NCT00932737

(Hyoscine Butylbromide) for Abdominal Pain Associated With Cramping on Demand Basis

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 197 (actual)
• Sponsor: Boehringer Ingelheim · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Abdominal Pain

Interventions

Type	Name	Description
DRUG	Placebo	1-5 tablets per episode
DRUG	HBB 20 mg	Active drug, one to five tablets per episode

Timeline

• Start date: 2009-06-09
• Primary completion: 2010-02-08
• Completion: 2010-02-08
• First posted: 2009-07-03
• Last updated: 2022-05-03
• Results posted: 2022-05-03

Locations

19 sites across 1 country: United States