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Efficacy and Safety of Meteospasmyl® in Irritable Bowel Syndrome

Primary Purpose

Irritable Bowel Syndrome

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
alverine citrate and simeticone
placebo
Sponsored by
Laboratoires Mayoly Spindler
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Irritable Bowel Syndrome

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

A

B

Arm Description

Outcomes

Primary Outcome Measures

Subject self assessment of abdominal pain/discomfort

Secondary Outcome Measures

IBS life impact, overall treatment assessment, concomitant factors

Full Information

First Posted
October 10, 2007
Last Updated
September 30, 2008
Sponsor
Laboratoires Mayoly Spindler
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1. Study Identification

Unique Protocol Identification Number
NCT00542295
Brief Title
Efficacy and Safety of Meteospasmyl® in Irritable Bowel Syndrome
Official Title
Efficacy and Safety of Meteospasmyl® in Irritable Bowel Syndrome. a 4-Week, Multicentre, Double-Blind, Randomised, Placebo-Controlled Phase IV Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2008
Overall Recruitment Status
Completed
Study Start Date
July 2007 (undefined)
Primary Completion Date
July 2008 (Actual)
Study Completion Date
September 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Laboratoires Mayoly Spindler

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Irritable Bowel Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Arm Title
B
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
alverine citrate and simeticone
Other Intervention Name(s)
Meteospasmyl®
Intervention Type
Drug
Intervention Name(s)
placebo
Primary Outcome Measure Information:
Title
Subject self assessment of abdominal pain/discomfort
Time Frame
Baseline and 4 weeks
Secondary Outcome Measure Information:
Title
IBS life impact, overall treatment assessment, concomitant factors
Time Frame
Baseline and 4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philippe Ducrotte, M.D
Official's Role
Study Chair
Facility Information:
City
Budapest
ZIP/Postal Code
1083
Country
Hungary
City
Budapest
ZIP/Postal Code
1106
Country
Hungary
City
Budapest
ZIP/Postal Code
1125
Country
Hungary
City
Budapest
ZIP/Postal Code
1204
Country
Hungary
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
City
Gyor
ZIP/Postal Code
9024
Country
Hungary
City
Gyula
ZIP/Postal Code
5700
Country
Hungary
City
Miskolc
ZIP/Postal Code
3501
Country
Hungary
City
Miskolc
ZIP/Postal Code
3529
Country
Hungary
City
Siofolk
ZIP/Postal Code
8600
Country
Hungary
City
Szeged
ZIP/Postal Code
6720
Country
Hungary
City
Székesfehérvár
ZIP/Postal Code
8000
Country
Hungary
City
Bydgoszcz
ZIP/Postal Code
85-168
Country
Poland
City
Katowice
ZIP/Postal Code
40-752
Country
Poland
City
Olawa
ZIP/Postal Code
55-200
Country
Poland
City
Szczecin
ZIP/Postal Code
71-252
Country
Poland
City
Wroclaw
ZIP/Postal Code
50-556
Country
Poland
City
Wroclaw
ZIP/Postal Code
51-149
Country
Poland

12. IPD Sharing Statement

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Efficacy and Safety of Meteospasmyl® in Irritable Bowel Syndrome

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