Gastroesophageal Reflux DiseasePhase 1PAN01NCT02186652

PK Study With Pantoprazole in Obese Children and Adolescents

A Phase 1 study testing Pantoprazole in people with Gastroesophageal Reflux Disease, run by Phillip Brian Smith at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Multicenter, comparative single-dose pharmacokinetic (PK) study Read more about this study

Who is it for?: Ages 6 to 17 years
Conditions the study is for: Gastroesophageal Reflux Disease
What is being tested?: Pantoprazole
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 41 participants
Where: 4 sitesUnited States
Study dates: 4 Jun 2014to 13 Sep 2015
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 6 to 17 years
All sexes
No healthy volunteers
Child

Who may be able to join

Participant is between 6 and 17 (inclusive) years of age at the time of consent
BMI ≥95th percentile
Diagnosis of GERD established prior to 7 days before receipt of study drug dose defined as 1 or more of the following:
clinical symptoms consistent with GERD as determined by the investigator
a diagnosis of erosive esophagitis by endoscopy
esophageal biopsy with histopathology consistent with reflux esophagitis

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abnormal pH-metry consistent with reflux esophagitis
other test result consistent with GERD
Written informed consent from the parent or legally authorized representative/guardian and participant assent per local IRB recommendation of age-appropriate consent and assent requirements

Who cannot join

Use of pantoprazole, lansoprazole, omeprazole, esomeprazole or rabeprazole within 48 hours prior to dose of study drug
Use of fluoxetine, fluvoxamine, ketoconazole, ticlopidine, felbamate, topiramate, valproic acid, phenobarbital, carbamazepine, erythromycin, clarithromycin, grapefruit juice, verapamil, diltiazem, cimetidine, St. John's Wort, rifampin, rifapentine within seven days prior to dose of study drug
Consumption of food after midnight on the day of the baseline visit
Symptomatic asthma
Type I diabetes
History of adverse reaction to PPI

Show all 11Show fewer

Impaired hepatic activity as defined as any of the following: AST ≥150 IU/L, ALT ≥150 IU/L, total bilirubin ≥2.0 mg/dl, or alkaline phosphatase ≥600 IU/L
Serum creatinine ≥2.0 mg/dL
For females of childbearing potential, a positive pregnancy test result
Known infection with hepatitis B, C, or HIV
Any other condition that, in the opinion of the principal investigator, makes participation unadvised or unsafe.

Trial locations and contacts

4 sites in 1 country.

United States4 sites

East Carolina University
Greenville, North Carolina, 27834
Children's Mercy Hospital
Kansas City, Missouri, 64108
University of Arkansas
Little Rock, Arkansas, 72202
University of Utah
Salt Lake City, Utah, 84108

Other trials in United States

About this study

Official title: The Effect of Obesity on the Pharmacokinetics of Pantoprazole in Children and Adolescents

Multicenter, comparative single-dose pharmacokinetic (PK) study

Read the detailed description

Evaluate the pharmacokinetics of pantoprazole in obese children and adolescents with gastroesophageal reflux disease (GERD) following administration of an oral dose of pantoprazole.

Conditions: Gastroesophageal Reflux Disease
Being tested: Pantoprazole
Keywords: obese, children, adolescents, GERD, pharmacokinetic
Medical subject headings: Gastroesophageal Reflux, Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PantoprazoleDrug

Study groups in NCT02186652
Study group	Role	What they receive
Pantoprazole	Other	Not described Receives: Drug: Pantoprazole

What is being measured

The primary outcome is the main question the study is designed to answer.

