Double-blind, Randomised, Placebo-controlled, Parallel-group, Multi-centre Phase III Clinical Study on the Efficacy and Tolerability of Mesalazine Pellets vs. Placebo in Diverticular Disease

Mesalamine for Uncomplicated Diverticular Disease: a Randomized, Double-blind, Placebo-controlled Study

Sponsors

Lead sponsor: Dr. Falk Pharma GmbH

Source Dr. Falk Pharma GmbH
Brief Summary

The purpose of this study is to determine whether mesalamine is effective in the treatment of uncomplicated diverticular disease by reducing the pain.

Overall Status Completed
Start Date May 2002
Completion Date April 2006
Primary Completion Date August 2004
Phase Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
The change in intensity of lower abdominal pain during the first four weeks of treatment (SPID 0-28) 4 weeks
Enrollment 123
Condition
Intervention

Intervention type: Drug

Intervention name: Mesalamine

Description: 3x1000mg mesalamine granules per day

Arm group label: Mesalamine

Other name: Salofalk granules

Intervention type: Drug

Intervention name: Placebo

Description: 3x1000mg placebo granules per day

Arm group label: Placebo

Other name: Placebo granules

Eligibility

Criteria:

Inclusion Criteria:

- Diagnosis of diverticular disease with acute pain without serious complications

- Lower abdominal pain of moderate or severe intensity at least during the last 4 days before study inclusion

Exclusion Criteria:

- Chronic inflammatory bowel disease

- Fever or other signs of serious complications.

Gender: All

Minimum age: 45 Years

Maximum age: 80 Years

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Wolfgang Kruis, MD Principal Investigator Ev. Krankenhaus Kalk, University of Cologne
Location
facility
Ev. Krankenhaus Kalk, University of Cologne
Location Countries

Germany

Verification Date

January 2016

Responsible Party

Responsible party type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Arm group label: Placebo

Arm group type: Placebo Comparator

Arm group label: Mesalamine

Arm group type: Experimental

Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: Triple (Participant, Investigator, Outcomes Assessor)

Source: ClinicalTrials.gov