CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 393 enrolled
Drug / intervention
Encapsulated Mesalamine Granules (eMG)drug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00326209
NCT00326209Phase 3Completed
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A Multicenter, Open-Label, Treatment Extension Trial to Evalaute the Long-Term Safety and Tolerability of Mesalamine Pellet Formulation

Bausch Health Americas, Inc.·interventional·Posted May 16, 2006·Updated Nov 1, 2019

In Brief

A Phase 3 clinical trial evaluating Encapsulated Mesalamine Granules (eMG) for Ulcerative Colitis. Completed, enrolled 393 participants across 61 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsUlcerative Colitis
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 16, 2006
Enrollment StartDec 22, 2005
Primary CompletionMay 5, 2008
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 20.1 years ago

Interventions

Encapsulated Mesalamine Granules (eMG)drug

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