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

This study has been completed.
Information provided by (Responsible Party):
Dr. Falk Pharma GmbH Identifier:
First received: June 21, 2012
Last updated: January 20, 2016
Last verified: January 2016
The purpose of this study is to determine whether mesalamine is effective in the treatment of uncomplicated diverticular disease by reducing the pain.

Condition Intervention Phase
Colonic Diverticulosis
Drug: Mesalamine
Drug: Placebo
Phase 2

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

Resource links provided by NLM:

Further study details as provided by Dr. Falk Pharma GmbH:

Primary Outcome Measures:
  • The change in intensity of lower abdominal pain during the first four weeks of treatment (SPID 0-28) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    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

Enrollment: 123
Study Start Date: May 2002
Study Completion Date: April 2006
Primary Completion Date: August 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo Drug: Placebo
3x1000mg placebo granules per day
Other Name: Placebo granules
Experimental: Mesalamine Drug: Mesalamine
3x1000mg mesalamine granules per day
Other Name: Salofalk granules


Ages Eligible for Study:   45 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT01627262

Ev. Krankenhaus Kalk, University of Cologne
Köln, Germany, 51103
Sponsors and Collaborators
Dr. Falk Pharma GmbH
Principal Investigator: Wolfgang Kruis, MD Ev. Krankenhaus Kalk, University of Cologne
  More Information

Responsible Party: Dr. Falk Pharma GmbH Identifier: NCT01627262     History of Changes
Other Study ID Numbers: SAG-20/DIV 
Study First Received: June 21, 2012
Last Updated: January 20, 2016
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Dr. Falk Pharma GmbH:
diverticular disease
colonic diverticulosis

Additional relevant MeSH terms:
Diverticulosis, Colonic
Colonic Diseases
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Pathological Conditions, Anatomical
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antirheumatic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Sensory System Agents processed this record on May 26, 2016