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Mesalazine Treatment in IBS, a Double-blind Placebo-controlled Phase II Intervention Study in Adult Patients

Phase 2
18 Years
70 Years
Open (Enrolling)
Irritable Bowel Syndrome

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Trial Information

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

- Treatment with systemic antibiotics within 28 days prior to Screening (Visit 1, Day

- 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

- Current participation in other intervention studies

- Female subjects of childbearing potential unwilling to use adequate contraceptive
measures throughout the duration of the study.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Global Irritable Bowel Syndrome (IBS) symptoms

Outcome Description:

The main measurement parameter of symptom alleviation will be a weekly question regarding satisfactory relief of global IBS symptoms. A treatment responder will be defined as answering "yes" ≥50% of the weeks (≥4 weeks)

Outcome Time Frame:

8 weeks

Safety Issue:


Principal Investigator

Hans Törnblom, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Sahlgrenska University Hospital, Sweden


Sweden: Medical Products Agency

Study ID:




Start Date:

April 2012

Completion Date:

October 2013

Related Keywords:

  • Irritable Bowel Syndrome
  • Irritable Bowel Syndrome
  • Inflammation
  • Mesalazine
  • Irritable Bowel Syndrome