MedTrace Logo

A Comparison of Once a Day Dose Compared to 2 Doses/Day

NCT00505778 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1027

Last updated 2013-04-22

Study results available
· View outcomes & findings →

Summary

The purpose of this study is to compare the efficacy in maintaining remission of ulcerative colitis between a once daily (QD) Asacol regimen and a divided, twice daily (BID) Asacol dosing regimen.

Conditions

Interventions

DRUG

Mesalamine Once-Daily

Mesalamine tablets, 1.6-2.4 g/day taken orally once a day for 52 weeks

DRUG

Mesalamine Twice-Daily

Mesalamine tablets, 1.6-2.4 g/day, taken twice daily for 52 weeks

Sponsors & Collaborators

  • Warner Chilcott

    lead INDUSTRY

Principal Investigators

  • Tom G Todaro, MD · Procter and Gamble

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-07-31
Primary Completion
2009-07-31
Completion
2009-07-31

Countries

  • United States
  • Canada
  • Puerto Rico

Study Locations

More Related Trials

Entities

Diseases

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 NCT00505778 on ClinicalTrials.gov