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CompletedNCT00259012Updated May 7, 2010Results posted

Study Evaluating Pantoprazole Sodium Enteric-Coated Spheroid Suspension In Infants With Presumed GERD

A Phase 3 interventional study of pantoprazole sodium enteric-coated spheroid suspension in Gastroesophageal Reflux, sponsored by Wyeth is now a wholly owned subsidiary of Pfizer. Completed at 31 sites in 8 countries. Open to participants aged 1 Month to 11 Months. Per ClinicalTrials.gov, last updated 2010-05-07.

Sponsored by Wyeth is now a wholly owned subsidiary of Pfizer · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
67
Allocation
Randomized
Ages
1 Month to 11 Months
Sex
All
01

Study summary

The purpose of this study is to characterize the pharmacokinetic (PK) and pharmacodynamic (PD) profiles to determine the safety and tolerability of single and multiple doses of pantoprazole in infants aged 1 through 11 months.

02

Conditions studied

  • Gastroesophageal Reflux

Keywords

  • GERD
  • Infant
03

In context

Gastroesophageal Reflux

1,067 studies on the registry are indexed under Gastroesophageal Reflux; 188 are open to participants now.

This study's enrollment of 67 is close to the median of 72 across 712 interventional studies indexed under Gastroesophageal Reflux.

Browse Gastroesophageal Reflux studies →

Lead sponsor

Wyeth is now a wholly owned subsidiary of Pfizer is the lead sponsor of 472 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Month to 11 Months
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Greater than 44 weeks beyond neonatal period but less than 12 months
  • Presumptive diagnosis of GERD
  • Weight greater than 2.5 kg but less than 15 kg

Exclusion criteria

Exclusion Criteria:

  • History of gastrointestinal (GI) disorders, ie, unrepaired tracheal esophageal fistula, GI malabsorption
  • Clinically significant medical or surgical abnormalities
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
67 participants (actual)

Study arms

  • Active comparator
    Low dose

    Drug: pantoprazole sodium enteric-coated spheroid suspension

  • Active comparator
    High dose

    Drug: pantoprazole sodium enteric-coated spheroid suspension

Interventions

  • Drugpantoprazole sodium enteric-coated spheroid suspension

    pediatric suspension taken daily x 7 days

06

What researchers measure

Primary outcomes

  1. Peak Concentration (Cmax)

    Pharmacokinetic (PK) parameters, including peak plasma concentration, were determined following a single oral dose of pantoprazole

    Time frame: 1 day

  2. Time to Peak Concentration (Tmax) Profile

    Pharmacokinetic (PK) parameters, including time to peak plasma concentration, were determined following a single oral dose of pantoprazole.

    Time frame: 1 day

  3. 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.

    Time frame: 1 day

  4. 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.

    Time frame: 1 day

  5. 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.

    Time frame: 1 day

  6. 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.

    Time frame: 7 days

  7. 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).

    Time frame: 7 days

  8. 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).

    Time frame: 7 days

  9. 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).

    Time frame: 7 days

  10. 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).

    Time frame: 7 days

  11. 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).

    Time frame: 7 days

  12. 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).

    Time frame: 7 days

  13. 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.

    Time frame: 7 days

  14. 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.

    Time frame: 7 days

07

Results

Posted May 7, 2010

Participant flow

Patients were recruited February 2006 to January 2008.

Participant flow — Overall Study
MilestoneLow Dose Pantoprazole (0.6 mg/kg)High Dose Pantoprazole (1.2 mg/kg)
Started3334
Completed3130
Not completed24
Withdrew: Adverse event01
Withdrew: Withdrawal by subject10
Withdrew: Physician decision01
Withdrew: Lost to follow-up01
Withdrew: Protocol violation11

Outcome measures

PrimaryPeak Concentration (Cmax)

Pharmacokinetic (PK) parameters, including peak plasma concentration, were determined following a single oral dose of pantoprazole

Time frame:
1 day
Reported as:
Mean · ng/mL
Peak Concentration (Cmax)
ng/mLLow Dose Pantoprazole (0.6 mg/kg)High Dose Pantoprazole (1.2 mg/kg)
Peak Concentration (Cmax)567 ± 5341527 ± 1298
PrimaryTime to Peak Concentration (Tmax) Profile

Pharmacokinetic (PK) parameters, including time to peak plasma concentration, were determined following a single oral dose of pantoprazole.

