Long-Term Safety and Tolerability of Mesalamine Pellets in Participants With Ulcerative Colitis in Remission
Condition: Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Intervention: Encapsulated Mesalamine Granules (eMG)
Intervention description: eMG capsules will be administered per dose and schedule specified in the arm.
Intervention MeSH terms: Mesalamine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 393.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: UC; Ulcerative colitis; Inflammatory bowel disease; IBD

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.
    

Eligibility criteria:

        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