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

Condition(s) targeted: Diverticulitis

Intervention: Mesalazine (Drug); Mesalazine (Drug); Placebo (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Dr. Falk Pharma GmbH

Official(s) and/or principal investigator(s):
Wolfgang Kruis, Professor, Principal Investigator, Affiliation: Evang. Krankenhaus Kalk, Medical department

Overall contact:
Ralf Mohrbacher, MSc, Phone: +49-761-1514, Ext: 156, Email: mohrbacher@drfalkpharma.de

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.

Official title: 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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Primary outcome: Proportion of recurrence-free patients at 48 weeks and at 96 weeks:

Secondary outcome:

Time to recurrence

Occurrence of diverticulitis-associated fever

Number of days with left lower quadrant pain

Stool consistency

Severity of diarrhea

Quality of Life (QoL)

Health assessment

Assessment of efficacy by investigator and patient

Detailed 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'.

Minimum age: 30 Years. Maximum age: 80 Years. Gender(s): Both.

Criteria:

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

Ralf Mohrbacher, MSc, Phone: +49-761-1514, Ext: 156, Email: mohrbacher@drfalkpharma.de

United Medical Research, New Smyrna Beach, Florida 32168, United States; Recruiting
M. Nagrani, MD

Starting date: January 2010
Last updated: June 7, 2011