Gastroesophageal RefluxPhase 3NCT00300755
Study Evaluating Pantoprazole in Children With Gastroesophageal Reflux Disease (GERD)
A Phase 3 study testing pantoprazole sodium enteric-coated spheroid in people with Gastroesophageal Reflux, run by Wyeth is now a wholly owned subsidiary of Pfizer at 43 sites in 2 countries.
Trial summary
To evaluate the clinical outcomes of treatment with oral pantoprazole in children 1 through 5 years of age with endoscopically proven symptomatic GERD. Read more about this study
- Who is it for?
- Ages 1 year to 5 years
- Conditions the study is for
- Gastroesophageal Reflux
- What is being tested?
- pantoprazole sodium enteric-coated spheroid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 43 sitesin 2 countries
- Study dates
- May 2006to Apr 2008
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- History or presence of upper gastrointestinal anatomic or motor disorders
- Known current or active cow's milk allergy
- Malignancy
- Other exclusions apply.
Trial locations and contacts
43 sites in 2 countries.
43 sites in 2 countries
United States36 sites
Study site
Boston, Massachusetts, 02114
Study site
Boston, Massachusetts, 02115
Study site
Buffalo, New York, 14222
Study site
Charleston, West Virginia, 25304
Study site
Danville, Pennsylvania, 17822-1320
Study site
Egg Harbor, New Jersey, 08234
Study site
Flint, Michigan, 48503
Study site
Gainesville, Florida, 32610
Study site
Houston, Texas, 77030
Study site
Huntington, West Virginia, 25701-3655
Study site
Jackson, Mississippi, 39216
Study site
Jacksonville, Florida, 32207
Study site
Las Vegas, Nevada, 89102
Study site
Lexington, Kentucky, 40536
Study site
Louisville, Kentucky, 40202
Study site
Miami, Florida, 33101
Study site
Milwaukee, Wisconsin, 53215
Study site
Mobile, Alabama, 36604
Study site
Morristown, New Jersey, 07962
Study site
New York, New York, 10032
Study site
Norfolk, Virginia, 23507
Study site
Oakland, California, 94609
Study site
Oklahoma City, Oklahoma, 73104
Study site
Omaha, Nebraska, 68105
Study site
Orange, California, 92868
Study site
Orlando, Florida, 32806
Study site
Pensacola, Florida, 32504
Study site
Peoria, Illinois, 61603
Study site
Philadelphia, Pennsylvania, 19104
Study site
Phoenix, Arizona, 85016
Study site
Sacramento, California, 95819
Study site
San Diego, California, 92103
Study site
Southfield, Michigan, 48075
Study site
Temple, Texas, 76508
Study site
Washington D.C., District of Columbia, 20010
Study site
Wilmington, Delaware, 19803
Canada7 sites
Study site
Edmonton, Alberta, T6G 2B7
Study site
Hamilton, Ontario, L8N 3Z5
Study site
London, Ontario, N6A 4G5
Study site
Montreal, Quebec, H3H 1P3
Study site
Montreal, Quebec, H3T 1C5
Study site
Ottawa, Ontario, K1H 8L1
Study site
St. John's, Newfoundland and Labrador, A1B 3V6
About this study
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)
To evaluate the clinical outcomes of treatment with oral pantoprazole in children 1 through 5 years of age with endoscopically proven symptomatic GERD.
- Conditions
- Gastroesophageal Reflux
- Being tested
- pantoprazole sodium enteric-coated spheroid
- Keywords
- GERD, Children, Child, Child, Preschool
- Medical subject headings
- Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pantoprazole sodium enteric-coated spheroidDrug
Pediatric spheroids administered once daily for 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Low Dose Pantoprazole (Approximately 0.3 mg/kg) Receives: Drug: pantoprazole sodium enteric-coated spheroid |
| 2 | Active comparator | Medium Dose Pantoprazole (Approximately 0.6 mg/kg) Receives: Drug: pantoprazole sodium enteric-coated spheroid |
| 3 | Active comparator | High Dose Pantoprazole (Approximately 1.2 mg/kg) Receives: Drug: pantoprazole sodium enteric-coated spheroid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Weekly Gastroesophageal Reflux Disease (GERD) Symptom Scores (WGSS)
Weekly GERD symptom score (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 during the treatment period.
Measured: Baseline and Weeks 1, 2, 3, 4, 5, 6, 7, 8, and Final Week
Secondary outcomes (3)
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.
Measured: Baseline and 8 weeks
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.
Measured: Baseline and 8 weeks
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).
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2006 (estimated)
- Study startMay 2006
- Primary completionApr 2008
- Study completionApr 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gastroesophageal RefluxStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Nycomed
- Investigators
- Medical Monitor, Study director, Wyeth is now a wholly owned subsidiary of Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00300755
- Sponsor's protocol ID
- 3001B3-328
- Status last verified
- Sep 2026
- First submitted
- 7 Mar 2006
- Last updated
- 25 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 20522615