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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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21 June 2021 |
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Main ID: |
NCT01130844 |
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Date of registration:
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20/05/2010 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Safety and Pharmacokinetics of MMX Mesalamine in Children and Adolescents With Ulcerative Colitis
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Scientific title:
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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 |
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Date of first enrolment:
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October 8, 2010 |
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Target sample size:
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52 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01130844 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Other. Masking: None (Open Label).
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Phase:
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Phase 1
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Countries of recruitment
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Australia
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Poland
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Slovakia
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United Kingdom
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United States
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Contacts
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Name:
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Study Director |
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Address:
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Telephone:
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Email:
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Affiliation:
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Takeda |
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Key inclusion & exclusion criteria
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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.
Age minimum:
5 Years
Age maximum:
17 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Ulcerative Colitis
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Intervention(s)
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Drug: MMX Mesalamine
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Primary Outcome(s)
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Tmax of MMX Mesalamine Major Metabolite (Ac-5-ASA) at Steady State
[Time Frame: Over a 24-hour period starting on day 7]
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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]
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Cmax of MMX Mesalamine Major Metabolite (Ac-5-ASA) at Steady State
[Time Frame: Over a 24-hour period starting on day 7]
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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]
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CL of MMX Mesalamine Major Metabolite (Ac-5-ASA) at Steady State
[Time Frame: Over a 24-hour period starting on day 7]
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Total Body Clearance (CL) of MMX Mesalamine (5-ASA) at Steady State
[Time Frame: Over a 24-hour period starting on day 7]
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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]
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Maximum Plasma Concentration (Cmax) of MMX Mesalamine (5-ASA) at Steady State
[Time Frame: Over a 24-hour period starting on day 7]
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Secondary Outcome(s)
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Cumulative Amount of MMX Mesalamine (5-ASA) Recovered in Urine at Steady State
[Time Frame: Over a 24-hour period starting on day 7]
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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]
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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]
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Secondary ID(s)
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SPD476-112
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2011-000164-10
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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