Text Size

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Laboratoires Mayoly Spindler
ClinicalTrials.gov Identifier:
NCT01404923
First received: July 27, 2011
Last updated: November 18, 2011
Last verified: November 2011
History of Changes
  Purpose

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

Resource links provided by NLM:

Drug Information available for: Simethicone
U.S. FDA Resources

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: 6 months ] [ Designated as safety issue: No ]

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 C.Y FRANCIS score 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
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Laboratoires Mayoly Spindler
ClinicalTrials.gov Identifier: NCT01404923     History of Changes
Other Study ID Numbers: FMTO901
Study First Received: July 27, 2011
Last Updated: November 18, 2011
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Irritable Bowel Syndrome
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Parasympatholytics
Alverine
Mebeverine
Simethicone
 Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Emollients
Dermatologic Agents
Therapeutic Uses
Anticonvulsants
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 19, 2013