Trial Outcomes & Findings for Observational Prospective Study to Evaluate AEs, Risk Factors and Drug Utilization of BUSCAPINA COMPOSITUM N in Adults From Metropolitan Lima (NCT NCT02910167)
NCT ID: NCT02910167
Last Updated: 2019-03-27
Results Overview
Percentage of patients with an incidence of Adverse Event (AE) associated to potential liver damage during the clinical evaluation of patients.
COMPLETED
360 participants
From the initial dose of study drug until end of the follow up period, up to 113 days
2019-03-27
Participant Flow
Observational prospective study to evaluate adverse events (AEs), Risk factors and drug utilization of Buscapina Compositum N in adults from metropolitan lima
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.
Participant milestones
| Measure |
Buscapina Compositum N
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).
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|---|---|
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Overall Study
STARTED
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360
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Overall Study
COMPLETED
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341
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Overall Study
NOT COMPLETED
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19
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Reasons for withdrawal
| Measure |
Buscapina Compositum N
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).
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|---|---|
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Overall Study
Adverse Event
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1
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Overall Study
Lost to Follow-up
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18
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Baseline Characteristics
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.
Baseline characteristics by cohort
| Measure |
Buscapina Compositum N
n=360 Participants
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).
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|---|---|
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Age, Continuous
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36.2 Years
STANDARD_DEVIATION 13.6 • n=360 Participants • 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.
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Sex: Female, Male
Female
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270 Participants
n=360 Participants • 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.
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Sex: Female, Male
Male
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90 Participants
n=360 Participants • 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.
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PRIMARY outcome
Timeframe: From the initial dose of study drug until end of the follow up period, up to 113 daysPopulation: 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.
Percentage of patients with an incidence of Adverse Event (AE) associated to potential liver damage during the clinical evaluation of patients.
Outcome measures
| Measure |
Buscapina Compositum N
n=342 Participants
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).
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|---|---|
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Percentage of Patients With an Incidence of Adverse Event (AE) Associated to Potential Liver Damage During the Clinical Evaluation of Patients
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0.0 Percentage of Patients
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SECONDARY outcome
Timeframe: From the initial dose of study drug until end of the follow up period, up to 113 daysPopulation: 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.
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.
Outcome measures
| Measure |
Buscapina Compositum N
n=342 Participants
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).
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Percentage of Patients With Different Transaminase Levels Found by the Doctor During the Clinical Evaluation of Patients With Symptoms Related to Potential Liver Damage.
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NA Percentage of Patients
No patient with symptoms related to potential liver damage was identified, thus analyses of transaminase levels was not performed.
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SECONDARY outcome
Timeframe: From the initial dose of study drug until end of the follow up period, up to 113 daysPopulation: 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.
Percentage of patients with different drug utilization patterns of Buscapina Compositum N in patients in Metropolitan Lima.
Outcome measures
| Measure |
Buscapina Compositum N
n=342 Participants
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).
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Percentage of Patients With Different Drug Utilization Patterns of Buscapina Compositum N in Patients in Metropolitan Lima
Patient took the medication with liquids (Yes)
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100.0 Percentage of Patients
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Percentage of Patients With Different Drug Utilization Patterns of Buscapina Compositum N in Patients in Metropolitan Lima
Patient took the medication with liquids (No)
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0.0 Percentage of Patients
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Percentage of Patients With Different Drug Utilization Patterns of Buscapina Compositum N in Patients in Metropolitan Lima
Type of liquid used (Water)
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94.7 Percentage of Patients
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Percentage of Patients With Different Drug Utilization Patterns of Buscapina Compositum N in Patients in Metropolitan Lima
Type of liquid used (Juice)
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8 Percentage of Patients
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Percentage of Patients With Different Drug Utilization Patterns of Buscapina Compositum N in Patients in Metropolitan Lima
Type of liquid used (Other)
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2.9 Percentage of Patients
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Percentage of Patients With Different Drug Utilization Patterns of Buscapina Compositum N in Patients in Metropolitan Lima
Amount of liquid used (A straw/sip)
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0.3 Percentage of Patients
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Percentage of Patients With Different Drug Utilization Patterns of Buscapina Compositum N in Patients in Metropolitan Lima
Amount of liquid used (1/4 cup)
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3.8 Percentage of Patients
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Percentage of Patients With Different Drug Utilization Patterns of Buscapina Compositum N in Patients in Metropolitan Lima
Amount of liquid used (1/2 cup)
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33.0 Percentage of Patients
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Percentage of Patients With Different Drug Utilization Patterns of Buscapina Compositum N in Patients in Metropolitan Lima
Amount of liquid used (A full cup)
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44.7 Percentage of Patients
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Percentage of Patients With Different Drug Utilization Patterns of Buscapina Compositum N in Patients in Metropolitan Lima
Amount of liquid used (More than a cup)