Pharmacokinetic Analysis in Obese Children After One Single Oral Dose of Pantoprazole (Cmax).
The pharmacokinetic blood samples will be 1.0 ml each and collected at pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, \& 8 hours after receiving one dose of Pantoprazole study drug. For those subjects with the poor metabolizer CYP2C19 genotype, an additional PK sample will be obtained at 12 hours after dosing. Here we report Cmax.
Measured: pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, & 8 hours
Pharmacokinetic Analysis in Obese Children After One Single Oral Dose of Pantoprazole (Tmax).
The pharmacokinetic blood samples will be 1.0 ml each and collected at pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, \& 8 hours after receiving one dose of Pantoprazole study drug. For those subjects with the poor metabolizer CYP2C19 genotype, an additional PK sample will be obtained at 12 hours after dosing. Here we report Tmax.
Measured: pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, & 8 hours
PK Sampling
Total number of fresh plasma samples (all participants)
Measured: Pre-dose (within 30 minutes), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours (±10 minutes) after dosing
Drug Concentration in Plasma Samples
Concentration of panto in plasma and concentration of panto sulfone in plasma
Measured: Pre-dose (within 30 minutes), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours (±10 minutes) after dosing
Pharmacokinetic Analysis in Obese Children After One Single Oral Dose of Pantoprazole (AUC).
The pharmacokinetic blood samples will be 1.0 ml each and collected at pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, \& 8 hours after receiving one dose of Pantoprazole study drug. For those subjects with the poor metabolizer CYP2C19 genotype, an additional PK sample will be obtained at 12 hours after dosing. Here we report AUC TBW.
Measured: pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, & 8 hours
Pharmacokinetic Analysis in Obese Children After One Single Oral Dose of Pantoprazole (AUC).
The pharmacokinetic blood samples will be 1.0 ml each and collected at pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, \& 8 hours after receiving one dose of Pantoprazole study drug. For those subjects with the poor metabolizer CYP2C19 genotype, an additional PK sample will be obtained at 12 hours after dosing. Here we report AUC LBW.
Measured: pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, & 8 hours
Pharmacokinetic Analysis in Obese Children After One Single Oral Dose of Pantoprazole (CL/F).
The pharmacokinetic blood samples will be 1.0 ml each and collected at pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, \& 8 hours after receiving one dose of Pantoprazole study drug. For those subjects with the poor metabolizer CYP2C19 genotype, an additional PK sample will be obtained at 12 hours after dosing. Here we report CL/F TBW.
Measured: pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, & 8 hours
Pharmacokinetic Analysis in Obese Children After One Single Oral Dose of Pantoprazole (Vd/F).
The pharmacokinetic blood samples will be 1.0 ml each and collected at pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, \& 8 hours after receiving one dose of Pantoprazole study drug. For those subjects with the poor metabolizer CYP2C19 genotype, an additional PK sample will be obtained at 12 hours after dosing. Here we report Vd/F TBW.
Measured: pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, & 8 hours
Pharmacokinetic Analysis in Obese Children After One Single Oral Dose of Pantoprazole (Vd/F).
The pharmacokinetic blood samples will be 1.0 ml each and collected at pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, \& 8 hours after receiving one dose of Pantoprazole study drug. For those subjects with the poor metabolizer CYP2C19 genotype, an additional PK sample will be obtained at 12 hours after dosing. Here we report Vd/F LBW.
Measured: pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, & 8 hours

Secondary outcomes (1)

The CYP2C19 Genotype and Its Association With CYP2C19 Phenotype
To examine the association of CYP2C19 genotype and its association with CYP2C19 phenotypes. To characterize the ability of the CYP2C19 genotype to predict pantoprazole plasma clearance, a correlation with CYP2C19 phenotype was explored using both standard linear and nonlinear regression techniques and their respective tests for significance and goodness of fit. In addition, the impact of all covariates on pantoprazole systemic exposure and apparent plasma clearance (e.g., demographic determinants of extent of obesity such as the waist:hip ratio, CYP2C19 genotype, BMI, and REE) was explored using validated population-based PK methods (NONMEM).
Measured: 0, 1, 2, 3, 4, 6, 8, 12 hours post-dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

4 Jun 201413 Sep 2015

First posted10 Jul 2014 (estimated)
Study start4 Jun 2014
Primary completion13 Sep 2015
Study completion13 Sep 2015

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 Gastroesophageal Reflux DiseaseStudies 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: Basic science
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 41 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02186652
Sponsor's protocol ID: Pro00048765
Acronym: PAN01
Status last verified: Sep 2019
First submitted: 3 Jul 2014
Last updated: 17 Sep 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Shakhnovich V, Smith PB, Guptill JT, James LP, Collier DN, Wu H, Livingston CE, Zhao J, Kearns GL; Best Pharmaceuticals for Children Act - Pediatric Trials Network. Obese Children Require Lower Doses of Pantoprazole Than Nonobese Peers to Achieve Equal Systemic Drug Exposures. J Pediatr. 2018 Feb;193:102-108.e1. doi: 10.1016/j.jpeds.2017.10.011.
PubMed 29389444

