Effectiveness of On-demand Meteospasmyl® Use in Irritable Bowel Syndrome (IBS)

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

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Key information

Conditions

Irritable Bowel Syndrome Colonic Diseases Colonic Diseases, Functional Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

anti spasmodic agents

Drug

best standard of care prescriptions

alverine citrate, simeticone

Drug

on-demand therapy

Primary outcomes

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.
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

Sponsors and collaborators

Lead sponsor

Laboratoires Mayoly Spindler

Industry

Registry information

Official study title

Assessment of On-demand MeteoSpasmyl® Use Effectiveness in Irritable Bowel Syndrome

Important dates

Study start: 2009
Primary completion: 2011
Study completion: 2011
First posted: Jul 28, 2011
Registry last updated: Nov 4, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed