Mesalazine Granules vs. Placebo for the Prevention of Recurrence of Diverticulitis

Dr. Falk Pharma

Status and phase: Terminated; Phase 3

Conditions: Diverticulitis

Treatments: Drug: Placebo; Drug: Mesalazine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00695643

SAG-37/DIV

2007-000680-22 (EudraCT Number)

Details and patient eligibility

About

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

Full 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.

Enrollment: 345 patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 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: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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345 participants in 2 patient groups, including a placebo group

A

Experimental group

Treatment:

Drug: Mesalazine

B

Placebo Comparator group

Treatment:

Drug: Placebo