Efficacy and Safety of Meteospasmyl® in Irritable Bowel Syndrome

NCT ID: NCT00542295

Last Updated: 2008-10-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-07-31

Study Completion Date

2008-09-30

Brief Summary

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To assess the effectiveness of alverine citrate and simeticone on IBS symptoms according to the latest recommended design

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

DOUBLE

Participants Investigators

Study Groups

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A

Group Type EXPERIMENTAL

alverine citrate and simeticone

Intervention Type DRUG

B

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

Interventions

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alverine citrate and simeticone

Intervention Type DRUG

placebo

Intervention Type DRUG

Other Intervention Names

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Meteospasmyl®

Eligibility Criteria

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Inclusion Criteria

* male or female ambulatory patients, aged 18-75 years
* with IBS as defined by Rome III criteria

Exclusion Criteria

* Functional bowel disorder other than IBS,
* Underlying cause for symptomatology, which excludes IBS diagnosis,
* Gastro-intestinal cancer or significant gastro-intestinal surgical background,
* Any acute/uncontrolled systemic pathology
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Laboratoires Mayoly Spindler

INDUSTRY

Sponsor Role lead

Principal Investigators

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Philippe Ducrotte, M.D

Role: STUDY_CHAIR

Locations

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Budapest, , Hungary

Site Status

Budapest, , Hungary

Site Status

Budapest, , Hungary

Site Status

Budapest, , Hungary

Site Status

Debrecen, , Hungary

Site Status

Győr, , Hungary

Site Status

Gyula, , Hungary

Site Status

Miskolc, , Hungary

Site Status

Miskolc, , Hungary

Site Status

Siofolk, , Hungary

Site Status

Szeged, , Hungary

Site Status

Székesfehérvár, , Hungary

Site Status

Bydgoszcz, , Poland

Site Status

Katowice, , Poland

Site Status

Oława, , Poland

Site Status

Szczecin, , Poland

Site Status

Wroclaw, , Poland

Site Status

Wroclaw, , Poland

Site Status

Countries

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Hungary Poland

Other Identifiers

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IMTO601

Identifier Type: -

Identifier Source: org_study_id