Safety and Efficacy of MMX Mesalamine/Mesalazine in Pediatric Subjects With Mild to Moderate Ulcerative Colitis



Status:Completed
Conditions:Colitis, Colitis, Gastrointestinal
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:5 - 17
Updated:12/2/2018
Start Date:December 12, 2014
End Date:November 28, 2018

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A Phase 3, Multicenter, Randomized, Double-blind Study to Determine the Safety and Efficacy of MMX Mesalamine/Mesalazine in Pediatric Subjects With Mild to Moderate Ulcerative Colitis, in Both Acute and Maintenance Phases

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.


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.
We found this trial at
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Rochester, Minnesota 55905
Principal Investigator: William Faubion, MD
Phone: 507-266-9917
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
Principal Investigator: Harland Winter, MD
Phone: 781-727-7729
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Baltimore, Maryland 21201
Principal Investigator: Howard Kader, MD
Phone: 410-328-4055
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Baltimore, Maryland 21287
Principal Investigator: Carmen Cuffari, MD
Phone: 410-955-6801
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500 University Dr
Hershey, Pennsylvania 17033
(717) 531-6955
Principal Investigator: Tolulope Falaiye, MD
Phone: 717-531-7765
Penn State Milton S. Hershey Medical Center Penn State Milton S. Hershey Medical Center, Penn...
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Minneapolis, Minnesota
Principal Investigator: Boris Sudel, MD
Phone: 612-625-0233
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2014 Washington St
Newton, Massachusetts 02462
(617) 243-6000
Principal Investigator: Harland Winter, MD
Phone: 617-243-5855
Newton-Wellesley Hospital A comprehensive medical center located right in Newton on Washington Street, Newton-Wellesley Hospital...
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Roanoke, Virginia 24014
Principal Investigator: Michael Hart, MD
Phone: 540-224-6751
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Southlake, Texas 76092
Principal Investigator: Manisha Dave
Phone: 817-310-4489
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