To evaluate the clinical outcomes of treatment with oral pantoprazole in children 1 through 5 years of age with endoscopically proven symptomatic GERD.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
60
pediatric spheroids taken daily x 8 weeks
Change in Weekly Gastroesophageal Reflux Disease (GERD) Symptom Scores (WGSS)
WGSS is the sum of 5 selected individual weekly GERD mean frequency scores: vomiting/regurgitation, choking/gagging, refusal to eat, difficulty swallowing and abdominal/belly pain. Symptoms were assessed using a parent-administered questionnaire. The score for each individual symptom ranged from 0 (no symptoms) to 3 (highest frequency of symptoms), giving a WGSS range of 0-15. Change = score at week of assessment minus baseline score. Final week was defined as the last 7 days of symptom scores collected in the treatment period.
Time frame: Baseline and 8 weeks
Change in Individual Weekly Mean Frequency Score for Each Gastroesophageal Reflux Disease (GERD) Symptom Score From Baseline to Final Week
Selected symptoms of GERD were assessed using a parent-administered questionnaire. The score for each symptom ranged from 0 (no symptom) to 3 (highest frequency of symptom), The weekly mean score was the sum of daily scores that week, divided by the number of days with scores for that week. Change = final week score minus baseline score. Final week was defined as the last 7 days of scores collected in the treatment period.
Time frame: Baseline and 8 weeks
Change in Individual Weekly Mean Score For Each Respiratory Symptom From Baseline
Individual respiratory symptoms weekly score was calculated as the average score / number of events for a patient in the corresponding week if the patient answered a question ≥3 times that week. Change = final week score minus baseline score. Final week was defined as the last 7 days of scores collected in the treatment period.
Time frame: Baseline and 8 weeks
Number of Patients With "Healed" Erosive Esophagitis (EE) at End of Study
Healed EE was defined as a modified Hetzel-Dent (HD) score \<2 on endoscopy at end of study. HD is a standardized rating scale for grading esophageal damage and severity of gastroesophageal reflux disease (GERD). HD score ranges from 0 (normal mucosa) to 4 (deep peptic ulceration).
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Unnamed facility
Mobile, Alabama, United States
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Phoenix, Arizona, United States
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Oakland, California, United States
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Orange, California, United States
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Sacramento, California, United States
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San Diego, California, United States
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Wilmington, Delaware, United States
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Washington D.C., District of Columbia, United States
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Gainesville, Florida, United States
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Jacksonville, Florida, United States
...and 33 more locations
Time frame: 8 weeks