- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00545389
Phase II Dose-Ranging Study in Subjects With Mild to Moderate Ulcerative Colitis Treated With SPD476
June 8, 2021 updated by: Shire
A Phase II, Randomized, Multi-centre, Double-blind, Parallel-group, Dose-ranging, Exploratory Study in Subjects With Mild to Moderate Ulcerative Colitis Treated With SPD476 (Mesalazine) Once Daily
Evaluate the percentage of subjects in remission at the end of an 8-week treatment period for three dose groups (SPD476 1.2 g/day, 2.4 g/day or 4.8 g/day, administered once daily).
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
38
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Bonheiden, Belgium
- Imelda General Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- male & female subjects greater than or equal to 18 years of age with newly diagnosed or relapsing mild to moderate ulcerative colitis
- general medical assessment satisfactory and no clinically significant and relevant abnormalities
Exclusion Criteria:
- severe ulcerative colitis
- subject in relapse for > 6 weeks
- use of systemic or rectal steroids within last 4 weeks prior to baseline
- subjects with proctitis, previous colonic surgery, Crohn's disease, bleeding disorders, active ulcer disease
- subjects hypersensitive to salicylates/aspirin
- subjects with moderate or severe renal impairment
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
% of subjects in remission (UC-DAI score)
Time Frame: Week 8
|
Week 8
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Safety and tolerability
Time Frame: 8 weeks
|
8 weeks
|
Change in UC-DAI score by dose and by diagnosis, change in symptoms, change in sigmoidoscopic (mucosal) appearance, change in histology
Time Frame: 8 weeks
|
8 weeks
|
Plasma levels & mucosal levels of 5-ASA and Ac-5-ASA
Time Frame: 8 weeks
|
8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 10, 2003
Primary Completion (Actual)
October 20, 2004
Study Completion (Actual)
October 20, 2004
Study Registration Dates
First Submitted
October 16, 2007
First Submitted That Met QC Criteria
October 16, 2007
First Posted (Estimate)
October 17, 2007
Study Record Updates
Last Update Posted (Actual)
June 11, 2021
Last Update Submitted That Met QC Criteria
June 8, 2021
Last Verified
June 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Pathologic Processes
- Gastrointestinal Diseases
- Gastroenteritis
- Colonic Diseases
- Intestinal Diseases
- Inflammatory Bowel Diseases
- Ulcer
- Colitis
- Colitis, Ulcerative
- Physiological Effects of Drugs
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Mesalamine
Other Study ID Numbers
- SPD476-202
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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