Multicenter, randomized, double-blind study comparing 10, 20 and 40 mg pantoprazole in children (5-11 years) with...

Area of Science:

• Pediatric Gastroenterology
• Pharmacology
• Clinical Therapeutics

Background:

• Gastroesophageal reflux disease (GERD) is a common condition in children, causing significant discomfort and impacting quality of life.
• Endoscopic confirmation of GERD is crucial for accurate diagnosis and appropriate treatment selection.
• Proton pump inhibitors like pantoprazole are frequently used to manage GERD symptoms.

Purpose of the Study:

• To assess the efficacy of pantoprazole in improving GERD symptoms in pediatric patients.
• To compare the effectiveness of different pantoprazole dosages (10, 20, and 40 mg) in children aged 5-11 years.
• To evaluate symptom reduction using the GERD Assessment of Symptoms in Pediatrics Questionnaire.

Main Methods:

• A study involving 53 children with endoscopically proven GERD.
• Treatment with pantoprazole at doses of 10, 20, or 40 mg for 8 weeks.
• Symptom assessment using the GERD Assessment of Symptoms in Pediatrics Questionnaire, measuring frequency and severity of various GERD-related symptoms.

Main Results:

• Significant decreases in the frequency and severity of all assessed GERD symptoms were observed over the 8-week study period.
• Pantoprazole treatment led to significant reductions in the composite symptom score (CSS) at week 8 compared to baseline across all dosage groups.
• The 20 mg and 40 mg doses of pantoprazole demonstrated significantly greater effectiveness in improving GERD symptoms by week 1 compared to the 10 mg dose.

Conclusions:

• Pantoprazole, particularly at 20 mg and 40 mg doses, is an effective treatment for reducing GERD symptoms in children with endoscopically confirmed disease.
• Symptomatic improvement was noted as early as one week of treatment with 20 mg and 40 mg pantoprazole.
• Adverse events were comparable across all treatment groups, suggesting a favorable safety profile.