Ulcerative ColitisPhase 1NCT01130844
Safety and Pharmacokinetics of MMX Mesalamine in Children and Adolescents With Ulcerative Colitis
A Phase 1 study testing MMX Mesalamine in people with Ulcerative Colitis, run by Shire at 19 sites in 5 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 17 years
- Conditions the study is for
- Ulcerative Colitis
- What is being tested?
- MMX Mesalamine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 19 sitesin 5 countries
- Study dates
- 8 Oct 2010to 27 Jun 2013
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Subjects aged 5-17 years, with appropriately obtained informed consent and assent.
- Subject has a documented history of ulcerative colitis for at least 3 months.
- 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.
- 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.
- Body weight of 18kg-82kg inclusive.
Who cannot join
- 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.
- Ulcerative Colitis known to be confined to the rectum (isolated rectal proctitis).
- Any history of hepatic impairment or moderate to severe renal impairment.
- 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.
Trial locations and contacts
19 sites in 5 countries.
19 sites in 5 countries
United States6 sites
Advanced Clinical Research Institute
Anaheim, California, 92801
University of Maryland Medical Center for Children
Baltimore, Maryland, 21201
Connecticut Children's Medical Center
Hartford, Connecticut, 06106
Arkansas Children's Hospital
Little Rock, Arkansas, 72202
Mayo Clinic
Rochester, Minnesota, 55905
University of California, San Francisco
San Francisco, California, 94143
Poland5 sites
Klinika Gastroenterolofii Pediatrii, Instytut Centrum Zdrowia Matki Polki
Lodz, 281/289
Klinika Pediatrii Dzieciecy Szpital Kliniczny im prof Antoniego Gebali
Lublin, 20-093
Kliniczny Oddzial Pediatrii z Pododdzialem Neurologii Dzieciecej Szpital Wojewodzki
Rzeszów, 35-301
Oddzial Gastroenterologii i Hepatologii, Instytut Pomnik-Centrum Zdrowia Dziecka
Warsaw, 04-730
Klinika Pediatrii Gastroenterologii i Zywienia, Uniwersytecki Szpital Dzieciecy w Krakowie
Wieliczka, Krakow, 30-663
United Kingdom4 sites
Alder Hey Children's NHS Foundation Trust
Liverpool, L12 2AP
Barts Health NHS Trust/Royal London Hospital
London, E1 1BB
Somers Clinical Research Facility/Great Ormond Street Hospital
London, WC1N 3JH
Southampton General Hospital
Southampton, SO16 6YD
Slovakia3 sites
DFNsP Banska Bystrica
Banská Bystrica, 974 09
Gastroenterologicka ambulancia
Bratislava, 824 02
Univerzitna nemocnica Martin
Martin, Kollarova 2, 036 01
Australia1 site
Royal Children's Hospital Melbourne
Parkville, Victoria, 3052
About this study
Official 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
The purpose of this study is to determine the safety and pharmacokinetics of MMX mesalamine following administration in children and adolescents with ulcerative colitis.
- Conditions
- Ulcerative Colitis
- Being tested
- MMX Mesalamine
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MMX MesalamineDrug
Also called Lialda, SPD476
30 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
MMX MesalamineDrug
Also called Lialda, SPD476
60 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
MMX MesalamineDrug
Also called Lialda, SPD476
100 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
| Study group | Role | What they receive |
|---|---|---|
| MMX Mesalamine (30mg/kg) | Experimental | Not described Receives: Drug: MMX Mesalamine |
| MMX Mesalamine (60 mg/kg) | Experimental | Not described Receives: Drug: MMX Mesalamine |
| MMX Mesalamine (100 mg/kg) | Experimental | Not described Receives: Drug: MMX Mesalamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: Over a 24-hour period starting on day 7
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.
Measured: Over a 24-hour period starting on day 7
Total Body Clearance (CL) of MMX Mesalamine (5-ASA) at Steady State
Clearance of a substance from the blood by the kidneys.
Measured: Over a 24-hour period starting on day 7
AUC of MMX Mesalamine Major Metabolite (Ac-5-ASA) at Steady State
Measured: 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
Measured: Over a 24-hour period starting on day 7
Tmax of MMX Mesalamine Major Metabolite (Ac-5-ASA) at Steady State
Measured: Over a 24-hour period starting on day 7
CL of MMX Mesalamine Major Metabolite (Ac-5-ASA) at Steady State
Measured: Over a 24-hour period starting on day 7
Secondary outcomes (3)
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.
Measured: Over a 24-hour period starting on day 7
Cumulative Amount of MMX Mesalamine (5-ASA) Recovered in Urine at Steady State
Measured: 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
Measured: Over a 24-hour period starting on day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2010 (estimated)
- Study start8 Oct 2010
- Primary completion27 Jun 2013
- Study completion27 Jun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shire
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01130844
- Sponsor's protocol ID
- SPD476-112
- Other IDs
- 2011-000164-10
- Status last verified
- Jun 2021
- First submitted
- 20 May 2010
- Last updated
- 14 Jun 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT01130844
- Acronym / sponsor ID
- SPD476-112
- Conditions
- Ulcerative Colitis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- ShireIndustry (pharma, biotech, devices)
- Study start
- 8 Oct 2010 (actual)
- Primary completion
- 27 Jun 2013 (actual)
- Study completion
- 27 Jun 2013 (actual)
- First posted
- 26 May 2010 (estimated)
- Results
- Posted 9 Jul 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| MMX Mesalamine (30mg/kg) | Experimental | Drug: MMX Mesalamine |
| MMX Mesalamine (60 mg/kg) | Experimental | Drug: MMX Mesalamine |
| MMX Mesalamine (100 mg/kg) | Experimental | Drug: MMX Mesalamine |
Who may qualify
- Ages
- 5 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Subjects aged 5-17 years, with appropriately obtained informed consent and assent.
- Subject has a documented history of ulcerative colitis for at least 3 months.
- 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.
- 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.
- Body weight of 18kg-82kg inclusive.
Key exclusion criteria (4 listed)
- 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.
- Ulcerative Colitis known to be confined to the rectum (isolated rectal proctitis).
- Any history of hepatic impairment or moderate to severe renal impairment.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MMX MesalamineAlso: Lialda, SPD47630 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days. | Drug | MMX Mesalamine (30mg/kg) |
| MMX MesalamineAlso: Lialda, SPD47660 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days. | Drug | MMX Mesalamine (60 mg/kg) |
| MMX MesalamineAlso: Lialda, SPD476100 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days. | Drug | MMX Mesalamine (100 mg/kg) |
Primary outcome
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.
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.
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.
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.
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
Cmax of MMX Mesalamine Major Metabolite (Ac-5-ASA) at Steady State
Time frame: 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
CL of MMX Mesalamine Major Metabolite (Ac-5-ASA) at Steady State
Time frame: Over a 24-hour period starting on day 7
3 secondary outcomes
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
Cumulative Amount of MMX Mesalamine (5-ASA) Recovered in Urine at Steady State
Time frame: 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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 26893546Cuffari 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Study Director study director
Takeda
19 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MMX Mesalamine in people with Ulcerative Colitis, run by Shire at 19 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in United States, Poland, United Kingdom, Slovakia, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Jul 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01130844, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2021.