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

Phase 3

Completed

• Conditions: Gastroesophageal Reflux
• Interventions: Drug: pantoprazole sodium enteric-coated spheroid

• Registration Number: NCT00300755
• Lead Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2006-03-07
• Study First Submitted QC: 2006-03-07
• Study First Posted: 2006-03-09
• Study Start: 2006-05
• Primary Completion: 2008-04
• Study Completion: 2008-04
• Disposition First Submitted: 2009-03-09
• Results First Submitted: 2009-11-30
• Status Verified: 2010-04
• Results First Submitted QC: 2010-04-14
• Disposition First Submitted QC: 2010-04-14
• Last Update Submitted: 2010-04-14
• Results First Posted: 2010-05-19
• Disposition First Posted: 2010-05-19
• Last Update Posted: 2010-05-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	pantoprazole sodium enteric-coated spheroid	Arm 2- Medium Dose pantoprazole
1	pantoprazole sodium enteric-coated spheroid	Arm 1- Low Dose pantoprazole
3	pantoprazole sodium enteric-coated spheroid	Arm 3- High Dose pantoprazole

Primary Outcome Measures

Name	Time	Method
Change in Weekly Gastroesophageal Reflux Disease (GERD) Symptom Scores (WGSS)	Baseline and 8 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Change in Individual Weekly Mean Frequency Score for Each Gastroesophageal Reflux Disease (GERD) Symptom Score From Baseline to Final Week	Baseline and 8 weeks	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.
Change in Individual Weekly Mean Score For Each Respiratory Symptom From Baseline	Baseline and 8 weeks	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.
Number of Patients With "Healed" Erosive Esophagitis (EE) at End of Study	8 weeks	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).