Mesalamine Pellet Formulation to Maintain Remission of Mild to Moderate Ulcerative Colitis
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
1 other identifier
interventional
305
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Dec 2004
Typical duration for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2007
CompletedFirst Submitted
Initial submission to the registry
August 27, 2008
CompletedFirst Posted
Study publicly available on registry
August 29, 2008
CompletedNovember 27, 2019
November 1, 2019
2.4 years
August 27, 2008
November 26, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Proportion of subjects who were relapse free after 6 months of treatment.
6 months
Study Arms (2)
2
PLACEBO COMPARATORPlacebo
1
ACTIVE COMPARATORGranulated mesalamine
Interventions
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
Eligibility Criteria
You may qualify if:
- Confirmed diagnosis of ulcerative colitis and in remission for at least 1 month.
- Greater than 18 years of age.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Unknown Facility
Bristol, Connecticut, 06010, United States
Related Publications (3)
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.
PMID: 26861051DERIVEDLichtenstein 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.
PMID: 26563167DERIVEDLichtenstein 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.
PMID: 22617015DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Audrey L Shaw, Ph.D.
Bausch Health Americas, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
August 27, 2008
First Posted
August 29, 2008
Study Start
December 1, 2004
Primary Completion
May 1, 2007
Study Completion
October 1, 2007
Last Updated
November 27, 2019
Record last verified: 2019-11