Status:
COMPLETED
Safety and Tolerability of SPD476 in Maintaining Remission in Patients With Ulcerative Colitis.
Lead Sponsor:
Shire
Conditions:
Colitis, Ulcerative
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 26 2003
Trial Type :
INTERVENTIONAL
End Date :
March 13 2006
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT00151944
Start Date
November 26 2003
End Date
March 13 2006
Last Update
June 23 2021
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