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
1 other identifier
interventional
123
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started May 2002
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2002
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2006
CompletedFirst Submitted
Initial submission to the registry
June 21, 2012
CompletedFirst Posted
Study publicly available on registry
June 25, 2012
CompletedJanuary 21, 2016
January 1, 2016
2.3 years
June 21, 2012
January 20, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
Placebo
PLACEBO COMPARATORMesalamine
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Diagnosis of diverticular disease with acute pain without serious complications
You may not qualify if:
- Chronic inflammatory bowel disease
- Fever or other signs of serious complications.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ev. Krankenhaus Kalk, University of Cologne
Cologne, 51103, Germany
Related 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 Ther. 2013 Apr;37(7):680-90. doi: 10.1111/apt.12248. Epub 2013 Feb 17.
PMID: 23414061RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Wolfgang Kruis, MD
Ev. Krankenhaus Kalk, University of Cologne
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 21, 2012
First Posted
June 25, 2012
Study Start
May 1, 2002
Primary Completion
August 1, 2004
Study Completion
April 1, 2006
Last Updated
January 21, 2016
Record last verified: 2016-01