A Phase 3 interventional study of pantoprazole sodium enteric-coated spheroid in Gastroesophageal Reflux, sponsored by Wyeth is now a wholly owned subsidiary of Pfizer. Completed at 43 sites in 2 countries. Open to participants aged 1 Year to 5 Years. Per ClinicalTrials.gov, last updated 2026-09-25.
Sponsored by Wyeth is now a wholly owned subsidiary of Pfizer (part of Pfizer) · Phase 3, Interventional, and Treatment
To evaluate the clinical outcomes of treatment with oral pantoprazole in children 1 through 5 years of age with endoscopically proven symptomatic GERD.
1,211 studies on the registry are indexed under Gastroesophageal Reflux; 202 are open to participants now.
This study's enrollment of 60 is below the median of 68 across 796 interventional studies indexed under Gastroesophageal Reflux.
Browse Gastroesophageal Reflux studies →Wyeth is now a wholly owned subsidiary of Pfizer is the lead sponsor of 484 studies on the registry; none are open to participants now.
First submitted before Wyeth became part of Pfizer.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Low Dose Pantoprazole (Approximately 0.3 mg/kg)
Drug: pantoprazole sodium enteric-coated spheroid
Medium Dose Pantoprazole (Approximately 0.6 mg/kg)
Drug: pantoprazole sodium enteric-coated spheroid
High Dose Pantoprazole (Approximately 1.2 mg/kg)
Drug: pantoprazole sodium enteric-coated spheroid
Pediatric spheroids administered once daily for 8 weeks.
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.
Time frame: Baseline and Weeks 1, 2, 3, 4, 5, 6, 7, 8, and Final Week
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.
Time frame: 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.
Time frame: 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).
Time frame: 8 weeks
Patients were recruited in the United States and Canada from May 2006 to February 2008.
| Milestone | Low Dose Pantoprazole (Approximately 0.3 mg/kg) | Medium Dose Pantoprazole (Approximately 0.6 mg/kg) | High Dose Pantoprazole (Approximately 1.2 mg/kg) |
|---|---|---|---|
| Started | 18 | 21 | 21 |
| Completed | 17 | 17 | 19 |
| Not completed | 1 | 4 | 2 |
| Withdrew: Adverse event | 1 | 2 | 1 |
| Withdrew: Withdrawal by subject | 0 | 2 | 0 |
| Withdrew: Protocol violation | 0 | 0 | 1 |
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.
| units on scale | Low Dose Pantoprazole (Approximately 0.3 mg/kg) | Medium Dose Pantoprazole (Approximately 0.6 mg/kg) | High Dose Pantoprazole (Approximately 1.2 mg/kg) |
|---|---|---|---|
| Week 1 Change from Baseline | -0.89 ± 1.41 | 0.02 ± 0.99 | -0.47 ± 1.25 |
| Week 2 Change from Baseline | -1.11 ± 1.29 | -0.11 ± 1.06 | -1.24 ± 1.42 |
| Week 3 Change from Baseline | -1.31 ± 1.43 | -0.16 ± 1.23 | -1.38 ± 1.47 |
| Week 4 Change from Baseline | -1.84 ± 1.95 | -0.20 ± 1.29 | -1.32 ± 1.36 |
| Week 5 Change from Baseline | -2.05 ± 2.08 | -0.48 ± 1.31 | -1.30 ± 1.63 |
| Week 6 Change from Baseline | -1.99 ± 1.83 | -0.61 ± 1.31 | -1.42 ± 1.59 |
| Week 7 Change from Baseline | -2.44 ± 1.75 | -0.58 ± 1.38 | -1.58 ± 1.62 |
| Week 8 Change from Baseline | -2.34 ± 1.81 | -0.60 ± 1.49 | -1.61 ± 1.61 |
| Final Week Change from Baseline | -2.37 ± 1.74 | -0.64 ± 1.40 | -1.66 ± 1.64 |
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.
| units on scale | Low Dose Pantoprazole (Approximately 0.3 mg/kg) | Medium Dose Pantoprazole (Approximately 0.6 mg/kg) | High Dose Pantoprazole (Approximately 1.2 mg/kg) |
|---|---|---|---|
| Vomiting/regurgitation | -0.77 ± 0.89 | -0.06 ± 0.28 | -0.25 ± 0.48 |
| Choking/gagging | -0.43 ± 0.33 | -0.05 ± 0.48 | -0.47 ± 0.59 |
| Refusal to eat | -0.34 ± 0.49 | -0.16 ± 0.61 | -0.26 ± 0.69 |
| Difficulty swallowing | -0.42 ± 0.52 | -0.13 ± 0.49 | -0.39 ± 0.79 |
| Abdominal/belly pain | -0.42 ± 0.49 | -0.24 ± 0.44 | -0.28 ± 0.49 |
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.
