Trial Outcomes & Findings for Study Evaluating Pantoprazole Sodium Enteric-Coated Spheroid Suspension In Infants With Presumed GERD (NCT NCT00259012)
NCT ID: NCT00259012
Last Updated: 2010-05-07
Results Overview
Pharmacokinetic (PK) parameters, including peak plasma concentration, were determined following a single oral dose of pantoprazole
COMPLETED
PHASE3
67 participants
1 day
2010-05-07
Participant Flow
Patients were recruited February 2006 to January 2008.
Patients were screened for seven days.
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
33
|
34
|
|
Overall Study
COMPLETED
|
31
|
30
|
|
Overall Study
NOT COMPLETED
|
2
|
4
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
|
Overall Study
Physician Decision
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
|
Overall Study
Protocol Violation
|
1
|
1
|
Baseline Characteristics
Study Evaluating Pantoprazole Sodium Enteric-Coated Spheroid Suspension In Infants With Presumed GERD
Baseline characteristics by cohort
| Measure |
Low Dose Pantoprazole (0.6 mg/kg)
n=33 Participants
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.
|
High Dose Pantoprazole (1.2 mg/kg)
n=34 Participants
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.
|
Total
n=67 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
5.98 months
STANDARD_DEVIATION 2.98 • n=99 Participants
|
5.91 months
STANDARD_DEVIATION 3.42 • n=107 Participants
|
5.94 months
STANDARD_DEVIATION 3.19 • n=206 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
28.0 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
39.0 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 1 dayPopulation: 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.
Pharmacokinetic (PK) parameters, including peak plasma concentration, were determined following a single oral dose of pantoprazole
Outcome measures
| Measure |
Low Dose Pantoprazole (0.6 mg/kg)
n=17 Participants
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.
|
High Dose Pantoprazole (1.2 mg/kg)
n=18 Participants
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.
|
|---|---|---|
|
Peak Concentration (Cmax)
|
567 ng/mL
Standard Deviation 534
|
1527 ng/mL
Standard Deviation 1298
|
PRIMARY outcome
Timeframe: 1 dayPopulation: 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.
Pharmacokinetic (PK) parameters, including time to peak plasma concentration, were determined following a single oral dose of pantoprazole.
Outcome measures
| Measure |
Low Dose Pantoprazole (0.6 mg/kg)
n=17 Participants
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.
|
High Dose Pantoprazole (1.2 mg/kg)
n=18 Participants
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.
|
|---|---|---|
|
Time to Peak Concentration (Tmax) Profile
|
1.03 hr
Interval 1.0 to 4.0
|
1.02 hr
Interval 0.5 to 4.08
|
PRIMARY outcome
Timeframe: 1 dayPopulation: 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.
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.
Outcome measures
| Measure |
Low Dose Pantoprazole (0.6 mg/kg)
n=17 Participants
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.
|
High Dose Pantoprazole (1.2 mg/kg)
n=18 Participants
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.
|
|---|---|---|
|
Disposition Half-life
|
1.78 hr
Standard Deviation 1.30
|
1.42 hr
Standard Deviation 0.78
|
PRIMARY outcome
Timeframe: 1 dayPopulation: 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.
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.
Outcome measures
| Measure |
Low Dose Pantoprazole (0.6 mg/kg)
n=17 Participants
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.
|
High Dose Pantoprazole (1.2 mg/kg)
n=18 Participants
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.
|
|---|---|---|
|
Area Under the Concentration-time Curve (AUC)
|
1046 ng*hr/mL
Standard Deviation 1043
|
3602 ng*hr/mL
Standard Deviation 3269
|
PRIMARY outcome
Timeframe: 1 dayPopulation: 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.
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.
Outcome measures
| Measure |
Low Dose Pantoprazole (0.6 mg/kg)
n=17 Participants
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.
|
High Dose Pantoprazole (1.2 mg/kg)
n=18 Participants
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.
|
|---|---|---|
|
Apparent Oral Clearance (CL/F)
|
1.54 L/hr/kg
Standard Deviation 2.35
|
0.87 L/hr/kg
Standard Deviation 1.36
|
PRIMARY outcome
Timeframe: 7 daysPopulation: 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.
Plasma concentration of pantoprazole after multiple doses was measured to see if there was any accumulation of the drug.
Outcome measures
| Measure |
Low Dose Pantoprazole (0.6 mg/kg)
n=19 Participants
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.
|
High Dose Pantoprazole (1.2 mg/kg)
n=18 Participants
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.
|
|---|---|---|
|
Pantoprazole Plasma Concentration After Multiple-Dose Oral Administration
2 hours
|
289 ng/mL
Standard Deviation 354
|
668 ng/mL
Standard Deviation 825
|
|
Pantoprazole Plasma Concentration After Multiple-Dose Oral Administration
4 hours
|
69 ng/mL
Standard Deviation 102
|
353 ng/mL
Standard Deviation 509
|
PRIMARY outcome
Timeframe: 7 daysPopulation: 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.
