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: 16.1Level: 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-NO
• Lead Sponsor: Sahlgrenska University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-11-12
• Last Update Posted: 27 January 2014

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.
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 (Visit 1, Day -21±2) and Baseline (Visit 2, Day 0)
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 65
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

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 (Visit 1, Day -21±2)
6) Treatment with systemic antibiotics within 28 days prior to Screening (Visit 1, Day -21±2)
7) Treatment with immunosuppressant drugs within 28 days prior to Screening (Visit 1, Day -21±2)
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 (Visit 1, Day -21±2)
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
12) History of, or current, drug or alcohol dependence
13) Pregnant or lactating women
14) Subjects suspected not to follow instructions based on the discretion of the Investigator
15) Current participation in other intervention studies
16) Female subjects of childbearing potential unwilling to use adequate contraceptive measures throughout the duration of the study. For the purpose of this study, adequate contraception is defined as:
- oral, injected or implanted hormonal methods of contraception; OR
- placement of an intrauterine device (IUD) or intrauterine system (IUS); OR
- barrier methods of contraception: Condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository

Note: Male sterilisation or abstinence are not acceptable methods of birth control and would preclude enrolment in the study.

Study & Design

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