At a glance
ClinicalIndex Comparison RecordN/ACompleted· 360 enrolled
Drug / intervention
Hyoscine n-butylbromide +3 moredrug
Likely dose
Hyoscine n-butylbromide 10 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
An observational study evaluating Hyoscine n-butylbromide and Paracetamol for Acute Pain and Dysmenorrhea. Completed, enrolled 360 participants across 1 site.
Detailed 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.
Study Details
Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsAcute Pain, Dysmenorrhea
CountriesPeru
Collaborators--
Timeline
N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedSep 2016
Enrollment StartOct 2016
Primary CompletionFeb 2017
TodayJul 2026
First PostedSep 21, 2016
Enrollment StartOct 15, 2016
Primary CompletionFeb 20, 2017
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 9.8 years ago
Interventions
Hyoscine n-butylbromidedrug
Hyoscine n-butylbromide 10 mg
Paracetamoldrug
Paracetamol 500 mg
Hyoscine n-butylbromidedrug
Hyoscine n-butylbromide 10 mg
Paracetamoldrug
Paracetamol 500 mg