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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
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
Secondary ID [1] 0 0
2011-000164-10
Secondary ID [2] 0 0
SPD476-112
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ulcerative Colitis 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Oral and Gastrointestinal 0 0 0 0
Inflammatory bowel disease

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Area Under the Plasma Concentration Versus Time Curve (AUC) of MMX Mesalamine (5-ASA) at Steady State
Timepoint [1] 0 0
2, 4, 6, 9, 12, 16, and 24 hours post-dose on day 7
Primary outcome [2] 0 0
Maximum Plasma Concentration (Cmax) of MMX Mesalamine (5-ASA) at Steady State
Timepoint [2] 0 0
Over a 24-hour period starting on day 7
Primary outcome [3] 0 0
Time to Maximum Plasma Concentration (Tmax) of MMX Mesalamine (5-ASA) at Steady State
Timepoint [3] 0 0
Over a 24-hour period starting on day 7
Primary outcome [4] 0 0
Total Body Clearance (CL) of MMX Mesalamine (5-ASA) at Steady State
Timepoint [4] 0 0
Over a 24-hour period starting on day 7
Primary outcome [5] 0 0
AUC of MMX Mesalamine Major Metabolite (Ac-5-ASA) at Steady State
Timepoint [5] 0 0
2, 4, 6, 9, 12, 16, and 24 hours post-dose on day 7
Primary outcome [6] 0 0
Cmax of MMX Mesalamine Major Metabolite (Ac-5-ASA) at Steady State
Timepoint [6] 0 0
Over a 24-hour period starting on day 7
Primary outcome [7] 0 0
Tmax of MMX Mesalamine Major Metabolite (Ac-5-ASA) at Steady State
Timepoint [7] 0 0
Over a 24-hour period starting on day 7
Primary outcome [8] 0 0
CL of MMX Mesalamine Major Metabolite (Ac-5-ASA) at Steady State
Timepoint [8] 0 0
Over a 24-hour period starting on day 7
Secondary outcome [1] 0 0
Percentage of Dose Absorbed For MMX Mesalamine (5-ASA) in Urine at Steady State
Timepoint [1] 0 0
Over a 24-hour period starting on day 7
Secondary outcome [2] 0 0
Cumulative Amount of MMX Mesalamine (5-ASA) Recovered in Urine at Steady State
Timepoint [2] 0 0
Over a 24-hour period starting on day 7
Secondary outcome [3] 0 0
Cumulative Amount of MMX Mesalamine Major Metabolite (Ac-5-ASA) Recovered in Urine at Steady State
Timepoint [3] 0 0
Over a 24-hour period starting on day 7

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.
Minimum age
5 Years
Maximum age
17 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Other
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
8/10/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
27/06/2013
Sample size
Target
Accrual to date
Final
52
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Royal Children's Hospital Melbourne - Parkville
Recruitment postcode(s) [1] 0 0
3052 - Parkville
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arkansas
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Connecticut
Country [4] 0 0
United States of America
State/province [4] 0 0
Maryland
Country [5] 0 0
United States of America
State/province [5] 0 0
Minnesota
Country [6] 0 0
Poland
State/province [6] 0 0
Krakow
Country [7] 0 0
Poland
State/province [7] 0 0
Lodz
Country [8] 0 0
Poland
State/province [8] 0 0
Lublin
Country [9] 0 0
Poland
State/province [9] 0 0
Rzeszow
Country [10] 0 0
Poland
State/province [10] 0 0
Warszawa
Country [11] 0 0
Slovakia
State/province [11] 0 0
Kollarova 2
Country [12] 0 0
Slovakia
State/province [12] 0 0
Banska Bystrica
Country [13] 0 0
Slovakia
State/province [13] 0 0
Bratislava
Country [14] 0 0
United Kingdom
State/province [14] 0 0
Liverpool
Country [15] 0 0
United Kingdom
State/province [15] 0 0
London
Country [16] 0 0
United Kingdom
State/province [16] 0 0
Southampton

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Shire
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01130844
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Study Director
Address 0 0
Takeda
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries