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

Boehringer Ingelheim360 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

360

Conditions

Acute Pain Dysmenorrhea

Interventions

Hyoscine n-butylbromideDRUG

Hyoscine n-butylbromide 10 mg

ParacetamolDRUG

Paracetamol 500 mg

Hyoscine n-butylbromideDRUG

Hyoscine n-butylbromide 10 mg

Paracetamol

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Unnamed facility

Multiple Locations, Peru

Outcomes

Primary Outcomes

Percentage of Patients With an Incidence of Adverse Event (AE) Associated to Potential Liver Damage During the Clinical Evaluation of Patients

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

Secondary Outcomes

Percentage of Patients With Different Transaminase Levels Found by the Doctor During the Clinical Evaluation of Patients With Symptoms Related to Potential Liver Damage.

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

Percentage of Patients With Different Drug Utilization Patterns of Buscapina Compositum N in Patients in Metropolitan Lima

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

Percentage of Patients Per Adverse Event Preferred Term in Patients 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.

Time frame: 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

Data from ClinicalTrials.gov

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