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

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Multicenter, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Use of Mesalamine Pellet Formulation 1.5G QD to Maintain Remission From Mild to Moderate Ulcerative Colitis

Conditions
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Ulcerative Colitis

Intervention / Treatment
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* Drug: Granulated mesalamine
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: 2<br>Placebo | Drug: Placebo<br>* Matching placebo capsules (4 capsules) were administered orally QD, in the morning<br>|
| Active Comparator: 1<br>Granulated mesalamine | Drug: Granulated mesalamine<br>* 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<br>* Other names: mesalamine pellets;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of subjects who were relapse free after 6 months of treatment. |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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UC, Ulcerative colitis, IBD, Inflammatory bowel disease