Two Doses Mesalazine Granules Versus Placebo for the Prevention of Recurrence of Diverticulitis
Status and phase
Conditions
Treatments
Study type
Funder types
Identifiers
Details and patient eligibility
About
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.
Full description
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'.
Enrollment
Sex
Ages
Volunteers
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
Trial design
Primary purpose
Allocation
Interventional model
Masking
330 participants in 3 patient groups, including a placebo group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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