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Observational Prospective Study to Evaluate AEs, Risk Factors and Drug Utilization of BUSCAPINA COMPOSITUM N in Adults From Metropolitan Lima

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ClinicalTrials.gov Identifier: NCT02910167
Recruitment Status : Completed
First Posted : September 21, 2016
Results First Posted : March 27, 2019
Last Update Posted : March 27, 2019
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Conditions Acute Pain
Dysmenorrhea
Interventions Drug: Hyoscine n-butylbromide
Drug: Paracetamol
Enrollment 360
Recruitment Details Observational prospective study to evaluate adverse events (AEs), Risk factors and drug utilization of Buscapina Compositum N in adults from metropolitan lima
Pre-assignment Details 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.
Arm/Group Title Buscapina Compositum N
Hide Arm/Group 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).
Period Title: Overall Study
Started 360
Completed 341
Not Completed 19
Reason Not Completed
Adverse Event             1
Lost to Follow-up             18
Arm/Group Title Buscapina Compositum N
Hide Arm/Group 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).
Overall Number of Baseline Participants 360
Hide Baseline Analysis Population Description
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.
Age, Continuous   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 360 participants
36.2  (13.6)
[1]
Measure Description: Age at the time of signing informed consent form is presented.
[2]
Measure Analysis Population Description: 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.
Sex: Female, Male   [1] [2] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 360 participants
Female
270
  75.0%
Male
90
  25.0%
[1]
Measure Description: Number of subjects is categorized as Male or Female.
[2]
Measure Analysis Population Description: 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.
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
1.Primary Outcome
Title Percentage of Patients With an Incidence of Adverse Event (AE) Associated to Potential Liver Damage During the Clinical Evaluation of Patients
Hide Description Percentage of patients with an incidence of Adverse Event (AE) associated to potential liver damage during the clinical evaluation of patients.
Time Frame From the initial dose of study drug until end of the follow up period, up to 113 days
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Buscapina Compositum N
Hide Arm/Group 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).
Overall Number of Participants Analyzed 342
Measure Type: Number
Unit of Measure: Percentage of Patients
0.0
2.Secondary Outcome
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.
Hide 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.
Time Frame From the initial dose of study drug until end of the follow up period, up to 113 days
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Buscapina Compositum N
Hide Arm/Group 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).
Overall Number of Participants Analyzed 342
Measure Type: Number
Unit of Measure: Percentage of Patients
NA [1] 
[1]
No patient with symptoms related to potential liver damage was identified, thus analyses of transaminase levels was not performed.
3.Secondary Outcome
Title Percentage of Patients With Different Drug Utilization Patterns of Buscapina Compositum N in Patients in Metropolitan Lima
Hide Description Percentage of patients with different drug utilization patterns of Buscapina Compositum N in patients in Metropolitan Lima.
Time Frame From the initial dose of study drug until end of the follow up period, up to 113 days
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Buscapina Compositum N
Hide Arm/Group 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).
Overall Number of Participants Analyzed 342
Measure Type: Number
Unit of Measure: Percentage of Patients
Patient took the medication with liquids (Yes) Number Analyzed 342 participants
100.0
Patient took the medication with liquids (No) Number Analyzed 342 participants
0.0
Type of liquid used (Water) Number Analyzed 342 participants
94.7
Type of liquid used (Juice) Number Analyzed 342 participants
8
Type of liquid used (Other) Number Analyzed 342 participants
2.9
Amount of liquid used (A straw/sip) Number Analyzed 342 participants
0.3
Amount of liquid used (1/4 cup) Number Analyzed 342 participants
3.8
Amount of liquid used (1/2 cup) Number Analyzed 342 participants
33.0
Amount of liquid used (A full cup) Number Analyzed 342 participants
44.7
Amount of liquid used (More than a cup) Number Analyzed 342 participants
18.1
Storage of medicine (In a dry and fresh location) Number Analyzed 342 participants
98.0
Storage of medicine (In a hot location) Number Analyzed 342 participants
0.3
Storage of medicine (In the refrigerator) Number Analyzed 342 participants
0.0
Storage of medicine (Other) Number Analyzed 342 participants
1.8
Reason - Not taking medicine (No symptoms anymore) Number Analyzed 107 participants
51.4
Reason - Not taking medicine (Forgot it) Number Analyzed 107 participants
23.4
Reason - Not taking medicine (Had no time) Number Analyzed 107 participants
5.6
Reason - Not taking medicine (Other) Number Analyzed 107 participants
12.2
Reason - Not taking medicine (No answer) Number Analyzed 107 participants
7.5
4.Secondary Outcome
Title Percentage of Patients Per Adverse Event Preferred Term in Patients Who Developed Any Adverse Event During Treatment
Hide Description Percentage of patients per adverse event preferred term in patients who developed any adverse event during treatment with Buscapina Compositum N.
Time Frame From the initial dose of study drug until end of the follow up period, up to 113 days
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Buscapina Compositum N
Hide Arm/Group 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).
Overall Number of Participants Analyzed 342
Measure Type: Number
Unit of Measure: Percentage of Patients
Abdominal pain (upper) 0.3
Diarrhoea 0.3
Nausea 0.3
Constipation 0.3
Abdominal Pain 0.3
Dizziness 0.3
Somnolence 1.2
Cough 0.3
Urine color abnormal 0.3
Headache + nausea 0.3
Nausea + constipation 0.3
Flatulence + constipation 0.3
Polydipsia + abdominal pain (upper) 0.3
5.Secondary Outcome
Title Percentage of Patients With Different Variables Related to the Occurrence of Increase of Transaminases in Patients Under Treatment With Buscapina Compositum N
Hide 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.
Time Frame From the initial dose of study drug until end of the follow up period, up to 113 days
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Buscapina Compositum N
Hide Arm/Group 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).
Overall Number of Participants Analyzed 342
Measure Type: Number
Unit of Measure: Percentage of Patients
NA [1] 
[1]
No patient with symptoms related to potential liver damage was identified, thus analyses of transaminase levels was not performed
Time Frame From the initial dose of study drug until end of the follow up period, up to 113 days
Adverse Event Reporting 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.
 
Arm/Group Title Buscapina Compositum N
Hide Arm/Group 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).
All-Cause Mortality
Buscapina Compositum N
Affected / at Risk (%)
Total   0/360 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Buscapina Compositum N
Affected / at Risk (%)
Total   0/360 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Buscapina Compositum N
Affected / at Risk (%)
Total   0/360 (0.00%) 
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
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Name/Title: Boehringer Ingelheim, Call Center
Organization: Boehringer Ingelheim
Phone: 1-800-243-0127
Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02910167     History of Changes
Other Study ID Numbers: 218.705
First Submitted: August 30, 2016
First Posted: September 21, 2016
Results First Submitted: February 9, 2018
Results First Posted: March 27, 2019
Last Update Posted: March 27, 2019