A Double Blind Study for the Treatment of Acute Ulcerative Colitis

Warner Chilcott

Status and phase

Completed

Phase 3

Conditions

Ulcerative Colitis

Treatments

Drug: Mesalamine

Study type

Interventional

Funder types

Industry

Identifiers

NCT00350415

2006444

Details and patient eligibility

About

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).

Full 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.

Enrollment

772 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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.