The purpose of this study is to test the long-term safety and tolerability of SPD476 in the maintenance of ulcerative colitis remission...
Date First Received: September 7, 2005
Last Updated: August 5, 2008
Verified by: Shire Pharmaceutical Development, June 2008
Clinical Trial Phase: Phase 3 | Start Date: November 2003
Overall Status: Completed
Estimated Enrollment: 400
Brief Summary
Official Title: “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.”
Condition Keyword(s):
Intervention(s):
The purpose of this study is to test the long-term safety and tolerability of SPD476 in the maintenance of ulcerative colitis remission.
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety Study
Intervention(s) in this Clinical Trial
- Drug: SPD476 (mesalazine)
Outcome Measures for this Clinical Trial
Primary Measures
- Treatment emergent adverse events over 12 months.
Secondary Measures
- Time to relapse
- Subject compliance
- Number of subjects in remission after 12 months
- UC-DAI score
- Patient questionnaire
Criteria for Participation in this Clinical Trial
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
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: Shire Pharmaceutical Development
Related Publications
Citations Reporting Results
Kamm MA, Lichtenstein GR, Sandborn WJ, Schreiber S, Lees KH, Barrett K, Joseph RE. Randomised trial of once- or twice-daily MMXTM mesalazine for maintenance of remission in ulcerative colitis. Gut. 2008 Feb 13; [Epub ahead of print]
Additional Information
Information obtained from ClinicalTrials.gov on August 28, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00151944
Study ID Number: SPD476-303
ClinicalTrials.gov Identifier: NCT00151944
Health Authority: United States: Food and Drug Administration
Clinical Trials Authorship and Review
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