Status:
COMPLETED
Effectiveness of On-demand Meteospasmyl® Use in Irritable Bowel Syndrome (IBS)
Lead Sponsor:
Laboratoires Mayoly Spindler
Conditions:
Irritable Bowel Syndrome
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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
Eligibility Criteria
Inclusion
- 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
- Acute diarrhea, bowel disorders due to an underlying cause
- Patient treated with MeteoSpasmyl® within the past 6 months
- Recent history of gastro intestinal surgery
Key Trial Info
Start Date :
December 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2011
Estimated Enrollment :
436 Patients enrolled
Trial Details
Trial ID
NCT01404923
Start Date
December 1 2009
End Date
October 1 2011
Last Update
November 4 2014
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