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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

436 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-12-31

Study Completion Date

2011-10-31

Brief Summary

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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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Detailed Description

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Conditions

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Irritable Bowel Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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meteospasmyl

Group Type EXPERIMENTAL

alverine citrate, simeticone

Intervention Type DRUG

on-demand therapy

standard of care

Group Type ACTIVE_COMPARATOR

anti spasmodic agents

Intervention Type DRUG

best standard of care prescriptions

Interventions

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anti spasmodic agents

best standard of care prescriptions

Intervention Type DRUG

alverine citrate, simeticone

on-demand therapy

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No