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CompletedNCT01130844Updated Jun 14, 2021Results posted

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

A Phase 1 interventional study of MMX Mesalamine and MMX Mesalamine in Ulcerative Colitis, sponsored by Shire. Completed at 19 sites in 5 countries. Open to participants aged 5 Years to 17 Years. Per ClinicalTrials.gov, last updated 2021-06-14.

Sponsored by Shire · Phase 1, Interventional, and Other

Phase
Phase 1
Study type
Interventional
Enrollment
52
Allocation
Randomized
Ages
5 Years to 17 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Ulcerative Colitis
03

In context

Colitis

1,073 studies on the registry are indexed under Colitis; 131 are open to participants now.

This study's enrollment of 52 is below the median of 60 across 771 interventional studies indexed under Colitis.

Browse Colitis studies →

Lead sponsor

Shire is the lead sponsor of 346 studies on the registry; 2 are open to participants now.

Of its 47 completed or terminated interventional studies of FDA-regulated products, 47 (100%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
5 Years to 17 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 1
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
52 participants (actual)

Study arms

  • Experimental
    MMX Mesalamine (30mg/kg)

    Drug: MMX Mesalamine

  • Experimental
    MMX Mesalamine (60 mg/kg)

    Drug: MMX Mesalamine

  • Experimental
    MMX Mesalamine (100 mg/kg)

    Drug: MMX Mesalamine

Interventions

  • DrugMMX Mesalamine

    30 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.

    Also known as: Lialda, SPD476

  • DrugMMX Mesalamine

    60 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.

    Also known as: Lialda, SPD476

  • DrugMMX Mesalamine

    100 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.

    Also known as: Lialda, SPD476

06

What researchers measure

Primary outcomes

  1. Area Under the Plasma Concentration Versus Time Curve (AUC) of MMX Mesalamine (5-ASA) at Steady State

    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

  2. Maximum Plasma Concentration (Cmax) of MMX Mesalamine (5-ASA) at Steady State

    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

  3. Time to Maximum Plasma Concentration (Tmax) of MMX Mesalamine (5-ASA) at Steady State

    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

  4. Total Body Clearance (CL) of MMX Mesalamine (5-ASA) at Steady State

    Clearance of a substance from the blood by the kidneys.

    Time frame: Over a 24-hour period starting on day 7

  5. 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

  6. Cmax of MMX Mesalamine Major Metabolite (Ac-5-ASA) at Steady State

    Time frame: Over a 24-hour period starting on day 7

  7. Tmax of MMX Mesalamine Major Metabolite (Ac-5-ASA) at Steady State

    Time frame: Over a 24-hour period starting on day 7

  8. CL of MMX Mesalamine Major Metabolite (Ac-5-ASA) at Steady State

    Time frame: Over a 24-hour period starting on day 7

Secondary outcomes

  1. Percentage of Dose Absorbed For MMX Mesalamine (5-ASA) in Urine at Steady State

    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

  2. Cumulative Amount of MMX Mesalamine (5-ASA) Recovered in Urine at Steady State

    Time frame: Over a 24-hour period starting on day 7

  3. 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

07

Results

Posted Jul 9, 2015

Participant flow

Participant flow — Overall Study
MilestoneMMX Mesalamine (30mg/kg)MMX Mesalamine (60 mg/kg)MMX Mesalamine (100 mg/kg)
Started21229
Completed21229
Not completed000

Outcome measures

PrimaryArea Under the Plasma Concentration Versus Time Curve (AUC) of MMX Mesalamine (5-ASA) at Steady State

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
Reported as:
Mean · ug*h/L
Area Under the Plasma Concentration Versus Time Curve (AUC) of MMX Mesalamine (5-ASA) at Steady State
ug*h/LMMX Mesalamine (30mg/kg)MMX Mesalamine (60 mg/kg)MMX Mesalamine (100 mg/kg)
Area Under the Plasma Concentration Versus Time Curve (AUC) of MMX Mesalamine (5-ASA) at Steady State21411 ± 1108146173 ± 2286449213 ± 17664
SecondaryPercentage of Dose Absorbed For MMX Mesalamine (5-ASA) in Urine at Steady State

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
Reported as:
Mean · percentage of dose absorbed
Percentage of Dose Absorbed For MMX Mesalamine (5-ASA) in Urine at Steady State
percentage of dose absorbedMMX Mesalamine (30mg/kg)MMX Mesalamine (60 mg/kg)MMX Mesalamine (100 mg/kg)
Percentage of Dose Absorbed For MMX Mesalamine (5-ASA) in Urine at Steady State29.4 ± 14.527.0 ± 13.522.1 ± 13.6
PrimaryMaximum Plasma Concentration (Cmax) of MMX Mesalamine (5-ASA) at Steady State

