Safety and Efficacy of MMX Mesalamine/Mesalazine in Pediatric Subjects With Mild to Moderate Ulcerative Colitis
Condition: Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Intervention: MMX Mesalamine/Mesalazine (Low Dose); MMX Mesalamine/Mesalazine (High Dose)
Intervention description: Once daily, tablets - the amount depends on the participants weight; 900 milligram per day (mg/day) for participants weighing 18 kg to less than or equal to (<=) 23 kilograms (kg); 1200 mg/day for participants weighing greater than (>) 23 kg to <= 35 kg; 1800 mg/day for participants weighing > 35 kg to <= 50 kg; 2400 mg/day for participants weighing > 50 kg to <= 90 kg.; Once daily, tablets - the amount depends on the participants weight;1800 mg/day for participants weighing 18 kg to <= 23 kg; 2400 mg/day for participants weighing > 23 kg to <= 35 kg; 3600 mg/day for participants weighing > 35 kg to <= 50 kg; 4800 mg/day for participants weighing > 50 kg to <= 90 kg.
Intervention MeSH terms: Mesalamine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 107.0
Sex: All
Minimum age: 5 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: Mild; Moderate

Summary:

      To assess clinical response to MMX mesalamine/mesalazine between a low and high dose in
      children and adolescents aged 5-17 years with mild to moderate Ulcerative Colitis (UC) or who
      are in remission.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Ability to voluntarily provide written, signed, and dated (personally or via a legally
             authorized representative [LAR]) informed consent or assent as applicable to
             participate in the study.

          2. Subject's parent/LAR demonstrates an understanding, ability, and willingness to fully
             comply with study procedures and restrictions.

          3. Male and female children and adolescents aged 5-17 years, inclusive.

          4. Body weight 18-90kg.

          5. Male, or non-pregnant, non-lactating female who agrees to comply with any applicable
             contraceptive requirements of the protocol or females of non-childbearing potential.

          6. Diagnosed with mild to moderate UC, established by sigmoidoscopy or colonoscopy with
             compatible histology. Screened subjects may also have an unconfirmed diagnosis of mild
             to moderate UC; however the diagnosis of mild to moderate UC must have been
             established by sigmoidoscopy or colonoscopy with compatible histology prior to
             baseline visit.

          7. Subject is able to swallow the investigational product whole.

             Double-blind Acute Phase:

          8. Partial UC-DAI score ≥2 (a combined rectal bleeding and stool frequency score ≥1 and
             PGA=1 or 2) at the Baseline Visit, for which 5-ASA would be used as part of normal
             treatment.

          9. If the subject is on 5-ASA treatment prior to study entry, then the dose must be
             stable. Stable therapy is defined as no change in dose, or no initiation of 5-ASA,
             from the onset of the current acute flare through discontinuation of therapy (required
             at the Baseline Visit).

             Double-blind Maintenance Phase:

         10. Partial UC-DAI ≤1 (rectal bleeding=0, stool frequency ≤1, and PGA=0) at the Baseline
             Visit.

        Exclusion Criteria:

          1. Severe UC (defined by PGA=3).

          2. Crohn's disease, bleeding disorders, active peptic ulcer disease, or UC known to be
             confined to the rectum (isolated rectal proctitis).

          3. Asthma, only if known to be 5 ASA sensitive.

          4. Positive stool culture for enteric pathogens (including Salmonella, Shigella,
             Yersinia, Aeromonas, Plesiomonas, or Campylobacter). Clostridium difficile toxin, ova,
             or parasites present.

          5. Systemic or rectal corticosteroid use within 4 weeks prior to the Screening Visit.
             Topical, intranasal, or inhaled use is not exclusionary.

          6. Immunomodulator (6-mercaptopurine, azathioprine) use within 6 weeks prior to the
             Screening Visit.

          7. History of biologic (eg, anti-tumor necrosis factor agents, integrin receptor
             antagonists) use at any time.

          8. Antibiotic use within 7 days prior to the Screening Visit.

          9. Any anti-inflammatory drugs, not including 5-ASA treatment but including non-steroidal
             anti-inflammatory drugs such as aspirin, COX-2 inhibitors or ibuprofen, within 7 days
             prior to the Screening Visit unless used at over-the-counter levels for <3 days.
             However, prophylactic use of a stable dose of aspirin up to 325mg/day for cardiac
             disease is permitted.

         10. Prebiotic/probiotic use within 7 days prior to the Screening Visit. Yogurt products
             are permitted.