A Phase 3 interventional study of Granulated mesalamine and Placebo in Ulcerative Colitis, sponsored by Bausch Health Americas, Inc.. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-11-27.
Sponsored by Bausch Health Americas, Inc. · Phase 3, Interventional, and Prevention
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.
This is a phase 3, multicenter, double-blind, randomized, placebo controlled study evaluating the effectiveness and safety of eMG 1.5 g given once daily (QD) compared with placebo in approximately 300 subjects with demonstrated remission from UC. Eligible subjects are randomized in a 2:1 ratio (active:placebo) to receive 1 of 2 treatments: 1.5g eMG QD (four capsules total) or matching placebo capsules QD for 6 months.
The study consists of a Screening phase (completed within 7 days prior to randomization), a Treatment phase (6 months), and a Follow-up visit (2 weeks after end-of-study [EOS] visit). The Treatment phase consists of 4 scheduled study visits: Visit 1 (Baseline)/Randomization (Day 1), Visit 2 (Month 1), Visit 3 (Month 3), Visit 4/EOS (Month 6).
Primary objective:
To compare the maintenance of remission from mild to moderate ulcerative colitis (UC) as measured by rectal bleeding and endoscopic mucosal appearance after 6 months of treatment with encapsulated mesalamine granules (eMG) at 1.5 g QD, as compared with placebo.
Secondary objective:
To compare the safety and tolerability of long-term dosing with eMG at 1.5 g QD as compared with placebo in the maintenance of remission from mild to moderate UC.
1,073 studies on the registry are indexed under Colitis; 133 are open to participants now.
This study's enrollment of 305 is above the median of 60 across 771 interventional studies indexed under Colitis.
Browse Colitis studies →Bausch Health Americas, Inc. is the lead sponsor of 209 studies on the registry; 9 are open to participants now.
Of its 23 completed or terminated interventional studies of FDA-regulated products, 16 (70%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Placebo
Drug: Placebo
Granulated mesalamine
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
Also known as: mesalamine pellets
Matching placebo capsules (4 capsules) were administered orally QD, in the morning
Proportion of subjects who were relapse free after 6 months of treatment.
Time frame: 6 months
This study is completed, as verified in Nov 2019. You cannot join it, but the record below documents what was studied.
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Bausch Health Americas, Inc.