Trial reportJournal of clinical pharmacology2011
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.
Trial report in Journal of clinical pharmacology, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 19 papers, 2 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
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
19 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- Pharmacological treatment of gastro-oesophageal reflux in children.The Cochrane database of systematic reviews · 2023Pooled it
- Pharmacological treatment of children with gastro-oesophageal reflux.The Cochrane database of systematic reviews · 2014Pooled it
- Evaluation of a pantoprazole and 4-desmethylpantoprazole-sulfate metabolic ratio as a novel CYP2C19 phenotyping method.British journal of clinical pharmacology · 2026Trial
- Utility of theClinical and translational science · 2022Trial
- Obese Children Require Lower Doses of Pantoprazole Than Nonobese Peers to Achieve Equal Systemic Drug Exposures.The Journal of pediatrics · 2018Trial
- Safety of intravenous pantoprazole sodium in paediatric patients aged 1 year to <2 years: a real-world retrospective cohort study in the USA.BMJ paediatrics open · 2026Article
- Physiologically-based pharmacokinetic modeling of pantoprazole to evaluate the role of CYP2C19 genetic variation and obesity in the pediatric population.CPT: pharmacometrics & systems pharmacology · 2024Article
- Safety of Intravenous Pantoprazole Sodium in Pediatric Patients Aged 1 Month to < 1 Year: A Real-World Retrospective Cohort Study.Therapeutic innovation & regulatory science · 2024Article
- Metabolomic profiling of extraesophageal reflux disease in children.Clinical and translational science · 2021Observational
- Assessing CYP2C19 Ontogeny in Neonates and Infants Using Physiologically Based Pharmacokinetic Models: Impact of Enzyme Maturation Versus Inhibition.CPT: pharmacometrics & systems pharmacology · 2019Article
- A Population-Based Pharmacokinetic Model Approach to Pantoprazole Dosing for Obese Children and Adolescents.Paediatric drugs · 2018Article
- Reply.The Journal of pediatrics · 2018Article
- Proton pump inhibitors: from CYP2C19 pharmacogenetics to precision medicine.Expert opinion on drug metabolism & toxicology · 2018Review
- A randomized, crossover pharmacodynamic study of immediate-release omeprazole/sodium bicarbonate and delayed-release lansoprazole in healthy adult volunteers.Pharmacology research & perspectives · 2016Article
- Adverse effects reported in the use of gastroesophageal reflux disease treatments in children: a 10 years literature review.British journal of clinical pharmacology · 2015Review
- Proton pump inhibitors in pediatrics : mechanism of action, pharmacokinetics, pharmacogenetics, and pharmacodynamics.Paediatric drugs · 2013Review
- Effect of proton pump inhibition on acid, weakly acid and weakly alkaline gastro-esophageal reflux in children.World journal of pediatrics : WJP · 2013Article
- Gastroesophageal reflux disease in children and adolescents: when and how to treat.Paediatric drugs · 2012Review
- Development of biomarkers to optimize pediatric patient management: what makes children different?Biomarkers in medicine · 2011Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
11 authors.
Funding
Abstract
Children with gastroesophageal reflux disease (GERD) may benefit from gastric acid suppression with proton pump inhibitors such as pantoprazole. Effective treatment with pantoprazole requires correct dosing and understanding of the drug's kinetic profile in children. The aim of these studies was to characterize the pharmacokinetic (PK) profile of single and multiple doses of pantoprazole delayed-release tablets in pediatric patients with GERD aged 6 to 11 years (study 1) and 12 to 16 years (study 2). Patients were randomly assigned to receive pantoprazole 20 or 40 mg once daily. Plasma pantoprazole concentrations were obtained at intervals through 12 hours after the single dose and at 2 and 4 hours after multiple doses for PK evaluation. PK parameters were derived by standard noncompartmental methods and examined as a function of both drug dose and patient age. Safety was also monitored. Pantoprazole PK was dose independent (when dose normalized) and similar to PK reported from adult studies. There was no evidence of accumulation with multiple dosing or reports of serious drug-associated adverse events. In children aged 6 to 16 years with GERD, currently available pantoprazole delayed-release tablets can be used to provide systemic exposure similar to that in adults.
Indexed as
Identifiers
What OpenQuestion holds
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.