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

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ClinicalTrials.gov Identifier: NCT01130844
Recruitment Status : Completed
First Posted : May 26, 2010
Results First Posted : July 9, 2015
Last Update Posted : July 9, 2015
Sponsor:
Information provided by (Responsible Party):
Shire

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label)
Condition Ulcerative Colitis
Intervention Drug: MMX Mesalamine
Enrollment 52
Recruitment Details  
Pre-assignment Details  
Arm/Group Title MMX Mesalamine (30mg/kg) MMX Mesalamine (60 mg/kg) MMX Mesalamine (100 mg/kg)
Hide Arm/Group Description MMX Mesalamine: 30 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days. MMX Mesalamine: 60 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days. MMX Mesalamine: 100 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
Period Title: Overall Study
Started 21 22 9
Completed 21 22 9
Not Completed 0 0 0
Arm/Group Title MMX Mesalamine (30mg/kg) MMX Mesalamine (60 mg/kg) MMX Mesalamine (100 mg/kg) Total
Hide Arm/Group Description MMX Mesalamine: 30 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days. MMX Mesalamine: 60 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days. MMX Mesalamine: 100 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days. Total of all reporting groups
Overall Number of Baseline Participants 21 22 9 52
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 21 participants 22 participants 9 participants 52 participants
14.0  (2.88) 13.9  (2.59) 10.6  (3.28) 13.3  (3.06)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
5 to 17 years, inclusive Number Analyzed 21 participants 22 participants 9 participants 52 participants
21 22 9 52
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants 22 participants 9 participants 52 participants
Female
14
  66.7%
11
  50.0%
5
  55.6%
30
  57.7%
Male
7
  33.3%
11
  50.0%
4
  44.4%
22
  42.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 21 participants 22 participants 9 participants 52 participants
United States 3 4 1 8
Slovakia 2 1 0 3
Poland 16 17 8 41
1.Primary Outcome
Title Area Under the Plasma Concentration Versus Time Curve (AUC) of MMX Mesalamine (5-ASA) at Steady State
Hide Description 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.
Time Frame 2, 4, 6, 9, 12, 16, and 24 hours post-dose on day 7
Hide Outcome Measure Data
Hide Analysis Population Description
The Pharmacokinetic Set (PKS) consisted of all subjects in the Safety Analysis Set who generated sufficient plasma samples to allow reliable determination of Cmax and AUC. The Safety Analysis Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
Arm/Group Title MMX Mesalamine (30mg/kg) MMX Mesalamine (60 mg/kg) MMX Mesalamine (100 mg/kg)
Hide Arm/Group Description:
MMX Mesalamine: 30 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
MMX Mesalamine: 60 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
MMX Mesalamine: 100 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
Overall Number of Participants Analyzed 21 22 9
Mean (Standard Deviation)
Unit of Measure: ug*h/L
21411  (11081) 46173  (22864) 49213  (17664)
2.Primary Outcome
Title Maximum Plasma Concentration (Cmax) of MMX Mesalamine (5-ASA) at Steady State
Hide Description 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 Frame Over a 24-hour period starting on day 7
Hide Outcome Measure Data
Hide Analysis Population Description
PKS
Arm/Group Title MMX Mesalamine (30mg/kg) MMX Mesalamine (60 mg/kg) MMX Mesalamine (100 mg/kg)
Hide Arm/Group Description:
MMX Mesalamine: 30 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
MMX Mesalamine: 60 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
MMX Mesalamine: 100 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
Overall Number of Participants Analyzed 21 22 9
Mean (Standard Deviation)
Unit of Measure: ug/L
1884  (1018) 3825  (1979) 4314  (2602)
3.Primary Outcome
Title Time to Maximum Plasma Concentration (Tmax) of MMX Mesalamine (5-ASA) at Steady State
Hide Description Tmax is the time after administration of a drug when the maximum plasma concentration in the body is reached.
