- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00151944
Safety and Tolerability of SPD476 in Maintaining Remission in Patients With Ulcerative Colitis.
June 21, 2021 updated by: Shire
A Phase III, Randomized, Multi-center, Open-label, 12 to 14 Month Extension Study to Evaluate the Safety and Tolerability of SPD476 (Mesalazine) Given Once Daily vs. Twice Daily for the Maintenance of Ulcerative Colitis in Remission.
The purpose of this study is to test the long-term safety and tolerability of SPD476 in the maintenance of ulcerative colitis remission.
Study Overview
Study Type
Interventional
Enrollment
400
Phase
- Phase 3
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:
- Subjects must have completed all assessments of SPD476-301 or SPD476-302 End of Study/Early Withdrawal Visit
- Subjects who did not achieve remission at the End of Study/Early Withdrawal Visits in Study 301 or 302 will be eligible to enter the Acute Phase; subjects who did achieve remission at the End of Study Visits in Study 301 or 302 will be eligible to enter directly into the Maintenance Phase
- Women of childbearing potential must use an acceptable contraceptive method while on study treatment
Exclusion Criteria:
- Subjects who withdrew from Study 301 or 302 before Study Visit 3, or who withdrew due to a possible or probably related severe adverse event or serious adverse event are not eligible to enter this study
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: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Treatment emergent adverse events
Time Frame: Throughout the study period of approximately 2 year, 4 months
|
Throughout the study period of approximately 2 year, 4 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Time to relapse
Time Frame: Up to 12-14 months
|
Up to 12-14 months
|
Participant compliance
Time Frame: Up to 12-14 months
|
Up to 12-14 months
|
Number of participants in remission
Time Frame: 12 months
|
12 months
|
Ulcerative colitis disease activity index (UC-DAI) score
Time Frame: Baseline, Month 2, and Month 12
|
Baseline, Month 2, and Month 12
|
Patient questionnaire
Time Frame: Month 6, and Month 12
|
Month 6, and Month 12
|
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.
General Publications
- Kamm MA, Lichtenstein GR, Sandborn WJ, Schreiber S, Lees K, Barrett K, Joseph R. Randomised trial of once- or twice-daily MMX mesalazine for maintenance of remission in ulcerative colitis. Gut. 2008 Jul;57(7):893-902. doi: 10.1136/gut.2007.138248. Epub 2008 Feb 13.
- Kamm MA, Lichtenstein GR, Sandborn WJ, Schreiber S, Lees K, Barrett K, Joseph R. Effect of extended MMX mesalamine therapy for acute, mild-to-moderate ulcerative colitis. Inflamm Bowel Dis. 2009 Jan;15(1):1-8. doi: 10.1002/ibd.20580.
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)
November 26, 2003
Primary Completion (Actual)
March 13, 2006
Study Completion (Actual)
March 13, 2006
Study Registration Dates
First Submitted
September 7, 2005
First Submitted That Met QC Criteria
September 7, 2005
First Posted (Estimate)
September 9, 2005
Study Record Updates
Last Update Posted (Actual)
June 23, 2021
Last Update Submitted That Met QC Criteria
June 21, 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
- SPD476-303
- 2004-000734-36 (EudraCT Number)
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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Clinical Trials on SPD476 (mesalazine)
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ShireCompletedDiverticulitisUnited States, Italy, Germany, Canada, Brazil, Romania, Netherlands, Finland, South Africa, Hungary
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ShireCompletedDiverticulitisNew Zealand, United States, United Kingdom, Sweden, Australia, Israel, India, Spain, Colombia, Argentina, France
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ShireCompletedUlcerative ColitisUnited States, Spain, Denmark, Korea, Republic of, Australia, Taiwan, Singapore, Sweden, Belgium, France, United Kingdom, Romania, New Zealand, India, Canada, South Africa, Brazil, Germany, Mexico, Hungary, Portugal, Chile, Netherlands and more
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ShireCompletedPhase II Dose-Ranging Study in Subjects With Mild to Moderate Ulcerative Colitis Treated With SPD476Colitis, UlcerativeBelgium
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Tillotts Pharma AGZeria PharmaceuticalCompletedActive Ulcerative ColitisChina
-
Tillotts Pharma AGZeria PharmaceuticalCompletedUlcerative Colitis in RemissionChina
-
Hospital Cristo ReCompletedDiverticular Disease of the ColonItaly
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Cardiff and Vale University Health BoardProcter and GambleCompleted
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Tillotts Pharma AGCompletedAcute Ulcerative ColitisSwitzerland