Time frame:
1 day
Reported as:
Median · hr
Time to Peak Concentration (Tmax) Profile
hrLow Dose Pantoprazole (0.6 mg/kg)High Dose Pantoprazole (1.2 mg/kg)
Time to Peak Concentration (Tmax) Profile1.03 (1.00 to 4.00)1.02 (0.50 to 4.08)
PrimaryDisposition 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.

Time frame:
1 day
Reported as:
Mean · hr
Disposition Half-life
hrLow Dose Pantoprazole (0.6 mg/kg)High Dose Pantoprazole (1.2 mg/kg)
Disposition Half-life1.78 ± 1.301.42 ± 0.78
PrimaryArea 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.

Time frame:
1 day
Reported as:
Mean · ng*hr/mL
Area Under the Concentration-time Curve (AUC)
ng*hr/mLLow Dose Pantoprazole (0.6 mg/kg)High Dose Pantoprazole (1.2 mg/kg)
Area Under the Concentration-time Curve (AUC)1046 ± 10433602 ± 3269
PrimaryApparent 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.

Time frame:
1 day
Reported as:
Mean · L/hr/kg
Apparent Oral Clearance (CL/F)
L/hr/kgLow Dose Pantoprazole (0.6 mg/kg)High Dose Pantoprazole (1.2 mg/kg)
Apparent Oral Clearance (CL/F)1.54 ± 2.350.87 ± 1.36
PrimaryPantoprazole 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.

Time frame:
7 days
Reported as:
Mean · ng/mL
Pantoprazole Plasma Concentration After Multiple-Dose Oral Administration
ng/mLLow Dose Pantoprazole (0.6 mg/kg)High Dose Pantoprazole (1.2 mg/kg)
2 hours289 ± 354668 ± 825
4 hours69 ± 102353 ± 509
PrimaryIntragastric 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).

Time frame:
7 days
Reported as:
Mean · units on scale
Intragastric pH
units on scaleLow Dose Pantoprazole (0.6 mg/kg)High Dose Pantoprazole (1.2 mg/kg)
Baseline4.2 ± 1.43.0 ± 1.4
Steady state4.8 ± 1.34.2 ± 1.5
Statistical analysis
  • Low Dose Pantoprazole (0.6 mg/kg) · t-test, 2 sided · p = 0.087paired
  • High Dose Pantoprazole (1.2 mg/kg) · t-test, 2 sided · p = 0.019paired
PrimaryMedian 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).

Time frame:
7 days
Reported as:
Mean · units on scale
Median Intragastric pH
units on scaleLow Dose Pantoprazole (0.6 mg/kg)High Dose Pantoprazole (1.2 mg/kg)
Baseline4.2 ± 1.72.8 ± 1.5
Steady state4.7 ± 1.74.2 ± 1.9
Statistical analysis
  • Low Dose Pantoprazole (0.6 mg/kg) · t-test, 2 sided · p = 0.255paired
  • High Dose Pantoprazole (1.2 mg/kg) · t-test, 2 sided · p = 0.031paired
PrimaryPercentage 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).

Time frame:
7 days
Reported as:
Mean · percentage of time
Percentage of Time Intragastric pH Was >4
percentage of timeLow Dose Pantoprazole (0.6 mg/kg)High Dose Pantoprazole (1.2 mg/kg)
Baseline55.5 ± 28.632.2 ± 24.1
Steady state68.5 ± 28.356.6 ± 31.1
Statistical analysis
  • Low Dose Pantoprazole (0.6 mg/kg) · t-test, 2 sided · p = 0.099
  • High Dose Pantoprazole (1.2 mg/kg) · t-test, 2 sided · p = 0.016
PrimaryMean 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).

Time frame:
7 days
Reported as:
Mean · units on scale
Mean Intraesophageal pH
units on scaleLow Dose Pantoprazole (0.6 mg/kg)High Dose Pantoprazole (1.2 mg/kg)
Baseline5.7 ± 0.75.2 ± 0.4
Steady state5.6 ± 0.84.9 ± 0.3
Statistical analysis
  • Low Dose Pantoprazole (0.6 mg/kg) · t-test, 2 sided · p = 0.347
  • High Dose Pantoprazole (1.2 mg/kg) · t-test, 2 sided · p = 0.012
PrimaryMedian 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).

