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

Laboratoires Mayoly Spindler436 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

436

Conditions

Irritable Bowel Syndrome

Interventions

anti spasmodic agentsDRUG

best standard of care prescriptions

alverine citrate, simeticoneDRUG

on-demand therapy

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: 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

Time frame: Baseline and 6 Months

Data from ClinicalTrials.gov

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