Clinical trial

Safety and Efficacy of Two Different Doses of Asacol in the Treatment of…

NCT00073021 · Warner Chilcott, Industry · Completed

Key facts

NCT number NCT00073021
Title Safety and Efficacy of Two Different Doses of Asacol in the Treatment of Moderately Active Ulcerative Colitis
Official title A Double-Blind, Randomized, 6-Week, Parallel-Group Design Clinical Trial to Assess Safety and Efficacy of Asacol 4.8 g/Day (800 mg Tablet) Versus Asacol 2.4 g/Day (400 mg Tablet) for the Treatment of Moderately Active Ulcerative Colitis
Lead sponsor Warner Chilcott, Industry
Status Completed
Phase Phase 3
Study type Interventional
Conditions Ulcerative Colitis
Intervention type Drug
Interventions Asacol 800 mg (mesalamine), Asacol 400 mg (mesalamine)
Enrollment 386
Start date Sep 1, 2000
Primary completion Sep 1, 2003
Completion Sep 1, 2003
First posted Nov 17, 2003
Last update posted Jun 29, 2015
Countries Canada, Puerto Rico, United States

At a glance

  • 10–99 Study sites
  • Yes Results posted
  • None Linked FDA submissions

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

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Source: U.S. National Library of Medicine (NLM), ClinicalTrials.gov · Source date:

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