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

April 14, 2010 updated by: Wyeth is now a wholly owned subsidiary of Pfizer

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 2B7
    • Newfoundland and Labrador
      • St. John's, Newfoundland and Labrador, Canada, A1B 3V6
    • Ontario
      • Hamilton, Ontario, Canada, L8N 3Z5
      • London, Ontario, Canada, N6A 4G5
      • Ottawa, Ontario, Canada, K1H 8L1
    • Quebec
      • Montreal, Quebec, Canada, H3H 1P3
      • Montreal, Quebec, Canada, H3T 1C5
  • United States
    • Alabama
      • Mobile, Alabama, United States, 36604
    • Arizona
      • Phoenix, Arizona, United States, 85016
    • California
      • Oakland, California, United States, 94609
      • Orange, California, United States, 92868
      • Sacramento, California, United States, 95819
      • San Diego, California, United States, 92103
    • Delaware
      • Wilmington, Delaware, United States, 19803
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
    • Florida
      • Gainesville, Florida, United States, 32610
      • Jacksonville, Florida, United States, 32207
      • Miami, Florida, United States, 33101
      • Orlando, Florida, United States, 32806
      • Pensacola, Florida, United States, 32504
    • Illinois
      • Peoria, Illinois, United States, 61603
    • Kentucky
      • Lexington, Kentucky, United States, 40536
      • Louisville, Kentucky, United States, 40202
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
      • Boston, Massachusetts, United States, 02115
    • Michigan
      • Flint, Michigan, United States, 48503
      • Southfield, Michigan, United States, 48075
    • Mississippi
      • Jackson, Mississippi, United States, 39216
    • Nebraska
      • Omaha, Nebraska, United States, 68105
    • Nevada
      • Las Vegas, Nevada, United States, 89102
    • New Jersey
      • Egg Harbor Township, New Jersey, United States, 08234
      • Morristown, New Jersey, United States, 07962
    • New York
      • Buffalo, New York, United States, 14222
      • New York, New York, United States, 10032
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
    • Pennsylvania
      • Danville, Pennsylvania, United States, 17822-1320
      • Philadelphia, Pennsylvania, United States, 19104
    • Texas
      • Houston, Texas, United States, 77030
      • Temple, Texas, United States, 76508
    • Virginia
      • Norfolk, Virginia, United States, 23507
    • West Virginia
      • Charleston, West Virginia, United States, 25304
      • Huntington, West Virginia, United States, 25701-3655
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53215

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 5 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Weekly Gastroesophageal Reflux Disease (GERD) Symptom Scores (WGSS)
Time Frame: 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.
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
Time Frame: 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.
Baseline and 8 weeks
Change in Individual Weekly Mean Score For Each Respiratory Symptom From Baseline
Time Frame: 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.
Baseline and 8 weeks
Number of Patients With "Healed" Erosive Esophagitis (EE) at End of Study
Time Frame: 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).
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Collaborators

Nycomed

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2006

Primary Completion (Actual)

April 1, 2008

Study Completion (Actual)

April 1, 2008

Study Registration Dates

First Submitted

March 7, 2006

First Submitted That Met QC Criteria

March 7, 2006

First Posted (Estimate)

March 9, 2006

Study Record Updates

Last Update Posted (Estimate)

May 19, 2010

Last Update Submitted That Met QC Criteria

April 14, 2010

Last Verified

April 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3001B3-328

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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