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Asacol Dosing Study for Active Ulcerative Colitis

NCT00194818 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2008-02-15

No results posted yet for this study

Summary

We, the investigators at University of Washington, plan on evaluating the effect of open label Asacol at a dose of 4.8 grams/day divided BID (twice per day) or TID (three times per day) on its ability to induce remission in patients with mild to moderately active ulcerative colitis. We hypothesize that both regimens will have the same efficacy and no difference in side effects.

Conditions

Interventions

DRUG

Asacol (mesalamine)

Available in 400mg delayed release tablet. Randomized to either 6 tablets BID (4.8 g/day) or 4 tablets TID (4.8 g/day) for a total of 12 weeks.

Sponsors & Collaborators

Principal Investigators

  • Scott D Lee, MD · University of Washington

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-06-30
Primary Completion
2007-08-31
Completion
2007-08-31

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00194818 on ClinicalTrials.gov