hour', 'description': 'Symptom severity assessment was determined by TSS, TSS ranged from 0 to 21 with less severity score at the given time point represented a better outcome measure.\n\nTSS was calculated as the sum of the non missing scores (all on a 0-3 scale measuring worsening or severity) of the following common cold symptoms: sore throat, headache, extremities pain, nasal congestion, runny nose, sneezing, and cough post treatment administration.\n\nParticipants self assessed symptoms severity using 4 points (0 = absent, 1 = mild, 2 = moderate, and 3 = severe) categorical scale at 1hour post product use.'}, {'measure': 'Symptom Severity Assessment at 2 Hours', 'timeFrame': '2 hours', 'description': 'Symptom severity assessment was determined by TSS, TSS ranged from 0 to 21 with less severity score at the given time point represented a better outcome measure.\n\nTSS was calculated as the sum of the non missing scores (all on a 0-3 scale measuring worsening or severity) of the following common cold symptoms: sore throat, headache, extremities pain, nasal congestion, runny nose, sneezing, and cough post treatment administration.\n\nParticipants self assessed symptoms severity using 4 points (0 = absent, 1 = mild, 2 = moderate, and 3 = severe) categorical scale at 2 hours post product use.'}, {'measure': 'Symptom Severity Assessment at 3 Hours', 'timeFrame': '3 hours', 'description': 'Symptom severity assessment was determined by TSS, TSS ranged from 0 to 21 with less severity score at the given time point represented a better outcome measure.\n\nTSS was calculated as the sum of the non missing scores (all on a 0-3 scale measuring worsening or severity) of the following common cold symptoms: sore throat, headache, extremities pain, nasal congestion, runny nose, sneezing, and cough post treatment administration.\n\nParticipants self assessed symptoms severity using 4 points (0 = absent, 1 = mild, 2 = moderate, and 3 = severe) categorical scale at 3 hours post product use.'}, {'measure': 'Symptom Severity Assessment at 4 Hours', 'timeFrame': '4 hours', 'description': 'Symptom severity assessment was determined by TSS, TSS ranged from 0 to 21 with less severity score at the given time point represented a better outcome measure.\n\nTSS was calculated as the sum of the non missing scores (all on a 0-3 scale measuring worsening or severity) of the following common cold symptoms: sore throat, headache, extremities pain, nasal congestion, runny nose, sneezing, and cough post treatment administration.\n\nParticipants self assessed symptoms severity using 4 points (0 = absent, 1 = mild, 2 = moderate, and 3 = severe) categorical scale at 4 hours post product use.'}], 'secondaryOutcomes': [{'measure': 'Global Assessment of Treatment', 'timeFrame': '4 hours', 'description': 'After completing the 4 hours symptom severity assessments, participants evaluated their treatment response on a 5-point scale by answering the question: "How well did the test medication control your symptoms?" (0-ineffective, 1-poor, 2-fair, 3-good, or 4-excellent).'}, {'measure': 'Sore Throat Severity Assessment', 'timeFrame': 'Change from baseline in 15, 30, 60,120, 180, and 240 minutes', 'description': 'Participants self-assessed sore throat severity using 4 points (0 = absent, 1 = mild, 2 = moderate, and 3 = severe) categorical scale at baseline and at 15, 30, 60, 120,180 and 240 minutes post product administration. All sore throat severity assessment values were recorded in questionnaire and tabulated. A reduction in severity score from baseline represented a better outcome measure.'}, {'measure': 'Headache Severity Assessment', 'timeFrame': 'Change from baseline in 15, 30, 60,120, 180, and 240 minutes', 'description': 'Participants self-assessed headache severity using 4 points (0 = absent, 1 = mild, 2 = moderate, and 3 = severe) categorical scale at baseline and at 15, 30, 60, 120,180 and 240 minutes post product administration. All headache severity assessment values were recorded in questionnaire and tabulated. A reduction in severity score from baseline represented a better outcome measure.'}, {'measure': 'Extremities Pain Severity Assessment', 'timeFrame': 'Change from baseline in 15, 30, 60,120, 180, and 240 minutes', 'description': 'Participants self-assessed extremities pain severity using 4 points (0 = absent, 1 = mild, 2 = moderate, and 3 = severe) categorical scale at baseline and at 15, 30, 60, 120,180 and 240 minutes post product administration. All extremities pain severity assessment values were recorded in a questionnaire and tabulated. A reduction in severity score from baseline represented a better outcome measure.'}, {'measure': 'Nasal Congestion Severity Assessment', 'timeFrame': 'Change from baseline in 15, 30, 60,120, 180, and 240 minutes', 'description': 'Participants self-assessed nasal congestion severity using 4 points (0 = absent, 1 = mild, 2 = moderate, and 3 = severe) categorical scale at baseline and at 15, 30, 60, 120,180 and 240 minutes post product administration. All nasal congestion severity assessment values were recorded in a questionnaire and tabulated. A reduction in severity score from baseline represented a better outcome measure.'}, {'measure': 'Runny Nose Severity Assessment', 'timeFrame': 'Change from baseline in 15, 30, 60,120, 180, and 240 minutes', 'description': 'Participants self-assessed runny nose severity using 4 points (0 = absent, 1 = mild, 2 = moderate, and 3 = severe) categorical scale at baseline and at 15, 30, 60, 120,180 and 240 minutes post product administration. All runny nose severity assessment values were recorded in questionnaire and tabulated. A reduction in severity score from baseline represented a better outcome measure.'