Ignite Creation Date:
2025-12-25 @ 12:29 AM
Ignite Modification Date:
2025-12-31 @ 4:47 PM
Study NCT ID:
NCT02910167
Status:
COMPLETED
Last Update Posted:
2019-03-27
First Post:
2016-08-30
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Observational Prospective Study to Evaluate AEs, Risk Factors and Drug Utilization of BUSCAPINA COMPOSITUM N in Adults From Metropolitan Lima
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059787', 'term': 'Acute Pain'}, {'id': 'D004412', 'term': 'Dysmenorrhea'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D008599', 'term': 'Menstruation Disturbances'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D017699', 'term': 'Pelvic Pain'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002086', 'term': 'Butylscopolammonium Bromide'}, {'id': 'D000082', 'term': 'Acetaminophen'}], 'ancestors': [{'id': 'D000644', 'term': 'Quaternary Ammonium Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D012602', 'term': 'Scopolamine Derivatives'}, {'id': 'D014326', 'term': 'Tropanes'}, {'id': 'D053961', 'term': 'Azabicyclo Compounds'}, {'id': 'D001372', 'term': 'Aza Compounds'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D019086', 'term': 'Bridged Bicyclo Compounds, Heterocyclic'}, {'id': 'D006572', 'term': 'Heterocyclic Compounds, Bridged-Ring'}, {'id': 'D000083', 'term': 'Acetanilides'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D000814', 'term': 'Aniline Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clintriage.rdg@boehringer-ingelheim.com', 'phone': '1-800-243-0127', 'title': 'Boehringer Ingelheim, Call Center', 'organization': 'Boehringer Ingelheim'}, 'certainAgreement': {'otherDetails': "Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'Since the study is conducted at some health centers, it cannot be generalized to the whole population who uses study drug. It is without a control group, thus not able to compare cumulative incidence of AE with the patients not exposed to this drug'}}, 'adverseEventsModule': {'timeFrame': 'From the initial dose of study drug until end of the follow up period, up to 113 days', 'description': 'During the observational period, all adverse events following exposure to Buscapina Compositum N were recorded in the case report form, regardless of seriousness or causality.', 'eventGroups': [{'id': 'EG000', 'title': 'Buscapina Compositum N', 'description': 'Combination of 10 milligram (mg) of hyoscine n-butylbromide (HBB) and 500 mg of paracetamol. The dose of Buscapina Compositum N was according to label instructions which patients had to acquire on their own (one to two tablets by mouth every 8 hours for 3 to 4 days, swallowed whole with sufficient water).', 'otherNumAtRisk': 360, 'deathsNumAtRisk': 360, 'otherNumAffected': 0, 'seriousNumAtRisk': 360, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Patients With an Incidence of Adverse Event (AE) Associated to Potential Liver Damage During the Clinical Evaluation of Patients', 'denoms': [{'units': 'Participants', 'counts': [{'value': '342', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Buscapina Compositum N', 'description': 'Combination of 10 milligram (mg) of hyoscine n-butylbromide (HBB) and 500 mg of paracetamol. The dose of Buscapina Compositum N was according to label instructions which patients had to acquire on their own (one to two tablets by mouth every 8 hours for 3 to 4 days, swallowed whole with sufficient water).'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From the initial dose of study drug until end of the follow up period, up to 113 days', 'description': 'Percentage of patients with an incidence of Adverse Event (AE) associated to potential liver damage during the clinical evaluation of patients.', 'unitOfMeasure': 'Percentage of Patients', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients who have received at least one dose of Buscapina Compositum N according to label indications, attended to one of the health centers selected for the study, and who provided data for the baseline and the follow-up visit.'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients With Different Transaminase Levels Found by the Doctor During the Clinical Evaluation of Patients With Symptoms Related to Potential Liver Damage.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '342', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Buscapina Compositum N', 'description': 'Combination of 10 milligram (mg) of hyoscine n-butylbromide (HBB) and 500 mg of paracetamol. The dose of Buscapina Compositum N was according to label instructions which patients had to acquire on their own (one to two tablets by mouth every 8 hours for 3 to 4 days, swallowed whole with sufficient water).'