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Effectiveness of On-demand Meteospasmyl® Use in Irritable Bowel Syndrome (IBS)

Primary Purpose

Irritable Bowel Syndrome

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
anti spasmodic agents
alverine citrate, simeticone
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 - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • male or female ambulatory patients, aged >= 18 years
  • with IBS as defined by Rome III criteria for more than 1 year and less than 10 years
  • with a IBS-SSS between 175 and 400

Exclusion Criteria:

  • Acute diarrhea, bowel disorders due to an underlying cause
  • Patient treated with MeteoSpasmyl® within the past 6 months
  • Recent history of gastro intestinal surgery

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    meteospasmyl

    standard of care

    Arm Description

    Outcomes

    Primary Outcome Measures

    Change From Baseline in Irritable Bowel Syndrome Quality Of Life Overall Score
    Irritable Bowel Syndrome Quality of Life total score (IBSQoL) is a health-related Quality of Life (QoL) disease-specific scale adapted for French patients. Total score ranges from minimum=0 to maximum = 100 representing the best outcome.
    Percentage of Improvement of the Total IBSQoL Scores
    Improvement of the total IBSQoL scores from baseline to month 6 calculated in percentage

    Secondary Outcome Measures

    Full Information

    First Posted
    July 27, 2011
    Last Updated
    November 3, 2014
    Sponsor
    Laboratoires Mayoly Spindler
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01404923
    Brief Title
    Effectiveness of On-demand Meteospasmyl® Use in Irritable Bowel Syndrome (IBS)
    Official Title
    Assessment of On-demand MeteoSpasmyl® Use Effectiveness in Irritable Bowel Syndrome
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2014
    Overall Recruitment Status
    Completed
    Study Start Date
    December 2009 (undefined)
    Primary Completion Date
    October 2011 (Actual)
    Study Completion Date
    October 2011 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Laboratoires Mayoly Spindler

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The purpose of this study is to compare the effectiveness of 2 IBS treatment strategies: Strategy A = MeteoSpasmyl®, on-demand therapy Strategy B = standard of care chosen by the physician

    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
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    436 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    meteospasmyl
    Arm Type
    Experimental
    Arm Title
    standard of care
    Arm Type
    Active Comparator
    Intervention Type
    Drug
    Intervention Name(s)
    anti spasmodic agents
    Intervention Description
    best standard of care prescriptions
    Intervention Type
    Drug
    Intervention Name(s)
    alverine citrate, simeticone
    Intervention Description
    on-demand therapy
    Primary Outcome Measure Information:
    Title
    Change From Baseline in Irritable Bowel Syndrome Quality Of Life Overall Score
    Description
    Irritable Bowel Syndrome Quality of Life total score (IBSQoL) is a health-related Quality of Life (QoL) disease-specific scale adapted for French patients. Total score ranges from minimum=0 to maximum = 100 representing the best outcome.
    Time Frame
    Baseline and 6 months
    Title
    Percentage of Improvement of the Total IBSQoL Scores
    Description
    Improvement of the total IBSQoL scores from baseline to month 6 calculated in percentage
    Time Frame
    Baseline and 6 Months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: male or female ambulatory patients, aged >= 18 years with IBS as defined by Rome III criteria for more than 1 year and less than 10 years with a IBS-SSS between 175 and 400 Exclusion Criteria: Acute diarrhea, bowel disorders due to an underlying cause Patient treated with MeteoSpasmyl® within the past 6 months Recent history of gastro intestinal surgery

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    24147869
    Citation
    Ducrotte P, Grimaud JC, Dapoigny M, Personnic S, O'Mahony V, Andro-Delestrain MC. On-demand treatment with alverine citrate/simeticone compared with standard treatments for irritable bowel syndrome: results of a randomised pragmatic study. Int J Clin Pract. 2014 Feb;68(2):245-54. doi: 10.1111/ijcp.12333. Epub 2013 Oct 21.
    Results Reference
    result

    Learn more about this trial

    Effectiveness of On-demand Meteospasmyl® Use in Irritable Bowel Syndrome (IBS)

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