Adults 6 to 17, any sex, with Gastroesophageal Reflux Disease. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Pharmacokinetic Analysis in Obese Children After One Single Oral Dose of Pantoprazole (Cmax).Primary· 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.
Group
Value
95% CI
Pantoprazole 6-11 Year Old
4.27
± 1.43
Pantoprazole 12-17 Year Old
4.1
± 1.18
Pharmacokinetic Analysis in Obese Children After One Single Oral Dose of Pantoprazole (Tmax).Primary· 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.
Total number of fresh plasma samples (all participants)
Group
Value
95% CI
Pantoprazole 6-11 Year Old
11
± 2
Pantoprazole 12-17 Year Old
11
± 2
Drug Concentration in Plasma SamplesPrimary· 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
Pantoprazole
Group
Value
95% CI
Pantoprazole 6-11 Year Old
1558
± 1584.6
Pantoprazole 12-17 Year Old
1626.1
± 1545.2
Pantoprazole Sulfone
Group
Value
95% CI
Pantoprazole 6-11 Year Old
94.7
± 49.1
Pantoprazole 12-17 Year Old
88.7
± 36.8
Pharmacokinetic Analysis in Obese Children After One Single Oral Dose of Pantoprazole (AUC).Primary· 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.
Group
Value
95% CI
Pantoprazole 6-11 Year Old
8.87
± 4.00
Pantoprazole 12-17 Year Old
11.56
± 4.81
Pharmacokinetic Analysis in Obese Children After One Single Oral Dose of Pantoprazole (AUC).Primary· 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.
Group
Value
95% CI
Pantoprazole 6-11 Year Old
5.73
± 2.48
Pantoprazole 12-17 Year Old
6.82
± 2.70
Pharmacokinetic Analysis in Obese Children After One Single Oral Dose of Pantoprazole (CL/F).Primary· 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.
Group
Value
95% CI
Pantoprazole 6-11 Year Old
0.14
± 0.07
Pantoprazole 12-17 Year Old
0.10
± 0.04
Pharmacokinetic Analysis in Obese Children After One Single Oral Dose of Pantoprazole (Vd/F).Primary· 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.
Group
Value
95% CI
Pantoprazole 6-11 Year Old
0.16
± 0.05
Pantoprazole 12-17 Year Old
0.14
± 0.04
Pharmacokinetic Analysis in Obese Children After One Single Oral Dose of Pantoprazole (Vd/F).Primary· 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.
Group
Value
95% CI
Pantoprazole 6-11 Year Old
0.25
± 0.09
Pantoprazole 12-17 Year Old
0.25
± 0.07
The CYP2C19 Genotype and Its Association With CYP2C19 PhenotypeSecondary· 0, 1, 2, 3, 4, 6, 8, 12 hours post-dose
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 usi
Group
Value
95% CI
*2*2 Allele
1.29
NA – NA
*1/*2 Allele
6.00
2.64 – 11.62
*1/*1 Allele or *1/*17 Allele
8.97
4.66 – 16.71
Adverse events — posted to ClinicalTrials.gov
Time frame: Adverse events were followed up to 10 days post study dose..
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Phillip Brian Smith
Last refreshed: 17 September 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02186652.