NCT02910167

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 360 (actual)
• Sponsor: Boehringer Ingelheim · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acute Pain
• Dysmenorrhea

Interventions

Type	Name	Description
DRUG	Hyoscine n-butylbromide	Hyoscine n-butylbromide 10 mg
DRUG	Paracetamol	Paracetamol 500 mg
DRUG	Hyoscine n-butylbromide	Hyoscine n-butylbromide 10 mg
DRUG	Paracetamol	Paracetamol 500 mg

Timeline

• Start date: 2016-10-15
• Primary completion: 2017-02-20
• Completion: 2017-02-20
• First posted: 2016-09-21
• Last updated: 2019-03-27
• Results posted: 2019-03-27

Locations

1 site across 1 country: Peru