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Completed

NCT Number: NCT00626288

Mesalazine Therapy in Patients With Irritable Bowel Syndrome

The purpose of this study is to determine whether Mesalazine is effective in the treatment of the abdominal discomfort or pain of Irritable Bowel Syndrome patients.

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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–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Ospedali Riuniti Torrette, Ancona, Italy

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About this study

The present study is a prospective, double blind, randomised, multicenter trial designed to study the efficacy of mesalazine treatment on symptoms of IBS. In a subgroup of patients the efficacy of this treatment will be also assessed on low-grade inflammation. We expect to confirm that mesalazine treatment reduces the number and activation of inflammatory cells in the colonic mucosa of IBS patients, thus providing the rationale for the assessment of this treatment on symptoms of IBS.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • IBS patients with positive diagnosis inclosing Rome III criteria

Exclusion criteria

  • Any organic or metabolic disease

Treatment and study plan

Mesalazine

Drug

Mesalazine 800mg t.i.d. 12 weeks

Other names: Pentacol 800, Sofar

Placebo

Drug

Placebo cpr, t.i.d. 12 weeks

Primary outcomes

  1. "Responder" is the patient who affirmatively answers on at least 50% of the weekly question:"Did you have satisfactory relief of your abdominal discomfort or pain during the last week?".

    Time frame: 3 months

Secondary outcomes

  1. "Responder" is the patient who affirmatively answers on at least 50% of the weekly question:"Did you have satisfactory relief of your overall IBS symptoms during the last week?". VAS scale IBS-QoL questionnaire and SF-36 questionnaire

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

SOFAR S.p.A.

Industry

Registry information

Official study title

A Randomised Controlled Multicenter Trial Assessing the Efficacy and Safety of Mesalazine Therapy in Patients With Irritable Bowel Syndrome.

Acronym: IBS-02/07

Important dates

Study start
2007
Primary completion
2012
Study completion
2012
First posted
Feb 29, 2008
Registry last updated
Jul 26, 2013

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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