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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dr. Falk Pharma GmbH
ClinicalTrials.gov Identifier:
NCT01627262
First received: June 21, 2012
Last updated: June 25, 2012
Last verified: June 2012
History of Changes
  Purpose

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:

U.S. FDA Resources

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

  Eligibility

Ages Eligible for Study:   45 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01627262

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

No publications provided

Responsible Party: Dr. Falk Pharma GmbH
ClinicalTrials.gov Identifier: NCT01627262     History of Changes
Other Study ID Numbers: SAG-20/DIV
Study First Received: June 21, 2012
Last Updated: June 25, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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

Additional relevant MeSH terms:
Diverticulum
Diverticulosis, Colonic
Pathological Conditions, Anatomical
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Mesalamine
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
 Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 21, 2013