Effectiveness of On-demand Meteospasmyl® Use in Irritable Bowel Syndrome (IBS)
Phase 4
Completed
- Conditions
- Irritable Bowel Syndrome
- Interventions
- Drug: anti spasmodic agents
- Registration Number
- NCT01404923
- Lead Sponsor
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 436
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description meteospasmyl alverine citrate, simeticone - standard of care anti spasmodic agents -
- Primary Outcome Measures
Name Time Method Change From Baseline in Irritable Bowel Syndrome Quality Of Life Overall Score 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.
Percentage of Improvement of the Total IBSQoL Scores Baseline and 6 Months Improvement of the total IBSQoL scores from baseline to month 6 calculated in percentage
- Secondary Outcome Measures
Name Time Method