Ignite Creation Date:
2025-12-24 @ 6:59 PM
Ignite Modification Date:
2026-01-26 @ 6:37 PM
Study NCT ID:
NCT01448057
Status:
COMPLETED
Last Update Posted:
2017-03-03
First Post:
2011-10-05
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Evaluation of Efficacy and Safety of Tablets of Paracetamol, Dimethindene Maleate and Phenylephrine Hydrochloride in Reducing Symptoms of Common Cold and Flu
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D015508', 'term': 'Nasal Obstruction'}, {'id': 'D000086722', 'term': 'Rhinorrhea'}, {'id': 'D012912', 'term': 'Sneezing'}, {'id': 'D003139', 'term': 'Common Cold'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D009668', 'term': 'Nose Diseases'}, {'id': 'D000402', 'term': 'Airway Obstruction'}, {'id': 'D012131', 'term': 'Respiratory Insufficiency'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010850', 'term': 'Picornaviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000082', 'term': 'Acetaminophen'}, {'id': 'D004115', 'term': 'Dimethindene'}, {'id': 'D010656', 'term': 'Phenylephrine'}], 'ancestors': [{'id': 'D000083', 'term': 'Acetanilides'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D007192', 'term': 'Indenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D004983', 'term': 'Ethanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'anna.x.grinienko@gsk.com', 'phone': '(1) 5512065988', 'title': 'Director Clinical research Respiratory', 'organization': 'Novartis consumer Health a GSK Consumer Healtcare company'}, 'certainAgreement': {'otherDetails': 'Preliminary agreement between Novartis Consumer Health and the investigator', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '3 days', 'eventGroups': [{'id': 'EG000', 'title': 'Arm A', 'description': 'Combination Product\n\nParacetamol (500 mg)/dimethindene maleate (1 mg)/ phenylephrine hydrochloride (10 mg) tablets: Paracetamol (500 mg)/dimethindene maleate (1 mg)/ phenylephrine hydrochloride (10 mg) tablets', 'otherNumAtRisk': 170, 'otherNumAffected': 77, 'seriousNumAtRisk': 170, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Arm B', 'description': 'Paracetamol (500 mg) tablets\n\nParacetamol (500 mg) tablets: Paracetamol (500 mg) tablets', 'otherNumAtRisk': 171, 'otherNumAffected': 39, 'seriousNumAtRisk': 171, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numEvents': 71, 'numAffected': 71}, {'groupId': 'EG001', 'numAtRisk': 171, 'numEvents': 37, 'numAffected': 37}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 171, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '3'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Physician Global Evaluation of Effectiveness on Nasal Symptoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '162', 'groupId': 'OG000'}, {'value': '170', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A', 'description': 'Combination Product Paracetamol (500 mg)/dimethindene maleate (1 mg)/ phenylephrine hydrochloride (10 mg) tablets'}, {'id': 'OG001', 'title': 'Arm B', 'description': 'Paracetamol (500 mg) tablets\n\nParacetamol (500 mg) tablets: Paracetamol (500 mg) tablets'}], 'classes': [{'categories': [{'measurements': [{'value': '1.9', 'spread': '0.84', 'groupId': 'OG000'}, {'value': '2.1', 'spread': '0.91', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 2', 'description': 'The Physician will measure the reduction of Nasal Symptoms (Nasal Congestion, Sneezing, and Rhinorrhea) on day 2.\n\nRange from 1 to 5 where 1 is excellent and 5 is bad :\n\n1 = excellent : 75% to 100% remission of signs and symptoms 5 = bad : exacerbation of nasal symptoms', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'In the combination product arm 8 subjects had missing assessment and 1 subject in the paracetamol arm'}, {'type': 'SECONDARY', 'title': 'Daily Average of the Sum of a 100 mm Visual Analog Scale for All Symptoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '159', 'groupId': 'OG000'}, {'value': '166', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A', 'description': 'Combination Product Paracetamol (500 