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

This study has been completed.
Sponsor:
Collaborator:
Nycomed
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00300755
First received: March 7, 2006
Last updated: April 14, 2010
Last verified: April 2010
  Purpose

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


Condition Intervention Phase
Gastroesophageal Reflux
Drug: pantoprazole sodium enteric-coated spheroid
Phase 3

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
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)

Resource links provided by NLM:


Further study details as provided by Wyeth is now a wholly owned subsidiary of Pfizer:

Primary Outcome Measures:
  • Change in Weekly Gastroesophageal Reflux Disease (GERD) Symptom Scores (WGSS) [ Time Frame: Baseline and 8 weeks ] [ Designated as safety issue: No ]
    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:
  • 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 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and 8 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    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).


Enrollment: 60
Study Start Date: May 2006
Study Completion Date: April 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Arm 1- Low Dose pantoprazole
Drug: pantoprazole sodium enteric-coated spheroid
pediatric spheroids taken daily x 8 weeks
Active Comparator: 2
Arm 2- Medium Dose pantoprazole
Drug: pantoprazole sodium enteric-coated spheroid
pediatric spheroids taken daily x 8 weeks
Active Comparator: 3
Arm 3- High Dose pantoprazole
Drug: pantoprazole sodium enteric-coated spheroid
pediatric spheroids taken daily x 8 weeks

  Eligibility

Ages Eligible for Study:   1 Year to 5 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00300755

  Show 43 Study Locations
Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Nycomed
Investigators
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
  More Information

No publications provided by Wyeth is now a wholly owned subsidiary of Pfizer

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
ClinicalTrials.gov Identifier: NCT00300755     History of Changes
Other Study ID Numbers: 3001B3-328
Study First Received: March 7, 2006
Results First Received: November 30, 2009
Last Updated: April 14, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:
GERD
Children
Child
Child, Preschool

Additional relevant MeSH terms:
Gastroesophageal Reflux
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Pantoprazole
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Ulcer Agents
Gastrointestinal Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 15, 2014