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

Vasundhara Tolia, Phyllis R. Bishop, V. Marc Tsou, David Gremse, Elaine F. Soffer, Gail M. Comer, P. Bishop, J. Blumer, R. Colletti, Y. Elitsur, D. Gremse, T. Gunasekaran, Sandeep Gupta, A. H. Hammo, J. F. Pohl, V. Tolia, V. M. Tsou, H. Winter

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Abstract

Objective: To evaluate symptom improvement in 53 children (aged 5-11 years) with endoscopically proven gastroesophageal reflux disease (GERD) treated with pantoprazole (10, 20 and 40 mg) using the GERD Assessment of Symptoms in Pediatrics Questionnaire. Methods: The GERD Assessment of Symptoms in Pediatrics Questionnaire was used to measure the frequency and severity over the previous 7 days of abdominal/belly pain, chest pain/ heartburn, difficulty swallowing, nausea, vomiting/regurgitation, burping/belching, choking when eating and pain after eating. Individual symptom scores were based on the product of the frequency and usual severity of each symptom. The sum of the individual symptom score values made up the composite symptom score (CSS). The primary end point was the change in the mean CSS from baseline to week 8. Results: Mean frequency and severity of each symptom significantly decreased (from P < 0.006 to P < 0.001) over time. Similar significant decreases in CSS at week 8 versus baseline (P < 0.001) were seen in all groups. Significant decreases from baseline in CSS were noted from weeks 1 to 8 in the 20-mg (P < 0.003) and 40-mg (P < 0.001) groups. The 20- and 40-mg doses were significantly (P < 0.05) more effective than the 10-mg dose in improving GERD symptoms at week 1. Adverse events were similar among the treatment groups. Conclusions: Pantoprazole (20 and 40 mg) is effective in reducing endoscopically proven GERD symptoms in children. Both 20 and 40 mg pantoprazole significantly reduced symptoms as early as 1 week.

Original languageEnglish
Pages (from-to)384-391
Number of pages8
JournalJournal of Pediatric Gastroenterology and Nutrition
Volume42
Issue number4
DOIs
StatePublished - Apr 2006

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gastroesophageal reflux
Gastroesophageal Reflux
Double-Blind Method
signs and symptoms (animals and humans)
Symptom Assessment
Eating
Eructation
Pediatrics
Heartburn
Airway Obstruction
Deglutition
Chest Pain
Nausea
Abdominal Pain
pain
Vomiting
pantoprazole
Pain
questionnaires
ingestion

Keywords

  • GERD
  • Pediatrics
  • PPIs
  • Symptoms

ASJC Scopus subject areas

  • Gastroenterology
  • Histology
  • Medicine (miscellaneous)
  • Food Science
  • Pediatrics, Perinatology, and Child Health

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Multicenter, randomized, double-blind study comparing 10, 20 and 40 mg pantoprazole in children (5-11 years) with symptomatic gastroesophageal reflux disease. / Tolia, Vasundhara; Bishop, Phyllis R.; Tsou, V. Marc; Gremse, David; Soffer, Elaine F.; Comer, Gail M.; Bishop, P.; Blumer, J.; Colletti, R.; Elitsur, Y.; Gremse, D.; Gunasekaran, T.; Gupta, Sandeep; Hammo, A. H.; Pohl, J. F.; Tolia, V.; Tsou, V. M.; Winter, H.

In: Journal of Pediatric Gastroenterology and Nutrition, Vol. 42, No. 4, 04.2006, p. 384-391.

Research output: Contribution to journalArticle

Tolia, V, Bishop, PR, Tsou, VM, Gremse, D, Soffer, EF, Comer, GM, Bishop, P, Blumer, J, Colletti, R, Elitsur, Y, Gremse, D, Gunasekaran, T, Gupta, S, Hammo, AH, Pohl, JF, Tolia, V, Tsou, VM & Winter, H 2006, 'Multicenter, randomized, double-blind study comparing 10, 20 and 40 mg pantoprazole in children (5-11 years) with symptomatic gastroesophageal reflux disease', Journal of Pediatric Gastroenterology and Nutrition, vol. 42, no. 4, pp. 384-391. https://doi.org/10.1097/01.mpg.0000214160.37574.d3
Tolia, Vasundhara ; Bishop, Phyllis R. ; Tsou, V. Marc ; Gremse, David ; Soffer, Elaine F. ; Comer, Gail M. ; Bishop, P. ; Blumer, J. ; Colletti, R. ; Elitsur, Y. ; Gremse, D. ; Gunasekaran, T. ; Gupta, Sandeep ; Hammo, A. H. ; Pohl, J. F. ; Tolia, V. ; Tsou, V. M. ; Winter, H. / Multicenter, randomized, double-blind study comparing 10, 20 and 40 mg pantoprazole in children (5-11 years) with symptomatic gastroesophageal reflux disease. In: Journal of Pediatric Gastroenterology and Nutrition. 2006 ; Vol. 42, No. 4. pp. 384-391.
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AU - Bishop, Phyllis R.

AU - Tsou, V. Marc

AU - Gremse, David

AU - Soffer, Elaine F.

AU - Comer, Gail M.

AU - Bishop, P.

AU - Blumer, J.

AU - Colletti, R.

AU - Elitsur, Y.

AU - Gremse, D.

AU - Gunasekaran, T.

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AU - Hammo, A. H.

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AU - Tsou, V. M.

AU - Winter, H.

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N2 - Objective: To evaluate symptom improvement in 53 children (aged 5-11 years) with endoscopically proven gastroesophageal reflux disease (GERD) treated with pantoprazole (10, 20 and 40 mg) using the GERD Assessment of Symptoms in Pediatrics Questionnaire. Methods: The GERD Assessment of Symptoms in Pediatrics Questionnaire was used to measure the frequency and severity over the previous 7 days of abdominal/belly pain, chest pain/ heartburn, difficulty swallowing, nausea, vomiting/regurgitation, burping/belching, choking when eating and pain after eating. Individual symptom scores were based on the product of the frequency and usual severity of each symptom. The sum of the individual symptom score values made up the composite symptom score (CSS). The primary end point was the change in the mean CSS from baseline to week 8. Results: Mean frequency and severity of each symptom significantly decreased (from P < 0.006 to P < 0.001) over time. Similar significant decreases in CSS at week 8 versus baseline (P < 0.001) were seen in all groups. Significant decreases from baseline in CSS were noted from weeks 1 to 8 in the 20-mg (P < 0.003) and 40-mg (P < 0.001) groups. The 20- and 40-mg doses were significantly (P < 0.05) more effective than the 10-mg dose in improving GERD symptoms at week 1. Adverse events were similar among the treatment groups. Conclusions: Pantoprazole (20 and 40 mg) is effective in reducing endoscopically proven GERD symptoms in children. Both 20 and 40 mg pantoprazole significantly reduced symptoms as early as 1 week.

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