Mesalazine Treatment in IBS, a Double-blind Placebo-controlled Phase II Intervention Study in Adult Patients
Inclusion Criteria:
- Males and females aged 18 to 70 years, both inclusive
- Subject is diagnosed with irritable bowel syndrome (IBS) prior to Screening based on
the Rome III diagnostic criteria.
- 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)
- Provision of signed informed consent
Exclusion Criteria:
- Subjects who are unable to understand the written and verbal instructions
- Presence of a systemic inflammatory disease
- Presence of other gastrointestinal diseases likely to explain the IBS symptoms
- Presence of other severe somatic disease
- 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)
- Treatment with systemic antibiotics within 28 days prior to Screening (Visit 1, Day
-21±2)
- Treatment with immunosuppressant drugs within 28 days prior to Screening (Visit 1,
Day -21±2)
- 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)
- Previously confirmed allergy towards ASA or mesalazine
- Presence of renal disease and/or concomitant treatment with medications with
potential renal side effects
- Current ongoing infection
- History of, or current, drug or alcohol dependence
- Pregnant or lactating women
- Subjects suspected not to follow instructions based on the discretion of the
Investigator
- Current participation in other intervention studies
- Female subjects of childbearing potential unwilling to use adequate contraceptive
measures throughout the duration of the study.