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A BE Study Comparing Mesalamine 400 mg to ASACOL® 400 mg in Patients With Mild To Moderately Active Ulcerative Colitis

NCT01045018 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2010-01-08

No results posted yet for this study

Summary

The objectives of this bioequivalence study in patients with ulcerative colitis (UC) were:

* To establish the therapeutic equivalence of mesalamine delayed release tablet (MDRT) and Asacol Delayed Release Tablets 2.4 g per day (800 mg three times daily) and
* To evaluate the safety of MDRT 2.4 g per day (800 mg three times daily) compared to placebo.

Conditions

  • Mild to Moderate Ulcerative Colitis

Interventions

DRUG

Placebo

placebo 400 mg

DRUG

Mesalamine

DRUG

Mesalamine

Sponsors & Collaborators

  • Eagle Pharmaceuticals, Inc.

    collaborator INDUSTRY

  • EMET Pharmaceuticals, LLC

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-01-31
Primary Completion
2009-06-30
Completion
2009-08-31

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Entities

Drugs

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 NCT01045018 on ClinicalTrials.gov