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'No patient with symptoms related to potential liver damage was identified, thus analyses of transaminase levels was not performed.', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From the initial dose of study drug until end of the follow up period, up to 113 days', 'description': 'Percentage of patients with different transaminase levels found by the doctor during the clinical evaluation of patients with symptoms related to potential liver damage. No patient with symptoms related to potential liver damage was identified, thus analyses of transaminase levels was not performed.', 'unitOfMeasure': 'Percentage of Patients', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients who have received at least one dose of Buscapina Compositum N according to label indications, attended to one of the health centers selected for the study, provided data for the baseline and the follow-up visit, and who reported symptoms related to potential liver damage at the follow-up visit.'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients With Different Drug Utilization Patterns of Buscapina Compositum N in Patients in Metropolitan Lima', 'denoms': [{'units': 'Participants', 'counts': [{'value': '342', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Buscapina Compositum N', 'description': 'Combination of 10 milligram (mg) of hyoscine n-butylbromide (HBB) and 500 mg of paracetamol. The dose of Buscapina Compositum N was according to label instructions which patients had to acquire on their own (one to two tablets by mouth every 8 hours for 3 to 4 days, swallowed whole with sufficient water).'}], 'classes': [{'title': 'Patient took the medication with liquids (Yes)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '342', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}]}]}, {'title': 'Patient took the medication with liquids (No)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '342', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'Type of liquid used (Water)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '342', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '94.7', 'groupId': 'OG000'}]}]}, {'title': 'Type of liquid used (Juice)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '342', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}, {'title': 'Type of liquid used (Other)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '342', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.9', 'groupId': 'OG000'}]}]}, {'title': 'Amount of liquid used (A straw/sip)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '342', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.3', 'groupId': 'OG000'}]}]}, {'title': 'Amount of liquid used (1/4 cup)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '342', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.8', 'groupId': 'OG000'}]}]}, {'title': 'Amount of liquid used (1/2 cup)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '342', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '33.0', 'groupId': 'OG000'}]}]}, {'title': 'Amount of liquid used (A full cup)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '342', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '44.7', 'groupId': 'OG000'}]}]}, {'title': 'Amount of liquid used (More than a cup)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '342', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '18.1', 'groupId': 'OG000'}]}]}, {'title': 'Storage of medicine (In a dry and fresh location)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '342', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '98.0', 'groupId': 'OG000'}]}]}, {'title': 'Storage of medicine (In a hot location)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '342', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.3', 'groupId': 'OG000'}]}]}, {'title': 'Storage of medicine (In the refrigerator)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '342', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'Storage of medicine (Other)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '342', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.8', 'groupId': 'OG000'}]}]}, {'title': 'Reason - Not taking medicine (No symptoms anymore)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '51.4', 'groupId': 'OG000'}]}]}, {'title': 'Reason - Not taking medicine (Forgot it)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '23.4', 'groupId': 'OG000'}]}]}, {'title': 'Reason - Not taking medicine (Had no time)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5.6', 'groupId': 'OG000'}]}]}, {'title': 'Reason - Not taking medicine (Other)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '12.2', 'groupId': 'OG000'}]}]}, {'title': 'Reason - Not taking medicine (No answer)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '7.5', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From the initial dose of study drug until end of the follow up period, up to 113 days', 'description': 'Percentage of patients with different drug utilization patterns of Buscapina Compositum N in patients in Metropolitan Lima.', 'unitOfMeasure': 'Percentage of Patients', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients who have received at least one dose of Buscapina Compositum N according to label indications, attended to one of the health centers selected for the study, and who provided data for the baseline and the follow-up visit.'