ArticleEuropean journal of clinical pharmacology2009
Off-label use of medicines in children: can available evidence avoid useless paediatric trials? The case of proton pump inhibitors for the treatment of gastroesophageal reflux disease.
Article in European journal of clinical pharmacology, 2009. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 18 papers.
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.
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Who cites it
18 citing papers in PubMed, 50 citations in OpenAlex.
- Developmental pharmacogenetics of CYP2C19 in neonates and young infants: omeprazole as a probe drug.British journal of clinical pharmacology · 2018Trial
- Prenatal and Early Childhood Exposure to Antibiotics or Gastric Acid Inhibitors and Increased Risk of Epilepsy: A Nationwide Population-Based Study.Clinical pharmacology and therapeutics · 2025Article
- Prenatal and Early Childhood Exposure to Proton Pump Inhibitors and Antibiotics and the Risk of Childhood Cancer: A Nationwide Population-Based Cohort Study.Drug safety · 2025Article
- Trends in Proton Pump Inhibitor Use in Sweden by Sex and Age: A Drug Utilisation Study.Drug safety · 2025Article
- Guidelines for proton pump inhibitor prescriptions in paediatric intensive care unit.International journal of clinical pharmacy · 2017Observational
- Failure of proton pump inhibitors to treat GERD in neonates and infants: a question of drug, diagnosis, or design.Clinical pharmacology and therapeutics · 2012Review
- Unlicensed and off-label drug use in hospitalized children in Croatia: a cross-sectional survey.European journal of clinical pharmacology · 2012Article
- Clinical utility of esomeprazole for treatment of gastroesophageal reflux disease in pediatric and adolescent patients.Adolescent health, medicine and therapeutics · 2012Review
- Drug utilisation pattern and off-label use of medicines in Estonian neonatal units.European journal of clinical pharmacology · 2011Article
- Predictive performance of a recently developed population pharmacokinetic model for morphine and its metabolites in new datasets of (preterm) neonates, infants and children.Clinical pharmacokinetics · 2011Article
- Management of gastroesophageal reflux disease and erosive esophagitis in pediatric patients: focus on delayed-release esomeprazole.Therapeutics and clinical risk management · 2010Article
- Off-label antibiotic use in children in three European countries.European journal of clinical pharmacology · 2010Article
- Impact of the CYP2C19*17 allele on the pharmacokinetics of omeprazole and pantoprazole in children: evidence for a differential effect.Drug metabolism and disposition: the biological fate of chemicals · 2010Article
- Can we get the necessary clinical trials in children and avoid the unnecessary ones?European journal of clinical pharmacology · 2009Article
- Knowledge of developmental pharmacology and modeling approaches should be used to avoid useless trials in children.European journal of clinical pharmacology · 2009Article
- Off-label use of medicines in children: can available evidence avoid useless paediatric trials? The case of proton pump inhibitors for the treatment of gastroesophageal reflux disease.European journal of clinical pharmacology · 2009Article
- Pantoprazole: a proton pump inhibitor.Clinical drug investigation · 2009Review
- Prevalence and nature of off-label antibiotic prescribing for children in a tertiary setting: A descriptive study from Jordan.Pharmacy practiceArticle
Corrections and comments
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Authors and funding
6 authors at 4 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeIn some cases of drug therapy, the available evidence might be sufficient to extend the indications to children without further clinical studies.
methodsWe reviewed the available evidence for one of the categories of drugs most frequently used off-label in children: proton pump inhibitors (PPIs) used for the treatment of gastroesophageal reflux disease (GERD). A classification of the appropriateness of off-label use of PPIs in children with GERD was also performed.
resultsOf the five PPIs evaluated, only omeprazole has a paediatric indication in Europe. Overall, 19 clinical trials were retrieved and evaluated on the basis of pharmacokinetics, efficacy and safety data. The off-label use of omeprazole, esomeprazole and lansoprazole in children was evaluated as appropriate given the consistent available evidence retrieved in literature.
conclusionThis study demonstrates the existence of a large body of clinical evidence on the use of PPIs in children. Regulatory agencies and ethical committees should cope with this issue for ethical reasons to avoid unnecessary trial replication.
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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.