Safety and Pharmacokinetics of MMX Mesalamine in Children and Adolescents With Ulcerative Colitis
NCT ID: NCT01130844
Last Updated: 2021-06-14
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
52 participants
INTERVENTIONAL
2010-10-08
2013-06-27
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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MMX Mesalamine (30mg/kg)
MMX Mesalamine
30 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
MMX Mesalamine (60 mg/kg)
MMX Mesalamine
60 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
MMX Mesalamine (100 mg/kg)
MMX Mesalamine
100 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
Interventions
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MMX Mesalamine
30 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
MMX Mesalamine
60 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
MMX Mesalamine
100 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Subject has a documented history of ulcerative colitis for at least 3 months.
3. 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.
4. 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.
5. Body weight of 18kg-82kg inclusive.
Exclusion Criteria
2. Ulcerative Colitis known to be confined to the rectum (isolated rectal proctitis).
3. Any history of hepatic impairment or moderate to severe renal impairment.
4. 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.
5 Years
17 Years
ALL
No
Sponsors
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Shire
INDUSTRY
Responsible Party
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Principal Investigators
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Study Director
Role: STUDY_DIRECTOR
Takeda
Locations
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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
Countries
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References
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Cuffari C, Pierce D, Korczowski B, Fyderek K, Van Heusen H, Hossack S, Wan H, Edwards AY, Martin P. Randomized clinical trial: pharmacokinetics and safety of multimatrix mesalamine for treatment of pediatric ulcerative colitis. Drug Des Devel Ther. 2016 Feb 4;10:593-607. doi: 10.2147/DDDT.S95316. eCollection 2016.
Other Identifiers
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2011-000164-10
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
SPD476-112
Identifier Type: -
Identifier Source: org_study_id
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