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
Reported as:
Mean · ug/L
Maximum Plasma Concentration (Cmax) of MMX Mesalamine (5-ASA) at Steady State
ug/LMMX Mesalamine (30mg/kg)MMX Mesalamine (60 mg/kg)MMX Mesalamine (100 mg/kg)
Maximum Plasma Concentration (Cmax) of MMX Mesalamine (5-ASA) at Steady State1884 ± 10183825 ± 19794314 ± 2602
PrimaryTime to Maximum Plasma Concentration (Tmax) of MMX Mesalamine (5-ASA) at Steady State

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
Reported as:
Median · hours
Time to Maximum Plasma Concentration (Tmax) of MMX Mesalamine (5-ASA) at Steady State
hoursMMX Mesalamine (30mg/kg)MMX Mesalamine (60 mg/kg)MMX Mesalamine (100 mg/kg)
Time to Maximum Plasma Concentration (Tmax) of MMX Mesalamine (5-ASA) at Steady State6.00 (0.00 to 24.0)8.98 (0.00 to 24.0)1.98 (0.00 to 24.0)
PrimaryTotal Body Clearance (CL) of MMX Mesalamine (5-ASA) at Steady State

Clearance of a substance from the blood by the kidneys.

Time frame:
Over a 24-hour period starting on day 7
Reported as:
Mean · L/h
Total Body Clearance (CL) of MMX Mesalamine (5-ASA) at Steady State
L/hMMX Mesalamine (30mg/kg)MMX Mesalamine (60 mg/kg)MMX Mesalamine (100 mg/kg)
Total Body Clearance (CL) of MMX Mesalamine (5-ASA) at Steady State6.48 ± 2.995.94 ± 2.954.95 ± 2.07
PrimaryAUC 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
Reported as:
Mean · ug*h/L
AUC of MMX Mesalamine Major Metabolite (Ac-5-ASA) at Steady State
ug*h/LMMX Mesalamine Metabolite (30mg/kg)MMX Mesalamine Metabolite (60 mg/kg)MMX Mesalamine Metabolite (100 mg/kg)
AUC of MMX Mesalamine Major Metabolite (Ac-5-ASA) at Steady State30942 ± 1374358119 ± 2272963067 ± 21752
PrimaryCmax of MMX Mesalamine Major Metabolite (Ac-5-ASA) at Steady State
Time frame:
Over a 24-hour period starting on day 7
Reported as:
Mean · ug/L
Cmax of MMX Mesalamine Major Metabolite (Ac-5-ASA) at Steady State
ug/LMMX Mesalamine Metabolite (30mg/kg)MMX Mesalamine Metabolite (60 mg/kg)MMX Mesalamine Metabolite (100 mg/kg)
Cmax of MMX Mesalamine Major Metabolite (Ac-5-ASA) at Steady State2396 ± 12174113 ± 16414968 ± 2911
PrimaryTmax of MMX Mesalamine Major Metabolite (Ac-5-ASA) at Steady State
Time frame:
Over a 24-hour period starting on day 7
Reported as:
Median · hours
Tmax of MMX Mesalamine Major Metabolite (Ac-5-ASA) at Steady State
hoursMMX Mesalamine Metabolite (30mg/kg)MMX Mesalamine Metabolite (60 mg/kg)MMX Mesalamine Metabolite (100 mg/kg)
Tmax of MMX Mesalamine Major Metabolite (Ac-5-ASA) at Steady State9.00 (0.00 to 24.0)7.48 (0.00 to 24.0)1.98 (0.00 to 24.0)
PrimaryCL of MMX Mesalamine Major Metabolite (Ac-5-ASA) at Steady State
Time frame:
Over a 24-hour period starting on day 7
Reported as:
Mean · L/h
CL of MMX Mesalamine Major Metabolite (Ac-5-ASA) at Steady State
L/hMMX Mesalamine Metabolite (30mg/kg)MMX Mesalamine Metabolite (60 mg/kg)MMX Mesalamine Metabolite (100 mg/kg)
CL of MMX Mesalamine Major Metabolite (Ac-5-ASA) at Steady State16.2 ± 6.7212.2 ± 4.4310.0 ± 4.36
SecondaryCumulative Amount of MMX Mesalamine (5-ASA) Recovered in Urine at Steady State
Time frame:
Over a 24-hour period starting on day 7
Reported as:
Mean · mg
Cumulative Amount of MMX Mesalamine (5-ASA) Recovered in Urine at Steady State
mgMMX Mesalamine (30mg/kg)MMX Mesalamine (60 mg/kg)MMX Mesalamine (100 mg/kg)
Cumulative Amount of MMX Mesalamine (5-ASA) Recovered in Urine at Steady State162 ± 132298 ± 221235 ± 121
SecondaryCumulative 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
Reported as:
Mean · mg
Cumulative Amount of MMX Mesalamine Major Metabolite (Ac-5-ASA) Recovered in Urine at Steady State
mgMMX Mesalamine Metabolite (30mg/kg)MMX Mesalamine Metabolite (60 mg/kg)MMX Mesalamine Metabolite (100 mg/kg)
Cumulative Amount of MMX Mesalamine Major Metabolite (Ac-5-ASA) Recovered in Urine at Steady State532 ± 411708 ± 341593 ± 251

