Clinical Trial: Safety, Efficacy, and Tolerability Study of ASP3291 in Patients With Active Ulcerative Colitis
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Phase 2, Randomized, Double-Blind, Parallel, Placebo-Controlled, Proof-of-Concept Study to Assess the Efficacy, Safety, and Tolerability of ASP3291 in Patients With Active Ulcerative This is a Phase 2, randomized, double-blind, multicenter, parallel, placebo controlled study. Approximately 120 eligible patients with mild-to-moderate active ulcerative colitis will be randomized to double blind treatment of either 1,000 mg twice daily (b.i.d.) ASP3291 (2,000 mg/d) or matching placebo in a 1:1 ratio for 8 weeks.
The study hypothesis is that treatment with ASP3291 compared to placebo will improve a patient's ulcerative colitis endoscopic score from baseline to Week 8.
Detailed Summary:
Sponsor: Telsar Pharma Inc.
Current Primary Outcome: Change from baseline (Visit 2) to Week 8 (Visit 7) in Modified Baron Score [ Time Frame: Baseline to Week 8 ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Proportion of subjects with Modified Baron Score of 0 or 1 at Week 8 (Visit 7) [ Time Frame: Week 8 ]
- Change in Ulcerative Colitis Clinical Score of >3 [ Time Frame: Basline to Week 8 ]
- Ulcerative Colitis Clinical Score stool frequency and rectal bleeding score of 0 [ Time Frame: Week 8 ]
Original Secondary Outcome: Same as current
Information By: Telsar Pharma Inc.
Dates:
Date Received: June 1, 2012
Date Started: July 2012
Date Completion:
Last Updated: September 26, 2016
Last Verified: September 2016