}, {'measure': 'Sneezing Severity Assessment', 'timeFrame': 'Change from baseline in 15, 30, 60,120, 180, and 240 minutes', 'description': 'Participants self-assessed sneezing severity using 4 points (0 = absent, 1 = mild, 2 = moderate, and 3 = severe) categorical scale at baseline and at 15, 30, 60, 120,180 and 240 minutes post product administration. All sneezing severity assessment values were recorded in a questionnaire and tabulated. A reduction in severity score from baseline represented a better outcome measure.'}, {'measure': 'Cough Severity Assessment', 'timeFrame': 'Change from baseline in 15, 30, 60,120, 180, and 240 minutes', 'description': 'Participants self-assessed cough severity using 4 points (0 = absent, 1 = mild, 2 = moderate, and 3 = severe) categorical scale at baseline and at 15, 30, 60, 120,180 and 240 minutes post product administration. All cough severity assessment values were recorded in a questionnaire and tabulated. A reduction in severity score from baseline represented a better outcome measure.'}, {'measure': 'Body Temperature Reduction', 'timeFrame': 'Change from baseline in 15, 30, 60,120, 180, and 240 minutes', 'description': 'Summary statistics for body temperature was presented at baseline and at 15, 30, 60, 120,180 and 240 minutes post treatment. Wilcoxon Rank Sum test was used to investigate if there are any significant treatment differences.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Common Cold']}, 'descriptionModule': {'briefSummary': 'This phase IV multi-centre, randomised, double-blind, placebo-controlled, parallel-group, single-dose study will assess the efficacy and tolerability of the active tablets versus placebo in participants suffering from cold and influenza. Eligible participants will be randomly assigned to one of 2 treatment groups (active or placebo tablets) and enter a four-hour (hr) treatment phase. Each participant will be administered only once during each study period. Participants will use a questionnaire to record the symptom severity scores as described, as well as time.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged at least 18 years and less than 65 years\n* Good general and mental health in the opinion of the investigator\n* Participants diagnosed with a common cold or flu and must have the following symptoms of at least "moderate" in intensity (≥ 2) at the screening visit (baseline), with a minimum total symptom score of 6:\n\n (i) At least one of pain symptoms: sore throat, headache, or extremities pain (ii) Mandatory: Nasal congestion (iii) At least one of catarrh symptoms: runny nose or sneezing\n* Onset of first symptoms of cold must have occurred within 48 hours of screening.\n\nExclusion Criteria:\n\n* Pregnant or breast feeding women\n* History of seasonal or perennial allergic rhinitis or acute, sub-chronic, or chronic cough due to any condition other than a common cold or flu, as determined by the investigator\n* Concurrent illness or medical history that is contraindicated or cautioned about in the drug label\n* Anatomical factors causing nasal congestion\n* Fever with body temperature \\>38.5°C at baseline\n* Have used any medication or herbal remedies to treat cold prior to screening (antibiotics in the last 7 days, antihistamines in the last 72 hours, analgesics or antipyretics in the last 24 hours, decongestant in the last 12 hours, antitussive, medicated lozenge or throat spray in the last 8 hours)\n* Any medication that has potential drug-drug interactions with study medications\n* Known or suspected intolerance or hypersensitivity to the study materials\n* Have a positive drug urine test or recent history (within the last 2 years) of alcohol or other substance abuse'}, 'identificationModule': {'nctId': 'NCT02246166', 'briefTitle': 'The Effect of Paracetamol, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide and Chlorpheniramine Maleate Tablets Compared to Placebo in Subjects Suffering From the Common Cold or Influenza.', 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': 'A Double-Blind, Randomised, Placebo-Controlled, Parallelgroup, Single-Dose Study to Evaluate Effect of Paracetamol, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide and Chlorpheniramine Maleate Tablets Compared to Placebo in Subjects Suffering From the Common Cold or Influenza Over a 4 Hour Period', 'orgStudyIdInfo': {'id': '202271'}, 'secondaryIdInfos': [{'id': 'RH02565', 'type': 'OTHER', 'domain': 'GSK'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Test tablet', 'description': 'Tablet containing Paracetamol, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide and Chlorpheniramine Maleate Tablets (II) (Paracetamol 500mg, pseudoephedrine 30mg, chlorpheniramine 2mg and dextromethorphan 15mg).', 'interventionNames': ['Drug: Test tablet']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Matching placebo tablet', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Test tablet', 'type': 'DRUG', 'description': 'The active tablet will be administered orally. Product administration will occur within 30mins of the baseline assessment of symptom severity', 'armGroupLabels': ['Test tablet']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'The placebo tablet will be administered orally. Product administration will occur within 30mins of the baseline assessment of symptom severity', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200025', 'city': 'Shanghai', 'country': 'China', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '200120', 'city': 'Shanghai', 'country': 'China', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'overallOfficials': [{'name': 'GSK Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'GlaxoSmithKline'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Sino-American Tianjin Smith Kline & French Laboratories Ltd', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}