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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01130844
First Posted: May 26, 2010
Last Update Posted: July 9, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Shire
  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
Intervention Model: Parallel Assignment
Masking: None (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:
  • Area Under the Plasma Concentration Versus Time Curve (AUC) of MMX Mesalamine (5-ASA) at Steady State [ Time Frame: 2, 4, 6, 9, 12, 16, and 24 hours post-dose on day 7 ]
    AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body.

  • Maximum Plasma Concentration (Cmax) of MMX Mesalamine (5-ASA) at Steady State [ Time Frame: Over a 24-hour period starting on day 7 ]
    Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administrated.

  • Time to Maximum Plasma Concentration (Tmax) of MMX Mesalamine (5-ASA) at Steady State [ Time Frame: Over a 24-hour period starting on day 7 ]
    Tmax is the time after administration of a drug when the maximum plasma concentration in the body is reached.

  • Total Body Clearance (CL) of MMX Mesalamine (5-ASA) at Steady State [ Time Frame: Over a 24-hour period starting on day 7 ]
    Clearance of a substance from the blood by the kidneys.

  • AUC of MMX Mesalamine Major Metabolite (Ac-5-ASA) at Steady State [ Time Frame: 2, 4, 6, 9, 12, 16, and 24 hours post-dose on day 7 ]
  • Cmax of MMX Mesalamine Major Metabolite (Ac-5-ASA) at Steady State [ Time Frame: Over a 24-hour period starting on day 7 ]
  • Tmax of MMX Mesalamine Major Metabolite (Ac-5-ASA) at Steady State [ Time Frame: Over a 24-hour period starting on day 7 ]
  • CL of MMX Mesalamine Major Metabolite (Ac-5-ASA) at Steady State [ Time Frame: Over a 24-hour period starting on day 7 ]

Secondary Outcome Measures:
  • Percentage of Dose Absorbed For MMX Mesalamine (5-ASA) in Urine at Steady State [ Time Frame: Over a 24-hour period starting on day 7 ]
    The percentage of the dose absorbed was calculated as: 100 x (Xu0-24h 5-ASA + [0.7847* Xu0-24h Ac-5-ASA])/dose, where 0.7847 is the ratio of the molecular weight of 5-ASA (153.14) to the molecular weight of Ac-5-ASA (195.15). Xu0-24h is equal to the cumulative amount recovered in urine in the time interval of 0 to 24 hours.

  • Cumulative Amount of MMX Mesalamine (5-ASA) Recovered in Urine at Steady State [ Time Frame: Over a 24-hour period starting on day 7 ]
  • Cumulative Amount of MMX Mesalamine Major Metabolite (Ac-5-ASA) Recovered in Urine at Steady State [ Time Frame: Over a 24-hour period starting on day 7 ]

Enrollment: 52
Study Start Date: October 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

Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Shire
ClinicalTrials.gov Identifier: NCT01130844     History of Changes
Other Study ID Numbers: SPD476-112
2011-000164-10 ( EudraCT Number )
First Submitted: May 20, 2010
First Posted: May 26, 2010
Results First Submitted: May 9, 2014
Results First Posted: July 9, 2015
Last Update Posted: July 9, 2015
Last Verified: June 2015

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