Endoscopically-Proven GERDPhase 1NCT00687245
Pharmacokinetic Study of Esomeprazole Magnesium in Patients 1 to 11 Years-Old With Endoscopically-Proven Gastroesophageal Reflux Disease (GERD)
A Phase 1 study testing esomeprazole magnesium in people with Endoscopically-Proven GERD and Reflux, run by AstraZeneca.
Trial summary
The purpose of this study is to determine the area under the plasma concentration-time curve (AUC) of esomeprazole after single oral doses of 5 mg, 10 mg or 20 mg esomeprazole in pediatric patients 1 to 11 years-old inclusive with endoscopically-proven GERD. Read more about this study
- Who is it for?
- Ages 1 year to 11 years
- Conditions the study is for
- Endoscopically-Proven GERD, Reflux
- What is being tested?
- esomeprazole magnesium
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Aug 2006to May 2008
- 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 1 year to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients must be able to take solid or bland food (eg, applesauce).
- Patients must weigh at least 8 kg and at the investigator's discretion be able to undergo extraction of an adequate volume of blood.
- The patient's weight for height percentile should be less than the 90th percentile and/or the BMI must be between the 5th and 85th percentile for age.
- Patients must be diagnosed with endoscopically-proven GERD
Who cannot join
- Use of any other investigational compound or participation in another clinical trial within 28 days prior to the screening visit.
- History or presence of gastrointestinal, hepatic or renal disease or other conditions that could interfere with absorption, distribution, metabolism or excretion of esomeprazole.
- Unstable diabetes mellitus or history of seizure disorder.
- Any acute or chronic illness or a medical history, which in the opinion of the investigator and/or sponsor, could compromise the patient's safety or successful participation in the study.
About this study
Official title: A Randomized, Open-Label Study to Evaluate the Pharmacokinetics of Single Oral Doses of Esomeprazole Magnesium in Pediatric Patients 1 to 11 Years-Old Inclusive With Endoscopically-Proven Gastroesophageal Reflux Disease (GERD)
The purpose of this study is to determine the area under the plasma concentration-time curve (AUC) of esomeprazole after single oral doses of 5 mg, 10 mg or 20 mg esomeprazole in pediatric patients 1 to 11 years-old inclusive with endoscopically-proven GERD.
- Conditions
- Endoscopically-Proven GERD, Reflux
- Being tested
- esomeprazole magnesium
- Keywords
- children, reflux, GERD, pediatric
- Medical subject headings
- Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
esomeprazole magnesiumDrug
Also called Nexium
capsules, oral, qd, one day
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | esomeprazole magnesium 5 mg, weight 8 kg to < 20kg Receives: Drug: esomeprazole magnesium |
| 2 | Experimental | esomeprazole magnesium 10 mg, weight 8 kg to < 20kg Receives: Drug: esomeprazole magnesium |
| 3 | Experimental | esomeprazole magnesium 10 mg, weight > 20 kg Receives: Drug: esomeprazole magnesium |
| 4 | Experimental | esomeprazole magnesium 20 mg, weight > 20 kg Receives: Drug: esomeprazole magnesium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the plasma concentration-time curve (AUC) of esomeprazole after single oral doses of 5 mg, 10 mg and 20 mg esomeprazole in pediatric patients 1 to 11 years old inclusive with endoscopically-proven GERD.
Measured: Day 1
Secondary outcomes (3)
The AUC(0-t), Cmax, tmax, and apparent volume of distribution during terminal phase (Vλz/F) of esomeprazole after single oral doses of 5 mg, 10 mg and 20 mg esomeprazole in pediatric patients 1 to 11 years-old inclusive with endoscopically-proven GERD.
Measured: Day 1
AUC, AUC(0-t), Cmax, tmax, t1/2λz of the 5-hydroxy and sulphone metabolites of esomeprazole after a single oral dose of 5 mg, 10 mg, and 20 mg esomeprazole in pediatric patients 1 to 11 years-old inclusive with endoscopically-proven GERD.
Measured: Day 1
Safety and tolerability after a single oral dose of esomeprazole in pediatric patients 1 to 11 years old inclusive with endoscopically- proven GERD.
