| Primary | Peak Concentration (Cmax) | Pharmacokinetic (PK) parameters, including peak plasma concentration, were determined following a single oral dose of pantoprazole | All patients without any major protocol violations who received 1 dose of pantoprazole on the day the PK samples were obtained, who had at least 4 blood samples, and for whom the pantoprazole terminal-phase disposition half-life could be estimated. | Posted | Nov 2009 | Mean | Standard Deviation | ng/mL | | 1 day | | | | ID | Title | Description |
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| OG000 | Low Dose Pantoprazole (0.6 mg/kg) | Patients weighing 2.5 to <7 kg received pantoprazole sodium enteric-coated spheroid suspension daily 2.5 mg. Patients weighing ≥7 to ≤15 kg received pantoprazole sodium enteric-coated spheroid suspension daily 5 mg. This dosing corresponds to approximately 0.6 mg/kg. | | OG001 | High Dose Pantoprazole (1.2 mg/kg) | Patients weighing 2.5 to <7 kg received pantoprazole sodium enteric-coated spheroid suspension daily 5 mg. Patients weighing ≥7 to ≤15 kg received pantoprazole sodium enteric-coated spheroid suspension daily 10 mg. This dosing corresponds to approximately 1.2 mg/kg. |
| | | Title | Denominators | Categories |
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| | | Title | Measurements |
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| - OG000567± 534
- OG0011527± 1298
|
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| Primary | Time to Peak Concentration (Tmax) Profile | Pharmacokinetic (PK) parameters, including time to peak plasma concentration, were determined following a single oral dose of pantoprazole. | All patients without any major protocol violations who received 1 dose of pantoprazole on the day the PK samples were obtained, who had at least 4 blood samples, and for whom the pantoprazole terminal-phase disposition half-life could be estimated. | Posted | Nov 2009 | Median | Full Range | hr | | 1 day | | | | ID | Title | Description |
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| OG000 | Low Dose Pantoprazole (0.6 mg/kg) | Patients weighing 2.5 to <7 kg received pantoprazole sodium enteric-coated spheroid suspension daily 2.5 mg. Patients weighing ≥7 to ≤15 kg received pantoprazole sodium enteric-coated spheroid suspension daily 5 mg. This dosing corresponds to approximately 0.6 mg/kg. | | OG001 | High Dose Pantoprazole (1.2 mg/kg) | Patients weighing 2.5 to <7 kg received pantoprazole sodium enteric-coated spheroid suspension daily 5 mg. Patients weighing ≥7 to ≤15 kg received pantoprazole sodium enteric-coated spheroid suspension daily 10 mg. This dosing corresponds to approximately 1.2 mg/kg. |
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| Primary | Disposition Half-life | 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. | All patients without any major protocol violations who received 1 dose of pantoprazole on the day the PK samples were obtained, who had at least 4 blood samples, and for whom the pantoprazole terminal-phase disposition half-life could be estimated. | Posted | Nov 2009 | Mean | Standard Deviation | hr | | 1 day | | | | ID | Title | Description |
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| OG000 | Low Dose Pantoprazole (0.6 mg/kg) | Patients weighing 2.5 to <7 kg received pantoprazole sodium enteric-coated spheroid suspension daily 2.5 mg. Patients weighing ≥7 to ≤15 kg received pantoprazole sodium enteric-coated spheroid suspension daily 5 mg. This dosing corresponds to approximately 0.6 mg/kg. | | OG001 | High Dose Pantoprazole (1.2 mg/kg) | Patients weighing 2.5 to <7 kg received pantoprazole sodium enteric-coated spheroid suspension daily 5 mg. Patients weighing ≥7 to ≤15 kg received pantoprazole sodium enteric-coated spheroid suspension daily 10 mg. This dosing corresponds to approximately 1.2 mg/kg. |
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| Primary | Area Under the Concentration-time Curve (AUC) | 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. | All patients without any major protocol violations who received 1 dose of pantoprazole on the day the PK samples were obtained, who had at least 4 blood samples, and for whom the pantoprazole terminal-phase disposition half-life could be estimated. | Posted | Nov 2009 | Mean | Standard Deviation | ng*hr/mL | | 1 day | | | | ID | Title | Description |
