Study Evaluating Pantoprazole in Children With Gastroesophageal Reflux Disease (GERD)
To evaluate the clinical outcomes of treatment with oral pantoprazole in children 1 through 5 years of age with endoscopically proven symptomatic GERD...
Brief Summary
Official Title: “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)”
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
- Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
- Study Primary Completion Date: April 2008
Intervention(s) in this Clinical Trial
- Drug: pantoprazole sodium enteric-coated spheroid
- pediatric spheroids taken daily x 8 weeks
Arms, Groups and Cohorts in this Clinical Trial
- Active Comparator: 1
- Arm 1- Low Dose pantoprazole
- Active Comparator: 2
- Arm 2- Medium Dose pantoprazole
- Active Comparator: 3
- Arm 3- High Dose pantoprazole
Outcome Measures for this Clinical Trial
Primary Measures
- Change in Weekly Gastroesophageal Reflux Disease (GERD) Symptom Scores (WGSS)
- Time Frame: Baseline and 8 weeks
Safety Issue?: No
- Time Frame: Baseline and 8 weeks
Secondary Measures
- Change in Individual Weekly Mean Frequency Score for Each Gastroesophageal Reflux Disease (GERD) Symptom Score From Baseline to Final Week
- Time Frame: Baseline and 8 weeks
Safety Issue?: No
- Time Frame: Baseline and 8 weeks
- Change in Individual Weekly Mean Score For Each Respiratory Symptom From Baseline
- Time Frame: Baseline and 8 weeks
Safety Issue?: No
- Time Frame: Baseline and 8 weeks
- Number of Patients With "Healed" Erosive Esophagitis (EE) at End of Study
- Time Frame: 8 weeks
Safety Issue?: No
- Time Frame: 8 weeks
Criteria for Participation in this Clinical Trial
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.
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 1 Year
Maximum Age for this Clinical Trial: 5 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Investigator Information
Lead Investigator: Wyeth is now a wholly owned subsidiary of Pfizer Industry
Overall Clinical Trial Officials and Contacts
Medical Monitor Study Director Wyeth is now a wholly owned subsidiary of Pfizer
Additional Information
Information obtained from ClinicalTrials.gov on February 12, 2012
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00300755
Study ID Number: 3001B3-328
ClinicalTrials.gov Identifier: NCT00300755
Health Authority: United States: Food and Drug Administration
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00300755
