CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 386 enrolled
Drug / intervention
Asacol 800 mg (mesalamine) +1 moredrug
Likely dose
Asacol 4.8 g/day (2 × 800 mg tablets plus 2 placebo tablets three times daily)AI-extracted
Key inclusion· 3
  • ✓Age 18-75 years
  • ✓Confirmed diagnosis of ulcerative colitis with extent from proctitis to pancolitis
  • ✓Currently demonstrating moderately active disease
Key exclusion· 9
  • ✕History of allergy or hypersensitivity to salicylates or aminosalicylates
  • ✕Extensive small bowel resection (>1/2 length) causing short bowel syndrome
  • ✕Current renal or hepatic disease
  • ✕Corticosteroids within 1 month prior to baseline

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00073021
NCT00073021Phase 3Completed
CompareCT.gov

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

Warner Chilcott·interventional·Posted Nov 17, 2003·Updated Jun 29, 2015

In Brief

A Phase 3 clinical trial evaluating Asacol 800 mg (mesalamine) and Asacol 400 mg (mesalamine) for Ulcerative Colitis. Completed, enrolled 386 participants across 57 sites in 3 countries.

Detailed Summary

This study is a prospective clinical study to evaluate the safety and efficacy of two different doses of Asacol for the treatment of moderately active ulcerative colitis. In addition, a new tablet formulation will be evaluated at one of the two doses.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsUlcerative Colitis
CountriesCanada, Puerto Rico, United States
Collaborators--

Timeline

Phase 3CompletedFinished
2000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedNov 17, 2003
Enrollment StartSep 1, 2000
Primary CompletionSep 1, 2003
TodayJul 2, 2026
Enrollment to primary: 3 yearsPosted 22.6 years ago

Interventions

Asacol 800 mg (mesalamine)drug

tablets, 4.8 g/day for 6 weeks, 2 - 800 mg Asacol tablets and 2 placebo tablets 3 times daily

Asacol 400 mg (mesalamine)drug

tablets, 2.4 g/day for 6 weeks, 2 - 400 mg Asacol tablets and 2 placebo tablets 3 times daily