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

Primary Purpose

Ulcerative Colitis

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Granulated mesalamine
Placebo
Sponsored by
Bausch Health Americas, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Ulcerative Colitis focused on measuring UC, Ulcerative colitis, IBD, Inflammatory bowel disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

2

1

Arm Description

Placebo

Granulated mesalamine

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
August 27, 2008
Last Updated
November 26, 2019
Sponsor
Bausch Health Americas, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00744016
Brief Title
Mesalamine Pellet Formulation to Maintain Remission of Mild to Moderate Ulcerative Colitis
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
December 2004 (undefined)
Primary Completion Date
May 2007 (Actual)
Study Completion Date
October 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Bausch Health Americas, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ulcerative Colitis
Keywords
UC, Ulcerative colitis, IBD, Inflammatory bowel disease

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
305 (Actual)

8. Arms, Groups, and Interventions

Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Placebo
Arm Title
1
Arm Type
Active Comparator
Arm Description
Granulated mesalamine
Intervention Type
Drug
Intervention Name(s)
Granulated mesalamine
Other Intervention Name(s)
mesalamine pellets
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matching placebo capsules (4 capsules) were administered orally QD, in the morning
Primary Outcome Measure Information:
Title
Proportion of subjects who were relapse free after 6 months of treatment.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Audrey L Shaw, Ph.D.
Organizational Affiliation
Bausch Health Americas, Inc.
Official's Role
Study Director
Facility Information:
City
Bristol
State/Province
Connecticut
ZIP/Postal Code
06010
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
26861051
Citation
Zakko SF, Gordon GL, Murthy U, Sedghi S, Pruitt R, Barrett AC, Bortey E, Paterson C, Forbes WP, Lichtenstein GR. Once-daily mesalamine granules for maintaining remission of ulcerative colitis: pooled analysis of efficacy, safety, and prognostic factors. Postgrad Med. 2016;128(3):273-81. doi: 10.1080/00325481.2016.1152876. Epub 2016 Mar 1.
Results Reference
derived
PubMed Identifier
26563167
Citation
Lichtenstein GR, Gordon GL, Zakko S, Murthy U, Sedghi S, Pruitt R, Barrett AC, Bortey E, Paterson C, Forbes WP. Long-Term Benefit of Mesalamine Granules for Patients Who Achieved Corticosteroid-Induced Ulcerative Colitis Remission. Dig Dis Sci. 2016 Jan;61(1):221-9. doi: 10.1007/s10620-015-3866-7. Epub 2015 Nov 12.
Results Reference
derived
PubMed Identifier
22617015
Citation
Lichtenstein GR, Zakko S, Gordon GL, Murthy U, Sedghi S, Pruitt R, Merchant K, Bortey E, Forbes WP. Mesalazine granules 1.5 g once-daily maintain remission in patients with ulcerative colitis who switch from other 5-ASA formulations: a pooled analysis from two randomised controlled trials. Aliment Pharmacol Ther. 2012 Jul;36(2):126-34. doi: 10.1111/j.1365-2036.2012.05142.x. Epub 2012 May 23.
Results Reference
derived

Learn more about this trial

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

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