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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01404923
Recruitment Status : Completed
First Posted : July 28, 2011
Results First Posted : November 4, 2014
Last Update Posted : November 4, 2014
Information provided by (Responsible Party):
Laboratoires Mayoly Spindler

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

Condition or disease Intervention/treatment Phase
Irritable Bowel Syndrome Drug: anti spasmodic agents Drug: alverine citrate, simeticone Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 436 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Assessment of On-demand MeteoSpasmyl® Use Effectiveness in Irritable Bowel Syndrome
Study Start Date : December 2009
Actual Primary Completion Date : October 2011
Actual Study Completion Date : October 2011

Arm Intervention/treatment
Experimental: meteospasmyl Drug: alverine citrate, simeticone
on-demand therapy

Active Comparator: standard of care Drug: anti spasmodic agents
best standard of care prescriptions

Primary Outcome Measures :
  1. Change From Baseline in Irritable Bowel Syndrome Quality Of Life Overall Score [ Time Frame: Baseline and 6 months ]
    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.

  2. Percentage of Improvement of the Total IBSQoL Scores [ Time Frame: Baseline and 6 Months ]
    Improvement of the total IBSQoL scores from baseline to month 6 calculated in percentage

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Additional Information:
Publications of Results:
Responsible Party: Laboratoires Mayoly Spindler Identifier: NCT01404923     History of Changes
Other Study ID Numbers: FMTO901
First Posted: July 28, 2011    Key Record Dates
Results First Posted: November 4, 2014
Last Update Posted: November 4, 2014
Last Verified: November 2014

Additional relevant MeSH terms:
Irritable Bowel Syndrome
Pathologic Processes
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs