A Double-blind, Randomized, 6-week, Parallel-group Design Clinical Trial to Assess the Safety and Efficacy of Asacol 4.8 g/Day Versus Asacol 2.4 g/Day for the Treatment of Moderately Active Ulcerative Colitis.
Overview
- Phase
- Phase 3
- Intervention
- Mesalamine
- Conditions
- Ulcerative Colitis
- Sponsor
- Warner Chilcott
- Enrollment
- 772
- Locations
- 2
- Primary Endpoint
- Proportion of patients (ITT) in each treatment group who achieve treatment success, defined as symptomatic and endoscopic improvement from baseline at Week 6.
- Status
- Completed
- Last Updated
- 13 years ago
Overview
Brief Summary
A Double-blind, Randomized, 6-week, Parallel-group Design Clinical trial to assess the Safety and Efficacy of Asacol 4.8 g/day (800 mg mesalamine tablet) versus Asacol 2.4 g/day (400 mg mesalamine tablet) for the Treatment of Moderately Active Ulcerative Colitis (ASCEND III).
Detailed Description
This is a double-blind, randomized, multi-center, multi-national, active-control study in patients who are experiencing a moderately active flare of UC. Patients will be randomly assigned to receive either Asacol 2.4 g/day (400 mg tablet) or Asacol 4.8 g/day (800 mg tablet) for 6 weeks. Patients will be randomized to one of the 2 treatment groups in a 1:1 ratio. The objective of the study is to evaluate the safety and efficacy of Asacol 4.8 g/day (800 mg tablet) compared to Asacol 2.4 g/day (400 mg tablet) in this patient population. Following successful screening, patients will be randomized to one of the two treatment arms. Patients will be evaluated after 6 weeks of treatment with an interim visit after 3 weeks.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients 18-75 years with a confirmed diagnosis of moderately active flare of ulcerative colitis.
- •Female patients need to be postmenopausal or using adequate contraception.
Exclusion Criteria
- •Patients with isolated proctitis
- •Patients with comorbidities or an investigative or commercialized treatments confounding interpretation of study results or compromising patients' safety in the trial.
Arms & Interventions
1
Asacol 2.4 g/day (400 mg tablet)
Intervention: Mesalamine
2
Asacol 4,8 g/day (800 mg tablet), oral, for 6 weeks
Intervention: Mesalamine
Outcomes
Primary Outcomes
Proportion of patients (ITT) in each treatment group who achieve treatment success, defined as symptomatic and endoscopic improvement from baseline at Week 6.
Time Frame: Week 6
Secondary Outcomes
- Proportion of patients (ITT) in pre-defined subgroups in each treatment group who achieve treatment success, defined as symptomatic and endoscopic improvement from baseline at Week 6 and Week 3.(week 3 and 6)