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

Phase 3

Completed

• Conditions: Ulcerative Colitis
• Interventions: Drug: Placebo; Drug: Granulated mesalamine

• Registration Number: NCT00744016
• Lead Sponsor: Bausch Health Americas, Inc.

Brief 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.

Detailed Description

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.

Study Timeline

• Study Start: 2004-12
• Primary Completion: 2007-05
• Study Completion: 2007-10
• Study First Submitted: 2008-08-27
• Study First Submitted QC: 2008-08-28
• Study First Posted: 2008-08-29
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-26
• Last Update Posted: 2019-11-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 305

Inclusion Criteria

• Confirmed diagnosis of ulcerative colitis and in remission for at least 1 month.
• Greater than 18 years of age.

Exclusion Criteria

• Allergy/intolerance to aspirin, mesalamine or other salicylates.
• Prior bowel surgery other than appendectomy.
• Pregnancy, at risk of pregnancy or lactating.
• HIV or hepatitis B or C.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Placebo	Placebo
1	Granulated mesalamine	Granulated mesalamine

Primary Outcome Measures

Name	Time	Method
Proportion of subjects who were relapse free after 6 months of treatment.	6 months