search
Back to results

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

Primary Purpose

Gastroesophageal Reflux

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
pantoprazole sodium enteric-coated spheroid
Sponsored by
Wyeth is now a wholly owned subsidiary of Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastroesophageal Reflux focused on measuring GERD, Children, Child, Child, Preschool

Eligibility Criteria

1 Year - 5 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

1

2

3

Arm Description

Arm 1- Low Dose pantoprazole

Arm 2- Medium Dose pantoprazole

Arm 3- High Dose pantoprazole

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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).

Full Information

First Posted
March 7, 2006
Last Updated
April 14, 2010
Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
Collaborators
Nycomed
search

1. Study Identification

Unique Protocol Identification Number
NCT00300755
Brief Title
Study Evaluating Pantoprazole in Children With Gastroesophageal Reflux Disease (GERD)
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)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2010
Overall Recruitment Status
Completed
Study Start Date
May 2006 (undefined)
Primary Completion Date
April 2008 (Actual)
Study Completion Date
April 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
Collaborators
Nycomed

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastroesophageal Reflux
Keywords
GERD, Children, Child, Child, Preschool

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Arm 1- Low Dose pantoprazole
Arm Title
2
Arm Type
Active Comparator
Arm Description
Arm 2- Medium Dose pantoprazole
Arm Title
3
Arm Type
Active Comparator
Arm Description
Arm 3- High Dose pantoprazole
Intervention Type
Drug
Intervention Name(s)
pantoprazole sodium enteric-coated spheroid
Intervention Description
pediatric spheroids taken daily x 8 weeks
Primary Outcome Measure Information:
Title
Change in Weekly Gastroesophageal Reflux Disease (GERD) Symptom Scores (WGSS)
Description
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.
Time Frame
Baseline and 8 weeks
Secondary Outcome Measure Information:
Title
Change in Individual Weekly Mean Frequency Score for Each Gastroesophageal Reflux Disease (GERD) Symptom Score From Baseline to Final Week
Description
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.
Time Frame
Baseline and 8 weeks
Title
Change in Individual Weekly Mean Score For Each Respiratory Symptom From Baseline
Description
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.
Time Frame
Baseline and 8 weeks
Title
Number of Patients With "Healed" Erosive Esophagitis (EE) at End of Study
Description
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).
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Wyeth is now a wholly owned subsidiary of Pfizer
Official's Role
Study Director
Facility Information:
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36604
Country
United States
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85016
Country
United States
City
Oakland
State/Province
California
ZIP/Postal Code
94609
Country
United States
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
City
Sacramento
State/Province
California
ZIP/Postal Code
95819
Country
United States
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
City
Wilmington
State/Province
Delaware
ZIP/Postal Code
19803
Country
United States
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32207
Country
United States
City
Miami
State/Province
Florida
ZIP/Postal Code
33101
Country
United States
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
City
Pensacola
State/Province
Florida
ZIP/Postal Code
32504
Country
United States
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61603
Country
United States
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
City
Flint
State/Province
Michigan
ZIP/Postal Code
48503
Country
United States
City
Southfield
State/Province
Michigan
ZIP/Postal Code
48075
Country
United States
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216
Country
United States
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68105
Country
United States
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89102
Country
United States
City
Egg Harbor Township
State/Province
New Jersey
ZIP/Postal Code
08234
Country
United States
City
Morristown
State/Province
New Jersey
ZIP/Postal Code
07962
Country
United States
City
Buffalo
State/Province
New York
ZIP/Postal Code
14222
Country
United States
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
City
Danville
State/Province
Pennsylvania
ZIP/Postal Code
17822-1320
Country
United States
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
City
Temple
State/Province
Texas
ZIP/Postal Code
76508
Country
United States
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
City
Charleston
State/Province
West Virginia
ZIP/Postal Code
25304
Country
United States
City
Huntington
State/Province
West Virginia
ZIP/Postal Code
25701-3655
Country
United States
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53215
Country
United States
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2B7
Country
Canada
City
St. John's
State/Province
Newfoundland and Labrador
ZIP/Postal Code
A1B 3V6
Country
Canada
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 3Z5
Country
Canada
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4G5
Country
Canada
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L1
Country
Canada
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3H 1P3
Country
Canada
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1C5
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
20522615
Citation
Baker R, Tsou VM, Tung J, Baker SS, Li H, Wang W, Rath N, Maguire MK, Comer GM. Clinical results from a randomized, double-blind, dose-ranging study of pantoprazole in children aged 1 through 5 years with symptomatic histologic or erosive esophagitis. Clin Pediatr (Phila). 2010 Sep;49(9):852-65. doi: 10.1177/0009922810369253. Epub 2010 Jun 3.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs