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Long-Term Safety and Tolerability of Mesalamine Pellets in Participants With Ulcerative Colitis in Remission | Clinical Trials | Clareo Health

COMPLETEDPHASE3

Long-Term Safety and Tolerability of Mesalamine Pellets in Participants With Ulcerative Colitis in Remission

A Multicenter, Open-Label, Treatment Extension Trial to Evalaute the Long-Term Safety and Tolerability of Mesalamine Pellet Formulation

NCT00326209•Bausch Health Americas, Inc.

View on ClinicalTrials.gov

Summary

To evaluate the long-term safety and tolerability of encapsulated mesalamine Granules (eMG) (formerly referred to as Mesalamine Pellets \[MP\]) in participants with ulcerative colitis currently in remission.

Detailed Description

This is a Phase 3, multicenter, open-label, treatment extension study evaluating the long-term safety and tolerability of eMG given once daily (QD) in participants who successfully participated in a double-blind lead-in study (MPUC3003 \[NCT00744016 \] or MPUC3004 \[NCT00767728 \]) or new participants who are currently in remission from symptoms of ulcerative colitis.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. An Institutional Review Board (IRB)/Ethics Committee (EC) approved informed consent is signed and dated prior to any study-related activities.
•2. Participant has successfully participated in a previous MP clinical study per investigator's discretion with successful participation minimally defined as compliant with study-related procedures and study drug dosing schedule in the previous study and did not discontinue from the previous study due to study drug-related AE(s) or if new participants:
•a. Participant is a male or,
•If the participant is female, she is eligible to enter if she is of:
•Non-childbearing potential (that is; physiologically incapable of becoming pregnant, including any female who has undergone sterilization \[hysterectomy or bilateral tubal ligation\] or is post-menopausal. For purposes of this study, postmenopausal is defined as 1 year without menses); or childbearing potential, has a negative serum pregnancy test at screen and, if heterosexually active, agrees to one of the following:
•i) Double barrier method of contraception, specifically, use of a condom and spermicide, for 1 week prior to study drug administration, throughout the 6-month Treatment Phase, and the 2-week follow-up phase.
•ii) Oral contraceptives administered for at least 2 monthly cycles prior to study drug administration during all 6 months of study drug administration and administered for 1 monthly cycle following completion of the study.
•iii) An intrauterine device (IUD), inserted by a qualified clinician, with published data showing that the lowest expected failure rate is less than (\<)1% per year (not all IUDs meet this criterion).
•iv) Medroxyprogesterone acetate (DEPO-PROVERA) administered for a minimum of 1 monthly cycle prior to the study drug administration, during all 6 months of study drug administration, and administered for 1 monthly cycle following study completion. Norelgestromin/ ethinyl estradiol transdermal system (Ortho Evra patch) administered for at least 2 monthly cycles prior to study drug administration and administered for 2 monthly cycles following study completion.
•v) Partner has undergone vasectomy and participant is in a monogamous relationship.
+5 more criteria

Exclusion Criteria

•1. Participant has any condition or circumstance that would, in the opinion of the investigator, prevent completion of the study or interfere with analysis of study results, including history of noncompliance with treatments or visits.
•2. Participant has a history of allergy or intolerance to aspirin, mesalamine or other salicylates.
•3. Participant has an abnormal clinical lab result which in the opinion of the investigator is significant enough to prevent participant's enrollment in the study.
•4. Participant or participant's parents are known to have phenylketonuria.
•5. Participant has participated in an investigational drug or device study within the 30 days prior to study screening.
•6. Participant shows evidence of current excessive alcohol consumption or drug dependence.
•7. Participant has uncontrolled, clinically significant renal disease manifested by 1.5 \* ULN of serum creatinine or blood urea nitrogen (BUN) levels.
•8. Participant has calculated creatinine clearance level of \<60 mL/min

Locations (61)

Birmingham Gastroenterology Associates

Birmingham, Alabama, United States

First Care Family Doctors South

Fayetteville, Arkansas, United States

Little Rock Diagnostic Clinic

Little Rock, Arkansas, United States

AGMG Clinical Research

Anaheim, California, United States

Lovelace Scientific Resources

Beverly Hills, California, United States

Digestive Liver Disease Specialists, Medical Group

Garden Grove, California, United States

Long Beach VA Medical Center

Long Beach, California, United States

Community Clinical Trials

Orange, California, United States

Rider Research Group

San Francisco, California, United States

John Jolley, M.D.

San Rafael, California, United States

Key Dates

Start Date

December 22, 2005

Primary Completion Date

May 5, 2008

Completion Date

May 5, 2008

Last Updated

November 1, 2019

Enrollment

393

ACTUAL participants

Conditions

Ulcerative Colitis

Interventions

Encapsulated Mesalamine Granules (eMG)

DRUG

Effectiveness of Ozanimod in Patients With Steroid-Dependent Ulcerative Colitis

NCT07271069

Ulcerative Colitis (UC)

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RECRUITINGPHASE2

A Study to Investigate the Efficacy and Safety of SAR442970 in Adult Participants With Ulcerative Colitis

NCT06975722

Ulcerative Colitis

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RECRUITINGPHASE3

A Maintenance Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Ulcerative Colitis

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 1, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Long-Term Safety and Tolerability of Mesalamine Pellets in Participants With Ulcerative Colitis in Remission

Inclusion Criteria

Exclusion Criteria

Effectiveness of Ozanimod in Patients With Steroid-Dependent Ulcerative Colitis

A Study to Investigate the Efficacy and Safety of SAR442970 in Adult Participants With Ulcerative Colitis

A Maintenance Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Ulcerative Colitis

An Induction Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Ulcerative Colitis

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