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| OG000 | Low Dose Pantoprazole (0.6 mg/kg) | Patients weighing 2.5 to <7 kg received pantoprazole sodium enteric-coated spheroid suspension daily 2.5 mg. Patients weighing ≥7 to ≤15 kg received pantoprazole sodium enteric-coated spheroid suspension daily 5 mg. This dosing corresponds to approximately 0.6 mg/kg. | | OG001 | High Dose Pantoprazole (1.2 mg/kg) | Patients weighing 2.5 to <7 kg received pantoprazole sodium enteric-coated spheroid suspension daily 5 mg. Patients weighing ≥7 to ≤15 kg received pantoprazole sodium enteric-coated spheroid suspension daily 10 mg. This dosing corresponds to approximately 1.2 mg/kg. |
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| Primary | Apparent Oral Clearance (CL/F) | 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. | All patients without any major protocol violations who received 1 dose of pantoprazole on the day the PK samples were obtained, who had at least 4 blood samples, and for whom the pantoprazole terminal-phase disposition half-life could be estimated. | Posted | Nov 2009 | Mean | Standard Deviation | L/hr/kg | | 1 day | | | | ID | Title | Description |
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| OG000 | Low Dose Pantoprazole (0.6 mg/kg) | Patients weighing 2.5 to <7 kg received pantoprazole sodium enteric-coated spheroid suspension daily 2.5 mg. Patients weighing ≥7 to ≤15 kg received pantoprazole sodium enteric-coated spheroid suspension daily 5 mg. This dosing corresponds to approximately 0.6 mg/kg. | | OG001 | High Dose Pantoprazole (1.2 mg/kg) | Patients weighing 2.5 to <7 kg received pantoprazole sodium enteric-coated spheroid suspension daily 5 mg. Patients weighing ≥7 to ≤15 kg received pantoprazole sodium enteric-coated spheroid suspension daily 10 mg. This dosing corresponds to approximately 1.2 mg/kg. |
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| Primary | Pantoprazole Plasma Concentration After Multiple-Dose Oral Administration | Plasma concentration of pantoprazole after multiple doses was measured to see if there was any accumulation of the drug. | All patients for whom at least 2 PK samples were obtained after 5 consecutive doses. Low dose population was 19 for both 2 and 4 hours. High dose population was 17 and 18 for 2 and 4 hours respectively. | Posted | Nov 2009 | Mean | Standard Deviation | ng/mL | | 7 days | | | | ID | Title | Description |
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| OG000 | Low Dose Pantoprazole (0.6 mg/kg) | Patients weighing 2.5 to <7 kg received pantoprazole sodium enteric-coated spheroid suspension daily 2.5 mg. Patients weighing ≥7 to ≤15 kg received pantoprazole sodium enteric-coated spheroid suspension daily 5 mg. This dosing corresponds to approximately 0.6 mg/kg. | | OG001 | High Dose Pantoprazole (1.2 mg/kg) | Patients weighing 2.5 to <7 kg received pantoprazole sodium enteric-coated spheroid suspension daily 5 mg. Patients weighing ≥7 to ≤15 kg received pantoprazole sodium enteric-coated spheroid suspension daily 10 mg. This dosing corresponds to approximately 1.2 mg/kg. |
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| Primary | Intragastric pH | 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). | Patients who had baseline and steady-state pH-metry performed, total pH-metry recording time of at least 16 hours, and received at least 5 consecutive daily doses of pantoprazole before the steady-state pH-metry was performed. | Posted | Nov 2009 | Mean | Standard Deviation | units on scale | | 7 days | | | | ID | Title | Description |
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| OG000 | Low Dose Pantoprazole (0.6 mg/kg) | Patients weighing 2.5 to <7 kg received pantoprazole sodium enteric-coated spheroid suspension daily 2.5 mg. Patients weighing ≥7 to ≤15 kg received pantoprazole sodium enteric-coated spheroid suspension daily 5 mg. This dosing corresponds to approximately 0.6 mg/kg. | | OG001 | High Dose Pantoprazole (1.2 mg/kg) | Patients weighing 2.5 to <7 kg received pantoprazole sodium enteric-coated spheroid suspension daily 5 mg. Patients weighing ≥7 to ≤15 kg received pantoprazole sodium enteric-coated spheroid suspension daily 10 mg. This dosing corresponds to approximately 1.2 mg/kg. |
