Two Doses Mesalazine Granules Versus Placebo for the Prevention of Recurrence of Diverticulitis
Status: | Terminated |
---|---|
Conditions: | Gastrointestinal, Diverticulitis |
Therapuetic Areas: | Gastroenterology |
Healthy: | No |
Age Range: | 30 - 80 |
Updated: | 7/22/2017 |
Start Date: | January 2010 |
End Date: | January 2013 |
Double-blind, Dose-response, Randomised, Placebo-controlled, Parallel Group, Multi-centre Phase III Clinical Study on the Efficacy and Tolerability of Mesalazine Granules vs. Placebo for the Prevention of Recurrence of Diverticulitis
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.
placebo is more effective in the prevention of recurrence of disease.
The primary purpose of the study is to demonstrate the superiority of mesalazine granules
compared to placebo in terms of the two primary efficacy variables 'proportion of
recurrence-free patients within 48 weeks' and 'proportion of recurrence-free patients within
96 weeks'.
compared to placebo in terms of the two primary efficacy variables 'proportion of
recurrence-free patients within 48 weeks' and 'proportion of recurrence-free patients within
96 weeks'.
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
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