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

October 14, 2019 updated by: Bausch Health Americas, Inc.

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

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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Interventional

Enrollment (Actual)

393

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Alabama
      • Birmingham, Alabama, United States, 35209
        • Birmingham Gastroenterology Associates
    • Arkansas
      • Fayetteville, Arkansas, United States, 72701
        • First Care Family Doctors South
      • Little Rock, Arkansas, United States, 72205
        • Little Rock Diagnostic Clinic
    • California
      • Anaheim, California, United States, 92801
        • AGMG Clinical Research
      • Beverly Hills, California, United States, 90211
        • Lovelace Scientific Resources
      • Garden Grove, California, United States, 92840
        • Digestive Liver Disease Specialists, Medical Group
      • Long Beach, California, United States, 90822
        • Long Beach VA Medical Center
      • Orange, California, United States, 92868
        • Community Clinical Trials
      • San Francisco, California, United States, 94117
        • Rider Research Group
      • San Rafael, California, United States, 94901
        • John Jolley, M.D.
      • Santa Ana, California, United States, 92704
        • Lovelace Scientific Resources
      • Santa Barbara, California, United States, 93108
        • Santa Barbara Clinical Research
    • Colorado
      • Littleton, Colorado, United States, 80120
        • Professionals for Clinical Research
    • Connecticut
      • Bristol, Connecticut, United States, 06010
        • Connecticut Gastroenterology Institute
    • Florida
      • Brooksville, Florida, United States, 34613
        • Clinical Research of Tampa Bay, Inc.
      • Hialeah, Florida, United States, 33013
        • Medical Research Unlimited
      • Hollywood, Florida, United States, 33021
        • Southern Clinical Research Consultants
      • New Smyrna Beach, Florida, United States, 32168
        • United Medical Research
      • North Miami Beach, Florida, United States, 33162
        • Venture Research Institute, LLC
      • Ormond Beach, Florida, United States, 32174
        • Penninsula Research, Inc.
      • Palm Harbor, Florida, United States, 34684
        • Advanced Gastroenterology Associates
      • Sarasota, Florida, United States, 34233
        • Lovelace Scientific Resources
      • Sarasota, Florida, United States, 34239
        • Advent Clinical Research
      • West Palm Beach, Florida, United States, 33401
        • Metabolic Research Institute, Inc.
    • Georgia
      • Atlanta, Georgia, United States, 30308
        • Consultative Gastroenterology
      • Austell, Georgia, United States, 30106
        • Digestive Care Associates
      • Decatur, Georgia, United States, 30033
        • Center for Gastroenterology
      • Macon, Georgia, United States, 31201
        • Gastroenterology Associates of Central Georgia
    • Illinois
      • Arlington Heights, Illinois, United States, 60005
        • Northwest Gastroenterologists S.C.
    • Iowa
      • Waterloo, Iowa, United States, 50702
        • Covenant Clinic
    • Kansas
      • Topeka, Kansas, United States, 66606
        • Cotton-O'Neil Digestive Health Center
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • University of Louisville
    • Maryland
      • Baltimore, Maryland, United States, 21215
        • Sinai Medical Office Building
      • Hollywood, Maryland, United States, 20636
        • Philip J. Beam Medical Center
    • Michigan
      • Chesterfield, Michigan, United States, 48047
        • Research Institute of Michigan, LLC
    • Missouri
      • Mexico, Missouri, United States, 65265
        • Center for Digestive & Liver Diseases
      • Saint Louis, Missouri, United States, 63128
        • St. Louis Center for Clinical Research
    • New Jersey
      • Ocean City, New Jersey, United States, 07712
        • Shore Health Group
    • New York
      • New York, New York, United States, 10128
        • Simon Lichtiger, M.D.
      • Northport, New York, United States, 11768
        • VA Medical Center, Northport
      • Syracuse, New York, United States, 13210
        • VA Medical Center
      • Troy, New York, United States, 12180
        • Upstate Gastroenterology Associates, PC
    • North Carolina
      • Greensboro, North Carolina, United States, 27403
        • LeBauer Research Associates, PA
      • High Point, North Carolina, United States, 27262
        • Bethany Medical Center
      • Rocky Mount, North Carolina, United States, 27804
        • Boice-Willis Clinic
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • Consultants For Clinical Research, Inc.
      • Warren, Ohio, United States, 44484
        • Avamar Center for Endoscopy
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74104
        • Oklahoma Gastroenterology Associates, LLC
    • South Carolina
      • Charleston, South Carolina, United States, 29414
        • Charleston Gastroenterology Specialists, LLC
      • Simpsonville, South Carolina, United States, 29681
        • Hillcrest Clinical Research, LLC
    • Tennessee
      • Nashville, Tennessee, United States, 37205
        • Medical Research Institute
    • Texas
      • Houston, Texas, United States, 77074
        • Clinical Trial Network
      • Houston, Texas, United States, 77034
        • Nationsmed Clinical Research
      • Houston, Texas, United States, 77090
        • Houston Digestive Disease Clinic
    • Virginia
      • Chesapeake, Virginia, United States, 23320
        • Gastroenterology Associates of Tidewater
      • Christiansburg, Virginia, United States, 24073
        • New River Research Institute
    • Washington
      • Seattle, Washington, United States, 98133
        • Seattle Gastroenterology Associates
      • Spokane, Washington, United States, 99204
        • Eastern Washington Clinical Research Center
      • Spokane, Washington, United States, 99204
        • Spokane Digestive Disease Center
      • Tacoma, Washington, United States, 98405
        • Digestive Disease Research Center
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53215
        • Center for Advanced Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

