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Mesalamine Pellet Formulation to Maintain Remission of Mild to Moderate Ulcerative Colitis

NCT00744016 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 305

Last updated 2019-11-27

No results posted yet for this study

Summary

The purpose of this study is to compare the maintenance of mild to moderate ulcerative colitis remission with six months of treatment with 1.5 grams of mesalamine pellets each day versus placebo.

Conditions

Interventions

DRUG

Granulated mesalamine

0.375 g of mesalamine granules were encapsulated in a hard gelatin shell. 1.5 g of eMG (4 capsules) were administered orally QD, in the morning

DRUG

Placebo

Matching placebo capsules (4 capsules) were administered orally QD, in the morning

Sponsors & Collaborators

  • Bausch Health Americas, Inc.

    lead INDUSTRY

Principal Investigators

  • Audrey L Shaw, Ph.D. · Bausch Health Americas, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-12-31
Primary Completion
2007-05-31
Completion
2007-10-31

Countries

  • United States

Study Locations

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Entities

Drugs
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 NCT00744016 on ClinicalTrials.gov