Efficacy and Safety of Meteospasmyl® in Irritable Bowel Syndrome

Efficacy and Safety of Meteospasmyl® in Irritable Bowel Syndrome. a 4-Week, Multicentre, Double-Blind, Randomised, Placebo-Controlled Phase IV Trial

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00542295

Enrollment

400

Registered

2007-10-11

Start date

2007-07-31

Completion date

2008-09-30

Last updated

2008-10-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Irritable Bowel Syndrome

Brief summary

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

Interventions

DRUGalverine citrate and simeticone

DRUGplacebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Subject self assessment of abdominal pain/discomfort	Baseline and 4 weeks

Secondary

Measure	Time frame
IBS life impact, overall treatment assessment, concomitant factors	Baseline and 4 weeks

Countries

Hungary, Poland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026