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Long-Term Safety and Tolerability of Mesalamine Pellets in Participants With Ulcerative Colitis in Remission

NCT00326209 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 393

Last updated 2019-11-01

Study results available
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Summary

To evaluate the long-term safety and tolerability of encapsulated mesalamine Granules (eMG) (formerly referred to as Mesalamine Pellets \[MP\]) in participants with ulcerative colitis currently in remission.

Conditions

Interventions

DRUG

Encapsulated Mesalamine Granules (eMG)

eMG capsules will be administered per dose and schedule specified in the arm.

Sponsors & Collaborators

  • Bausch Health Americas, Inc.

    lead INDUSTRY

Principal Investigators

  • Lindsey Mathew · Bausch Health Americas, Inc.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-12-22
Primary Completion
2008-05-05
Completion
2008-05-05

Countries

  • United States

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 NCT00326209 on ClinicalTrials.gov