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

NCT00326209 | Completed Phase 3 Results

• 1 other identifier: MPUC3005
• Study Type: interventional
• Target: 393
• Locations: 1 country
• Sites: 61

Brief 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.

Conditions

Ulcerative Colitis

Keywords

UC; Ulcerative colitis; Inflammatory bowel disease; IBD

Outcome Measures

Primary Outcomes (4)

• Number of Participants With Treatment-Emergent Adverse Events (TEAEs)

  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

  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

  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

  Vital signs included systolic and diastolic blood pressure, pulse rate, body temperature, or body weight.

  Baseline, up to follow-up visit (Month 24.5)

Study Arms (1)

Encapsulated Mesalamine Granules (eMG)

EXPERIMENTAL

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.

Drug: Encapsulated Mesalamine Granules (eMG)

Interventions

Encapsulated Mesalamine Granules (eMG) DRUG

eMG capsules will be administered per dose and schedule specified in the arm.

Also known as: Mesalamine pellets

Encapsulated Mesalamine Granules (eMG)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• An Institutional Review Board (IRB)/Ethics Committee (EC) approved informed consent is signed and dated prior to any study-related activities.
• 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.
• Participant and investigator consider there is the potential for benefit to the participant with MP treatment.
• Participant is capable and willing to comply with all study procedures.

You may not qualify if:

• 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.
• Participant has a history of allergy or intolerance to aspirin, mesalamine or other salicylates.
• 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.
• Participant or participant's parents are known to have phenylketonuria.
• Participant has participated in an investigational drug or device study within the 30 days prior to study screening.
• Participant shows evidence of current excessive alcohol consumption or drug dependence.
• Participant has uncontrolled, clinically significant renal disease manifested by 1.5 \* ULN of serum creatinine or blood urea nitrogen (BUN) levels.
• Participant has calculated creatinine clearance level of \<60 mL/min

Sponsors & Collaborators

• Bausch Health Americas, Inc.: lead

Study Sites (61)

Birmingham Gastroenterology Associates

Birmingham, Alabama, 35209, United States

Location

First Care Family Doctors South

Fayetteville, Arkansas, 72701, United States

Location

Little Rock Diagnostic Clinic

Little Rock, Arkansas, 72205, United States

Location

AGMG Clinical Research

Anaheim, California, 92801, United States

Location

Lovelace Scientific Resources

Beverly Hills, California, 90211, United States

Location

Digestive Liver Disease Specialists, Medical Group

Garden Grove, California, 92840, United States

Location

Long Beach VA Medical Center

Long Beach, California, 90822, United States

Location

Community Clinical Trials

Orange, California, 92868, United States

Location

Rider Research Group

San Francisco, California, 94117, United States

Location

John Jolley, M.D.

San Rafael, California, 94901, United States

Location

Lovelace Scientific Resources

Santa Ana, California, 92704, United States

Location

Santa Barbara Clinical Research

Santa Barbara, California, 93108, United States

Location

Professionals for Clinical Research

Littleton, Colorado, 80120, United States

Location

Connecticut Gastroenterology Institute

Bristol, Connecticut, 06010, United States

Location

Clinical Research of Tampa Bay, Inc.

Brooksville, Florida, 34613, United States

Location

Medical Research Unlimited

Hialeah, Florida, 33013, United States

Location

Southern Clinical Research Consultants

Hollywood, Florida, 33021, United States

Location

United Medical Research

New Smyrna Beach, Florida, 32168, United States

Location

Venture Research Institute, LLC

North Miami Beach, Florida, 33162, United States

Location

Penninsula Research, Inc.

Ormond Beach, Florida, 32174, United States

Location

Advanced Gastroenterology Associates

Palm Harbor, Florida, 34684, United States

Location

Lovelace Scientific Resources

Sarasota, Florida, 34233, United States

Location

Advent Clinical Research

Sarasota, Florida, 34239, United States

Location

Metabolic Research Institute, Inc.

