Two Doses Mesalazine Granules Versus Placebo for the Prevention of Recurrence of Diverticulitis

• Status: Terminated
• Trial end date: 2013-01-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the study is to determine which dose of mesalazine granules compared to placebo is more effective in the prevention of recurrence of disease.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dr. Falk Pharma GmbH
• Treatments: Mesalamine

Criteria

Inclusion Criteria:

• Diagnosis of left-sided uncomplicated diverticular disease confirmed by computed tomography

• Presence of at least one diverticulum of the left colon

• Most recent attack of left-sided uncomplicated diverticulitis responding to antibiotics and/or dietary modification within the last 6 months

• C-reactive protein (CRP) > upper limit of normal (ULN) or leucocytosis at the start of the most recent attack

Exclusion Criteria:

• Complicated diverticular disease

• Right-sided diverticulitis

• Previous colonic surgery

• Presence of symptomatic organic disease of the gastrointestinal tract

• Active colorectal cancer or a history of colorectal cancer

• Hemorrhagic diathesis

• Active peptic ulcer disease, local intestinal infection

• Asthma if careful medical monitoring is not ensured

• Abnormal hepatic function or liver cirrhosis

• Abnormal renal function