Title: Multicenter, randomized, double-blind study comparing 20 and 40 mg of pantoprazole for symptom relief in adolescents (12 to 16 years of age) with gastroesophageal reflux disease (GERD) Authors
|Tsou, Marc - NORFOLK, VA|
|Baker, Robert - UNIVERSITY OF UTAH|
|Book, Linda - UNIVERSITY OF UTAH|
|Hammo, Abdel-Hai - RHODE ISLAND HOSPITAL|
|Soffer, Elaine - WYETH RESEARCH|
|Wang, Wenjin - WYETH RESEARCH|
|Comer, Gail - WYETH RESEARCH|
Submitted to: Journal of Clinical Pediatrics
Publication Type: Peer Reviewed Journal
Publication Acceptance Date: March 25, 2006
Publication Date: August 13, 2006
Citation: Tsou, M.V., Baker, R., Book, L., Hammo, A., Soffer, E.F., Wang, W., Comer, G.M., Members of the 326 Study Group. 2006. Multicenter, randomized, double-blind study comparing 20 and 40 mg of pantoprazole for symptom relief in adolescents (12 to 16 years of age) with Gastroesophageal Reflux Disease (GERD). Clinical Pediatrics. 45(8):741-749. Interpretive Summary: Acid reflux (heartburn) is common in children and can adversely impact their nutritional intake. The objective of this study was to compare the effectiveness of two dose levels of an acid stomach blocker in reducing the symptoms of acid reflux in children. Both dosage levels significantly improved the children's symptoms, were well tolerated, and appeared to be safe. Thus, this medicine can be used in children for this common condition that affects children's nutrition.
Technical Abstract: An age-appropriate questionnaire (GASP-Q) was used to assess the frequency and severity of the gastroesophageal reflux disease (GERD) symptoms: abdominal/belly pain, chest pain/heartburn, pain after eating, nausea, burping/belching, vomiting/regurgitation, choking when eating, and difficulty swallowing, in adolescents age 12 to 16 years. The primary objective was to compare the mean composite symptom score (CSS) at week 8 with baseline after treatment with 20 or 40 mg of pantoprazole. Statistically significant (p < 0.001) improvement in CSS occurred in both groups. Safety was comparable between the 2 groups. Pantoprazole was safe, well tolerated, and effective in reducing symptoms of GERD in adolescents.