| units on scale | Low Dose Pantoprazole (Approximately 0.3 mg/kg) | Medium Dose Pantoprazole (Approximately 0.6 mg/kg) | High Dose Pantoprazole (Approximately 1.2 mg/kg) |
|---|---|---|---|
| Presence of cold or fever: scale 1=yes 0=no | 0.11 ± 0.41 | 0.13 ± 0.43 | 0.11 ± 0.52 |
| Cough without cold: scale 1=yes 0=no | -0.38 ± 0.34 | -0.20 ± 0.38 | -0.24 ± 0.36 |
| Noisy breathing: scale 0(none)-3(most of the time) | -0.48 ± 0.97 | -0.19 ± 0.35 | -0.16 ± 0.36 |
| Noisy breathing on exhale: scale 1=yes 0=no | -0.11 ± 0.55 | -0.15 ± 0.29 | -0.16 ± 0.29 |
| Wheezing or whistling sound: scale 1=yes 0=no | -0.15 ± 0.46 | -0.04 ± 0.12 | -0.02 ± 0.08 |
| Noisy breathing on inhale: scale 1=yes 0=no | -0.11 ± 0.49 | -0.16 ± 0.30 | -0.16 ± 0.31 |
| Croupy or barky sound: scale 1=yes 0=no | -0.09 ± 0.30 | -0.03 ± 0.11 | -0.13 ± 0.32 |
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).
| patients | Low Dose Pantoprazole (Approximately 0.3 mg/kg) | Medium Dose Pantoprazole (Approximately 0.6 mg/kg) | High Dose Pantoprazole (Approximately 1.2 mg/kg) |
|---|---|---|---|
| Number of Patients With "Healed" Erosive Esophagitis (EE) at End of Study | — | 2 | 2 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Low Dose Pantoprazole (Approximately 0.3 mg/kg) | — | — | — |
| Medium Dose Pantoprazole (Approximately 0.6 mg/kg) | — | — | — |
| High Dose Pantoprazole (Approximately 1.2 mg/kg) | — | — | — |
| Event | Low Dose Pantoprazole (Approximately 0.3 mg/kg) | Medium Dose Pantoprazole (Approximately 0.6 mg/kg) | High Dose Pantoprazole (Approximately 1.2 mg/kg) |
|---|---|---|---|
| Abdominal painGeneral disorders | 0/18 | 1/21 | 0/21 |
| AnorexiaGastrointestinal disorders | 0/18 | 0/21 | 1/21 |
| DehydrationMetabolism and nutrition disorders | 0/18 | 0/21 | 1/21 |
| Event | Low Dose Pantoprazole (Approximately 0.3 mg/kg) | Medium Dose Pantoprazole (Approximately 0.6 mg/kg) | High Dose Pantoprazole (Approximately 1.2 mg/kg) |
|---|---|---|---|
| Upper respiratory infectionRespiratory, thoracic and mediastinal disorders | 8/18 | 7/21 | 8/21 |
| FeverGeneral disorders | 2/18 | 5/21 | 4/21 |
| RhinitisRespiratory, thoracic and mediastinal disorders | 3/18 | 1/21 | 5/21 |
| DiarrheaGastrointestinal disorders | 4/18 | 2/21 | 3/21 |
| HeadacheGeneral disorders | 3/18 | 1/21 | 4/21 |
| VomitingGastrointestinal disorders | 2/18 | 4/21 | 3/21 |
| Accidental injuryGeneral disorders | 3/18 | 3/21 | 2/21 |
| Cough increasedRespiratory, thoracic and mediastinal disorders | 3/18 | 3/21 | 1/21 |
| PharyngitisRespiratory, thoracic and mediastinal disorders | 3/18 | 2/21 | 0/21 |
| Abdominal painGeneral disorders | 1/18 | 1/21 | 3/21 |
| Age, Continuous(years) | Low Dose Pantoprazole (Approximately 0.3 mg/kg) | Medium Dose Pantoprazole (Approximately 0.6 mg/kg) | High Dose Pantoprazole (Approximately 1.2 mg/kg) | Total |
|---|---|---|---|---|
| Mean | 2.67 ± 1.61 | 1.90 ± 1.18 | 2.76 ± 1.34 | 2.43 ± 1.41 |
| Sex: Female, Male(Participants) | Low Dose Pantoprazole (Approximately 0.3 mg/kg) | Medium Dose Pantoprazole (Approximately 0.6 mg/kg) | High Dose Pantoprazole (Approximately 1.2 mg/kg) | Total |
|---|---|---|---|---|
| Female | 6 | 4 | 13 | 23 |
| Male | 12 | 17 | 8 | 37 |
The record gives a start of May 2006, a primary completion of Apr 2008 and a completion of Apr 2008. It does not say whether these dates are actual or estimated.
Results were first posted in May 2010, 2 years 1 month after primary completion. A results delay was requested in Mar 2009.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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