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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01627262
First Posted: June 25, 2012
Last Update Posted: January 21, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Dr. Falk Pharma GmbH
June 21, 2012
June 25, 2012
January 21, 2016
May 2002
August 2004   (Final data collection date for primary outcome measure)
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
Change in intensity of lower abdominal pain during the first four weeks of treatment [ Time Frame: 4 weeks ]
Complete list of historical versions of study NCT01627262 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Mesalamine for Uncomplicated Diverticular Disease: a Randomized, Double-blind, Placebo-controlled Study
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
The purpose of this study is to determine whether mesalamine is effective in the treatment of uncomplicated diverticular disease by reducing the pain.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Colonic Diverticulosis
  • Drug: Mesalamine
    3x1000mg mesalamine granules per day
    Other Name: Salofalk granules
  • Drug: Placebo
    3x1000mg placebo granules per day
    Other Name: Placebo granules
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
  • Experimental: Mesalamine
    Intervention: Drug: Mesalamine
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 Ther. 2013 Apr;37(7):680-90. doi: 10.1111/apt.12248. Epub 2013 Feb 17.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
123
April 2006
August 2004   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
45 Years to 80 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
 
NCT01627262
SAG-20/DIV
No
Not Provided
Not Provided
Dr. Falk Pharma GmbH
Dr. Falk Pharma GmbH
Not Provided
Principal Investigator: Wolfgang Kruis, MD Ev. Krankenhaus Kalk, University of Cologne
Dr. Falk Pharma GmbH
January 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP