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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Shire
ClinicalTrials.gov Identifier:
NCT01130844
First received: May 20, 2010
Last updated: December 3, 2013
Last verified: December 2013
  Purpose

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


Condition Intervention Phase
Ulcerative Colitis
Drug: MMX Mesalamine
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: A Phase 1, Multicenter, Open-label Study to Determine the Safety and Pharmacokinetics of MMX Mesalamine Following Administration in Children and Adolescents With Ulcerative Colitis

Resource links provided by NLM:


Further study details as provided by Shire:

Primary Outcome Measures:
  • Assess the pharmacokinetics of 3 doses of the study drug and its' associated metabolite after 7 days of dose administration. [ Time Frame: Assessed over a 24-hour period starting on day 7 of the study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Evaluate the extent of study drug absorption by determining the total percentage of study drug excreted in urine. [ Time Frame: Assessed over a 24-hour period starting on day 7 of the study ] [ Designated as safety issue: No ]

Enrollment: 52
Study Start Date: December 2010
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MMX Mesalamine (30mg/kg) Drug: MMX Mesalamine
30 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
Other Name: Lialda, SPD476
Experimental: MMX Mesalamine (60 mg/kg) Drug: MMX Mesalamine
60 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
Other Name: Lialda, SPD476
Experimental: MMX Mesalamine (100 mg/kg) Drug: MMX Mesalamine
100 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
Other Name: Lialda, SPD476

  Eligibility

Ages Eligible for Study:   5 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subjects aged 5-17 years, with appropriately obtained informed consent and assent.
  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:

  1. 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.
  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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01130844

Locations
United States, Arkansas
Arkansas Children's Hospital
Little Rock, Arkansas, United States, 72202
United States, California
Advanced Clinical Research Institute
Anaheim, California, United States, 92801
University of California, San Francisco
San Francisco, California, United States, 94143
United States, Connecticut
Connecticut Children's Medical Center
Hartford, Connecticut, United States, 06106
United States, Maryland
University of Maryland Medical Center for Children
Baltimore, Maryland, United States, 21201
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Australia, Victoria
Royal Children's Hospital Melbourne
Parkville, Victoria, Australia, 3052
Poland
Klinika Pediatrii Gastroenterologii i Zywienia, Uniwersytecki Szpital Dzieciecy w Krakowie
Wieliczka, Krakow, Poland, 30-663
Klinika Pediatrii Dzieciecy Szpital Kliniczny im prof Antoniego Gebali
Lublin, Poland, 20-093
Kliniczny Oddzial Pediatrii z Pododdzialem Neurologii Dzieciecej Szpital Wojewodzki
Rzeszow, Poland, 35-301
Klinika Gastroenterolofii Pediatrii, Instytut Centrum Zdrowia Matki Polki
Rzgowska, Poland, 281/289
Oddzial Gastroenterologii i Hepatologii, Instytut Pomnik-Centrum Zdrowia Dziecka
Warszawa, Poland, 04-730
Slovakia
Gastroenterologicka ambulancia
Limbova 2, Bratislava, Slovakia, 824 02
Univerzitna nemocnica Martin
Martin, Kollarova 2, Slovakia, 036 01
DFNsP Banska Bystrica
Banska Bystrica, Slovakia, 974 09
United Kingdom
Alder Hey Children's NHS Foundation Trust
Liverpool, United Kingdom, L12 2AP
Barts Health NHS Trust/Royal London Hospital
London, United Kingdom, E1 1BB
Somers Clinical Research Facility/Great Ormond Street Hospital
London, United Kingdom, WC1N 3JH
Southampton General Hospital
Southampton, United Kingdom, SO16 6YD
Sponsors and Collaborators
Shire
  More Information

No publications provided

Responsible Party: Shire
ClinicalTrials.gov Identifier: NCT01130844     History of Changes
Other Study ID Numbers: SPD476-112
Study First Received: May 20, 2010
Last Updated: December 3, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Colitis
Colitis, Ulcerative
Ulcer
Colonic Diseases
Digestive System Diseases
Gastroenteritis
Gastrointestinal Diseases
Inflammatory Bowel Diseases
Intestinal Diseases
Pathologic Processes
Mesalamine
Analgesics
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antirheumatic Agents
Central Nervous System Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014