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OpenTrials
Completed

NCT Number: NCT00542295

Efficacy and Safety of Meteospasmyl® in Irritable Bowel Syndrome

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

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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–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Budapest, Hungary

Loading trial locations.

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 18-75 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

Treatment and study plan

alverine citrate and simeticone

Drug

Other names: Meteospasmyl®

Placebo

Drug

Primary outcomes

  1. Subject self assessment of abdominal pain/discomfort

    Time frame: Baseline and 4 weeks

Secondary outcomes

  1. IBS life impact, overall treatment assessment, concomitant factors

    Time frame: Baseline and 4 weeks

Sponsors and collaborators

Lead sponsor

Laboratoires Mayoly Spindler

Industry

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Oct 11, 2007
Registry last updated
Oct 1, 2008

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.

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