CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 197 enrolled
Drug / intervention
Placebo +1 moredrug
Likely dose
HBB 20 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.

Search/NCT00932737
NCT00932737Phase 2Completed
CompareCT.gov

A Double-blind, Placebo-controlled, Randomized, Parallel-group Pilot Study of the Efficacy and Safety of Oral Doses of 20 mg Hyoscine Butylbromide When Used on Demand for the Treatment of Self-reported Functional Abdominal Pain Associated With Cramping

Boehringer Ingelheim·interventional·Posted Jul 3, 2009·Updated May 3, 2022

In Brief

A Phase 2 clinical trial evaluating Placebo and HBB 20 mg for Abdominal Pain. Completed, enrolled 197 participants across 19 sites.

Detailed Summary

The primary objective of this pilot study is to assess effects of Hyoscine Butylbromide (HBB) 20 mg in comparison to placebo, when used as needed, as measured by the subject's assessment of intensity of abdominal pain associated with cramping (APC) in the treatment of two episodes.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAbdominal Pain
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedJul 3, 2009
Enrollment StartJun 9, 2009
Primary CompletionFeb 8, 2010
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 17.0 years ago

Interventions

Placebodrug

1-5 tablets per episode

HBB 20 mgdrug

Active drug, one to five tablets per episode