West Palm Beach, Florida, 33401, United States

Location

Consultative Gastroenterology

Atlanta, Georgia, 30308, United States

Location

Digestive Care Associates

Austell, Georgia, 30106, United States

Location

Center for Gastroenterology

Decatur, Georgia, 30033, United States

Location

Gastroenterology Associates of Central Georgia

Macon, Georgia, 31201, United States

Location

Northwest Gastroenterologists S.C.

Arlington Heights, Illinois, 60005, United States

Location

Covenant Clinic

Waterloo, Iowa, 50702, United States

Location

Cotton-O'Neil Digestive Health Center

Topeka, Kansas, 66606, United States

Location

University of Louisville

Louisville, Kentucky, 40202, United States

Location

Sinai Medical Office Building

Baltimore, Maryland, 21215, United States

Location

Philip J. Beam Medical Center

Hollywood, Maryland, 20636, United States

Location

Research Institute of Michigan, LLC

Chesterfield, Michigan, 48047, United States

Location

Center for Digestive & Liver Diseases

Mexico, Missouri, 65265, United States

Location

St. Louis Center for Clinical Research

St Louis, Missouri, 63128, United States

Location

Shore Health Group

Ocean City, New Jersey, 07712, United States

Location

Simon Lichtiger, M.D.

New York, New York, 10128, United States

Location

VA Medical Center, Northport

Northport, New York, 11768, United States

Location

VA Medical Center

Syracuse, New York, 13210, United States

Location

Upstate Gastroenterology Associates, PC

Troy, New York, 12180, United States

Location

LeBauer Research Associates, PA

Greensboro, North Carolina, 27403, United States

Location

Bethany Medical Center

High Point, North Carolina, 27262, United States

Location

Boice-Willis Clinic

Rocky Mount, North Carolina, 27804, United States

Location

Consultants for Clinical Research, Inc.

Cincinnati, Ohio, 45219, United States

Location

Avamar Center for Endoscopy

Warren, Ohio, 44484, United States

Location

Oklahoma Gastroenterology Associates, LLC

Tulsa, Oklahoma, 74104, United States

Location

Charleston Gastroenterology Specialists, LLC

Charleston, South Carolina, 29414, United States

Location

Hillcrest Clinical Research, LLC

Simpsonville, South Carolina, 29681, United States

Location

Medical Research Institute

Nashville, Tennessee, 37205, United States

Location

NationsMed Clinical Research

Houston, Texas, 77034, United States

Location

Clinical Trial Network

Houston, Texas, 77074, United States

Location

Houston Digestive Disease Clinic

Houston, Texas, 77090, United States

Location

Gastroenterology Associates of Tidewater

Chesapeake, Virginia, 23320, United States

Location

New River Research Institute

Christiansburg, Virginia, 24073, United States

Location

Seattle Gastroenterology Associates

Seattle, Washington, 98133, United States

Location

Eastern Washington Clinical Research Center

Spokane, Washington, 99204, United States

Location

Spokane Digestive Disease Center

Spokane, Washington, 99204, United States

Location

Digestive Disease Research Center

Tacoma, Washington, 98405, United States

Location

Center for Advanced Research

Milwaukee, Wisconsin, 53215, United States

Location

Related Publications (1)

• 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.

  PMID: 26563167 DERIVED

MeSH Terms

Conditions

Colitis, Ulcerative; Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Colonic Diseases; Intestinal Diseases

Results Point of Contact

• Title: Director of Clinical Operations
• Organization: Bausch Health Americas, Inc.

lindsey.mathew@bauschhealth.com

Study Officials

• Lindsey Mathew

  Bausch Health Americas, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2006
• First Posted: May 16, 2006
• Study Start: December 22, 2005
• Primary Completion: May 5, 2008
• Study Completion: May 5, 2008
• Last Updated: November 1, 2019
• Results First Posted: November 1, 2019

Record last verified: 2019-10

Locations

US (61)