Study Evaluating Pantoprazole in Children With Gastroesophageal Reflux Disease (GERD)
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)
1 other identifier
interventional
60
2 countries
43
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started May 2006
43 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 7, 2006
CompletedFirst Posted
Study publicly available on registry
March 9, 2006
CompletedStudy Start
First participant enrolled
May 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2008
CompletedResults Posted
Study results publicly available
May 19, 2010
CompletedMay 19, 2010
April 1, 2010
1.9 years
March 7, 2006
November 30, 2009
April 14, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Baseline and 8 weeks
Secondary Outcomes (3)
Change in Individual Weekly Mean Frequency Score for Each Gastroesophageal Reflux Disease (GERD) Symptom Score From Baseline to Final Week
Baseline and 8 weeks
Change in Individual Weekly Mean Score For Each Respiratory Symptom From Baseline
Baseline and 8 weeks
Number of Patients With "Healed" Erosive Esophagitis (EE) at End of Study
8 weeks
Study Arms (3)
1
ACTIVE COMPARATORArm 1- Low Dose pantoprazole
2
ACTIVE COMPARATORArm 2- Medium Dose pantoprazole
3
ACTIVE COMPARATORArm 3- High Dose pantoprazole
Interventions
Eligibility Criteria
You may qualify if:
- Ability to undergo endoscopy with required biopsy
- Ages 1 through 5 years
You may not qualify if:
- History or presence of upper gastrointestinal anatomic or motor disorders
- Known current or active cow's milk allergy
- Malignancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Wyeth is now a wholly owned subsidiary of Pfizerlead
- Nycomedcollaborator
Study Sites (43)
Unknown Facility
Mobile, Alabama, 36604, United States
Unknown Facility
Phoenix, Arizona, 85016, United States
Unknown Facility
Oakland, California, 94609, United States
Unknown Facility
Orange, California, 92868, United States
Unknown Facility
Sacramento, California, 95819, United States
Unknown Facility
San Diego, California, 92103, United States
Unknown Facility
Wilmington, Delaware, 19803, United States
Unknown Facility
Washington D.C., District of Columbia, 20010, United States
Unknown Facility
Gainesville, Florida, 32610, United States
Unknown Facility
Jacksonville, Florida, 32207, United States
Unknown Facility
Miami, Florida, 33101, United States
Unknown Facility
Orlando, Florida, 32806, United States
Unknown Facility
Pensacola, Florida, 32504, United States
Unknown Facility
Peoria, Illinois, 61603, United States
Unknown Facility
Lexington, Kentucky, 40536, United States
Unknown Facility
Louisville, Kentucky, 40202, United States
Unknown Facility
Boston, Massachusetts, 02114, United States
Unknown Facility
Boston, Massachusetts, 02115, United States
Unknown Facility
Flint, Michigan, 48503, United States
Unknown Facility
Southfield, Michigan, 48075, United States
Unknown Facility
Jackson, Mississippi, 39216, United States
Unknown Facility
Omaha, Nebraska, 68105, United States
Unknown Facility
Las Vegas, Nevada, 89102, United States
Unknown Facility
Egg Harbor, New Jersey, 08234, United States
Unknown Facility
Morristown, New Jersey, 07962, United States
Unknown Facility
Buffalo, New York, 14222, United States
Unknown Facility
New York, New York, 10032, United States
Unknown Facility
Oklahoma City, Oklahoma, 73104, United States
Unknown Facility
Danville, Pennsylvania, 17822-1320, United States
Unknown Facility
Philadelphia, Pennsylvania, 19104, United States
Unknown Facility
Houston, Texas, 77030, United States
Unknown Facility
Temple, Texas, 76508, United States
Unknown Facility
Norfolk, Virginia, 23507, United States
Unknown Facility
Charleston, West Virginia, 25304, United States
Unknown Facility
Huntington, West Virginia, 25701-3655, United States
Unknown Facility
Milwaukee, Wisconsin, 53215, United States
Unknown Facility
Edmonton, Alberta, T6G 2B7, Canada
Unknown Facility
St. John's, Newfoundland and Labrador, A1B 3V6, Canada
Unknown Facility
Hamilton, Ontario, L8N 3Z5, Canada
Unknown Facility
London, Ontario, N6A 4G5, Canada
Unknown Facility
Ottawa, Ontario, K1H 8L1, Canada
Unknown Facility
Montreal, Quebec, H3H 1P3, Canada
Unknown Facility
Montreal, Quebec, H3T 1C5, Canada
Related Publications (1)
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.
PMID: 20522615DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- U. S. Contact Center
- Organization
- Wyeth
Study Officials
- STUDY DIRECTOR
Medical Monitor
Wyeth is now a wholly owned subsidiary of Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
March 7, 2006
First Posted
March 9, 2006
Study Start
May 1, 2006
Primary Completion
April 1, 2008
Study Completion
April 1, 2008
Last Updated
May 19, 2010
Results First Posted
May 19, 2010
Record last verified: 2010-04