Time Frame Over a 24-hour period starting on day 7
Hide Outcome Measure Data
Hide Analysis Population Description
PKS
Arm/Group Title MMX Mesalamine (30mg/kg) MMX Mesalamine (60 mg/kg) MMX Mesalamine (100 mg/kg)
Hide Arm/Group Description:
MMX Mesalamine: 30 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
MMX Mesalamine: 60 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
MMX Mesalamine: 100 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
Overall Number of Participants Analyzed 21 22 9
Median (Full Range)
Unit of Measure: hours
6.00
(0.00 to 24.0)
8.98
(0.00 to 24.0)
1.98
(0.00 to 24.0)
4.Primary Outcome
Title Total Body Clearance (CL) of MMX Mesalamine (5-ASA) at Steady State
Hide Description Clearance of a substance from the blood by the kidneys.
Time Frame Over a 24-hour period starting on day 7
Hide Outcome Measure Data
Hide Analysis Population Description
PKS
Arm/Group Title MMX Mesalamine (30mg/kg) MMX Mesalamine (60 mg/kg) MMX Mesalamine (100 mg/kg)
Hide Arm/Group Description:
MMX Mesalamine: 30 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
MMX Mesalamine: 60 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
MMX Mesalamine: 100 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
Overall Number of Participants Analyzed 21 22 9
Mean (Standard Deviation)
Unit of Measure: L/h
6.48  (2.99) 5.94  (2.95) 4.95  (2.07)
5.Primary Outcome
Title AUC of MMX Mesalamine Major Metabolite (Ac-5-ASA) at Steady State
Hide Description [Not Specified]
Time Frame 2, 4, 6, 9, 12, 16, and 24 hours post-dose on day 7
Hide Outcome Measure Data
Hide Analysis Population Description
PKS
Arm/Group Title MMX Mesalamine Metabolite (30mg/kg) MMX Mesalamine Metabolite (60 mg/kg) MMX Mesalamine Metabolite (100 mg/kg)
Hide Arm/Group Description:
MMX Mesalamine: 30 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
MMX Mesalamine: 60 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
MMX Mesalamine: 100 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
Overall Number of Participants Analyzed 21 22 9
Mean (Standard Deviation)
Unit of Measure: ug*h/L
30942  (13743) 58119  (22729) 63067  (21752)
6.Primary Outcome
Title Cmax of MMX Mesalamine Major Metabolite (Ac-5-ASA) at Steady State
Hide Description [Not Specified]
Time Frame Over a 24-hour period starting on day 7
Hide Outcome Measure Data
Hide Analysis Population Description
PKS
Arm/Group Title MMX Mesalamine Metabolite (30mg/kg) MMX Mesalamine Metabolite (60 mg/kg) MMX Mesalamine Metabolite (100 mg/kg)
Hide Arm/Group Description:
MMX Mesalamine: 30 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
MMX Mesalamine: 60 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
MMX Mesalamine: 100 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
Overall Number of Participants Analyzed 21 22 9
Mean (Standard Deviation)
Unit of Measure: ug/L
2396  (1217) 4113  (1641) 4968  (2911)
7.Primary Outcome
Title Tmax of MMX Mesalamine Major Metabolite (Ac-5-ASA) at Steady State
Hide Description [Not Specified]
Time Frame Over a 24-hour period starting on day 7
Hide Outcome Measure Data
Hide Analysis Population Description
PKS
Arm/Group Title MMX Mesalamine Metabolite (30mg/kg) MMX Mesalamine Metabolite (60 mg/kg) MMX Mesalamine Metabolite (100 mg/kg)
Hide Arm/Group Description:
MMX Mesalamine: 30 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
MMX Mesalamine: 60 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
MMX Mesalamine: 100 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
Overall Number of Participants Analyzed 21 22 9
Median (Full Range)
Unit of Measure: hours
9.00
(0.00 to 24.0)
7.48
(0.00 to 24.0)
1.98
(0.00 to 24.0)
8.Primary Outcome
Title CL of MMX Mesalamine Major Metabolite (Ac-5-ASA) at Steady State
Hide Description [Not Specified]
Time Frame Over a 24-hour period starting on day 7
Hide Outcome Measure Data
Hide Analysis Population Description
PKS
Arm/Group Title MMX Mesalamine Metabolite (30mg/kg) MMX Mesalamine Metabolite (60 mg/kg) MMX Mesalamine Metabolite (100 mg/kg)
Hide Arm/Group Description:
MMX Mesalamine: 30 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
MMX Mesalamine: 60 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
MMX Mesalamine: 100 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
Overall Number of Participants Analyzed 21 22 9
Mean (Standard Deviation)
Unit of Measure: L/h
16.2  (6.72) 12.2  (4.43) 10.0  (4.36)
9.Secondary Outcome
Title Percentage of Dose Absorbed For MMX Mesalamine (5-ASA) in Urine at Steady State
Hide Description 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.
