Phase 4
Completed N=436
Effectiveness of On-demand Meteospasmyl® Use in Irritable Bowel Syndrome (IBS)
Source: ClinicalTrials.gov NCT01404923 ↗Enrolled (actual)
436
Serious AEs
1.4%
Results posted
Nov 2014
Primary outcomePrimary: Change From Baseline in Irritable Bowel Syndrome Quality Of Life Overall Score — 13.8; 8.4 units on a scale — p=0.0008
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
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Irritable Bowel Syndrome Quality Of Life Overall Score |
13.8; 8.4 | 0.0008 sig |
| PRIMARY Percentage of Improvement of the Total IBSQoL Scores |
28.5; 18.6 | — |
Eligibility 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 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
Data sourced from ClinicalTrials.gov (NCT01404923). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.