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| Primary | Median Intragastric pH | 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). | Patients who had baseline and steady-state pH-metry performed, total pH-metry recording time of at least 16 hours, and received at least 5 consecutive daily doses of pantoprazole before the steady-state pH-metry was performed. | Posted | Nov 2009 | Mean | Standard Deviation | units on scale | | 7 days | | | | ID | Title | Description |
|---|
| OG000 | Low Dose Pantoprazole (0.6 mg/kg) | Patients weighing 2.5 to <7 kg received pantoprazole sodium enteric-coated spheroid suspension daily 2.5 mg. Patients weighing ≥7 to ≤15 kg received pantoprazole sodium enteric-coated spheroid suspension daily 5 mg. This dosing corresponds to approximately 0.6 mg/kg. | | OG001 | High Dose Pantoprazole (1.2 mg/kg) | Patients weighing 2.5 to <7 kg received pantoprazole sodium enteric-coated spheroid suspension daily 5 mg. Patients weighing ≥7 to ≤15 kg received pantoprazole sodium enteric-coated spheroid suspension daily 10 mg. This dosing corresponds to approximately 1.2 mg/kg. |
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| Primary | Percentage of Time Intragastric pH Was >4 | 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). | Patients who had baseline and steady-state pH-metry performed, total pH-metry recording time of at least 16 hours, and received at least 5 consecutive daily doses of pantoprazole before the steady-state pH-metry was performed. | Posted | Nov 2009 | Mean | Standard Deviation | percentage of time | | 7 days | | | | ID | Title | Description |
|---|
| OG000 | Low Dose Pantoprazole (0.6 mg/kg) | Patients weighing 2.5 to <7 kg received pantoprazole sodium enteric-coated spheroid suspension daily 2.5 mg. Patients weighing ≥7 to ≤15 kg received pantoprazole sodium enteric-coated spheroid suspension daily 5 mg. This dosing corresponds to approximately 0.6 mg/kg. | | OG001 | High Dose Pantoprazole (1.2 mg/kg) | Patients weighing 2.5 to <7 kg received pantoprazole sodium enteric-coated spheroid suspension daily 5 mg. Patients weighing ≥7 to ≤15 kg received pantoprazole sodium enteric-coated spheroid suspension daily 10 mg. This dosing corresponds to approximately 1.2 mg/kg. |
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| Primary | Mean Intraesophageal pH | 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). | Patients who had baseline and steady-state pH-metry performed, total pH-metry recording time of at least 16 hours, and received at least 5 consecutive daily doses of pantoprazole before the steady-state pH-metry was performed. | Posted | Nov 2009 | Mean | Standard Deviation | units on scale | | 7 days | | | | ID | Title | Description |
|---|
| OG000 | Low Dose Pantoprazole (0.6 mg/kg) | Patients weighing 2.5 to <7 kg received pantoprazole sodium enteric-coated spheroid suspension daily 2.5 mg. Patients weighing ≥7 to ≤15 kg received pantoprazole sodium enteric-coated spheroid suspension daily 5 mg. This dosing corresponds to approximately 0.6 mg/kg. | | OG001 | High Dose Pantoprazole (1.2 mg/kg) | Patients weighing 2.5 to <7 kg received pantoprazole sodium enteric-coated spheroid suspension daily 5 mg. Patients weighing ≥7 to ≤15 kg received pantoprazole sodium enteric-coated spheroid suspension daily 10 mg. This dosing corresponds to approximately 1.2 mg/kg. |
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| Primary | Median Intraesophageal pH | 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). | Patients who had baseline and steady-state pH-metry performed, total pH-metry recording time of at least 16 hours, and received at least 5 consecutive daily doses of pantoprazole before the steady-state pH-metry was performed. | Posted | Nov 2009 | Mean | Standard Deviation | units on scale | | 7 days | | | | ID | Title | Description |
