Safety and Tolerability of SPD476 in Maintaining Remission in Patients With Ulcerative Colitis.
NCT00151944 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 400
Last updated 2021-06-23
Summary
The purpose of this study is to test the long-term safety and tolerability of SPD476 in the maintenance of ulcerative colitis remission.
Conditions
- Colitis, Ulcerative
Interventions
- DRUG
-
SPD476 (mesalazine)
Sponsors & Collaborators
-
Shire
lead INDUSTRY
Principal Investigators
-
Study Director · Takeda
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2003-11-26
- Primary Completion
- 2006-03-13
- Completion
- 2006-03-13
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