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

June 8, 2021 updated by: Shire

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

The purpose of this study is to determine the safety and pharmacokinetics of MMX mesalamine following administration in children and adolescents with ulcerative colitis.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
52

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

5 years to 17 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: MMX Mesalamine (30mg/kg)
Drug: MMX Mesalamine
30 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
Other Names:
  • Lialda, SPD476
Drug: MMX Mesalamine
60 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
Other Names:
  • Lialda, SPD476
Drug: MMX Mesalamine
100 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
Other Names:
  • Lialda, SPD476
EXPERIMENTAL: MMX Mesalamine (60 mg/kg)
Drug: MMX Mesalamine
30 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
Other Names:
  • Lialda, SPD476
Drug: MMX Mesalamine
60 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
Other Names:
  • Lialda, SPD476
Drug: MMX Mesalamine
100 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
Other Names:
  • Lialda, SPD476
EXPERIMENTAL: MMX Mesalamine (100 mg/kg)
Drug: MMX Mesalamine
30 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
Other Names:
  • Lialda, SPD476
Drug: MMX Mesalamine
60 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
Other Names:
  • Lialda, SPD476
Drug: MMX Mesalamine
100 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
Other Names:
  • Lialda, SPD476

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
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.
2, 4, 6, 9, 12, 16, and 24 hours post-dose on day 7
Maximum Plasma Concentration (Cmax) of MMX Mesalamine (5-ASA) at Steady State
Time Frame: Over a 24-hour period starting on day 7
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.
Over a 24-hour period starting on day 7
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
Tmax is the time after administration of a drug when the maximum plasma concentration in the body is reached.
Over a 24-hour period starting on day 7
Total Body Clearance (CL) of MMX Mesalamine (5-ASA) at Steady State
Time Frame: Over a 24-hour period starting on day 7
Clearance of a substance from the blood by the kidneys.
Over a 24-hour period starting on day 7
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
2, 4, 6, 9, 12, 16, and 24 hours post-dose on day 7
Cmax of MMX Mesalamine Major Metabolite (Ac-5-ASA) at Steady State
Time Frame: Over a 24-hour period starting on day 7
Over a 24-hour period starting on day 7
Tmax of MMX Mesalamine Major Metabolite (Ac-5-ASA) at Steady State
Time Frame: Over a 24-hour period starting on day 7
Over a 24-hour period starting on day 7
CL of MMX Mesalamine Major Metabolite (Ac-5-ASA) at Steady State
Time Frame: Over a 24-hour period starting on day 7
Over a 24-hour period starting on day 7

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
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.
Over a 24-hour period starting on day 7
Cumulative Amount of MMX Mesalamine (5-ASA) Recovered in Urine at Steady State
Time Frame: Over a 24-hour period starting on day 7
Over a 24-hour period starting on day 7
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
Over a 24-hour period starting on day 7

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Shire

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 8, 2010

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 27, 2013

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 27, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 20, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 25, 2010

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 26, 2010

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 14, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 8, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SPD476-112
  • 2011-000164-10 (EUDRACT_NUMBER)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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