- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01404923
Effectiveness of On-demand Meteospasmyl® Use in Irritable Bowel Syndrome (IBS)
November 3, 2014 updated by: Laboratoires Mayoly Spindler
Assessment of On-demand MeteoSpasmyl® Use Effectiveness in Irritable Bowel Syndrome
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
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
436
Phase
- Phase 4
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: meteospasmyl
|
on-demand therapy
|
Active Comparator: standard of care
|
best standard of care prescriptions
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change From Baseline in Irritable Bowel Syndrome Quality Of Life Overall Score
Time Frame: 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.
|
Baseline and 6 months
|
Percentage of Improvement of the Total IBSQoL Scores
Time Frame: Baseline and 6 Months
|
Improvement of the total IBSQoL scores from baseline to month 6 calculated in percentage
|
Baseline and 6 Months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2009
Primary Completion (Actual)
October 1, 2011
Study Completion (Actual)
October 1, 2011
Study Registration Dates
First Submitted
July 27, 2011
First Submitted That Met QC Criteria
July 27, 2011
First Posted (Estimate)
July 28, 2011
Study Record Updates
Last Update Posted (Estimate)
November 4, 2014
Last Update Submitted That Met QC Criteria
November 3, 2014
Last Verified
November 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Pathologic Processes
- Disease
- Gastrointestinal Diseases
- Colonic Diseases, Functional
- Colonic Diseases
- Intestinal Diseases
- Syndrome
- Irritable Bowel Syndrome
- Physiological Effects of Drugs
- Autonomic Agents
- Peripheral Nervous System Agents
- Anticonvulsants
- Mebeverine
- Alverine
- Parasympatholytics
Other Study ID Numbers
- FMTO901
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Irritable Bowel Syndrome
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ProgenaBiomeRecruitingIrritable Bowel Syndrome | Irritable Bowel Syndrome With Diarrhea | Irritable Bowel Syndrome With Constipation | Irritable Bowel Syndrome Characterized by Constipation | Irritable Bowel Syndrome Mixed | Irritable Bowel Syndrome Without Diarrhea | Irritable Bowel | Irritable Bowel Syndrome Aggravated and other conditionsUnited States
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ClasadoCR2O B.V.RecruitingIrritable Bowel Syndrome | Irritable Bowel Syndrome - Constipation | Irritable Bowel Syndrome - Diarrhoea | Irritable Bowel Syndrome - MixedBelgium, Netherlands, United Kingdom
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Istanbul Medipol University HospitalTepecik Training and Research Hospital; Bozyaka Training and Research Hospital and other collaboratorsRecruitingIrritable Bowel Syndrome | Irritable Bowel Syndrome With Diarrhea | Irritable Bowel Syndrome With Constipation | Irritable Bowel Syndrome MixedTurkey
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Federal Stare Budgetary Scientific Institution,...I.M. Sechenov First Moscow State Medical University; RML INVEST, Torkhovsky...CompletedIrritable Bowel Syndrome | Irritable Bowel Syndrome With Diarrhea | Irritable Bowel Syndrome With Constipation | Irritable Bowel Syndrome MixedRussian Federation
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University of California, Los AngelesCompletedIrritable Bowel Syndrome With Diarrhea | Irritable Bowel Syndrome With Mixed Bowel HabitsUnited States
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University of ViennaCompleted
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Shahid Beheshti University of Medical SciencesCompletedIrritable Bowel DiseaseIran, Islamic Republic of
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Universidad Autonoma de ChihuahuaNot yet recruitingIrritable Bowel Syndrome | Constipation-predominant Irritable Bowel Syndrome | Diarrhea- Irritable Bowel Syndrome
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Vasily IsakovRussian Science Foundation; Azbuka vkusa; Federal Research Centre of Nutrition...CompletedIrritable Bowel Syndrome With Constipation | Constipation-predominant Irritable Bowel SyndromeRussian Federation
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Laboratoires Mayoly SpindlerCompletedIrritable Bowel SyndromePoland, Hungary
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Boehringer IngelheimCompleted
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Hospital Juarez de MexicoCompletedIrritable Bowel SyndromeMexico
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AbbottCompletedPost-cholecystectomy Gastrointestinal SpasmsRussian Federation
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McNeil ABCompleted
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TecnoquimicasCompleted
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Tanta UniversityRecruitingIBS - Irritable Bowel SyndromeEgypt
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Hazel EverittNational Institute for Health Research, United KingdomCompletedIrritable Bowel SyndromeUnited Kingdom