Official Title: “Double-Blind, Randomized, 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 whether mesalazine granules compared to placebo is effective in prevention of recurrence of disease.

Study Type: Interventional

Study Design: Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: January 2010

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.

Intervention(s) in this Clinical Trial

• Drug: Mesalazine
  • 3 g per day
• Drug: Placebo
  • 0 g per day

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: A
• Placebo Comparator: B

Primary Measures

• Proportion of recurrence-free patients within 48 weeks
  • Time Frame: 48 weeks
    Safety Issue?: No

Secondary Measures

• Time to recurrence
  • Safety Issue?: No
• Occurrence of diverticulitis-associated fever
  • Time Frame: 48 weeks
    Safety Issue?: No
• Number of days with left lower quadrant pain
  • Time Frame: 48 weeks
    Safety Issue?: No
• Stool consistency
  • Time Frame: 48 weeks
    Safety Issue?: No
• Severity of diarrhea
  • Time Frame: 48 weeks
    Safety Issue?: No
• QoL
  • Time Frame: 48 weeks
    Safety Issue?: No
• Health assessment
  • Time Frame: 48 weeks
    Safety Issue?: No
• PGA
  • Time Frame: 48 weeks
    Safety Issue?: No

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
• CRP > 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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 40 Years

Maximum Age for this Clinical Trial: 80 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Dr. Falk Pharma GmbH

Overall Clinical Trial Officials and Contacts

Wolfgang Kruis, Professor Principal Investigator Evang. Krankenhaus Kalk, Medical department  

Overall Contact: Ralf Mohrbacher, MSc 49-761-1514 mohrbacher@drfalkpharma.de

Information obtained from ClinicalTrials.gov on October 10, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00695643

Study ID Number: SAG-37/DIV

ClinicalTrials.gov Identifier: NCT00695643

Health Authority: Germany: Federal Institute for Drugs and Medical Devices