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients Per Adverse Event Preferred Term in Patients Who Developed Any Adverse Event During Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '342', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Buscapina Compositum N', 'description': 'Combination of 10 milligram (mg) of hyoscine n-butylbromide (HBB) and 500 mg of paracetamol. The dose of Buscapina Compositum N was according to label instructions which patients had to acquire on their own (one to two tablets by mouth every 8 hours for 3 to 4 days, swallowed whole with sufficient water).'}], 'classes': [{'title': 'Abdominal pain (upper)', 'categories': [{'measurements': [{'value': '0.3', 'groupId': 'OG000'}]}]}, {'title': 'Diarrhoea', 'categories': [{'measurements': [{'value': '0.3', 'groupId': 'OG000'}]}]}, {'title': 'Nausea', 'categories': [{'measurements': [{'value': '0.3', 'groupId': 'OG000'}]}]}, {'title': 'Constipation', 'categories': [{'measurements': [{'value': '0.3', 'groupId': 'OG000'}]}]}, {'title': 'Abdominal Pain', 'categories': [{'measurements': [{'value': '0.3', 'groupId': 'OG000'}]}]}, {'title': 'Dizziness', 'categories': [{'measurements': [{'value': '0.3', 'groupId': 'OG000'}]}]}, {'title': 'Somnolence', 'categories': [{'measurements': [{'value': '1.2', 'groupId': 'OG000'}]}]}, {'title': 'Cough', 'categories': [{'measurements': [{'value': '0.3', 'groupId': 'OG000'}]}]}, {'title': 'Urine color abnormal', 'categories': [{'measurements': [{'value': '0.3', 'groupId': 'OG000'}]}]}, {'title': 'Headache + nausea', 'categories': [{'measurements': [{'value': '0.3', 'groupId': 'OG000'}]}]}, {'title': 'Nausea + constipation', 'categories': [{'measurements': [{'value': '0.3', 'groupId': 'OG000'}]}]}, {'title': 'Flatulence + constipation', 'categories': [{'measurements': [{'value': '0.3', 'groupId': 'OG000'}]}]}, {'title': 'Polydipsia + abdominal pain (upper)', 'categories': [{'measurements': [{'value': '0.3', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From the initial dose of study drug until end of the follow up period, up to 113 days', 'description': 'Percentage of patients per adverse event preferred term in patients who developed any adverse event during treatment with Buscapina Compositum N.', 'unitOfMeasure': 'Percentage of Patients', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients who have received at least one dose of Buscapina Compositum N according to label indications, attended to one of the health centers selected for the study, provided data for the baseline and the follow-up visit, and who developed any adverse event during treatment.'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients With Different Variables Related to the Occurrence of Increase of Transaminases in Patients Under Treatment With Buscapina Compositum N', 'denoms': [{'units': 'Participants', 'counts': [{'value': '342', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Buscapina Compositum N', 'description': 'Combination of 10 milligram (mg) of hyoscine n-butylbromide (HBB) and 500 mg of paracetamol. The dose of Buscapina Compositum N was according to label instructions which patients had to acquire on their own (one to two tablets by mouth every 8 hours for 3 to 4 days, swallowed whole with sufficient water).'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'No patient with symptoms related to potential liver damage was identified, thus analyses of transaminase levels was not performed', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From the initial dose of study drug until end of the follow up period, up to 113 days', 'description': 'Percentage of patients with different variables related to the occurrence of increase of transaminases in patients under treatment with Buscapina Compositum N in Metropolitan Lima. No patient with symptoms related to potential liver damage was identified, thus analyses of transaminase levels was not performed.', 'unitOfMeasure': 'Percentage of Patients', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients who have received at least one dose of Buscapina Compositum N according to label indications, attended to one of the health centers selected for the study, provided data for the baseline and the follow-up visit.