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

Completed

• Conditions: Acute Pain; Dysmenorrhea
• Interventions: Drug: Hyoscine n-butylbromide; Drug: Paracetamol

• Registration Number: NCT02910167
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-08-30
• Study First Submitted QC: 2016-09-19
• Study First Posted: 2016-09-21
• Study Start: 2016-10-15
• Primary Completion: 2017-02-20
• Study Completion: 2017-02-20
• Results First Submitted: 2018-02-09
• Status Verified: 2019-03
• Results First Submitted QC: 2019-03-26
• Last Update Submitted: 2019-03-26
• Results First Posted: 2019-03-27
• Last Update Posted: 2019-03-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 360

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Men with spasmodic syndromes	Paracetamol	Men with any type of gastrointestinal, hepato-biliary, urinary or genital spasmodic syndromes
Women with spasmodic syndromes	Hyoscine n-butylbromide	Women with any type of gastrointestinal, hepato-biliary, urinary or genital spasmodic syndromes
Women with spasmodic syndromes	Paracetamol	Women with any type of gastrointestinal, hepato-biliary, urinary or genital spasmodic syndromes
Men with spasmodic syndromes	Hyoscine n-butylbromide	Men with any type of gastrointestinal, hepato-biliary, urinary or genital spasmodic syndromes

Primary Outcome Measures

Name	Time	Method
Percentage of Patients With an Incidence of Adverse Event (AE) Associated to Potential Liver Damage During the Clinical Evaluation of Patients	From the initial dose of study drug until end of the follow up period, up to 113 days	Percentage of patients with an incidence of Adverse Event (AE) associated to potential liver damage during the clinical evaluation of patients.

Secondary Outcome Measures

Name	Time	Method
Percentage of Patients With Different Transaminase Levels Found by the Doctor During the Clinical Evaluation of Patients With Symptoms Related to Potential Liver Damage.	From the initial dose of study drug until end of the follow up period, up to 113 days	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.
Percentage of Patients With Different Drug Utilization Patterns of Buscapina Compositum N in Patients in Metropolitan Lima	From the initial dose of study drug until end of the follow up period, up to 113 days	Percentage of patients with different drug utilization patterns of Buscapina Compositum N in patients in Metropolitan Lima.
Percentage of Patients Per Adverse Event Preferred Term in Patients Who Developed Any Adverse Event During Treatment	From the initial dose of study drug until end of the follow up period, up to 113 days	Percentage of patients per adverse event preferred term in patients who developed any adverse event during treatment with Buscapina Compositum N.
Percentage of Patients With Different Variables Related to the Occurrence of Increase of Transaminases in Patients Under Treatment With Buscapina Compositum N	From the initial dose of study drug until end of the follow up period, up to 113 days	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.