Back to resultsMesalamine for Uncomplicated Diverticular Disease: a Randomized, Double-blind, Placebo-controlled Study
Primary Purpose
Colonic Diverticulosis
Status
Completed
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
Mesalamine
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Colonic Diverticulosis focused on measuring diverticular disease, colonic diverticulosis, mesalamine, placebo, randomized
Eligibility 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.
Sites / Locations
- Ev. Krankenhaus Kalk, University of Cologne
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Placebo
Mesalamine
Arm Description
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01627262
Brief Title
Mesalamine for Uncomplicated Diverticular Disease: a Randomized, Double-blind, Placebo-controlled Study
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 Type
Interventional
2. Study Status
Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
May 2002 (undefined)
Primary Completion Date
August 2004 (Actual)
Study Completion Date
April 2006 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dr. Falk Pharma GmbH
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colonic Diverticulosis
Keywords
diverticular disease, colonic diverticulosis, mesalamine, placebo, randomized
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
123 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Title
Mesalamine
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Mesalamine
Other Intervention Name(s)
Salofalk granules
Intervention Description
3x1000mg mesalamine granules per day
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Placebo granules
Intervention Description
3x1000mg placebo granules per day
Primary Outcome Measure Information:
Title
The change in intensity of lower abdominal pain during the first four weeks of treatment (SPID 0-28)
Description
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
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wolfgang Kruis, MD
Organizational Affiliation
Ev. Krankenhaus Kalk, University of Cologne
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ev. Krankenhaus Kalk, University of Cologne
City
Köln
ZIP/Postal Code
51103
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
23414061
Citation
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.
Results Reference
result
Learn more about this trial
Mesalamine for Uncomplicated Diverticular Disease: a Randomized, Double-blind, Placebo-controlled Study
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