Efficacy of Mesalamine in Diarrhea-predominant Irritable Bowel Syndrome (dIBS)
Condition: Irritable Bowel Syndrome
MeSH terms: Irritable Bowel Syndrome; Syndrome; Diarrhea
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to find whether treating patients with diarrhea predominant
      Irritable Bowel Syndrome (IBS) with an anti-inflammatory drug called Mesalamine will help
      improve their symptoms of diarrhea, bloating and abdominal pain.
    

Detailed description: 
      Irritable bowel syndrome (IBS) is a common gastrointestinal disorder affecting about 20% of
      the United States population and comprising almost 50% of referrals to gastroenterology
      practices. Although the pathophysiology of IBS is poorly understood, more recently, both
      inflammation and an increased intestinal permeability have been identified as potential
      factors in the etiology of diarrhea-predominant IBS patients(dIBS). Despite the potential of
      an inflammatory etiology for IBS, few studies have examined the efficacy of anti-inflammatory
      agents such as mesalamine in patients with IBS. The primary objective of our study is to
      determine the efficacy of Apriso™ (Salix Pharmaceuticals Inc), a long-acting mesalamine, in
      the treatment of patients with dIBS. Apriso™, is a mesalamine approved by the Food and Drug
      Administration (FDA) on October 31, 2008 for the maintenance of remission in patients with
      active, mild to moderate ulcerative colitis. The investigators will perform a randomized,
      double-blind, cross-over trial of mesalamine compared to placebo in patients with dIBS. This
      study will analyze both the objective and subjective measures of improvement in IBS symptoms.
      The subjective measures will include improvements in the overall symptom severity scores and
      the Global Improvement Scale (GIS) and the objective measures will include histological
      measures of inflammation as well as improvements in the intestinal membrane permeability of
      treated subjects. The investigators will demonstrate that during the 12 weeks treatment
      period with mesalamine, subjects will have improvements in their overall symptom scores, GIS
      scores, and will have a reduction in intestinal inflammation and also prohibit a likely
      improvement in Intestinal membrane permeability.
    

Intervention name(s): Mesalamine; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Apriso is a 5-ASA drug with Intellicor ™ extended-release delivery technology. A 1.5 gram dosage of Apriso (equaling four 375 mg capsules) once a day will be administered orally for a period of 12 weeks followed by a 3 week wash out prior to crossing over to the placebo arm.; 4 capsules (.375 gm sugar pill capsules) administered orally once a day. This group will receive the placebo for 12 weeks then a wash out for 3 weeks prior to crossing over to the drug arm.
Other intervention name(s): Apriso ™
Intervention MeSH terms: Mesalamine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Irritable Bowel Syndrome; Irritable Bowel Syndrome Treatment; Mesalamine; Anti-inflammatory drugs; 5-ASA drugs; Apriso ™