Mechanistic Randomized Controlled Trial (RCT) of Mesalazine in Symptomatic Diverticular Disease

• Status: Completed
• Trial end date: 2011-01-01
• Target enrollment: 0
• Participant gender: All

Summary

Diverticulosis (bulges in the bowel wall) affects two third of the elderly population in the UK. Diverticular disease and its complications are responsible for 68000 hospital admissions and 2000 deaths per year. It commonly produces recurrent short lived abdominal pain, changes in bowel habit and incontinence. The causes of symptoms are not known and the treatments unsatisfactory. Recent studies have found an association between inflammation, alteration of bowel nerves and symptoms. Mesalazine is an anti-inflammatory drug used in inflammatory bowel conditions, such as ulcerative colitis and crohn's disease. We plan to perform a randomized double blind (neither the patients or the doctors known which treatment the patient is taking) placebo (sham medication) controlled trial of mesalazine in symptomatic diverticular disease patients. We anticipate a reduction in the amount of inflammation, bowel nerve changes and symptoms in patients taking mesalazine compare to those taking the placebo.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Nottingham
• Treatments: Mesalamine

Criteria

Inclusion Criteria:

• Symptomatic diverticular disease with short lived recurrent abdominal pain on 3 or more days a month.

• 18 - 85 years of age.

• Signed informed consent

• Presence of at least one diverticulum in the left colon

Exclusion Criteria:

• Pregnant or lactating women.

• Severe co-morbidity, alcoholism or drug dependence or inability to give informed consent.

• Contraindications to use of Mesalazine as detailed in SmPC.

• Inability to stop NSAIDs (non-steroidal anti-inflammatory agents) or long term antibiotics.

• The use of specific concomitant medications as detailed in the section below.

• Presence of other gastrointestinal inflammatory conditions such as ulcerative colitis, Crohn's disease and Coeliac disease.