Safety and Tolerability of SPD476 in Maintaining Remission in Patients With Ulcerative Colitis.
Information source: Shire Pharmaceutical Development
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Colitis, Ulcerative
Intervention: SPD476 (mesalazine) (Drug)
Phase: Phase 3
Sponsored by: Shire Pharmaceutical Development
The purpose of this study is to test the long-term safety and tolerability of SPD476 in the
maintenance of ulcerative colitis remission.
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.
Study design: Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety Study
Primary outcome: Treatment emergent adverse events over 12 months.
Time to relapse
Number of subjects in remission after 12 months
Minimum age: 18 Years.
Maximum age: N/A.
- 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
- 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
Locations and Contacts
FDA Recall information
FDA-approved labelling information, US only
FDA Medical Product Safety Alerts
Starting date: November 2003
Ending date: October 2006
Last updated: June 17, 2008