Study Evaluating Pantoprazole in Children With Gastroesophageal Reflux Disease (GERD)

Study Overview
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Brief Summary
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To evaluate the clinical outcomes of treatment with oral pantoprazole in children 1 through 5 years of age with endoscopically proven symptomatic GERD.

Official Title
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A Multicenter, Randomized, Double-Blind Study of the Clinical Outcomes, Safety and Tolerability of Multiple Doses of Pantoprazole Sodium Enteric-Coated Spheroids in Children Ages 1 to 5 With Endoscopically Proven Symptomatic Gastroesophageal Reflux Disease (GERD)

Conditions
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Gastroesophageal Reflux

Intervention / Treatment
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* Drug: pantoprazole sodium enteric-coated spheroid


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ability to undergo endoscopy with required biopsy Ages 1 through 5 years Endoscopically confirmed GERD by positive endoscopic evidence of reflux related esophagitis or positive histologic evidence of esophagitis consistent with GERD Other inclusions apply. Exclusion Criteria: History or presence of upper gastrointestinal anatomic or motor disorders Known current or active cow's milk allergy Malignancy Other exclusions apply.

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 5 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Arm 1- Low Dose pantoprazole | Drug: pantoprazole sodium enteric-coated spheroid<br>* pediatric spheroids taken daily x 8 weeks<br>|
| Active Comparator: 2<br>Arm 2- Medium Dose pantoprazole | Drug: pantoprazole sodium enteric-coated spheroid<br>* pediatric spheroids taken daily x 8 weeks<br>|
| Active Comparator: 3<br>Arm 3- High Dose pantoprazole | Drug: pantoprazole sodium enteric-coated spheroid<br>* pediatric spheroids taken daily x 8 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline and 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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). | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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GERD, Children, Child, Child, Preschool