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).
Outcome measures
| Measure |
Low Dose Pantoprazole (0.6 mg/kg)
n=11 Participants
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.
|
High Dose Pantoprazole (1.2 mg/kg)
n=10 Participants
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.
|
|---|---|---|
|
Intragastric pH
Baseline
|
4.2 units on scale
Standard Deviation 1.4
|
3.0 units on scale
Standard Deviation 1.4
|
|
Intragastric pH
Steady state
|
4.8 units on scale
Standard Deviation 1.3
|
4.2 units on scale
Standard Deviation 1.5
|
PRIMARY outcome
Timeframe: 7 daysPopulation: 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.
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).
Outcome measures
| Measure |
Low Dose Pantoprazole (0.6 mg/kg)
n=11 Participants
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.
|
High Dose Pantoprazole (1.2 mg/kg)
n=10 Participants
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.
|
|---|---|---|
|
Median Intragastric pH
Baseline
|
4.2 units on scale
Standard Deviation 1.7
|
2.8 units on scale
Standard Deviation 1.5
|
|
Median Intragastric pH
Steady state
|
4.7 units on scale
Standard Deviation 1.7
|
4.2 units on scale
Standard Deviation 1.9
|
PRIMARY outcome
Timeframe: 7 daysPopulation: 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.
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).
Outcome measures
| Measure |
Low Dose Pantoprazole (0.6 mg/kg)
n=11 Participants
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.
|
High Dose Pantoprazole (1.2 mg/kg)
n=10 Participants
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.
|
|---|---|---|
|
Percentage of Time Intragastric pH Was >4
Baseline
|
55.5 percentage of time
Standard Deviation 28.6
|
32.2 percentage of time
Standard Deviation 24.1
|
|
Percentage of Time Intragastric pH Was >4
Steady state
|
68.5 percentage of time
Standard Deviation 28.3
|
56.6 percentage of time
Standard Deviation 31.1
|
PRIMARY outcome
Timeframe: 7 daysPopulation: 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.
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).
Outcome measures
| Measure |
Low Dose Pantoprazole (0.6 mg/kg)
n=11 Participants
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.
|
High Dose Pantoprazole (1.2 mg/kg)
n=10 Participants
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.
|
|---|---|---|
|
Mean Intraesophageal pH
Baseline
|
5.7 units on scale
Standard Deviation 0.7
|
5.2 units on scale
Standard Deviation 0.4
|
|
Mean Intraesophageal pH
Steady state
|
5.6 units on scale
Standard Deviation 0.8
|
4.9 units on scale
Standard Deviation 0.3
|
PRIMARY outcome
Timeframe: 7 daysPopulation: 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.
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).
Outcome measures
| Measure |
Low Dose Pantoprazole (0.6 mg/kg)
n=11 Participants
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.
|
High Dose Pantoprazole (1.2 mg/kg)
n=10 Participants
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.
|
|---|---|---|
|
Median Intraesophageal pH
Baseline
|
5.8 units on scale
Standard Deviation 0.7 • Interval 4.7 to 7.1
|
5.3 units on scale
Standard Deviation 0.5 • Interval 4.6 to 6.0
|
|
Median Intraesophageal pH
Steady state
|
5.6 units on scale
Standard Deviation 0.8 • Interval 4.5 to 7.3
|
4.9 units on scale
Standard Deviation 0.4 • Interval 4.5 to 5.7
|
PRIMARY outcome
Timeframe: 7 daysPopulation: 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.
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).
Outcome measures
| Measure |
Low Dose Pantoprazole (0.6 mg/kg)
n=11 Participants
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.
|
High Dose Pantoprazole (1.2 mg/kg)
n=10 Participants
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.
|
|---|---|---|
|
Percentage of Time That Intraesophageal pH Was <4
Baseline
|
4.6 percentage of time
Standard Deviation 3.9
|
8.0 percentage of time
Standard Deviation 5.6
|
|
Percentage of Time That Intraesophageal pH Was <4
Steady state
|
4.6 percentage of time
Standard Deviation 5.6
|
9.4 percentage of time
Standard Deviation 5.8
|
PRIMARY outcome
Timeframe: 7 daysPopulation: 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.
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.
Outcome measures
| Measure |
Low Dose Pantoprazole (0.6 mg/kg)
n=11 Participants
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.
|
High Dose Pantoprazole (1.2 mg/kg)
n=10 Participants
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.
|
|---|---|---|
|
Normalized Area of Gastric Hydrogen Ion Activity Over Time
Baseline
|
259.7 H*mmol/L
Standard Deviation 442.7
|
921.0 H*mmol/L
Standard Deviation 1290.1
|
|
Normalized Area of Gastric Hydrogen Ion Activity Over Time
Steady state
|
102.3 H*mmol/L
Standard Deviation 118.6
|
303.6 H*mmol/L
Standard Deviation 524.9
|
PRIMARY outcome
Timeframe: 7 daysPopulation: 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.