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
A Study to Evaluate the Efficacy and Safety of Long-term Administration of K-CAB Tab./K-CAB ODT(Tegoprazan) 25 mg as Maintenance Therapy Following the Treatment of GERD
Maintenance Therapy Following Treatment for Gastroesophageal Reflux Disease(GERD)
Active, not recruitingObservational study
RETHINK REFLUX Registry
Gastroesophageal Reflux
RecruitingObservational study
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Recruiting
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All Gastroesophageal Reflux Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Effect of Obesity on the Pharmacokinetics of Pantoprazole in Children and Adolescents
ClinicalTrials.gov ID: NCT02186652
Acronym / sponsor ID: PAN01 / Pro00048765
Conditions: Gastroesophageal Reflux Disease
Keywords: obese, children, adolescents, GERD, pharmacokinetic
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 41 participants (actual)
Lead sponsor: Phillip Brian SmithUniversity, hospital or other
Collaborators: The Emmes Company, LLC
Study start: 4 Jun 2014 (actual)
Primary completion: 13 Sep 2015 (actual)
Study completion: 13 Sep 2015 (actual)
First posted: 10 Jul 2014 (estimated)
Results: Posted 5 Aug 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Multicenter, comparative single-dose pharmacokinetic (PK) study

Detailed description

Evaluate the pharmacokinetics of pantoprazole in obese children and adolescents with gastroesophageal reflux disease (GERD) following administration of an oral dose of pantoprazole.

Study design

Primary purpose: Basic science
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Pantoprazole	Other	Drug: Pantoprazole

Who may qualify

Ages: 6 to 17 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (9 listed)

Participant is between 6 and 17 (inclusive) years of age at the time of consent
BMI ≥95th percentile
Diagnosis of GERD established prior to 7 days before receipt of study drug dose defined as 1 or more of the following:
Written informed consent from the parent or legally authorized representative/guardian and participant assent per local IRB recommendation of age-appropriate consent and assent requirements

Key exclusion criteria (11 listed)

Use of pantoprazole, lansoprazole, omeprazole, esomeprazole or rabeprazole within 48 hours prior to dose of study drug
Use of fluoxetine, fluvoxamine, ketoconazole, ticlopidine, felbamate, topiramate, valproic acid, phenobarbital, carbamazepine, erythromycin, clarithromycin, grapefruit juice, verapamil, diltiazem, cimetidine, St. John's Wort, rifampin, rifapentine within seven days prior to dose of study drug
Consumption of food after midnight on the day of the baseline visit
Symptomatic asthma
Type I diabetes

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
Pantoprazole	Drug	Pantoprazole

Primary outcome

Pharmacokinetic Analysis in Obese Children After One Single Oral Dose of Pantoprazole (Cmax).
Time frame: pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, & 8 hours
The pharmacokinetic blood samples will be 1.0 ml each and collected at pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, \& 8 hours after receiving one dose of Pantoprazole study drug. For those subjects with the poor metabolizer CYP2C19 genotype, an additional PK sample will be obtained at 12 hours after dosing. Here we report Cmax.
Pharmacokinetic Analysis in Obese Children After One Single Oral Dose of Pantoprazole (Tmax).
Time frame: pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, & 8 hours
The pharmacokinetic blood samples will be 1.0 ml each and collected at pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, \& 8 hours after receiving one dose of Pantoprazole study drug. For those subjects with the poor metabolizer CYP2C19 genotype, an additional PK sample will be obtained at 12 hours after dosing. Here we report Tmax.
PK Sampling
Time frame: Pre-dose (within 30 minutes), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours (±10 minutes) after dosing
Total number of fresh plasma samples (all participants)
Drug Concentration in Plasma Samples
Time frame: Pre-dose (within 30 minutes), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours (±10 minutes) after dosing
Concentration of panto in plasma and concentration of panto sulfone in plasma
Pharmacokinetic Analysis in Obese Children After One Single Oral Dose of Pantoprazole (AUC).
Time frame: pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, & 8 hours
The pharmacokinetic blood samples will be 1.0 ml each and collected at pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, \& 8 hours after receiving one dose of Pantoprazole study drug. For those subjects with the poor metabolizer CYP2C19 genotype, an additional PK sample will be obtained at 12 hours after dosing. Here we report AUC TBW.
Pharmacokinetic Analysis in Obese Children After One Single Oral Dose of Pantoprazole (AUC).
Time frame: pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, & 8 hours
The pharmacokinetic blood samples will be 1.0 ml each and collected at pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, \& 8 hours after receiving one dose of Pantoprazole study drug. For those subjects with the poor metabolizer CYP2C19 genotype, an additional PK sample will be obtained at 12 hours after dosing. Here we report AUC LBW.
Pharmacokinetic Analysis in Obese Children After One Single Oral Dose of Pantoprazole (CL/F).
Time frame: pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, & 8 hours
The pharmacokinetic blood samples will be 1.0 ml each and collected at pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, \& 8 hours after receiving one dose of Pantoprazole study drug. For those subjects with the poor metabolizer CYP2C19 genotype, an additional PK sample will be obtained at 12 hours after dosing. Here we report CL/F TBW.
Pharmacokinetic Analysis in Obese Children After One Single Oral Dose of Pantoprazole (Vd/F).
Time frame: pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, & 8 hours
The pharmacokinetic blood samples will be 1.0 ml each and collected at pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, \& 8 hours after receiving one dose of Pantoprazole study drug. For those subjects with the poor metabolizer CYP2C19 genotype, an additional PK sample will be obtained at 12 hours after dosing. Here we report Vd/F TBW.
Pharmacokinetic Analysis in Obese Children After One Single Oral Dose of Pantoprazole (Vd/F).
Time frame: pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, & 8 hours
The pharmacokinetic blood samples will be 1.0 ml each and collected at pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, \& 8 hours after receiving one dose of Pantoprazole study drug. For those subjects with the poor metabolizer CYP2C19 genotype, an additional PK sample will be obtained at 12 hours after dosing. Here we report Vd/F LBW.

