NCT00350415

A Double Blind Study for the Treatment of Acute Ulcerative Colitis

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.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 772 (actual)
• Sponsor: Warner Chilcott · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Ulcerative Colitis

Interventions

Type	Name	Description
DRUG	Mesalamine	Asacol 400g/day (400 mg tablet), oral, for 6 weeks OR Asacol 4,8 g/day (800 mg table), oral, for 6 weeks

Timeline

• Start date: 2006-06-01
• Primary completion: 2007-05-01
• Completion: 2007-05-01
• First posted: 2006-07-10
• Last updated: 2013-04-17

Locations

135 sites across 15 countries: United States, Belarus, Canada, Croatia, Czechia, Estonia, Hungary, Latvia, Lithuania, Poland, Puerto Rico, Romania, Russia, Serbia, Ukraine