Safety and Tolerability of SPD476 in Maintaining Remission in Patients With Ulcerative Colitis.
Phase 3
Completed
- Conditions
- Colitis, Ulcerative
- Registration Number
- NCT00151944
- Lead Sponsor
- Shire
- Brief Summary
The purpose of this study is to test the long-term safety and tolerability of SPD476 in the maintenance of ulcerative colitis remission.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 400
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Treatment emergent adverse events Throughout the study period of approximately 2 year, 4 months
- Secondary Outcome Measures
Name Time Method Participant compliance Up to 12-14 months Patient questionnaire Month 6, and Month 12 Time to relapse Up to 12-14 months Number of participants in remission 12 months Ulcerative colitis disease activity index (UC-DAI) score Baseline, Month 2, and Month 12