Mesalamine Pellet to Maintain Remission of Mild to Moderate Ulcerative Colitis

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.

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Key information

Conditions

Ulcerative Colitis Colitis Colitis, Ulcerative Colonic Diseases Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Mexico, Missouri, 65265, United States

About this study

This is a Phase 3 study evaluating the effectiveness and safety of eMG 1.5 g given once daily (QD) compared to placebo in subjects with demonstrated remission from UC. Eligible subjects are randomized in a 2:1 ratio (active:placebo) to receive 1 or 2 treatments: 1.5g eMG (4 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 as measured by rectal bleeding and endoscopic mucosal appearance after 6 months of treatment with encapsulated mesalamine granules (eMG) of 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 to placebo in the maintenance of remission from mild to moderate UC.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Granulated mesalamine

Drug

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.

Placebo

Drug

Matching placebo capsules (4 capsules) were administered orally QD, in the morning.

Primary outcomes

Proportion of subject who were relapse free after 6 months of treatment

Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Bausch Health Americas, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start: 2004
Primary completion: 2007
Study completion: 2007
First posted: Oct 7, 2008
Registry last updated: Nov 27, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed