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

NCT00663247 | Completed DMC

• 1 other identifier: 07057
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Diverticulosis, Colonic

Keywords

Diverticular disease; Inflammation; Mesalazine

Outcome Measures

Primary Outcomes (1)

• Difference in galanin expression in mucosal nerves from 0 to 12 weeks

  12 weeks

Study Arms (2)

B

PLACEBO COMPARATOR

placebo used as control for comparison with active drug

Drug: Placebo

A

ACTIVE COMPARATOR

Device: Mesalazine

Interventions

Mesalazine DEVICE

3 grams daily for 3 months

Also known as: Salofalk®, 5 ASA

A

Placebo DRUG

3 grams daily for 3 months

Also known as: Sham medication

B

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Symptomatic diverticular disease with short lived recurrent abdominal pain on 3 or more days a month.
• years of age.
• Signed informed consent
• Presence of at least one diverticulum in the left colon

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Nottingham: lead

Study Sites (1)

NIHR Biomedical Research Unit, Nottingham University Hospital

Nottingham, Nottinghamshire, NG7 2UH, United Kingdom

Location

MeSH Terms

Conditions

Diverticulosis, Colonic; Diverticular Diseases; Inflammation

Condition Hierarchy (Ancestors)

Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Gastroenteritis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• RC Spiller, Prof

  Nottingham University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2008
• First Posted: April 22, 2008
• Study Start: April 1, 2008
• Primary Completion: January 1, 2011
• Study Completion: January 1, 2011
• Last Updated: June 14, 2012

Record last verified: 2012-06

Locations

GB (1)