mg)/dimethindene maleate (1 mg)/ phenylephrine hydrochloride (10 mg) tablets'}, {'id': 'OG001', 'title': 'Arm B', 'description': 'Paracetamol (500 mg) tablets\n\nParacetamol (500 mg) tablets: Paracetamol (500 mg) tablets'}], 'classes': [{'categories': [{'measurements': [{'value': '169.2', 'spread': '231.14', 'groupId': 'OG000'}, {'value': '225.3', 'spread': '262.59', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 3', 'description': 'Subject will assess Nasal and non Nasal symptoms using a 100 mm Visual Analog Scale for each symptom, 0=no symptoms 100= the worst possible symptoms', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'In the combination product arm 11 subjects had missing assessment and 5 subject in the paracetamol arm'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Combination Product', 'description': 'Paracetamol (500 mg)/dimethindene maleate (1 mg)/ phenylephrine hydrochloride (10 mg) tablets\n\nParacetamol (500 mg)/dimethindene maleate (1 mg)/ phenylephrine hydrochloride (10 mg) tablets: Paracetamol (500 mg)/dimethindene maleate (1 mg)/ phenylephrine hydrochloride (10 mg) tablets'}, {'id': 'FG001', 'title': 'Paracetamol Tablets', 'description': 'Paracetamol (500 mg) tablets\n\nParacetamol (500 mg) tablets: Paracetamol (500 mg) tablets'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '170'}, {'groupId': 'FG001', 'numSubjects': '171'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '162'}, {'groupId': 'FG001', 'numSubjects': '167'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '170', 'groupId': 'BG000'}, {'value': '171', 'groupId': 'BG001'}, {'value': '341', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Arm A', 'description': 'Combination Product\n\nParacetamol (500 mg)/dimethindene maleate (1 mg)/ phenylephrine hydrochloride (10 mg) tablets: Paracetamol (500 mg)/dimethindene maleate (1 mg)/ phenylephrine hydrochloride (10 mg) tablets'}, {'id': 'BG001', 'title': 'Arm B', 'description': 'Paracetamol (500 mg) tablets\n\nParacetamol (500 mg) tablets: Paracetamol (500 mg) tablets'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '170', 'groupId': 'BG000'}, {'value': '171', 'groupId': 'BG001'}, {'value': '341', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '36', 'spread': '11.64', 'groupId': 'BG000'}, {'value': '34.5', 'spread': '11.76', 'groupId': 'BG001'}, {'value': '35.3', 'spread': '11.71', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Gender', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '122', 'groupId': 'BG000'}, {'value': '134', 'groupId': 'BG001'}, {'value': '256', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '48', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '85', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Brazil', 'categories': [{'measurements': [{'value': '170', 'groupId': 'BG000'}, {'value': '171', 'groupId': 'BG001'}, {'value': '341', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 341}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-01-18', 'studyFirstSubmitDate': '2011-10-05', 'resultsFirstSubmitDate': '2016-08-16', 'studyFirstSubmitQcDate': '2011-10-06', 'lastUpdatePostDateStruct': {'date': '2017-03-03', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2016-11-17', 'studyFirstPostDateStruct': {'date': '2011-10-07', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-01-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Physician Global Evaluation of Effectiveness on Nasal Symptoms', 'timeFrame': 'Day 2', 'description': 'The Physician will measure the reduction of Nasal Symptoms (Nasal Congestion, Sneezing, and Rhinorrhea) on day 2.