Trial reportBMC pediatrics2010
Esomeprazole for the treatment of erosive esophagitis in children: an international, multicenter, randomized, parallel-group, double-blind (for dose) study.
Trial report in BMC pediatrics, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00228527 (A Phase III, Multicentre, Randomized, Double-blind Parallel-group Study to Evaluate the Safety and Clinical Outcome of Once Daily Esomeprazole for the Treatment of Gastroesophageal Reflux Disease), which is not on this map. Cited by 7 papers, 2 of them syntheses 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.
A Phase III, Multicentre, Randomized, Double-blind Parallel-group Study to Evaluate the Safety and Clinical Outcome of Once Daily Esomeprazole for the Treatment of Gastroesophageal Reflux Disease (GERD) in Pediatric Patients 1 to 11 Years of Age, Inclusive.
Who cites it
7 citing papers in PubMed, 2 syntheses or guidelines pooled it, 31 citations in OpenAlex.
- 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
- Proton Pump Inhibitors in Pediatric Gastroesophageal Reflux Disease: A Systematic Review of Randomized Controlled Trials.Children (Basel, Switzerland) · 2024Review
- Adverse effects reported in the use of gastroesophageal reflux disease treatments in children: a 10 years literature review.British journal of clinical pharmacology · 2015Review
- Gastro-esophageal reflux disease in healthy older children and adolescents.Pediatric gastroenterology, hepatology & nutrition · 2012Review
- Clinical utility of esomeprazole for treatment of gastroesophageal reflux disease in pediatric and adolescent patients.Adolescent health, medicine and therapeutics · 2012Review
- Proton Pump Inhibitors Interfere With Zinc Absorption and Zinc Body Stores.Gastroenterology research · 2011Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors at 4 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundAcid suppression with a proton pump inhibitor is standard treatment for gastroesophageal reflux disease and erosive esophagitis in adults and increasingly is becoming first-line therapy for children aged 1-17 years. We evaluated endoscopic healing of erosive esophagitis with esomeprazole in young children with gastroesophageal reflux disease and described esophageal histology.
methodsChildren aged 1-11 years with endoscopically or histologically confirmed gastroesophageal reflux disease were randomized to esomeprazole 5 or 10 mg daily (< 20 kg) or 10 or 20 mg daily (> or = 20 kg) for 8 weeks. Patients with erosive esophagitis underwent an endoscopy after 8 weeks to assess healing of erosions.
resultsOf 109 patients, 49% had erosive esophagitis and 51% had histologic evidence of reflux esophagitis without erosive esophagitis. Of the 45 patients who had erosive esophagitis and underwent follow-up endoscopy, 89% experienced erosion resolution. Dilation of intercellular space was reported in 24% of patients with histologic examination.
conclusionsEsomeprazole (0.2-1.0 mg/kg) effectively heals macroscopic and microscopic erosive esophagitis in this pediatric population with gastroesophageal reflux disease. Dilation of intercellular space may be an important histologic marker of erosive esophagitis in children.
trial registrationD9614C00097; ClinicalTrials.gov identifier NCT00228527.
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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.