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.
Outcome measures
| Measure |
Low Dose Pantoprazole (0.6 mg/kg)
n=11 Participants
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.
|
High Dose Pantoprazole (1.2 mg/kg)
n=10 Participants
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.
|
|---|---|---|
|
Normalized Area of Esophageal Hydrogen Ion Activity Over Time
Baseline
|
2.1 H*mmol/L
Standard Deviation 1.6
|
3.5 H*mmol/L
Standard Deviation 2.3
|
|
Normalized Area of Esophageal Hydrogen Ion Activity Over Time
Steady state
|
1.5 H*mmol/L
Standard Deviation 2.4
|
1.5 H*mmol/L
Standard Deviation 0.6
|
Adverse Events
Low Dose Pantoprazole (0.6 mg/kg)
High Dose Pantoprazole (1.2 mg/kg)
Serious adverse events
| Measure |
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.
|
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.
|
|---|---|---|
|
Gastrointestinal disorders
Gastroenteritis
|
3.0%
1/33
|
2.9%
1/34
|
|
Gastrointestinal disorders
Vomiting
|
3.0%
1/33
|
0.00%
0/34
|
|
Metabolism and nutrition disorders
Dehydration
|
3.0%
1/33
|
0.00%
0/34
|
|
Respiratory, thoracic and mediastinal disorders
Apnea
|
0.00%
0/33
|
2.9%
1/34
|
|
Respiratory, thoracic and mediastinal disorders
Stridor
|
3.0%
1/33
|
0.00%
0/34
|
Other adverse events
| Measure |
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.
|
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.
|
|---|---|---|
|
General disorders
Abdominal pain
|
3.0%
1/33
|
2.9%
1/34
|
|
General disorders
Fever
|
9.1%
3/33
|
11.8%
4/34
|
|
General disorders
Infection
|
3.0%
1/33
|
5.9%
2/34
|
|
General disorders
Injection site pain
|
0.00%
0/33
|
2.9%
1/34
|
|
General disorders
Sepsis
|
3.0%
1/33
|
0.00%
0/34
|
|
Cardiac disorders
Atrial septal defect
|
3.0%
1/33
|
0.00%
0/34
|
|
Gastrointestinal disorders
Diarrhea
|
6.1%
2/33
|
11.8%
4/34
|
|
Gastrointestinal disorders
Eructation
|
3.0%
1/33
|
0.00%
0/34
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/33
|
5.9%
2/34
|
|
Gastrointestinal disorders
Gastroenteritis
|
3.0%
1/33
|
5.9%
2/34
|
|
Gastrointestinal disorders
Tooth disorder
|
0.00%
0/33
|
5.9%
2/34
|
|
Gastrointestinal disorders
Vomiting
|
6.1%
2/33
|
0.00%
0/34
|
|
Metabolism and nutrition disorders
Creatine phosphokinase increased
|
3.0%
1/33
|
0.00%
0/34
|
|
Metabolism and nutrition disorders
Dehydration
|
3.0%
1/33
|
0.00%
0/34
|
|
Metabolism and nutrition disorders
Weight loss
|
0.00%
0/33
|
2.9%
1/34
|
|
Respiratory, thoracic and mediastinal disorders
Apnea
|
0.00%
0/33
|
2.9%
1/34
|
|
Respiratory, thoracic and mediastinal disorders
Cough increased
|
0.00%
0/33
|
2.9%
1/34
|
|
Respiratory, thoracic and mediastinal disorders
Laryngitis
|
0.00%
0/33
|
2.9%
1/34
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis
|
3.0%
1/33
|
8.8%
3/34
|
|
Skin and subcutaneous tissue disorders
Contact dermatitis
|
6.1%
2/33
|
8.8%
3/34
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
3.0%
1/33
|
0.00%
0/34
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/33
|
2.9%
1/34
|
|
Skin and subcutaneous tissue disorders
Maculopapular rash
|
3.0%
1/33
|
0.00%
0/34
|
|
Skin and subcutaneous tissue disorders
Rash
|
3.0%
1/33
|
2.9%
1/34
|
|
Ear and labyrinth disorders
Otitis media
|
0.00%
0/33
|
8.8%
3/34
|
|
Renal and urinary disorders
Urine abnormality
|
0.00%
0/33
|
2.9%
1/34
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The PIs agreed to allow the sponsor 60 days to review and require changes to presentations or publications but only to protect confidential information and intellectual property, and for the sponsor to file a patent application, as applicable. The PIs also agreed for data to be presented first as a joint, multi-center publication.
- Publication restrictions are in place
Restriction type: OTHER