A phase III, randomized, multi-center, open-label, 12 to 14 months extension study to evaluate the safety and tolerability of SPD476 (mesalazine) give once daily vs. twice daily for the maintenance of ulcerative colitis in remission.
- Conditions
- Subject not in remission of Ulcerative Colitis (UC-DAI score of >1) at the End of Study/Early Withdrawal Visit of Study 301 or 302.Subject in remission of UC (UC-DAI<1 with a score of 0 for rectal bleeding and stool frequency, and at least a 1 point reduction in the sigmoidocsopy score from Study 301 or 302 baseline) at the End of Study Visit of Study 301 or 302, or at the end of the Acute Phase of this study
- Registration Number
- EUCTR2004-000734-36-CZ
- Lead Sponsor
- Shire Pharmaceutical Development Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 125
Subjects must sign the study 303 informed consent form, meet all eligibility requirements and have completed all assessments of the Study 301 or 302 End of Study /Early Withdrawal Visit.
Women of child bearing potential (WOP) must use an acceptable contraceptive method while the subject is on the study treatment.
Subject and investigator must egree that participation in the Acute and/or Maintenance Phase of this study is in the best interest of the subject
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Subject who have withdrawn from Study 301 or 302 before study visit 3, or subject who withdrew from Study 301 or 302 due to a possibly or probably related severe AE or SAE are not eligible to enter this study.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method