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

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Diverticulitis

In brief

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.

Key facts

Study ID

NCT01038739

Run by

Dr. Falk Pharma GmbH

People needed

330

Starts

2010-01-01

Expected to finish

2013-01-01

Last updated by the study team

2017-07-21

Who can join

Age: 30 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• United Medical Research — New Smyrna Beach, Florida, United States

Full record on ClinicalTrials.gov

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