Status:
COMPLETED
Mechanistic Randomized Controlled Trial (RCT) of Mesalazine in Symptomatic Diverticular Disease
Lead Sponsor:
University of Nottingham
Conditions:
Diverticulosis, Colonic
Eligibility:
All Genders
18-85 years
Phase:
NA
Brief 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 death...
Detailed Description
Diverticular disease affects two thirds of the elderly population in the United Kingdom. Only a small fraction of individuals with diverticulosis develop symptoms, perhaps 1 in 10, for reasons which a...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2011
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00663247
Start Date
April 1 2008
End Date
January 1 2011
Last Update
June 14 2012
Active Locations (1)
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1
NIHR Biomedical Research Unit, Nottingham University Hospital
Nottingham, Nottinghamshire, United Kingdom, NG7 2UH