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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT01130844
Registration number
NCT01130844
Ethics application status
Date submitted
20/05/2010
Date registered
26/05/2010
Date last updated
14/06/2021
Titles & IDs
Public title
Safety and Pharmacokinetics of MMX Mesalamine in Children and Adolescents With Ulcerative Colitis
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Scientific 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
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Secondary ID [1]
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2011-000164-10
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Secondary ID [2]
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SPD476-112
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Ulcerative Colitis
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Condition category
Condition code
Oral and Gastrointestinal
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Inflammatory and Immune System
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Other inflammatory or immune system disorders
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Oral and Gastrointestinal
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Inflammatory bowel disease
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - MMX Mesalamine
Treatment: Drugs - MMX Mesalamine
Treatment: Drugs - MMX Mesalamine
Experimental: MMX Mesalamine (30mg/kg) -
Experimental: MMX Mesalamine (60 mg/kg) -
Experimental: MMX Mesalamine (100 mg/kg) -
Treatment: Drugs: MMX Mesalamine
30 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
Treatment: Drugs: MMX Mesalamine
60 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
Treatment: Drugs: MMX Mesalamine
100 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Area Under the Plasma Concentration Versus Time Curve (AUC) of MMX Mesalamine (5-ASA) at Steady State
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Assessment method [1]
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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.
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Timepoint [1]
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2, 4, 6, 9, 12, 16, and 24 hours post-dose on day 7
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Primary outcome [2]
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Maximum Plasma Concentration (Cmax) of MMX Mesalamine (5-ASA) at Steady State
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Assessment method [2]
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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.
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Timepoint [2]
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Over a 24-hour period starting on day 7
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Primary outcome [3]
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Time to Maximum Plasma Concentration (Tmax) of MMX Mesalamine (5-ASA) at Steady State
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Assessment method [3]
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Tmax is the time after administration of a drug when the maximum plasma concentration in the body is reached.
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Timepoint [3]
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Over a 24-hour period starting on day 7
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Primary outcome [4]
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Total Body Clearance (CL) of MMX Mesalamine (5-ASA) at Steady State
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Assessment method [4]
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Clearance of a substance from the blood by the kidneys.
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Timepoint [4]
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Over a 24-hour period starting on day 7
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Primary outcome [5]
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AUC of MMX Mesalamine Major Metabolite (Ac-5-ASA) at Steady State
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Assessment method [5]
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Timepoint [5]
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2, 4, 6, 9, 12, 16, and 24 hours post-dose on day 7
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Primary outcome [6]
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Cmax of MMX Mesalamine Major Metabolite (Ac-5-ASA) at Steady State
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Assessment method [6]
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Timepoint [6]
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Over a 24-hour period starting on day 7
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Primary outcome [7]
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Tmax of MMX Mesalamine Major Metabolite (Ac-5-ASA) at Steady State
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Assessment method [7]
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Timepoint [7]
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Over a 24-hour period starting on day 7
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Primary outcome [8]
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CL of MMX Mesalamine Major Metabolite (Ac-5-ASA) at Steady State
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Assessment method [8]
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Timepoint [8]
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Over a 24-hour period starting on day 7
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Secondary outcome [1]
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Percentage of Dose Absorbed For MMX Mesalamine (5-ASA) in Urine at Steady State
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Assessment method [1]
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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.
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Timepoint [1]
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Over a 24-hour period starting on day 7
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Secondary outcome [2]
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Cumulative Amount of MMX Mesalamine (5-ASA) Recovered in Urine at Steady State
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Assessment method [2]
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Timepoint [2]
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Over a 24-hour period starting on day 7
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Secondary outcome [3]
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Cumulative Amount of MMX Mesalamine Major Metabolite (Ac-5-ASA) Recovered in Urine at Steady State
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Assessment method [3]
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Timepoint [3]
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Over a 24-hour period starting on day 7
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Eligibility
Key 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.
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Minimum age
5
Years
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Maximum age
17
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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.
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Study design
Purpose of the study
Other
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
8/10/2010
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
27/06/2013
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Sample size
Target
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Accrual to date
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Final
52
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Royal Children's Hospital Melbourne - Parkville
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Recruitment postcode(s) [1]
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3052 - Parkville
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Arkansas
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Country [2]
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United States of America
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State/province [2]
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California
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Country [3]
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United States of America
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State/province [3]
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Connecticut
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Country [4]
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United States of America
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State/province [4]
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Maryland
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Country [5]
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United States of America
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State/province [5]
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Minnesota
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Country [6]
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Poland
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State/province [6]
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Krakow
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Country [7]
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Poland
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State/province [7]
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Lodz
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Country [8]
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Poland
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State/province [8]
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Lublin
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Country [9]
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Poland
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State/province [9]
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Rzeszow
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Country [10]
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Poland
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State/province [10]
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Warszawa
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Country [11]
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Slovakia
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State/province [11]
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Kollarova 2
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Country [12]
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Slovakia
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State/province [12]
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Banska Bystrica
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Country [13]
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Slovakia
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State/province [13]
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Bratislava
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Country [14]
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United Kingdom
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State/province [14]
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Liverpool
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Country [15]
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United Kingdom
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State/province [15]
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London
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Country [16]
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United Kingdom
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State/province [16]
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Southampton
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Shire
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of this study is to determine the safety and pharmacokinetics of MMX mesalamine
following administration in children and adolescents with ulcerative colitis.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01130844
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Study Director
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Address
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Takeda
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01130844
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