|---|
| OG000 | Low Dose Pantoprazole (0.6 mg/kg) | Patients weighing 2.5 to <7 kg received pantoprazole sodium enteric-coated spheroid suspension daily 2.5 mg. Patients weighing ≥7 to ≤15 kg received pantoprazole sodium enteric-coated spheroid suspension daily 5 mg. This dosing corresponds to approximately 0.6 mg/kg. | | OG001 | High Dose Pantoprazole (1.2 mg/kg) | Patients weighing 2.5 to <7 kg received pantoprazole sodium enteric-coated spheroid suspension daily 5 mg. Patients weighing ≥7 to ≤15 kg received pantoprazole sodium enteric-coated spheroid suspension daily 10 mg. This dosing corresponds to approximately 1.2 mg/kg. |
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| Primary | Percentage of Time That Intraesophageal pH Was <4 | 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). | Patients who had baseline and steady-state pH-metry performed, total pH-metry recording time of at least 16 hours, and received at least 5 consecutive daily doses of pantoprazole before the steady-state pH-metry was performed. | Posted | Nov 2009 | Mean | Standard Deviation | percentage of time | | 7 days | | | | ID | Title | Description |
|---|
| OG000 | Low Dose Pantoprazole (0.6 mg/kg) | Patients weighing 2.5 to <7 kg received pantoprazole sodium enteric-coated spheroid suspension daily 2.5 mg. Patients weighing ≥7 to ≤15 kg received pantoprazole sodium enteric-coated spheroid suspension daily 5 mg. This dosing corresponds to approximately 0.6 mg/kg. | | OG001 | High Dose Pantoprazole (1.2 mg/kg) | Patients weighing 2.5 to <7 kg received pantoprazole sodium enteric-coated spheroid suspension daily 5 mg. Patients weighing ≥7 to ≤15 kg received pantoprazole sodium enteric-coated spheroid suspension daily 10 mg. This dosing corresponds to approximately 1.2 mg/kg. |
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| Primary | Normalized Area of Gastric Hydrogen Ion Activity Over Time | 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. | Patients who had baseline and steady-state pH-metry performed, total pH-metry recording time of at least 16 hours, and received at least 5 consecutive daily doses of pantoprazole before the steady-state pH-metry was performed. | Posted | Nov 2009 | Mean | Standard Deviation | H*mmol/L | | 7 days | | | | ID | Title | Description |
|---|
| OG000 | Low Dose Pantoprazole (0.6 mg/kg) | Patients weighing 2.5 to <7 kg received pantoprazole sodium enteric-coated spheroid suspension daily 2.5 mg. Patients weighing ≥7 to ≤15 kg received pantoprazole sodium enteric-coated spheroid suspension daily 5 mg. This dosing corresponds to approximately 0.6 mg/kg. | | OG001 | High Dose Pantoprazole (1.2 mg/kg) | Patients weighing 2.5 to <7 kg received pantoprazole sodium enteric-coated spheroid suspension daily 5 mg. Patients weighing ≥7 to ≤15 kg received pantoprazole sodium enteric-coated spheroid suspension daily 10 mg. This dosing corresponds to approximately 1.2 mg/kg. |
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| Primary | Normalized Area of Esophageal Hydrogen Ion Activity Over Time | 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. | Patients who had baseline and steady-state pH-metry performed, total pH-metry recording time of at least 16 hours, and received at least 5 consecutive daily doses of pantoprazole before the steady-state pH-metry was performed. | Posted | Nov 2009 | Mean | Standard Deviation | H*mmol/L | | 7 days | | | | ID | Title | Description |
|---|
| OG000 | Low Dose Pantoprazole (0.6 mg/kg) | Patients weighing 2.5 to <7 kg received pantoprazole sodium enteric-coated spheroid suspension daily 2.5 mg. Patients weighing ≥7 to ≤15 kg received pantoprazole sodium enteric-coated spheroid suspension daily 5 mg. This dosing corresponds to approximately 0.6 mg/kg. | | OG001 | High Dose Pantoprazole (1.2 mg/kg) | Patients weighing 2.5 to <7 kg received pantoprazole sodium enteric-coated spheroid suspension daily 5 mg. Patients weighing ≥7 to ≤15 kg received pantoprazole sodium enteric-coated spheroid suspension daily 10 mg. This dosing corresponds to approximately 1.2 mg/kg. |
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