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Mesalazine Treatment in IBS (The MIBS Study) (MIBS)

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ClinicalTrials.gov Identifier: NCT01699438
Recruitment Status : Completed
First Posted : October 3, 2012
Last Update Posted : February 24, 2017
Sponsor:
Collaborators:
Sahlgrenska University Hospital, Sweden
Smerud Medical Research International AS
Alimenta AB
Tillotts Pharma AG
Karolinska University Hospital
Haukeland University Hospital
Oslo University Hospital
Sykehuset Innlandet HF
Information provided by (Responsible Party):
Hans Törnblom, Göteborg University

September 16, 2012
October 3, 2012
February 24, 2017
April 2012
December 2016   (Final data collection date for primary outcome measure)
Global Irritable Bowel Syndrome (IBS) symptoms [ Time Frame: 8 weeks ]
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)
Same as current
Complete list of historical versions of study NCT01699438 on ClinicalTrials.gov Archive Site
  • Inflammatory mediators [ Time Frame: 8 weeks ]
    Measured by the Mucosal Patch Technology (MPT), e.g. neutrophil mediators (myeloperoxidase (MPO)), eosinophilic mediators (eosinophil cationic protein (ECP)), mast cell activity mediators (tryptase) and cytokines (Interleukin (IL)-2, IL-6, Tumor necrosis factor (TNF)-alpha, IL-1beta etc) by Enzyme-Linked Immunosorbent Assays (ELISA), (ug/ml).
  • Effect on immune cells and cytokines in mucosal biopsies [ Time Frame: 8 weeks ]
    Counts per high-power field in microscopy and by immunohistochemistry
  • Levels of calprotectin in faeces [ Time Frame: 8 weeks ]
    Enzyme-Linked Immunosorbent Assay (ELISA), mg/kg
  • Change in total IBS symptom severity score (IBS-SSS) [ Time Frame: 8 weeks ]
    Absolute change in IBS-SSS compared to baseline.
  • Individual symptom parameters in IBS symptom severity score (IBS-SSS) and the IBS diary [ Time Frame: 8 weeks ]
    Reduction of scores regarding individual question components (visual analog scale (VAS)) in IBS-SSS. Stool frequency and consistency expressed by Bristol Stool Form Scale in a separate IBS diary.
  • Exploratory responder variables [ Time Frame: 8 weeks ]
    1. Satisfactory symptom relief ≥75% of the time
    2. Reduction in IBS-SSS ≥50 at end of treatment compared to baseline
Same as current
Not Provided
Not Provided
 
Mesalazine Treatment in IBS (The MIBS Study)
Mesalazine Treatment in IBS, a Double-blind Placebo-controlled Phase II Intervention Study in Adult Patients

Irritable bowel syndrome (IBS) is a condition characterised by abdominal pain or discomfort in combination with altered bowel function (stool frequency and/or stool consistency), currently defined by the Rome III criteria. The current IBS definition specifies that there are no structural or biochemical abnormalities to account for the symptoms but there is growing evidence that in at least a subset of IBS patients, a discrete immune activation might be a key pathogenetic factor. The condition is prone to develop after a gastroenteritis, post-infectious IBS, and increased numbers of lymphocytes, mast cells and pro-inflammatory cytokines like Interleukin (IL)-1β, IL-6, Tumor necrosis factor (TNF)-α and a general increase in mucosal cellularity have been reported. Despite this, the efficacy of anti-inflammatory agents has been poorly investigated.

This will be a randomised, double blind, placebo-controlled, parallel-group, multi-centre study that aims to include a total of 200 subjects with irritable bowel syndrome (IBS). All subjects will be randomised to receive either 3x800 mg of mesalazine (Asacol®) or corresponding placebo once daily for a total treatment duration of 8 weeks. Males and females aged 18 to 70 years who already are diagnosed with IBS based on the Rome III diagnostic criteria and with a 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) will be eligible to enter the study.

Primary aim:

To assess the effect of mesalazine (Asacol®) treatment compared to placebo on global IBS symptoms: A treatment responder will be defined by answering the satisfactory relief of IBS-symptoms question "yes" at the end of at least 4 out of of 8 treatment weeks.

Secondary aims:

To assess mesalazine (Asacol®) treatment compared to placebo regarding:

  1. Levels of inflammatory mediators in the rectal mucosa (e.g. neutrophil mediators, eosinophilic mediators, mast cell activity mediators and cytokines) measured by a new diagnostic tool, the Mucosal Patch Technology (MPT) by means of Enzyme-Linked Immunosorbent Assays (ELISA)
  2. Effects on number of immune cells (count per high power field) and cytokine content (immunohistochemistry) in mucosal biopsies
  3. Calprotectin levels in faeces (mg/kg)
  4. Individual IBS symptom parameters derived from a symptom diary and also measured by IBS-SSS
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Irritable Bowel Syndrome
  • Drug: Mesalazine
    2400 mg q.d. for 8 weeks
    Other Name: Asacol
  • Drug: Placebo
    3 tablets q.d. for 8 weeks
  • Experimental: Mesalazine
    Intervention: Drug: Mesalazine
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
211
200
February 2017
December 2016   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Sweden
 
 
NCT01699438
SMR-2268
Yes
Not Provided
Not Provided
Hans Törnblom, Göteborg University
Hans Törnblom
  • Sahlgrenska University Hospital, Sweden
  • Smerud Medical Research International AS
  • Alimenta AB
  • Tillotts Pharma AG
  • Karolinska University Hospital
  • Haukeland University Hospital
  • Oslo University Hospital
  • Sykehuset Innlandet HF
Principal Investigator: Hans Törnblom, MD, PhD Sahlgrenska University Hospital, Sweden
Göteborg University
February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP