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).
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.
Tsou
V Marc
VM
Children's Hospital of The King's Daughter, Norfolk, VA, USA
Baker
Robert
R
Book
Linda
L
Hammo
Abdel-Hai
AH
Soffer
Elaine F
EF
Wang
Wenjin
W
Comer
Gail M
GM
D053799:2-Pyridinylmethylsulfinylbenzimidazoles / Q000008:administration & dosage / Q000627:therapeutic use*; D000293:Adolescent; D000536:Aluminum Hydroxide; D000863:Antacids; D000897:Anti-Ulcer Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D002648:Child; D004311:Double-Blind Method; D004338:Drug Combinations; D005260:Female; D005764:Gastroesophageal Reflux / Q000188:drug therapy*; D006801:Humans; D008276:Magnesium Hydroxide; D008297:Male; D000077402:Pantoprazole; D012841:Simethicone; D011795:Surveys and Questionnaires
D053799:2-Pyridinylmethylsulfinylbenzimidazoles; D000863:Antacids; D000897:Anti-Ulcer Agents; D004338:Drug Combinations; C008570:aluminum hydroxide, magnesium hydroxide, simethicone drug combination; D000536:Aluminum Hydroxide; D012841:Simethicone; D000077402:Pantoprazole; D008276:Magnesium Hydroxide