    The investigator is responsible for determining whether the participant has adequate birth control for study participation.

    b. Participant is greater than or equal to (≥) 18 years of age. c. Participant has historically confirmed diagnosis (physician letter for newly/recently diagnosed and by medical records for previously diagnosed participants) of mild to moderate UC in remission for greater than (>) 1 month and <12 months.

    d. Confirmed current remission defined as both: A screening rectal bleeding score of 0 as described in the Disease Activity Index (DAI) (Sutherland Index) where 0 = None A screening sigmoidoscopy score of 0 to 1 for mucosal appearance as described in the (Sutherland Index where 0 = intact mucosa with preserved or distorted vessels and 1 = Erythema, decreased vascular pattern, granularity, no mucosal hemorrhage.

  3. Participant and investigator consider there is the potential for benefit to the participant with MP treatment.
  4. Participant is capable and willing to comply with all study procedures.

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.

    If a new participant, the following additional exclusion criteria will apply:

  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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Encapsulated Mesalamine Granules (eMG)
Participants will receive eMG 1.5 grams (4 capsules of eMG 0.375 grams each) QD orally in the morning for up to 24 months.
eMG capsules will be administered per dose and schedule specified in the arm.
Other Names:
  • Mesalamine pellets

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Time Frame: Baseline (Day 1) up to follow-up (24.5 months)
An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A TEAE was defined as any event with a start date occurring on or after treatment Day 1 or, if pre-existing, worsening after treatment Day 1. Serious AEs were defined as death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized participant and required medical intervention to prevent 1 of the outcomes listed in this definition. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.
Baseline (Day 1) up to follow-up (24.5 months)
Number of Participants Who Prematurely Discontinued Treatment
Time Frame: Baseline up to Month 24
Number of participants who prematurely discontinued treatment due to any reason were reported.
Baseline up to Month 24
Number of Participants With Potentially Clinically Significant (PCS) Hematology and Blood Chemistry Abnormalities
Time Frame: Baseline up to follow-up (24.5 months)
Criteria for potentially clinically significant abnormal hematology and blood chemistry values included: hemoglobin (grams/deciliter [g/dL]): <10 and ≥3 decrease, or >20; hematocrit (%): <30 and ≥10 decrease, or >60; platelets (*10^9 cells/liter): <100 or >700 (normal: 150-400); white blood cells (*10^9 cells/liter): <2.3 or >16.2 (normal: 3.5-11.1); alanine aminotransferase (units/liter [U/L]): ≥3 * upper limit of normal (ULN) (normal range 0-47 U/L); aspartate aminotransferase (U/L): ≥3 * ULN (normal range 0-37 U/L); total bilirubin (micromoles/liter [µmol/L]): >2 times; and calcium creatinine clearance (milliliters/minute [mL/min]): ≤50.
Baseline up to follow-up (24.5 months)
Number of Participants With Clinically Significant Change From Baseline in Vital Signs
Time Frame: Baseline, up to follow-up visit (Month 24.5)
Vital signs included systolic and diastolic blood pressure, pulse rate, body temperature, or body weight.
Baseline, up to follow-up visit (Month 24.5)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 22, 2005

Primary Completion (Actual)

May 5, 2008

Study Completion (Actual)

May 5, 2008

Study Registration Dates

First Submitted

May 12, 2006

First Submitted That Met QC Criteria

May 12, 2006

First Posted (Estimate)

May 16, 2006

Study Record Updates

Last Update Posted (Actual)

November 1, 2019

Last Update Submitted That Met QC Criteria

October 14, 2019

Last Verified

October 1, 2019

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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