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

Bausch Health

Status and phase: Completed; Phase 3

Conditions: Ulcerative Colitis

Treatments: Drug: Placebo; Drug: Granulated mesalamine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00744016

MPUC3003

Details and patient eligibility

About

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.

Full 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.

Enrollment: 305 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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305 participants in 2 patient groups, including a placebo group

2

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo

1

Active Comparator group

Description:

Granulated mesalamine

Treatment:

Drug: Granulated mesalamine