PharmacokineticsPhase 1NCT00474019
Phase 1 Pharmacokinetics of Intravenous Nexium in Children
A Phase 1 study testing esomeprazole in people with Pharmacokinetics, run by AstraZeneca at 15 sites in 5 countries.
Trial summary
The purpose of this research study is to evaluate how much of repeated once daily intravenous (IV, meaning through a vein) doses of esomeprazole gets into the bloodstream of hospitalized children aged 0-17 years old that require acid suppression therapy. Read more about this study
- Who is it for?
- Ages Up to 17 years
- Conditions the study is for
- Pharmacokinetics
- What is being tested?
- esomeprazole
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 15 sitesin 5 countries
- Study dates
- Oct 2007to Oct 2009
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 Up to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- parent/guardian must sign consent form and the child will be asked to sign and Assent Form if he/she is old enough and is able to sign
- verbal assent will be acceptable if the child is old enough to understand, but unable to write
- female and/or male hospitalized patients aged 0-17 years old who should be considered for treatment with acid suppressive therapy.
Who cannot join
- female patients that are pregnant, or plan to become pregnant during the study period or is breast-feeding a child
- patients with a history of multiple drug allergies
- any illness, medical history, abnormal laboratory values, abnormal physical examination findings or abnormal vitals signs that could put the patient at risk when participating in the study
Trial locations and contacts
15 sites in 5 countries.
15 sites in 5 countries
United States11 sites
Research Site
Buffalo, New York
Research Site
Cleveland, Ohio
Research Site
Detroit, Michigan
Research Site
Fort Worth, Texas
Research Site
Hartford, Connecticut
Research Site
Houston, Texas
Research Site
Little Rock, Arkansas
Research Site
Louisville, Kentucky
Research Site
New Brunswick, New Jersey
Research Site
Park Ridge, Illinois
Research Site
Southfield, Michigan
About this study
Official title: A Phase I, Randomised, Open-label, Multi-National Study to Evaluate the Pharmacokinetics of Repeated Once-Daily Intravenous Doses of Esomeprazole in Paediatric Patients 0 to 17 Years Old, Inclusive.
The purpose of this research study is to evaluate how much of repeated once daily intravenous (IV, meaning through a vein) doses of esomeprazole gets into the bloodstream of hospitalized children aged 0-17 years old that require acid suppression therapy.
- Conditions
- Pharmacokinetics
- Being tested
- esomeprazole
- Keywords
- pediatrics, neonates
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
esomeprazoleDrug
Also called Nexium
IV qd for 4 days
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Based on age and/or weight dose of esomeprazole IV qd in milligrams 20,40,10,20,10, 1.0 mg/kg, 0,5 mg/kg Receives: Drug: esomeprazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic-area under plasma concentration versus time curve within a dosing interval
Measured: Day 4 of study
Secondary outcomes (3)
Maximum plasma concentration, total, plasma clearance, steady-state volume of distribution of esomeprazole
Measured: Day 4 of study
Safety and tolerability will be assessed by AEs, laboratory values, blood pressure, heart rate, respiratory rate, body temperature, and ECG
Measured: Days 1-4 (during treatment), Days 1-28 (post treatment)
Evaluate main metabolites of esomeprazole (sulphone metabolite and 5-hydroxy metabolite) by assessment of max plasma conc, total area under the plasma concentration vs time curve within a dosing interval, clearance scaled by fraction metabolised
Measured: Day 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2007 (estimated)
- Study startOct 2007
- Study completionOct 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for PharmacokineticsStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Kurt Brown, MD, Study director, AstraZenecaPer Lundborg, MD, Study director, AstraZenecaJill McGuinn, Study director, AstraZeneca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00474019
- Sponsor's protocol ID
- D9615C00021
- Status last verified
- Dec 2010
- First submitted
- 14 May 2007
- Last updated
- 3 Dec 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Earp JC, Mehrotra N, Peters KE, Fiorentino RP, Griebel D, Lee SC, Mulberg A, Rohss K, Sandstrom M, Taylor A, Tornoe CW, Wynn EL, Van der Walt JS, Garnett C. Esomeprazole FDA Approval in Children With GERD: Exposure-Matching and Exposure-Response. J Pediatr Gastroenterol Nutr. 2017 Sep;65(3):272-277. doi: 10.1097/MPG.0000000000001467.
