Efficacy and Safety of Meteospasmyl® in Irritable Bowel Syndrome

Efficacy and Safety of Meteospasmyl® in Irritable Bowel Syndrome. a 4-Week, Multicentre, Double-Blind, Randomised, Placebo-Controlled Phase IV Trial

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

Study Overview

• Status: Completed
• Conditions: Irritable Bowel Syndrome
• Intervention / Treatment: Drug: placebo; Drug: alverine citrate and simeticone

• Study Type: Interventional
• Enrollment (Anticipated): 400
• Phase: Phase 4

Contacts and Locations

Study Locations

• Hungary
  • Budapest, Hungary, 1125
  • Budapest, Hungary, 1083
  • Budapest, Hungary, 1106
  • Budapest, Hungary, 1204
  • Debrecen, Hungary, 4032
  • Gyor, Hungary, 9024
  • Gyula, Hungary, 5700
  • Miskolc, Hungary, 3529
  • Miskolc, Hungary, 3501
  • Siofolk, Hungary, 8600
  • Szeged, Hungary, 6720
  • Székesfehérvár, Hungary, 8000
• Poland
  • Bydgoszcz, Poland, 85-168
  • Katowice, Poland, 40-752
  • Olawa, Poland, 55-200
  • Szczecin, Poland, 71-252
  • Wroclaw, Poland, 50-556
  • Wroclaw, Poland, 51-149

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: A	Drug: alverine citrate and simeticone; Other Names: Meteospasmyl®
Placebo Comparator: B	Drug: placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Subject self assessment of abdominal pain/discomfort	Baseline and 4 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
IBS life impact, overall treatment assessment, concomitant factors	Baseline and 4 weeks

Collaborators and Investigators

• Sponsor: Laboratoires Mayoly Spindler
• Investigators: Study Chair: Philippe Ducrotte, M.D

Study record dates

Study Major Dates

• Study Start: July 1, 2007
• Primary Completion (Actual): July 1, 2008
• Study Completion (Actual): September 1, 2008

Study Registration Dates

• First Submitted: October 10, 2007
• First Submitted That Met QC Criteria: October 10, 2007
• First Posted (Estimate): October 11, 2007

Study Record Updates

• Last Update Posted (Estimate): October 1, 2008
• Last Update Submitted That Met QC Criteria: September 30, 2008
• Last Verified: September 1, 2008

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Disease; Gastrointestinal Diseases; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Syndrome; Irritable Bowel Syndrome; Physiological Effects of Drugs; Parasympatholytics; Autonomic Agents; Peripheral Nervous System Agents; Anticonvulsants; Mebeverine; Alverine
• Other Study ID Numbers: IMTO601