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Efficacy and Safety of Meteospasmyl® in Irritable Bowel Syndrome

Sponsor
Laboratoires Mayoly Spindler (Industry)
Overall Status
Completed
CT.gov ID
NCT00542295
Collaborator
(none)
400
Enrollment
18
Locations
2
Arms
14.1
Duration (Months)
22.2
Patients Per Site
1.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Drug: alverine citrate and simeticone
  • Drug: placebo
 Phase 4

Study Design

Study Type:
Interventional
Anticipated Enrollment :
400 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
Efficacy and Safety of Meteospasmyl® in Irritable Bowel Syndrome. a 4-Week, Multicentre, Double-Blind, Randomised, Placebo-Controlled Phase IV Trial
Study Start Date :
Jul 1, 2007
Actual Primary Completion Date :
Jul 1, 2008
Actual Study Completion Date :
Sep 1, 2008

Arms and Interventions

Arm Intervention/Treatment
Experimental: A

Drug: alverine citrate and simeticone
Other Names:
  • Meteospasmyl®

    		•
    Placebo Comparator: B

    Drug: placebo

    Outcome Measures

    Primary Outcome Measures

    1. Subject self assessment of abdominal pain/discomfort [Baseline and 4 weeks]

    Secondary Outcome Measures

    1. IBS life impact, overall treatment assessment, concomitant factors [Baseline and 4 weeks]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Budapest Hungary 1083
    2 Budapest Hungary 1106
    3 Budapest Hungary 1125
    4 Budapest Hungary 1204
    5 Debrecen Hungary 4032
    6 Gyor Hungary 9024
    7 Gyula Hungary 5700
    8 Miskolc Hungary 3501
    9 Miskolc Hungary 3529
    10 Siofolk Hungary 8600
    11 Szeged Hungary 6720
    12 Székesfehérvár Hungary 8000
    13 Bydgoszcz Poland 85-168
    14 Katowice Poland 40-752
    15 Olawa Poland 55-200
    16 Szczecin Poland 71-252
    17 Wroclaw Poland 50-556
    18 Wroclaw Poland 51-149

    Sponsors and Collaborators

    • Laboratoires Mayoly Spindler

    Investigators

    • Study Chair: Philippe Ducrotte, M.D,

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00542295
    Other Study ID Numbers:
    • IMTO601
    First Posted:
    Oct 11, 2007
    Last Update Posted:
    Oct 1, 2008
    Last Verified:
    Sep 1, 2008
    Additional relevant MeSH terms:
    Irritable Bowel Syndrome
    Syndrome
    Mebeverine
    Alverine

    Study Results

    No Results Posted as of Oct 1, 2008