PubMed 27875488Sandstrom M, Davidson G, Tolia V, Sullivan JE, Langstrom G, Lundborg P, Brown K. Phase I, multicenter, randomized, open-label study evaluating the pharmacokinetics and safety profile of repeated once-daily doses of intravenous esomeprazole in children 0 to 17 years of age. Clin Ther. 2012 Aug;34(8):1828-38. doi: 10.1016/j.clinthera.2012.06.028. Epub 2012 Jul 24.
PubMed 22832034
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Randomised, Open-label, Multi-National Study to Evaluate the Pharmacokinetics of Repeated Once-Daily Intravenous Doses of Esomeprazole in Paediatric Patients 0 to 17 Years Old, Inclusive.
- ClinicalTrials.gov ID
- NCT00474019
- Acronym / sponsor ID
- D9615C00021
- Conditions
- Pharmacokinetics
- Keywords
- pediatrics, neonates
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Oct 2007
- Study completion
- Oct 2009 (actual)
- First posted
- 16 May 2007 (estimated)
- Results
- Not posted in the source record
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 research study is to evaluate how much of repeated once daily intravenous (IV, meaning through a vein) doses of esomeprazole gets into the bloodstream of hospitalized children aged 0-17 years old that require acid suppression therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: esomeprazoleBased on age and/or weight dose of esomeprazole IV qd in milligrams 20,40,10,20,10, 1.0 mg/kg, 0,5 mg/kg |
Who may qualify
- Ages
- Up to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- parent/guardian must sign consent form and the child will be asked to sign and Assent Form if he/she is old enough and is able to sign
- verbal assent will be acceptable if the child is old enough to understand, but unable to write
- female and/or male hospitalized patients aged 0-17 years old who should be considered for treatment with acid suppressive therapy.
Key exclusion criteria (3 listed)
- female patients that are pregnant, or plan to become pregnant during the study period or is breast-feeding a child
- patients with a history of multiple drug allergies
- any illness, medical history, abnormal laboratory values, abnormal physical examination findings or abnormal vitals signs that could put the patient at risk when participating in the study
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 |
|---|---|---|
| esomeprazoleAlso: NexiumIV qd for 4 days | Drug | 1 |
Primary outcome
Pharmacokinetic-area under plasma concentration versus time curve within a dosing interval
Time frame: Day 4 of study
3 secondary outcomes
Maximum plasma concentration, total, plasma clearance, steady-state volume of distribution of esomeprazole
Time frame: Day 4 of study
Safety and tolerability will be assessed by AEs, laboratory values, blood pressure, heart rate, respiratory rate, body temperature, and ECG
Time frame: Days 1-4 (during treatment), Days 1-28 (post treatment)
Evaluate main metabolites of esomeprazole (sulphone metabolite and 5-hydroxy metabolite) by assessment of max plasma conc, total area under the plasma concentration vs time curve within a dosing interval, clearance scaled by fraction metabolised
Time frame: Day 4
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2010.
- Derived from this study: PubMed 27875488Earp JC, Mehrotra N, Peters KE, Fiorentino RP, Griebel D, Lee SC, Mulberg A, Rohss K, Sandstrom M, Taylor A, Tornoe CW, Wynn EL, Van der Walt JS, Garnett C. Esomeprazole FDA Approval in Children With GERD: Exposure-Matching and Exposure-Response. J Pediatr Gastroenterol Nutr. 2017 Sep;65(3):272-277. doi: 10.1097/MPG.0000000000001467.
- Derived from this study: PubMed 22832034Sandstrom M, Davidson G, Tolia V, Sullivan JE, Langstrom G, Lundborg P, Brown K. Phase I, multicenter, randomized, open-label study evaluating the pharmacokinetics and safety profile of repeated once-daily doses of intravenous esomeprazole in children 0 to 17 years of age. Clin Ther. 2012 Aug;34(8):1828-38. doi: 10.1016/j.clinthera.2012.06.028. Epub 2012 Jul 24.
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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.
Kurt Brown, MD study director
AstraZeneca
Per Lundborg, MD study director
AstraZeneca
Jill McGuinn study director
AstraZeneca
15 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 esomeprazole in people with Pharmacokinetics, run by AstraZeneca at 15 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 3 inclusion and 3 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 3 Dec 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States, Australia, Belgium, Hungary, Sweden. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Pharmacokinetic-area under plasma concentration versus time curve within a dosing interval (time frame: Day 4 of study). 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 NCT00474019, which also lists 2 linked publications.
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 3 Dec 2010.