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

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ClinicalTrials.gov Identifier: NCT01627262
Recruitment Status : Completed
First Posted : June 25, 2012
Last Update Posted : January 21, 2016
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Colonic Diverticulosis Drug: Mesalamine Drug: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 123 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, 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
Study Start Date : May 2002
Actual Primary Completion Date : August 2004
Actual Study Completion Date : April 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. The change in intensity of lower abdominal pain during the first four weeks of treatment (SPID 0-28) [ Time Frame: 4 weeks ]
    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



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Ages Eligible for Study:   45 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications of Results:
Responsible Party: Dr. Falk Pharma GmbH
ClinicalTrials.gov Identifier: NCT01627262     History of Changes
Other Study ID Numbers: SAG-20/DIV
First Posted: June 25, 2012    Key Record Dates
Last Update Posted: January 21, 2016
Last Verified: January 2016

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
Anti-Inflammatory Agents
Antirheumatic Agents