\n\nRange from 1 to 5 where 1 is excellent and 5 is bad :\n\n1 = excellent : 75% to 100% remission of signs and symptoms 5 = bad : exacerbation of nasal symptoms'}], 'secondaryOutcomes': [{'measure': 'Daily Average of the Sum of a 100 mm Visual Analog Scale for All Symptoms', 'timeFrame': 'Day 3', 'description': 'Subject will assess Nasal and non Nasal symptoms using a 100 mm Visual Analog Scale for each symptom, 0=no symptoms 100= the worst possible symptoms'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Paracetamol', 'dimethindene maleate', 'phenylephrine hydrochloride', 'cold and flu symptoms'], 'conditions': ['Upper Respiratory Tract Infection', 'Nasal Congestion', 'Rhinorrhea', 'Sneezing']}, 'descriptionModule': {'briefSummary': 'The study is a clinical evaluation of an over the counter (OTC) combination product containing paracetamol (500 mg), dimethindene maleate (1 mg), phenylephrine hydrochloride (10 mg) compared to paracetamol (500 mg) alone in the treatment of nasal congestion, rhinorrhea, sneezing and other symptoms due to upper respiratory tract infection (URTI).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': '* Inclusion criteria:\n\n • acute URTI, diagnosed by a health care professional at the study site, with the following symptoms having started within 72 hours before the screening/baseline Visit: nasal congestion, sneezing, and rhinorrhea.\n* Exclusion criteria:\n\n * Use of other investigational drugs within 30 days or 10 half-lives before enrollment, whichever is longer.\n * History of or known hypersensitivity to any of the study drugs, excipients or to drugs of similar chemical classes.\n\nOther protocol-defined inclusion/exclusion criteria may apply'}, 'identificationModule': {'nctId': 'NCT01448057', 'briefTitle': 'Evaluation of Efficacy and Safety of Tablets of Paracetamol, Dimethindene Maleate and Phenylephrine Hydrochloride in Reducing Symptoms of Common Cold and Flu', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A Prospective, Randomized, Investigator-Blind Study to Compare Three Days of Treatment With Paracetamol (500 mg) / Dimethindene Maleate (1 mg) / Phenylephrine Hydrochloride (10 mg) Tablets Versus Paracetamol 500 mg Alone in the Treatment of Nasal Congestion and Other Symptoms Due to Cold and Flu', 'orgStudyIdInfo': {'id': '381-A-301'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Combination Product', 'description': 'Paracetamol (500 mg)/dimethindene maleate (1 mg)/ phenylephrine hydrochloride (10 mg) tablets', 'interventionNames': ['Drug: Paracetamol (500 mg)/dimethindene maleate (1 mg)/ phenylephrine hydrochloride (10 mg) tablets']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Paracetamol tablets', 'description': 'Paracetamol (500 mg) tablets', 'interventionNames': ['Drug: Paracetamol (500 mg) tablets']}], 'interventions': [{'name': 'Paracetamol (500 mg)/dimethindene maleate (1 mg)/ phenylephrine hydrochloride (10 mg) tablets', 'type': 'DRUG', 'description': 'Paracetamol (500 mg)/dimethindene maleate (1 mg)/ phenylephrine hydrochloride (10 mg) tablets', 'armGroupLabels': ['Combination Product']}, {'name': 'Paracetamol (500 mg) tablets', 'type': 'DRUG', 'description': 'Paracetamol (500 mg) tablets', 'armGroupLabels': ['Paracetamol tablets']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30150-221', 'city': 'Belo Horizonte/MG', 'country': 'Brazil', 'facility': 'Santa Casa De Misericordia De Belo Horizonte - Avenida Francisco Sales 1111, Santa Efigenia'}, {'city': 'Campinas/SP', 'country': 'Brazil', 'facility': 'Sociedade Campineira De Educacao E Instrucao - Rodovia Dom Pedro I, KM 136 Parque das Universidades'}, {'zip': '60170-320', 'city': 'Fortaleza/CE', 'country': 'Brazil', 'facility': 'Instituto de Ensino e Pesquisa Clínica do Ceará, Rua Coronel Jucá, 1952 - Dionísio Torres -'}, {'zip': '17210-070', 'city': 'Jau/SP', 'country': 'Brazil', 'facility': 'Polonio Clinica De Servicios Medicos EM Gastroenterologia E Cirurgia Toracica S/S LTDA - ME, Rua Major Alfredo Servulo de Oliveira Romao, 103, Chacara Braz Miraglia'}, {'zip': '13271-130', 'city': 'São Paulo', 'country': 'Brazil', 'facility': ': Lal Clinica Centro de Pesquisa e Desenvolvimento Ltda, Rua General Osório, 503, Vila Martina / Valinhos', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}, {'city': 'São Paulo', 'country': 'Brazil', 'facility': 'Associacao Fundo De Incentivo A Pesquisa - AFIP - Rua Marselhesa 500 - Vila Clementino', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}