Adverse events

Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
MMX Mesalamine (30mg/kg)—0/21 (0%)0/21 (0%)
MMX Mesalamine (60 mg/kg)—0/22 (0%)0/22 (0%)
MMX Mesalamine (100 mg/kg)—0/9 (0%)0/9 (0%)

Baseline characteristics

Age, Continuous
Age, Continuous(years)MMX Mesalamine (30mg/kg)MMX Mesalamine (60 mg/kg)MMX Mesalamine (100 mg/kg)Total
Mean14.0 ± 2.8813.9 ± 2.5910.6 ± 3.2813.3 ± 3.06
Age, Customized
Age, Customized(Participants)MMX Mesalamine (30mg/kg)MMX Mesalamine (60 mg/kg)MMX Mesalamine (100 mg/kg)Total
5 to 17 years, inclusive2122952
Sex: Female, Male
Sex: Female, Male(Participants)MMX Mesalamine (30mg/kg)MMX Mesalamine (60 mg/kg)MMX Mesalamine (100 mg/kg)Total
Female1411530
Male711422
Region of Enrollment
Region of Enrollment(Participants)MMX Mesalamine (30mg/kg)MMX Mesalamine (60 mg/kg)MMX Mesalamine (100 mg/kg)Total
United States3418
Slovakia2103
Poland1617841
08

Study locations

19 sites
  • Arkansas Children's Hospital
    Little Rock, Arkansas 72202, United States
  • Advanced Clinical Research Institute
    Anaheim, California 92801, United States
  • University of California, San Francisco
    San Francisco, California 94143, United States
  • Connecticut Children's Medical Center
    Hartford, Connecticut 06106, United States
  • University of Maryland Medical Center for Children
    Baltimore, Maryland 21201, United States
  • Mayo Clinic
    Rochester, Minnesota 55905, United States
  • Royal Children's Hospital Melbourne
    Parkville, Victoria 3052, Australia
  • Klinika Pediatrii Gastroenterologii i Zywienia, Uniwersytecki Szpital Dzieciecy w Krakowie
    Wieliczka, Krakow 30-663, Poland
  • Klinika Gastroenterolofii Pediatrii, Instytut Centrum Zdrowia Matki Polki
    Lodz, 281/289, Poland
  • Klinika Pediatrii Dzieciecy Szpital Kliniczny im prof Antoniego Gebali
    Lublin, 20-093, Poland
  • Kliniczny Oddzial Pediatrii z Pododdzialem Neurologii Dzieciecej Szpital Wojewodzki
    Rzeszow, 35-301, Poland
  • Oddzial Gastroenterologii i Hepatologii, Instytut Pomnik-Centrum Zdrowia Dziecka
    Warszawa, 04-730, Poland
  • Univerzitna nemocnica Martin
    Martin, Kollarova 2 036 01, Slovakia
  • DFNsP Banska Bystrica
    Banska Bystrica, 974 09, Slovakia
  • Gastroenterologicka ambulancia
    Bratislava, 824 02, Slovakia
  • Alder Hey Children's NHS Foundation Trust
    Liverpool, L12 2AP, United Kingdom
  • Barts Health NHS Trust/Royal London Hospital
    London, E1 1BB, United Kingdom
  • Somers Clinical Research Facility/Great Ormond Street Hospital
    London, WC1N 3JH, United Kingdom
  • Southampton General Hospital
    Southampton, SO16 6YD, United Kingdom
09

References and documents

Publications

  • Cuffari C, Pierce D, Korczowski B, Fyderek K, Van Heusen H, Hossack S, Wan H, Edwards AY, Martin P. Randomized clinical trial: pharmacokinetics and safety of multimatrix mesalamine for treatment of pediatric ulcerative colitis. Drug Des Devel Ther. 2016 Feb 4;10:593-607. doi: 10.2147/DDDT.S95316. eCollection 2016. PubMed 26893546 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 14, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT01130844
Lead sponsor
Shire
Responsible party
Sponsor
First posted
May 26, 2010
Start date
Oct 8, 2010
Primary completion
Jun 27, 2013
Completion
Jun 27, 2013
Results posted
Jul 9, 2015
Last update
Jun 14, 2021

Study contacts

Study Director
study director · Takeda

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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