Safety and Pharmacokinetics of MMX Mesalamine in Children and Adolescents With Ulcerative Colitis

Completed · Phase 1

Conditions studied: Ulcerative Colitis

In brief

The purpose of this study is to determine the safety and pharmacokinetics of MMX mesalamine following administration in children and adolescents with ulcerative colitis.

Key facts

Study ID

NCT01130844

Run by

Shire

People needed

52

Starts

2010-10-08

Expected to finish

2013-06-27

Last updated by the study team

2021-06-14

Who can join

Age: 5 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subjects aged 5-17 years, with appropriately obtained informed consent and assent.
• Subject has a documented history of ulcerative colitis for at least 3 months.
• Subjects who are currently on 5-ASA or product(s) containing or metabolized to mesalamine must have been on a stable regimen for at least 4 weeks prior to first dose of investigational medicinal product.
• Subjects who are not currently on a drug regimen, or on a 5-ASA or product containing or metabolized to mesalamine, must have been on a stable regimen for at least 4 weeks prior to first dose at least 4 weeks prior first dose of investigational medicinal product.
• Body weight of 18kg-82kg inclusive.

You may not qualify if…

• Current or recurrent disease (eg cardiovascular, renal, liver, malignancy or other conditions) that could affect the colon, the action, absorption or disposition of the IMP, or clinical or laboratory assessments with the exception of their existing ulcerative colitis.
• Ulcerative Colitis known to be confined to the rectum (isolated rectal proctitis).
• Any history of hepatic impairment or moderate to severe renal impairment.
• The use of systemic or rectal steroids within the last 4 weeks, immunomodulators within the last 6 weeks, biologics within 6 months, antibiotic use within the last 7 days prior to the first dose of investigational medicinal product.

Where it is running

• Arkansas Children's Hospital — Little Rock, Arkansas, United States
• Advanced Clinical Research Institute — Anaheim, California, United States
• University of California, San Francisco — San Francisco, California, United States
• Connecticut Children's Medical Center — Hartford, Connecticut, United States
• University of Maryland Medical Center for Children — Baltimore, Maryland, United States
• Mayo Clinic — Rochester, Minnesota, United States
• Royal Children's Hospital Melbourne — Parkville, Victoria, Australia
• Klinika Pediatrii Gastroenterologii i Zywienia, Uniwersytecki Szpital Dzieciecy w Krakowie — Wieliczka, Krakow, Poland
• Klinika Gastroenterolofii Pediatrii, Instytut Centrum Zdrowia Matki Polki — Lodz, Poland
• Klinika Pediatrii Dzieciecy Szpital Kliniczny im prof Antoniego Gebali — Lublin, Poland
• Kliniczny Oddzial Pediatrii z Pododdzialem Neurologii Dzieciecej Szpital Wojewodzki — Rzeszów, Poland
• Oddzial Gastroenterologii i Hepatologii, Instytut Pomnik-Centrum Zdrowia Dziecka — Warsaw, Poland
• Univerzitna nemocnica Martin — Martin, Kollarova 2, Slovakia
• DFNsP Banska Bystrica — Banská Bystrica, Slovakia
• Gastroenterologicka ambulancia — Bratislava, Slovakia
• Alder Hey Children's NHS Foundation Trust — Liverpool, United Kingdom
• Barts Health NHS Trust/Royal London Hospital — London, United Kingdom
• Somers Clinical Research Facility/Great Ormond Street Hospital — London, United Kingdom
• Southampton General Hospital — Southampton, United Kingdom

Full record on ClinicalTrials.gov

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