Time Frame Over a 24-hour period starting on day 7
Hide Outcome Measure Data
Hide Analysis Population Description
PKS
Arm/Group Title MMX Mesalamine (30mg/kg) MMX Mesalamine (60 mg/kg) MMX Mesalamine (100 mg/kg)
Hide Arm/Group Description:
MMX Mesalamine: 30 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
MMX Mesalamine: 60 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
MMX Mesalamine: 100 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
Overall Number of Participants Analyzed 21 22 9
Mean (Standard Deviation)
Unit of Measure: percentage of dose absorbed
29.4  (14.5) 27.0  (13.5) 22.1  (13.6)
10.Secondary Outcome
Title Cumulative Amount of MMX Mesalamine (5-ASA) Recovered in Urine at Steady State
Hide Description [Not Specified]
Time Frame Over a 24-hour period starting on day 7
Hide Outcome Measure Data
Hide Analysis Population Description
PKS
Arm/Group Title MMX Mesalamine (30mg/kg) MMX Mesalamine (60 mg/kg) MMX Mesalamine (100 mg/kg)
Hide Arm/Group Description:
MMX Mesalamine: 30 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
MMX Mesalamine: 60 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
MMX Mesalamine: 100 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
Overall Number of Participants Analyzed 21 22 9
Mean (Standard Deviation)
Unit of Measure: mg
162  (132) 298  (221) 235  (121)
11.Secondary Outcome
Title Cumulative Amount of MMX Mesalamine Major Metabolite (Ac-5-ASA) Recovered in Urine at Steady State
Hide Description [Not Specified]
Time Frame Over a 24-hour period starting on day 7
Hide Outcome Measure Data
Hide Analysis Population Description
PKS
Arm/Group Title MMX Mesalamine Metabolite (30mg/kg) MMX Mesalamine Metabolite (60 mg/kg) MMX Mesalamine Metabolite (100 mg/kg)
Hide Arm/Group Description:
MMX Mesalamine: 30 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
MMX Mesalamine: 60 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
MMX Mesalamine: 100 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
Overall Number of Participants Analyzed 21 22 9
Mean (Standard Deviation)
Unit of Measure: mg
532  (411) 708  (341) 593  (251)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title MMX Mesalamine (30mg/kg) MMX Mesalamine (60 mg/kg) MMX Mesalamine (100 mg/kg)
Hide Arm/Group Description MMX Mesalamine: 30 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days. MMX Mesalamine: 60 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days. MMX Mesalamine: 100 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
All-Cause Mortality
MMX Mesalamine (30mg/kg) MMX Mesalamine (60 mg/kg) MMX Mesalamine (100 mg/kg)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
MMX Mesalamine (30mg/kg) MMX Mesalamine (60 mg/kg) MMX Mesalamine (100 mg/kg)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/21 (0.00%)   0/22 (0.00%)   0/9 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
MMX Mesalamine (30mg/kg) MMX Mesalamine (60 mg/kg) MMX Mesalamine (100 mg/kg)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/21 (0.00%)   0/22 (0.00%)   0/9 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
If a multicenter publication is not submitted within twelve (12) months after conclusion, abandonment or termination of the Study at all sites, or after Sponsor confirms there shall be no multicenter Study publication, the Institution and/or such Principal Investigator may publish the results from the Institution site individually.
Results Point of Contact
Name/Title: Study Physician
Organization: Shire Development LLC
Phone: +1 866 842 5335
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