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

Shire

Status and phase: Completed; Phase 3

Conditions: Colitis, Ulcerative

Treatments: Drug: SPD476 (mesalazine)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00151944

2004-000734-36 (EudraCT Number)

SPD476-303

Details and patient eligibility

About

The purpose of this study is to test the long-term safety and tolerability of SPD476 in the maintenance of ulcerative colitis remission.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)