At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 302 enrolled
Drug / intervention
Hyoscine Butylbromide - Tablet +2 moredrug
Likely dose
Not stated in 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.
A Randomized, Double-blind, Double-dummy, Active-controlled, Parallel-group, Multi-center Trial, in Contrast With Hyoscine Butylbromide Capsule 10mg, to Evaluate the Efficacy and Safety of Hyoscine Butylbromide Tablets 10 mg (20mg, 3 Times Daily, Orally) Over a Period of 3 Days for the Treatment of Occasional or Recurrent Episodes of Self-reported Gastric or Intestinal Spasm-like Pain
In Brief
A Phase 3 clinical trial evaluating Hyoscine Butylbromide - Tablet, Hyoscine Butylbromide - Capsule, and 1 other intervention for Abdominal Pain. Completed, enrolled 302 participants.
Detailed Summary
In contrast with Hyoscine Butylbromide Capsule 10mg, Study is to evaluate the efficacy and safety of Hyoscine Butylbromide tablets 10 mg (20mg, 3 times daily, orally) over a period of 3 days for the treatment of occasional or recurrent episodes of self-reported gastric or intestinal spasm-like pain or discomfort
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAbdominal Pain
Countries--
Collaborators--
Timeline
Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartNov 2008
Primary CompletionJul 2009
First PostedSep 2014
TodayJul 2026
First PostedSep 17, 2014
Enrollment StartNov 1, 2008
Primary CompletionJul 20, 2009
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 11.8 years ago
Interventions
Hyoscine Butylbromide - Tabletdrug
Hyoscine Butylbromide - Capsuledrug
Placebodrug