Skip to main content
OpenTrials
Completed

NCT Number: NCT02910167

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Acute Pain Dysmenorrhea Menstruation Disturbances Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Pelvic Pain Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Multiple Locations, Peru

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Hyoscine n-butylbromide

Drug

Hyoscine n-butylbromide 10 mg

Paracetamol

Drug

Paracetamol 500 mg

Primary outcomes

  1. 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

    Percentage of patients with an incidence of Adverse Event (AE) associated to potential liver damage during the clinical evaluation of patients.

Secondary outcomes

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

    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 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.

  2. 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 with different drug utilization patterns of Buscapina Compositum N in patients in Metropolitan Lima.

  3. Percentage of Patients Per Adverse Event Preferred Term in Patients Who Developed Any Adverse Event During Treatment

    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 with Buscapina Compositum N.

  4. Percentage of Patients With Different Variables Related to the Occurrence of Increase of Transaminases in Patients Under 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 in Metropolitan Lima. No patient with symptoms related to potential liver damage was identified, thus analyses of transaminase levels was not performed.

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Sep 21, 2016
Registry last updated
Mar 27, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.