Efficacy and Safety of Meteospasmyl® in Irritable Bowel Syndrome

Phase 4

Completed

• Conditions: Irritable Bowel Syndrome
• Interventions: Drug: placebo; Drug: alverine citrate and simeticone

• Registration Number: NCT00542295
• Lead Sponsor: Laboratoires Mayoly Spindler

Brief Summary

To assess the effectiveness of alverine citrate and simeticone on IBS symptoms according to the latest recommended design

Detailed Description

Not available

Study Timeline

• Study Start: 2007-07
• Study First Submitted: 2007-10-10
• Study First Submitted QC: 2007-10-10
• Study First Posted: 2007-10-11
• Primary Completion: 2008-07
• Status Verified: 2008-09
• Study Completion: 2008-09
• Last Update Submitted: 2008-09-30
• Last Update Posted: 2008-10-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

• male or female ambulatory patients, aged 18-75 years
• with IBS as defined by Rome III criteria

Exclusion Criteria

• Functional bowel disorder other than IBS,
• Underlying cause for symptomatology, which excludes IBS diagnosis,
• Gastro-intestinal cancer or significant gastro-intestinal surgical background,
• Any acute/uncontrolled systemic pathology

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
B	placebo	-
A	alverine citrate and simeticone	-

Primary Outcome Measures

Name	Time	Method
Subject self assessment of abdominal pain/discomfort	Baseline and 4 weeks

Secondary Outcome Measures

Name	Time	Method
IBS life impact, overall treatment assessment, concomitant factors	Baseline and 4 weeks