Measured: Day 1, Day 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2008 (estimated)
- Study startAug 2006
- Primary completionMay 2008
- Study completionMay 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Endoscopically-Proven GERDStudies 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Marta Illueca, Study director, AstraZenecaLynne Durborow, Study chair, AstraZeneca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00687245
- Sponsor's protocol ID
- D9614C00007
- Status last verified
- Jun 2008
- First submitted
- 28 May 2008
- Last updated
- 11 Jun 2008
- 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 27875488
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-Label Study to Evaluate the Pharmacokinetics of Single Oral Doses of Esomeprazole Magnesium in Pediatric Patients 1 to 11 Years-Old Inclusive With Endoscopically-Proven Gastroesophageal Reflux Disease (GERD)
- ClinicalTrials.gov ID
- NCT00687245
- Acronym / sponsor ID
- D9614C00007
- Conditions
- Endoscopically-Proven GERD, Reflux
- Keywords
- children, reflux, GERD, pediatric
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Aug 2006
- Primary completion
- May 2008 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 30 May 2008 (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 study is to determine the area under the plasma concentration-time curve (AUC) of esomeprazole after single oral doses of 5 mg, 10 mg or 20 mg esomeprazole in pediatric patients 1 to 11 years-old inclusive with endoscopically-proven GERD.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: esomeprazole magnesiumesomeprazole magnesium 5 mg, weight 8 kg to < 20kg |
| 2 | Experimental | Drug: esomeprazole magnesiumesomeprazole magnesium 10 mg, weight 8 kg to < 20kg |
| 3 | Experimental | Drug: esomeprazole magnesiumesomeprazole magnesium 10 mg, weight > 20 kg |
| 4 | Experimental | Drug: esomeprazole magnesiumesomeprazole magnesium 20 mg, weight > 20 kg |
Who may qualify
- Ages
- 1 year to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Patients must be able to take solid or bland food (eg, applesauce).
- Patients must weigh at least 8 kg and at the investigator's discretion be able to undergo extraction of an adequate volume of blood.
- The patient's weight for height percentile should be less than the 90th percentile and/or the BMI must be between the 5th and 85th percentile for age.
- Patients must be diagnosed with endoscopically-proven GERD
Key exclusion criteria (4 listed)
- Use of any other investigational compound or participation in another clinical trial within 28 days prior to the screening visit.
- History or presence of gastrointestinal, hepatic or renal disease or other conditions that could interfere with absorption, distribution, metabolism or excretion of esomeprazole.
- Unstable diabetes mellitus or history of seizure disorder.
- Any acute or chronic illness or a medical history, which in the opinion of the investigator and/or sponsor, could compromise the patient's safety or successful participation 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 |
|---|---|---|
| esomeprazole magnesiumAlso: Nexiumcapsules, oral, qd, one day | Drug | 1, 2, 3, 4 |
Primary outcome
Area under the plasma concentration-time curve (AUC) of esomeprazole after single oral doses of 5 mg, 10 mg and 20 mg esomeprazole in pediatric patients 1 to 11 years old inclusive with endoscopically-proven GERD.
Time frame: Day 1
3 secondary outcomes
The AUC(0-t), Cmax, tmax, and apparent volume of distribution during terminal phase (Vλz/F) of esomeprazole after single oral doses of 5 mg, 10 mg and 20 mg esomeprazole in pediatric patients 1 to 11 years-old inclusive with endoscopically-proven GERD.
Time frame: Day 1
AUC, AUC(0-t), Cmax, tmax, t1/2λz of the 5-hydroxy and sulphone metabolites of esomeprazole after a single oral dose of 5 mg, 10 mg, and 20 mg esomeprazole in pediatric patients 1 to 11 years-old inclusive with endoscopically-proven GERD.
Time frame: Day 1
Safety and tolerability after a single oral dose of esomeprazole in pediatric patients 1 to 11 years old inclusive with endoscopically- proven GERD.
Time frame: Day 1, Day 15
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 11 Jun 2008.
- 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.
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.
Marta Illueca study director
AstraZeneca
Lynne Durborow study chair
AstraZeneca
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing esomeprazole magnesium in people with Endoscopically-Proven GERD and Reflux, run by AstraZeneca.
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 4 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 11 Jun 2008. Status can change between updates, so confirm with the study contact before making plans.
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?
Area under the plasma concentration-time curve (AUC) of esomeprazole after single oral doses of 5 mg, 10 mg and 20 mg esomeprazole in pediatric patients 1 to 11 years old inclusive with endoscopically-proven GERD. (time frame: Day 1). 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 NCT00687245, 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 11 Jun 2008.