1 secondary outcome

The CYP2C19 Genotype and Its Association With CYP2C19 Phenotype
Time frame: 0, 1, 2, 3, 4, 6, 8, 12 hours post-dose

Results and safety

Results posted to the registry on 5 Aug 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Pantoprazole 6-11 Year Old	19	17
Pantoprazole 12-17 Year Old	22	22

Primary outcome: Pharmacokinetic Analysis in Obese Children After One Single Oral Dose of Pantoprazole (Cmax).

Time frame: pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, & 8 hours. Mean (Standard Deviation). Unit: mcg/ml

Measure	Pantoprazole 6-11 Year Old n = 18	Pantoprazole 12-17 Year Old n = 21
Value	4.27 (1.43)	4.1 (1.18)

Population analysed: All participants with evaluable data.

Primary outcome: Pharmacokinetic Analysis in Obese Children After One Single Oral Dose of Pantoprazole (Tmax).

Time frame: pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, & 8 hours. Median (Full Range). Unit: hours

Measure	Pantoprazole 6-11 Year Old n = 18	Pantoprazole 12-17 Year Old n = 21
Value	2.3 (1.5 to 3)	2.5 (1.5 to 8)

Population analysed: All participants with evaluable data.

Primary outcome: PK Sampling

Time frame: Pre-dose (within 30 minutes), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours (±10 minutes) after dosing. Mean (Standard Deviation). Unit: Plasma samples

Measure	Pantoprazole 6-11 Year Old n = 19	Pantoprazole 12-17 Year Old n = 22
Value	11 (2)	11 (2)

Population analysed: All participants with evaluable data

Primary outcome: Drug Concentration in Plasma Samples

Time frame: Pre-dose (within 30 minutes), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours (±10 minutes) after dosing. Mean (Standard Deviation). Unit: ng/ml

Measure	Pantoprazole 6-11 Year Old n = 19	Pantoprazole 12-17 Year Old n = 22
Pantoprazole	1558 (1584.6)	1626.1 (1545.2)
Pantoprazole Sulfone	94.7 (49.1)	88.7 (36.8)

Population analysed: All participants with evaluable data

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Adverse events were followed up to 10 days post study dose.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
6-11 Year Old Adverse Events	0 of 19 (0%)	1 of 19 (5.3%)	0 of 19
12-17 Year Old Adverse Events	0 of 22 (0%)	6 of 22 (27.3%)	0 of 22

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 29389444Shakhnovich V, Smith PB, Guptill JT, James LP, Collier DN, Wu H, Livingston CE, Zhao J, Kearns GL; Best Pharmaceuticals for Children Act - Pediatric Trials Network. Obese Children Require Lower Doses of Pantoprazole Than Nonobese Peers to Achieve Equal Systemic Drug Exposures. J Pediatr. 2018 Feb;193:102-108.e1. doi: 10.1016/j.jpeds.2017.10.011.

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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.

Phillip B Smith, MD principal investigator

Duke Clinical Research Institute

4 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Pantoprazole in people with Gastroesophageal Reflux Disease, run by Phillip Brian Smith at 4 sites in United States.

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 9 inclusion and 11 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 17 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. 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 5 Aug 2019). 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?

Pharmacokinetic Analysis in Obese Children After One Single Oral Dose of Pantoprazole (Cmax). (time frame: pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, & 8 hours). The study lists 9 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 NCT02186652, 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 17 Sep 2019; AzTrials last refreshed its copy on 7 Nov 2026.