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Buscapina Compositum N', 'description': 'Combination of 10 milligram (mg) of hyoscine n-butylbromide (HBB) and 500 mg of paracetamol. The dose of Buscapina Compositum N was according to label instructions which patients had to acquire on their own (one to two tablets by mouth every 8 hours for 3 to 4 days, swallowed whole with sufficient water).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '360'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '341'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '18'}]}]}], 'recruitmentDetails': 'Observational prospective study to evaluate adverse events (AEs), Risk factors and drug utilization of Buscapina Compositum N in adults from metropolitan lima', 'preAssignmentDetails': 'All patients were screened for eligibility to participate in the trial. Patients attended one of 4 specialist sites which ensured that they met all strictly implemented inclusion/exclusion criteria. Patients were not to be entered to trial treatment if any one of the specific entry criteria was violated.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '360', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Buscapina Compositum N', 'description': 'Combination of 10 milligram (mg) of hyoscine n-butylbromide (HBB) and 500 mg of paracetamol. The dose of Buscapina Compositum N was according to label instructions which patients had to acquire on their own (one to two tablets by mouth every 8 hours for 3 to 4 days, swallowed whole with sufficient water).'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '360', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '36.2', 'spread': '13.6', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'Age at the time of signing informed consent form is presented.', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Patients who have received at least one dose of Buscapina Compositum N according to label indications and who attended to one of the health centers selected for the study.'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '360', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '270', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '90', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Number of subjects is categorized as Male or Female.', 'unitOfMeasure': 'Participants', 'populationDescription': 'Patients who have received at least one dose of Buscapina Compositum N according to label indications and who attended to one of the health centers selected for the study.'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}], 'populationDescription': 'Patients who have received at least one dose of Buscapina Compositum N according to label indications and who attended to one of the health centers selected for the study.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-01-10', 'size': 280594, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-03-25T07:46', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 360}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-10-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'completionDateStruct': {'date': '2017-02-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-03-26', 'studyFirstSubmitDate': '2016-08-30', 'resultsFirstSubmitDate': '2018-02-09', 'studyFirstSubmitQcDate': '2016-09-19', 'lastUpdatePostDateStruct': {'date': '2019-03-27', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-03-26', 'studyFirstPostDateStruct': {'date': '2016-09-21', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-03-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-02-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Patients With an Incidence of Adverse Event (AE) Associated to Potential Liver Damage During the Clinical Evaluation of Patients', 'timeFrame': 'From the initial dose of study drug until end of the follow up period, up to 113 days', 'description': 'Percentage of patients with an incidence of Adverse Event (AE) associated to potential liver damage during the clinical evaluation of patients.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Patients With Different Transaminase Levels Found by the Doctor During the Clinical Evaluation of Patients With Symptoms Related to Potential Liver Damage.', 'timeFrame': 'From the initial dose of study drug until end of the follow up period, up to 113 days', 'description': 'Percentage of patients with different transaminase levels found by the doctor during the clinical evaluation of patients with symptoms related to potential liver damage. No patient with symptoms related to potential liver damage was identified, thus analyses of transaminase levels was not performed.'}, {'measure': 'Percentage of Patients With Different Drug Utilization Patterns of Buscapina Compositum N in Patients in Metropolitan Lima', 'timeFrame': 'From the initial dose of study drug until end of the follow up period, up to 113 days', 'description': 'Percentage of patients with different drug utilization patterns of Buscapina Compositum N in patients in Metropolitan Lima.'