Approval Probability
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Label indication PROTONIX For Delayed-Release Oral Suspension and PROTONIX Delayed-Release Tablets are indicated for: PROTONIX is a proton pump inhibitor (PPI) indicated for the following: • Short-Term Treatment of Erosive Esophagitis Associated with Gastroesophageal Reflux Disease (GERD) ( 1.1 ) • Maintenance of Healing of Erosive Esophagitis ( 1.2 ) • Pathological Hypersecretory Conditions Including Zollinger-Ellison (ZE) Syndrome… FDA label
pantoprazole · 6 trials · 2 indications
Lack of efficacy defined as 1 or more of the following occurring during the double blind treatment-withdrawal phase: significant worsening of gastroesophageal reflux disease (GERD) symptoms frequency, a diagnostic test (e.g., endoscopy) demonstrating worsening of esophagitis, maximal antacid intake for ≥ 7 continuous days, or severe GERD symptoms based on physician's judgment.
Samples were divided between 2 groups for each dose: Group A at baseline, 2, 8, 18 hours; Group B at baseline, 1, 4, 12 hours to reduce the number of blood draws per infant. The variance of oral bioavailability was assessed to determine if further PK assessment was appropriate. It would be considered highly variable if the square root of the sum of the standard deviation squares of the area under the concentration-time curves from time zero to the time of the last quantifiable concentration (AUCT) for group A and Group B divided by the sum of the mean AUCT for group A and Group B was \>1.2.
Pre-defined criteria were established for each laboratory test to define the values that would be identified as of potential clinical importance. Criteria are as follows: Potassium ≤ 3.0 mEq/L or ≥ 6.2 mEq/L; Carbon dioxide \< 12 mEq/L or \> 35 mEq/L; Total bilirubin \> 1.5xULN; CPK \> 3xULN; Gastrin ≥ 600 pg/mL; Neutrophils \< 10% or \> 80%; Platelet count \< 100 x10 to the third power/ul or \> 600 x10 to the third power/ul; Urine protein albumin \> 2+ (dipstick) 100mg/dL or positive; Urine leukocyte esterase \> 2+ (dipstick) moderate or positive.
Z-Score is a statistical measure to evaluate how a single data point compares to a standard. A Z-Score describes whether a mean is above or below the standard and how unusual the measurement is. Z-scores primarily range from -3 to +3. A Z-score of 0 indicates the same mean, \>0 a greater mean, and \<0 a lesser mean than the standard. In this study, infant growth parameters were compared to a standard defined by Centers for Disease Control's growth charts.
| Arm | Type | Description |
|---|---|---|
| Pantoprazole | ACTIVE_COMPARATOR | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Low dose | ACTIVE_COMPARATOR | - |
| High dose | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| pantoprazole | DRUG | - |
| Placebo | DRUG | - |
Inclusion Criteria: * 12-16 years old * clinical diagnosis of GERD * ability to swallow tablets Exclusion Criteria: * GI or malabsorption disorders * chronic use of warfarin * positive pregnancy test
Pantoprazole is used for gastroesophageal reflux and peptic ulcer hemorrhage. It is a small molecule developed by Pfizer, Inc. and studied in Phase 3 clinical trials. The completed trials enrolled infants, neonates, preterm infants, and adolescents with gastroesophageal reflux disease, evaluating safety and efficacy in these pediatric populations.
Pantoprazole targets ATP4A and ATP4B, which are subunits of the gastric proton pump. It acts as an inhibitor of this target. By inhibiting the proton pump, pantoprazole reduces gastric acid secretion, which is the mechanism underlying its use in gastroesophageal reflux and peptic ulcer hemorrhage.
Pantoprazole is developed by Pfizer, Inc., which trades under the ticker PFE. Pfizer conducted the Phase 3 clinical program evaluating pantoprazole in pediatric patients with gastroesophageal reflux disease, including infants, neonates, preterm infants, and adolescents.
Pantoprazole is in Phase 3 clinical development for gastroesophageal reflux and peptic ulcer hemorrhage. Four Phase 3 trials have been completed, with no active trials currently listed. The completed studies were randomized, double-blind, and placebo-controlled, enrolling a total of 266 participants across the program.
Pantoprazole has been studied in four completed Phase 3 trials: NCT00868296, an open-label safety study in infants under 12 months with presumed GERD; NCT00367614 in adolescents with GERD; NCT00365300, a placebo-controlled efficacy and safety study in infants; and NCT00362609 in neonates and preterm infants with GERD.
Pantoprazole is an investigational therapy in Phase 3 clinical development for gastroesophageal reflux and peptic ulcer hemorrhage. The four Phase 3 trials supporting this program have been completed, and no active trials are currently listed. The development stage indicates it remains in clinical development for these indications.