Safety and Tolerability of SPD476 in Maintaining Remission in Patients With Ulcerative Colitis.

Condition(s) targeted: Colitis, Ulcerative

Intervention: SPD476 (mesalazine) (Drug)

Phase: Phase 3

Status: Completed

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.

Secondary outcome:

Time to relapse

Subject compliance

Number of subjects in remission after 12 months

UC-DAI score

Patient questionnaire

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

FDA Recall information

FDA-approved labelling information, US only

Study results

FDA Medical Product Safety Alerts

Starting date: November 2003
Ending date: October 2006
Last updated: June 17, 2008