A Randomised, Double Blind, Placebo Controlled, Multi-centre, Parallel Group, Interventional Study of Mesalazine (Asacol®) Treatment in Irritable Bowel Syndrome and the Evaluation of Rectal Inflammation using the Diagnostic Tool 'Mucosal Patch Technique'

• Conditions: Irritable Bowel Syndrome; MedDRA version: 14.1Level: PTClassification code 10023003Term: Irritable bowel syndromeSystem Organ Class: 10017947 - Gastrointestinal disorders; Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]

• Registration Number: EUCTR2011-003418-18-SE
• Lead Sponsor: Sahlgrenska University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-12-05
• Last Update Posted: 3 April 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

1) Males and females aged 18 to 70 years, both inclusive
2) Subject is diagnosed with irritable bowel syndrome (IBS) prior to Screening based on the Rome III diagnostic criteria for IBS
3) Subject presents with IBS symptom intensity of at least moderate level; defined as an IBS Severity Scoring System (IBS-SSS) score of =175 at both Screening and Baseline
4) Provision of signed informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 180
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion Criteria

1) Subjects who are unable to understand the written and verbal instructions
2) Presence of a systemic inflammatory disease
3) Presence of other gastrointestinal diseases likely to explain the IBS symptoms
4) Presence of other severe somatic disease
5) Treatment with non-steroidal anti-inflammatory drugs (NSAID), opioid analgetics or acetylsalicylic acid (ASA) compounds within 7 days prior to Screening
6) Treatment with systemic antibiotics within 28 days prior to Screening
7) Treatment with immunosuppressant drugs within 28 days prior to Screening
8) Other significant medical treatment, which, in the opinion of the investigator, may compromise the safety and efficacy objectives of the study, within 28 days prior to Screening
9) Previously confirmed allergy towards ASA or mesalazine
10) Presence of renal disease and/or concomitant treatment with medications with potential renal side effects
11) Current ongoing infection
11) History of, or current, drug or alcohol dependence
12) Pregnant or lactating women
13) Subjects suspected not to follow instructions based on the discretion of the Investigator
14) Current participation in other intervention studies
15) Female subjects of childbearing potential unwilling to use adequate contraceptive measures throughout the duration of the study.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified