A Double Blind Study for the Treatment of Acute Ulcerative Colitis

Completed · Phase 3

Conditions studied: Ulcerative Colitis

In brief

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).

Key facts

Study ID

NCT00350415

Run by

Warner Chilcott

People needed

772

Starts

2006-06-01

Expected to finish

2007-05-01

Last updated by the study team

2013-04-17

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Research Facility — Birmingham, Alabama, United States
• Research Facility — Tucson, Arizona, United States
• Research Facility — Fayetteville, Arkansas, United States
• Research Facility — Little Rock, Arkansas, United States
• Research Facility — Anaheim, California, United States
• Research Facility — Burbank, California, United States
• Research Facility — Encinitas, California, United States
• Research Facility — Los Angeles, California, United States
• Research Facility — Los Angeles, California, United States
• Research Facility — Mission Hills, California, United States
• Research Facility — Orange, California, United States
• Research Facility — Pasadena, California, United States
• Research Facility — Roseville, California, United States
• Research Facility — Sacramento, California, United States
• Research Facility — San Carlos, California, United States
• Research Facility — San Francisco, California, United States
• Research Facility — Lakewood, Colorado, United States
• Research Facility — Littleton, Colorado, United States
• Research Facility — Hamden, Connecticut, United States
• Research Facility — DeLand, Florida, United States
• Research Facility — Harbor Village, Florida, United States
• Research Facility — Hollywood, Florida, United States
• Research Facility — Jacksonville, Florida, United States
• Research Facility — Panama City, Florida, United States
• Research Facility — Alabaster, Alabama, United States

Full record on ClinicalTrials.gov

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