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

Boehringer Ingelheim

Status: Completed

Conditions: Dysmenorrhea; Acute Pain

Treatments: Drug: Paracetamol; Drug: Hyoscine n-butylbromide

Study type: Observational

Funder types: Industry

Identifiers

NCT02910167

218.705

Details and patient eligibility

About

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.

Enrollment: 360 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. 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.
2. Patients who agree to adhere to the protocol procedures of this study.
3. Women who are not pregnant or breast feeding
4. Persons who sign the informed consent

Exclusion criteria

1. Patients with allergy to BUSCAPINA COMPOSITUM N or any of the compounds in the formula.
2. Patients with mechanical stenosis of the gastrointestinal tract.
3. Patients with myasthenia gravis.
4. Patients with megacolon.
5. Patients breastfeeding at the time of enrollment or who have become pregnant during treatment with BUSCAPINA COMPOSITUM N.
6. Patients with clinical evidence of immunosuppression.
7. Patients with urinary retention subvesical obstruction (such as prostatic adenoma).
8. Patients with right-angle glaucoma.
9. Patients with tachycardia and tachyarrhythmia.
10. Patients with severe hepatic impairment.
11. Patients with psychiatric disorders.
12. Patients with alcohol dependence or drugs.
13. Patients who discontinue the protocol are not eligible for re-enrollment.
14. Researchers, company personnel or their relatives.

Trial design

360 participants in 2 patient groups

Men with spasmodic syndromes

Description:

Men with any type of gastrointestinal, hepato-biliary, urinary or genital spasmodic syndromes

Treatment:

Drug: Hyoscine n-butylbromide

Drug: Hyoscine n-butylbromide

Drug: Paracetamol

Drug: Paracetamol

Women with spasmodic syndromes

Description:

Women with any type of gastrointestinal, hepato-biliary, urinary or genital spasmodic syndromes

Treatment:

Drug: Hyoscine n-butylbromide

Drug: Hyoscine n-butylbromide

Drug: Paracetamol

Drug: Paracetamol