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.
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
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
393
eMG capsules will be administered per dose and schedule specified in the arm.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
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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
...and 51 more locations
Time frame: Baseline, up to follow-up visit (Month 24.5)