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18.1 Percentage of Patients
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Percentage of Patients With Different Drug Utilization Patterns of Buscapina Compositum N in Patients in Metropolitan Lima
Storage of medicine (In a dry and fresh location)
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98.0 Percentage of Patients
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Percentage of Patients With Different Drug Utilization Patterns of Buscapina Compositum N in Patients in Metropolitan Lima
Storage of medicine (In a hot location)
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0.3 Percentage of Patients
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Percentage of Patients With Different Drug Utilization Patterns of Buscapina Compositum N in Patients in Metropolitan Lima
Storage of medicine (In the refrigerator)
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0.0 Percentage of Patients
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Percentage of Patients With Different Drug Utilization Patterns of Buscapina Compositum N in Patients in Metropolitan Lima
Storage of medicine (Other)
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1.8 Percentage of Patients
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Percentage of Patients With Different Drug Utilization Patterns of Buscapina Compositum N in Patients in Metropolitan Lima
Reason - Not taking medicine (No symptoms anymore)
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51.4 Percentage of Patients
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Percentage of Patients With Different Drug Utilization Patterns of Buscapina Compositum N in Patients in Metropolitan Lima
Reason - Not taking medicine (Forgot it)
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23.4 Percentage of Patients
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Percentage of Patients With Different Drug Utilization Patterns of Buscapina Compositum N in Patients in Metropolitan Lima
Reason - Not taking medicine (Had no time)
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5.6 Percentage of Patients
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Percentage of Patients With Different Drug Utilization Patterns of Buscapina Compositum N in Patients in Metropolitan Lima
Reason - Not taking medicine (Other)
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12.2 Percentage of Patients
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Percentage of Patients With Different Drug Utilization Patterns of Buscapina Compositum N in Patients in Metropolitan Lima
Reason - Not taking medicine (No answer)
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7.5 Percentage of Patients
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SECONDARY outcome
Timeframe: From the initial dose of study drug until end of the follow up period, up to 113 daysPopulation: 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.
Percentage of patients per adverse event preferred term in patients who developed any adverse event during treatment with Buscapina Compositum N.
Outcome measures
| Measure |
Buscapina Compositum N
n=342 Participants
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).
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Percentage of Patients Per Adverse Event Preferred Term in Patients Who Developed Any Adverse Event During Treatment
Nausea
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0.3 Percentage of Patients
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Percentage of Patients Per Adverse Event Preferred Term in Patients Who Developed Any Adverse Event During Treatment
Nausea + constipation
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0.3 Percentage of Patients
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Percentage of Patients Per Adverse Event Preferred Term in Patients Who Developed Any Adverse Event During Treatment
Flatulence + constipation
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0.3 Percentage of Patients
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Percentage of Patients Per Adverse Event Preferred Term in Patients Who Developed Any Adverse Event During Treatment
Abdominal pain (upper)
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0.3 Percentage of Patients
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Percentage of Patients Per Adverse Event Preferred Term in Patients Who Developed Any Adverse Event During Treatment
Diarrhoea
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0.3 Percentage of Patients
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Percentage of Patients Per Adverse Event Preferred Term in Patients Who Developed Any Adverse Event During Treatment
Constipation
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0.3 Percentage of Patients
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Percentage of Patients Per Adverse Event Preferred Term in Patients Who Developed Any Adverse Event During Treatment
Abdominal Pain
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0.3 Percentage of Patients
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Percentage of Patients Per Adverse Event Preferred Term in Patients Who Developed Any Adverse Event During Treatment
Dizziness
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0.3 Percentage of Patients
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Percentage of Patients Per Adverse Event Preferred Term in Patients Who Developed Any Adverse Event During Treatment
Somnolence
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1.2 Percentage of Patients
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Percentage of Patients Per Adverse Event Preferred Term in Patients Who Developed Any Adverse Event During Treatment
Cough
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0.3 Percentage of Patients
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Percentage of Patients Per Adverse Event Preferred Term in Patients Who Developed Any Adverse Event During Treatment
Urine color abnormal
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0.3 Percentage of Patients
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Percentage of Patients Per Adverse Event Preferred Term in Patients Who Developed Any Adverse Event During Treatment
Headache + nausea
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0.3 Percentage of Patients
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Percentage of Patients Per Adverse Event Preferred Term in Patients Who Developed Any Adverse Event During Treatment
Polydipsia + abdominal pain (upper)
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0.3 Percentage of Patients
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SECONDARY outcome
Timeframe: From the initial dose of study drug until end of the follow up period, up to 113 daysPopulation: 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.
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.
Outcome measures
| Measure |
Buscapina Compositum N
n=342 Participants
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).
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|---|---|
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Percentage of Patients With Different Variables Related to the Occurrence of Increase of Transaminases in Patients Under Treatment With Buscapina Compositum N
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NA Percentage of Patients
No patient with symptoms related to potential liver damage was identified, thus analyses of transaminase levels was not performed
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Adverse Events
Buscapina Compositum N
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Boehringer Ingelheim, Call Center
Boehringer Ingelheim
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER