Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as pantoprazole sodium enteric-coated spheroid suspension, pantoprazole sodium enteric-coated spheroid
pantoprazole enteric-coated spheroid · 2 trials · 1 indication
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.
Pharmacokinetic (PK) parameters, including peak plasma concentration, were determined following a single oral dose of pantoprazole
Pharmacokinetic (PK) parameters, including time to peak plasma concentration, were determined following a single oral dose of pantoprazole.
Pharmacokinetic (PK) parameters, including the terminal-phase disposition half-life, were determined following a single oral dose of pantoprazole. Half-life is the time required for half the quantity of absorbed drug to be metabolized or eliminated by normal biological processes.
Pharmacokinetic (PK) parameters, including AUC, were determined following a single oral dose of pantoprazole. AUC is a measure of the plasma concentration of the drug over time. It is used to characterize drug absorption.
Pharmacokinetic (PK) parameters, including apparent oral clearance, were determined following a single oral dose of pantoprazole. Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed.
Plasma concentration of pantoprazole after multiple doses was measured to see if there was any accumulation of the drug.
Intragastric pH is a method for evaluating gastric acidity scaled 0-9. A lower pH means more acidity. A longer duration of esophageal mucosa exposure to a gastric refluxate with a pH \<4.0 correlates with more severe mucosal injury in patients with gastroesophageal reflux disease (GERD).
Intragastric pH is a method for evaluating gastric acidity scaled 0-9. A lower pH means more acidity. A longer duration of esophageal mucosa exposure to a gastric refluxate with a pH \<4.0 correlates with more severe mucosal injury in patients with gastroesophageal reflux disease (GERD).
Intragastric pH is a method for evaluating gastric acidity. A lower pH means more acidity. A longer duration of esophageal mucosa exposure to a gastric refluxate with a pH \<4.0 correlates with more severe mucosal injury in patients with gastroesophageal reflux disease (GERD).
Intraesophagel pH is a method for evaluating acidity of gastric refluxate scaled 0-9. A lower pH means more acidity. A longer duration of esophageal mucosa exposure to a gastric refluxate with a pH \<4.0 correlates with more severe mucosal injury in patients with gastroesophageal reflux disease (GERD).
Intraesophagel pH is a method for evaluating acidity of gastric refluxate scaled 0-9. A lower pH means more acidity. A longer duration of esophageal mucosa exposure to a gastric refluxate with a pH \<4.0 correlates with more severe mucosal injury in patients with gastroesophageal reflux disease (GERD).
Intraesophagel pH is a method for evaluating acidity of gastric refluxate. A lower pH means more acidity. A longer duration of esophageal mucosa exposure to a gastric refluxate with a pH \<4.0 correlates with more severe mucosal injury in patients with gastroesophageal reflux disease (GERD).
Normalized Area of Gastric Hydrogen Ion Activity Over Time is a measure of the area under the curve of the gastric hydrogen ion activity over time, which is normalized for a 24-hour period.
Normalized Area of Esophageal Hydrogen Ion Activity Over Time is a measure of the area under the curve of the esophageal hydrogen ion activity over time, which is normalized for a 24-hour period.
| Arm | Type | Description |
|---|---|---|
| 1 | ACTIVE_COMPARATOR | Low Dose Pantoprazole (Approximately 0.3 mg/kg) |
| 2 | ACTIVE_COMPARATOR | Medium Dose Pantoprazole (Approximately 0.6 mg/kg) |
| 3 | ACTIVE_COMPARATOR | High Dose Pantoprazole (Approximately 1.2 mg/kg) |
| Low dose | ACTIVE_COMPARATOR | - |
| High dose | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| pantoprazole sodium enteric-coated spheroid | DRUG | Pediatric spheroids administered once daily for 8 weeks. |
| pantoprazole sodium enteric-coated spheroid suspension | DRUG | pediatric suspension taken daily x 7 days |
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 Crite...
Pantoprazole enteric-coated spheroid is being developed for the treatment of gastroesophageal reflux disease, or GERD. It is a small molecule formulated as an enteric-coated spheroid, a dosage form designed to release the drug in the intestine. The clinical program has focused on pediatric and infant patients with GERD or presumed GERD.
Pantoprazole enteric-coated spheroid targets ATP4A and ATP4B, the subunits of the gastric proton pump, also known as the hydrogen-potassium ATPase. It acts as an inhibitor of this pump, which is the final step in gastric acid secretion. Inhibiting ATP4A and ATP4B reduces acid production in the stomach.
Pantoprazole enteric-coated spheroid is being developed by Pfizer, Inc., which trades on the New York Stock Exchange under the ticker PFE. Pfizer is the sponsor of the clinical trials evaluating this enteric-coated spheroid formulation in pediatric and infant patients with gastroesophageal reflux disease.
Pantoprazole enteric-coated spheroid is in Phase 3 clinical development. It is an investigational formulation and is not approved for marketing based on the development information available. The Phase 3 program has been conducted in pediatric and infant populations with gastroesophageal reflux disease or presumed GERD.
Pantoprazole enteric-coated spheroid has been studied in two completed Phase 3 trials. NCT00300755 evaluated pantoprazole in children with gastroesophageal reflux disease in the United States and Canada. NCT00259012 evaluated pantoprazole sodium enteric-coated spheroid suspension in infants with presumed GERD across the United States, Australia, Belgium, France, Germany, Italy, Poland, and Switzerland.
Yes, pantoprazole enteric-coated spheroid is also known as pantoprazole sodium enteric-coated spheroid suspension and pantoprazole sodium enteric-coated spheroid. These names refer to the same Pfizer development program. The suspension formulation was the one studied in the infant trial NCT00259012, while the broader spheroid program covered pediatric GERD.