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

Colonic Diverticulosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01627262
• Other study ID #: SAG-20/DIV
• Status: Completed
• Phase: Phase 2
• First received: June 21, 2012
• Last updated: January 20, 2016
• Start date: May 2002
• Est. completion date: April 2006

Study information

• Verified date: January 2016
• Source: Dr. Falk Pharma GmbH
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 123
• Est. completion date: April 2006
• Est. primary completion date: August 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 45 Years to 80 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colonic Diverticulosis
• Diverticulosis, Colonic
• Diverticulum

Intervention

Drug:
• Mesalamine
3x1000mg mesalamine granules per day
• Placebo
3x1000mg placebo granules per day

Locations

Country	Name	City	State
Germany	Ev. Krankenhaus Kalk, University of Cologne	Köln

Sponsors (1)

Lead Sponsor	Collaborator
Dr. Falk Pharma GmbH

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Kruis W, Meier E, Schumacher M, Mickisch O, Greinwald R, Mueller R; German SAG-20 Study Group. Randomised clinical trial: mesalazine (Salofalk granules) for uncomplicated diverticular disease of the colon--a placebo-controlled study. Aliment Pharmacol The — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The change in intensity of lower abdominal pain during the first four weeks of treatment (SPID 0-28)	The change in intensity of lower abdominal pain during the first four weeks of treatment, defined as the cumulative difference of the daily pain intensity score from the first day of study medication intake (day 1) to week 4	4 weeks	No