Trial reportEuropean journal of clinical pharmacology2010
Single-dose, multiple-dose, and population pharmacokinetics of pantoprazole in neonates and preterm infants with a clinical diagnosis of gastroesophageal reflux disease (GERD).
Trial report in European journal of clinical pharmacology, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 35 papers, 1 of them a synthesis that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
35 citing papers in PubMed, 1 synthesis or guideline pooled it, 65 citations in OpenAlex.
- Safety and efficacy of proton pump inhibitors in preterm infants with gastroesophageal reflux disease.The Cochrane database of systematic reviews · 2025Pooled it
- GERD management in neonatal ICU infants: study protocol for a randomized controlled trial comparing maturation, added rice starch formula and proton pump inhibitors.BMC pediatrics · 2026Trial
- Novel Implementation of Genotype-Guided Proton Pump Inhibitor Medication Therapy in Children: A Pilot, Randomized, Multisite Pragmatic Trial.Clinical and translational science · 2019Trial
- Developmental pharmacogenetics of CYP2C19 in neonates and young infants: omeprazole as a probe drug.British journal of clinical pharmacology · 2018Trial
- Safety, pharmacokinetics, and pharmacodynamics of S-(-)-pantoprazole sodium injections after single and multiple intravenous doses in healthy Chinese subjects.European journal of clinical pharmacology · 2018Trial
- A multicenter, randomized, open-label, pharmacokinetics and safety study of pantoprazole tablets in children and adolescents aged 6 through 16 years with gastroesophageal reflux disease.Journal of clinical pharmacology · 2011Trial
- Developmental age and clinical illness driveFrontiers in pharmacology · 2026Article
- Challenges of pediatric pharmacotherapy: A narrative review of pharmacokinetics, pharmacodynamics, and pharmacogenetics.European journal of clinical pharmacology · 2024Review
- Safety of Proton Pump Inhibitors in Pediatric Population: A Systematic Review.Global pediatric health · 2024Review
- Impact of Pharmacogenomics in Clinical Practice.Pharmaceuticals (Basel, Switzerland) · 2023Review
- A Review of Histamine-2 Receptor Antagonist and Proton Pump Inhibitor Therapy for Gastroesophageal Reflux Disease in Neonates and Infants.Paediatric drugs · 2023Review
- Correlation analysis and prognostic value of miR-29a-3p expression and CYP2C19 genotypes in exfoliated cells from tongue coating of patients with gastroesophageal reflux disease.Genes & genomics · 2023Article
- Advancing Precision Medicine in Paediatrics: Past, present and future.Cambridge prisms. Precision medicine · 2023Review
- Practice of CYP450 genotyping and phenotyping in children in a real-life setting.Frontiers in pharmacology · 2023Article
- Pharmacogenetic Expression of CYP2C19 in a Pediatric Population.Journal of personalized medicine · 2022Review
- Perspectives from the Society for Pediatric Research: pharmacogenetics for pediatricians.Pediatric research · 2022Review
- The Impact of Pharmacogenetics on Pharmacokinetics and Pharmacodynamics in Neonates and Infants: A Systematic Review.Pharmacogenomics and personalized medicine · 2022Review
- The Blind Spot of Pharmacology: A Scoping Review of Drug Metabolism in Prematurely Born Children.Frontiers in pharmacology · 2022Article
- Pharmacogenomics for Drug Dosing in Children: Current Use, Knowledge, and Gaps.Journal of clinical pharmacology · 2021Article
- Therapeutic Drug Monitoring Is a Feasible Tool to Personalize Drug Administration in Neonates Using New Techniques: An Overview on the Pharmacokinetics and Pharmacodynamics in Neonatal Age.International journal of molecular sciences · 2020Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
8 authors at 4 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeThe pharmacokinetic profile of pantoprazole granules was assessed in neonates and preterm infants with gastroesophageal reflux disease (GERD) in a multicenter, randomized, open-label trial.
methodsPatients were randomly assigned to either the pantoprazole 1.25 mg (approx. 0.6 mg/kg) or 2.5 mg (approx. 1.2-mg/kg) group and treated for > or =5 consecutive days. Blood was sampled either at 0, 2, 8, and 18 h postdose or at 0, 1, 4, and 12 h postdose on day 1 and at 3 and 6 h postdose after > or =5 consecutive doses. Cytochrome P450 2C19 (CYP2C19) and CYP3A4 genotypes were determined. Safety was monitored. Population pharmacokinetics (popPK) analyses were conducted using nonlinear mixed-effects modeling.
resultsThe popPK modeling of the pantoprazole 1.25 mg and 2.5 mg groups obtained mean (+/-standard deviation) estimates for the area under the plasma concentration versus time curve (AUC) of 3.54 (+/-2.82) and 7.27 (+/-5.30) microg h/mL, respectively, and mean estimates for half-life of 3.1 (+/-1.5) and 2.7 (+/-1.1) h, respectively. Pantoprazole did not accumulate following multiple-dose administration. The two patients with the CYP2C19 poor metabolizer genotype had a substantially higher AUC than extensive metabolizers. No safety-related discontinuations occurred.
conclusionsIn preterm infants and neonates, pantoprazole granules were generally well tolerated, mean exposures with pantoprazole 2.5 mg were slightly higher than that in adults who received 40 mg. While the half-life was longer, accumulation did not occur.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.