Document Detail


Clinical results from a randomized, double-blind, dose-ranging study of pantoprazole in children aged 1 through 5 years with symptomatic histologic or erosive esophagitis.
MedLine Citation:
PMID:  20522615     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
In an 8-week, multicenter, randomized, double-blind study, we evaluated the efficacy and tolerability of pantoprazole (0.3mg/kg [low dose (LD)], 0.6 mg/kg [medium dose (MD)], and 1.2 mg/kg [high dose (HD)]) for delayed-release oral suspension (granules) in patients 1 to 5 years with documented symptoms of gastroesophageal reflux disease (GERD) and endoscopic evidence of reflux-related erosive esophagitis (EE) or histologic esophagitis (HE) consistent with GERD. Patients with HE were randomly assigned to LD, MD, or HD, and patients with EE, to MD or HD. A daily eDiary captured 5 individual GERD symptoms. A total of 60 patients (56 HE, 4 EE) were randomized. Mean weekly GERD symptom score (WGSS, sum of weekly mean frequency scores for 5 individual GERD symptoms) for the modified intention-to-treat HE population at the final week was improved with LD ( P < .001), MD (P = .063), and HD (P < 0.001) (paired t-tests). Patients with EE were healed at week 8. Adverse event incidences did not increase with dose.
Authors:
Robert Baker; V Marc Tsou; John Tung; Susan Sestini Baker; Huihua Li; Wenjin Wang; Natalie Rath; Mary K Maguire; Gail M Comer
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Publication Detail:
Type:  Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't     Date:  2010-06-03
Journal Detail:
Title:  Clinical pediatrics     Volume:  49     ISSN:  1938-2707     ISO Abbreviation:  Clin Pediatr (Phila)     Publication Date:  2010 Sep 
Date Detail:
Created Date:  2010-08-09     Completed Date:  2011-03-30     Revised Date:  2013-06-04    
Medline Journal Info:
Nlm Unique ID:  0372606     Medline TA:  Clin Pediatr (Phila)     Country:  United States    
Other Details:
Languages:  eng     Pagination:  852-65     Citation Subset:  AIM; IM    
Affiliation:
Women and Children's Hospital of Buffalo, Buffalo, NY, USA.
Data Bank Information
Bank Name/Acc. No.:
ClinicalTrials.gov/NCT00300755
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MeSH Terms
Descriptor/Qualifier:
2-Pyridinylmethylsulfinylbenzimidazoles / administration & dosage,  adverse effects,  therapeutic use*
Biopsy
Canada
Child
Child, Preschool
Delayed-Action Preparations / administration & dosage,  adverse effects,  therapeutic use
Dose-Response Relationship, Drug
Double-Blind Method
Esophagitis, Peptic / drug therapy*,  pathology
Esophagoscopy
Female
Gastroesophageal Reflux / drug therapy*
Humans
Infant
Male
Medical Records
Proton Pump Inhibitors / administration & dosage,  adverse effects,  therapeutic use*
Questionnaires
Treatment Outcome
United States
Chemical
Reg. No./Substance:
0/2-Pyridinylmethylsulfinylbenzimidazoles; 0/Delayed-Action Preparations; 0/Proton Pump Inhibitors; D8TST4O562/pantoprazole

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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