Status:
TERMINATED
Mesalazine Granules vs. Placebo for the Prevention of Recurrence of Diverticulitis
Lead Sponsor:
Dr. Falk Pharma GmbH
Conditions:
Diverticulitis
Eligibility:
All Genders
40-80 years
Phase:
PHASE3
Brief Summary
The purpose of the study is to determine whether mesalazine granules compared to placebo is effective in prevention of recurrence of disease.
Detailed Description
The purpose of the study is to demonstrate the superiority of mesalazine granules compared to placebo in terms of the primary efficacy variable proportion of recurrence-free patients within 48 weeks.
Eligibility Criteria
Inclusion
- Diagnosis of left-sided uncomplicated diverticular disease confirmed by ultrasonography or 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) at the start of the most recent attack
Exclusion
- 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
Key Trial Info
Start Date :
January 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2012
Estimated Enrollment :
345 Patients enrolled
Trial Details
Trial ID
NCT00695643
Start Date
January 1 2008
End Date
January 1 2012
Last Update
July 24 2017
Active Locations (1)
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1
Evang. Krankenhaus Kalk, Medical department
Cologne, Germany, 51103