}, {'measure': 'Percentage of Patients Per Adverse Event Preferred Term in Patients Who Developed Any Adverse Event During Treatment', 'timeFrame': 'From the initial dose of study drug until end of the follow up period, up to 113 days', 'description': 'Percentage of patients per adverse event preferred term in patients who developed any adverse event during treatment with Buscapina Compositum N.'}, {'measure': 'Percentage of Patients With Different Variables Related to the Occurrence of Increase of Transaminases in Patients Under Treatment With Buscapina Compositum N', 'timeFrame': 'From the initial dose of study drug until end of the follow up period, up to 113 days', 'description': 'Percentage of patients with different variables related to the occurrence of increase of transaminases in patients under treatment with Buscapina Compositum N in Metropolitan Lima. No patient with symptoms related to potential liver damage was identified, thus analyses of transaminase levels was not performed.'}]}, 'conditionsModule': {'conditions': ['Acute Pain', 'Dysmenorrhea']}, 'descriptionModule': {'briefSummary': 'What AE occur in routine clinical practice, what is the incidence of AE and Adverse Drug Reaction, how many patients present with AE symptoms related to a potential liver injury. What are the drug utilization patterns in patients, what are the predisposing factors for the occurrence of adverse events and adverse drug reactions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Metropolitan Lima', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n1. Patients 18 years of age and older who have received at least one dose of BUSCAPINA COMPOSITUM N according to label indications and who attend to one of the pharmacies, clinics, or private doctors office selected for the study.\n2. Patients who agree to adhere to the protocol procedures of this study.\n3. Women who are not pregnant or breast feeding\n4. Persons who sign the informed consent\n\nExclusion criteria:\n\n1. Patients with allergy to BUSCAPINA COMPOSITUM N or any of the compounds in the formula.\n2. Patients with mechanical stenosis of the gastrointestinal tract.\n3. Patients with myasthenia gravis.\n4. Patients with megacolon.\n5. Patients breastfeeding at the time of enrollment or who have become pregnant during treatment with BUSCAPINA COMPOSITUM N.\n6. Patients with clinical evidence of immunosuppression.\n7. Patients with urinary retention subvesical obstruction (such as prostatic adenoma).\n8. Patients with right-angle glaucoma.\n9. Patients with tachycardia and tachyarrhythmia.\n10. Patients with severe hepatic impairment.\n11. Patients with psychiatric disorders.\n12. Patients with alcohol dependence or drugs.\n13. Patients who discontinue the protocol are not eligible for re-enrollment.\n14. Researchers, company personnel or their relatives.'}, 'identificationModule': {'nctId': 'NCT02910167', 'briefTitle': 'Observational Prospective Study to Evaluate AEs, Risk Factors and Drug Utilization of BUSCAPINA COMPOSITUM N in Adults From Metropolitan Lima', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': 'Observational Prospective Cohort Study to Evaluate the Incidence of Adverse Events (AE), Risk Factors, and Drug Utilization Patterns Related to Treatment With BUSCAPINA COMPOSITUM N From March to December 2016 in Patients From Metropolitan Lima', 'orgStudyIdInfo': {'id': '218.705'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Men with spasmodic syndromes', 'description': 'Men with any type of gastrointestinal, hepato-biliary, urinary or genital spasmodic syndromes', 'interventionNames': ['Drug: Hyoscine n-butylbromide', 'Drug: Paracetamol']}, {'label': 'Women with spasmodic syndromes', 'description': 'Women with any type of gastrointestinal, hepato-biliary, urinary or genital spasmodic syndromes', 'interventionNames': ['Drug: Hyoscine n-butylbromide', 'Drug: Paracetamol']}], 'interventions': [{'name': 'Hyoscine n-butylbromide', 'type': 'DRUG', 'description': 'Hyoscine n-butylbromide 10 mg', 'armGroupLabels': ['Men with spasmodic syndromes']}, {'name': 'Paracetamol', 'type': 'DRUG', 'description': 'Paracetamol 500 mg', 'armGroupLabels': ['Men with spasmodic syndromes']}, {'name': 'Hyoscine n-butylbromide', 'type': 'DRUG', 'description': 'Hyoscine n-butylbromide 10 mg', 'armGroupLabels': ['Women with spasmodic syndromes']}, {'name': 'Paracetamol', 'type': 'DRUG', 'description': 'Paracetamol 500 mg', 'armGroupLabels': ['Women with spasmodic syndromes']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Multiple Locations', 'country': 'Peru'}], 'overallOfficials': [{'name': 'Boehringer Ingelheim', 'role': 'STUDY_CHAIR', 'affiliation': 'Boehringer Ingelheim'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boehringer Ingelheim', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}