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
Conditions
Sponsors
Shire Pharmaceutical Development Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: Subject who have withdrawn from Study 301 or 302 before study visit 3, or subject who withdrew from Study 301 or 302 due to a possibly or probably related severe AE or SAE are not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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the safety and tolerability od SPD476 2.4 g/day (2.4 g dosed once daily) and SPD476 2.4 g/day (1.2 g dosed twice daily) in long-term (12 month)study;Secondary Objective: Acute Phase: 1.To evaluate the percentage of subjects in the Acute Phase who are in remission(a UC-DAI score of <1 , with a score of 0 for rectal bleeding and stool frequency, and at least a 1-point reduction from the Study 301 or 302 baseline in the sigmoidoscopy score) at the end of the treatment period with SPD476 4.8 g/day (2.4 g dosed twice daily) 2.To assess the safety and tolerability of SPD476 4.8 g/day (2.4 g dosed twice daily) Maintenance Phase: 1.To compare subject compliance between SPD476 2.4 g/day (2,4 g dosed once daily) and SPD476 2.4 g/day (1.2 g dosed twice daily). 2.To compare the time to relapse between SPD476 2.4 g (2.4 g dosed once daily) and SPD476 2.4 g/day (1.2 g dosed twice daily) over 12 months. 3.To compare the percentage of subjects in remission at the end of the 12 month treatment period between SPD476 2.4 g (2.4 g dosed once daily) and SPD476 2.4 g/day (1.2 g dosed twice daily). 4.To compare Patient Questionnaire scores between treatment groups.;Primary end point(s): Safety and tolerability will be assesed by EAs, laboratory testing (hematology and biochemistry) urinalysis, physical examination and vital signs. Remission is defined as a UC-DAI of <1 with a score of 0 for rectal bleeding and stool frequency and at least a 1-point reduction the sigmoidoscopy score from baseline of Study 301 or 302. Compliance will assessed by counting the number of tablets dispensed to the subjects and counting the number of tablets returned | — |
Countries
Czech Republic
Outcome results
None listed