N/A
Completed N=360
Observational Prospective Study to Evaluate AEs, Risk Factors and Drug Utilization of BUSCAPINA COMPOSITUM N in Adults From Metropolitan Lima
Source: ClinicalTrials.gov NCT02910167 ↗Enrolled (actual)
360
Serious AEs
0.0%
Results posted
Mar 2019
Primary outcomePrimary: Percentage of Patients With an Incidence of Adverse Event (AE) Associated to Potential Liver Damage During the Clinical Evaluation of Patients — 0.0 Percentage of Patients
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Patients With an Incidence of Adverse Event (AE) Associated to Potential Liver Damage During the Clinical Evaluation of Patients |
0.0 | — |
| SECONDARY Percentage of Patients With Different Transaminase Levels Found by the Doctor During the Clinical Evaluation of Patients With Symptoms Related to Potential Liver Damage. |
NA | — |
| SECONDARY Percentage of Patients With Different Drug Utilization Patterns of Buscapina Compositum N in Patients in Metropolitan Lima |
100.0; 0.0; 94.7; 8; 2.9; 0.3 | — |
| SECONDARY Percentage of Patients Per Adverse Event Preferred Term in Patients Who Developed Any Adverse Event During Treatment |
0.3; 0.3; 0.3; 0.3; 0.3; 0.3 | — |
| SECONDARY Percentage of Patients With Different Variables Related to the Occurrence of Increase of Transaminases in Patients Under Treatment With Buscapina Compositum N |
NA | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT02910167). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.