NCT02242305

Study to Evaluate the Efficacy and Safety of Hyoscine Butylbromide Tablets for the Treatment of Occasional or Recurrent Episodes of Gastric or Intestinal Spasm-like Pain or Discomfort

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 302 (actual)
• Sponsor: Boehringer Ingelheim · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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

Conditions

• Abdominal Pain

Interventions

Type	Name	Description
DRUG	Hyoscine Butylbromide - Tablet
DRUG	Hyoscine Butylbromide - Capsule
DRUG	Placebo

Timeline

• Start date: 2008-11-01
• Primary completion: 2009-07-20
• Completion: 2009-07-20
• First posted: 2014-09-17
• Last updated: 2017-07-27
• Results posted: 2017-07-27