Safety and Tolerability of SPD476 in Maintaining Remission in Patients With Ulcerative Colitis.
The purpose of this study is to test the long-term safety and tolerability of SPD476 in the maintenance of ulcerative colitis remission...
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.”
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: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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 Investigator Information
Lead Investigator: Shire Pharmaceutical Development Industry
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]
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. 2008 Jul 31; [Epub ahead of print]
Additional Information
Information obtained from ClinicalTrials.gov on February 09, 2012
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 content is provided directly by the U.S. National Institutes of Health via ClinicalTrials.gov and is not reviewed separately by ClinicalTrialsFeeds.org. Every page of specific clinical trials information contains a unique identifier which can be used to find further details directly from the National Institutes of Health.
The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00151944
