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

This study has been completed.
Information provided by (Responsible Party):
Laboratoires Mayoly Spindler
ClinicalTrials.gov Identifier:
First received: July 27, 2011
Last updated: November 3, 2014
Last verified: November 2014

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 Intervention Phase
Irritable Bowel Syndrome
Drug: anti spasmodic agents
Drug: alverine citrate, simeticone
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Assessment of On-demand MeteoSpasmyl® Use Effectiveness in Irritable Bowel Syndrome

Further study details as provided by Laboratoires Mayoly Spindler:

Primary Outcome Measures:
  • Change From Baseline in Irritable Bowel Syndrome Quality Of Life Overall Score [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and 6 Months ] [ Designated as safety issue: No ]
    Improvement of the total IBSQoL scores from baseline to month 6 calculated in percentage

Enrollment: 436
Study Start Date: December 2009
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: meteospasmyl Drug: alverine citrate, simeticone
on-demand therapy
Active Comparator: standard of care Drug: anti spasmodic agents
best standard of care prescriptions


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

Additional Information:
Responsible Party: Laboratoires Mayoly Spindler
ClinicalTrials.gov Identifier: NCT01404923     History of Changes
Other Study ID Numbers: FMTO901 
Study First Received: July 27, 2011
Results First Received: October 14, 2014
Last Updated: November 3, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

ClinicalTrials.gov processed this record on May 25, 2016