A Double Blind Study for the Treatment of Acute Ulcerative Colitis

Phase 3

Completed

• Conditions: Ulcerative Colitis
• Interventions: Drug: Mesalamine

• Registration Number: NCT00350415
• Lead Sponsor: Warner Chilcott

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.

Study Timeline

• Study Start: 2006-06
• Study First Submitted: 2006-07-06
• Study First Submitted QC: 2006-07-06
• Study First Posted: 2006-07-10
• Primary Completion: 2007-05
• Study Completion: 2007-05
• Status Verified: 2013-04
• Last Update Submitted: 2013-04-15
• Last Update Posted: 2013-04-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 772

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Mesalamine	Asacol 2.4 g/day (400 mg tablet)
2	Mesalamine	Asacol 4,8 g/day (800 mg tablet), oral, for 6 weeks

Primary Outcome Measures

Name	Time	Method
Proportion of patients (ITT) in each treatment group who achieve treatment success, defined as symptomatic and endoscopic improvement from baseline at Week 6.	Week 6

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

Research Facility; 🇺🇦 Zaporizhzhya, Ukraine

Research FacilityPanevezys; 🇱🇹 Panevezys, Lithuania