Effectiveness of On-demand Meteospasmyl® Use in Irritable Bowel Syndrome (IBS)
Assessment of On-demand MeteoSpasmyl® Use Effectiveness in Irritable Bowel Syndrome
1 other identifier
interventional
436
0 countries
N/A
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Dec 2009
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2009
CompletedFirst Submitted
Initial submission to the registry
July 27, 2011
CompletedFirst Posted
Study publicly available on registry
July 28, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2011
CompletedResults Posted
Study results publicly available
November 4, 2014
CompletedNovember 4, 2014
November 1, 2014
1.8 years
July 27, 2011
October 14, 2014
November 3, 2014
Conditions
Outcome Measures
Primary Outcomes (2)
Change From Baseline in Irritable Bowel Syndrome Quality Of Life Overall Score
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.
Baseline and 6 months
Percentage of Improvement of the Total IBSQoL Scores
Improvement of the total IBSQoL scores from baseline to month 6 calculated in percentage
Baseline and 6 Months
Study Arms (2)
meteospasmyl
EXPERIMENTALstandard of care
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Acute diarrhea, bowel disorders due to an underlying cause
- Patient treated with MeteoSpasmyl® within the past 6 months
- Recent history of gastro intestinal surgery
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Ducrotte P, Grimaud JC, Dapoigny M, Personnic S, O'Mahony V, Andro-Delestrain MC. On-demand treatment with alverine citrate/simeticone compared with standard treatments for irritable bowel syndrome: results of a randomised pragmatic study. Int J Clin Pract. 2014 Feb;68(2):245-54. doi: 10.1111/ijcp.12333. Epub 2013 Oct 21.
PMID: 24147869RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Clinical trials Manager
- Organization
- Laboratoires Mayoly Spindler
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 27, 2011
First Posted
July 28, 2011
Study Start
December 1, 2009
Primary Completion
October 1, 2011
Study Completion
October 1, 2011
Last Updated
November 4, 2014
Results First Posted
November 4, 2014
Record last verified: 2014-11