Time frame:
7 days
Reported as:
Mean · units on scale
Median Intraesophageal pH
units on scaleLow Dose Pantoprazole (0.6 mg/kg)High Dose Pantoprazole (1.2 mg/kg)
Baseline5.8 ± 0.75.3 ± 0.5
Steady state5.6 ± 0.84.9 ± 0.4
Statistical analysis
  • Low Dose Pantoprazole (0.6 mg/kg) · t-test, 2 sided · p = 0.339
  • High Dose Pantoprazole (1.2 mg/kg) · t-test, 2 sided · p = 0.003
PrimaryPercentage 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).

Time frame:
7 days
Reported as:
Mean · percentage of time
Percentage of Time That Intraesophageal pH Was <4
percentage of timeLow Dose Pantoprazole (0.6 mg/kg)High Dose Pantoprazole (1.2 mg/kg)
Baseline4.6 ± 3.98.0 ± 5.6
Steady state4.6 ± 5.69.4 ± 5.8
Statistical analysis
  • Low Dose Pantoprazole (0.6 mg/kg) · t-test, 2 sided · p = 0.982
  • High Dose Pantoprazole (1.2 mg/kg) · t-test, 2 sided · p = 0.534
PrimaryNormalized 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.

Time frame:
7 days
Reported as:
Mean · H*mmol/L
Normalized Area of Gastric Hydrogen Ion Activity Over Time
H*mmol/LLow Dose Pantoprazole (0.6 mg/kg)High Dose Pantoprazole (1.2 mg/kg)
Baseline259.7 ± 442.7921.0 ± 1290.1
Steady state102.3 ± 118.6303.6 ± 524.9
Statistical analysis
  • Low Dose Pantoprazole (0.6 mg/kg) · t-test, 2 sided · p = 0.166
  • High Dose Pantoprazole (1.2 mg/kg) · t-test, 2 sided · p = 0.119
PrimaryNormalized 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.

Time frame:
7 days
Reported as:
Mean · H*mmol/L
Normalized Area of Esophageal Hydrogen Ion Activity Over Time
H*mmol/LLow Dose Pantoprazole (0.6 mg/kg)High Dose Pantoprazole (1.2 mg/kg)
Baseline2.1 ± 1.63.5 ± 2.3
Steady state1.5 ± 2.41.5 ± 0.6
Statistical analysis
  • Low Dose Pantoprazole (0.6 mg/kg) · t-test, 2 sided · p = 0.387
  • High Dose Pantoprazole (1.2 mg/kg) · t-test, 2 sided · p = 0.021

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Low Dose Pantoprazole (0.6 mg/kg)———
High Dose Pantoprazole (1.2 mg/kg)———
Most frequent serious events
Most frequent serious events
EventLow Dose Pantoprazole (0.6 mg/kg)High Dose Pantoprazole (1.2 mg/kg)
GastroenteritisGastrointestinal disorders1/331/34
VomitingGastrointestinal disorders1/330/34
DehydrationMetabolism and nutrition disorders1/330/34
StridorRespiratory, thoracic and mediastinal disorders1/330/34
ApneaRespiratory, thoracic and mediastinal disorders0/331/34
Most frequent other events
Showing 10 of 26
Most frequent other events
EventLow Dose Pantoprazole (0.6 mg/kg)High Dose Pantoprazole (1.2 mg/kg)
FeverGeneral disorders3/334/34
DiarrheaGastrointestinal disorders2/334/34
RhinitisRespiratory, thoracic and mediastinal disorders1/333/34
Contact dermatitisSkin and subcutaneous tissue disorders2/333/34
Otitis mediaEar and labyrinth disorders0/333/34
VomitingGastrointestinal disorders2/330/34
InfectionGeneral disorders1/332/34
FlatulenceGastrointestinal disorders0/332/34
GastroenteritisGastrointestinal disorders1/332/34
Tooth disorderGastrointestinal disorders0/332/34

Baseline characteristics

Age Continuous
Age Continuous(months)Low Dose Pantoprazole (0.6 mg/kg)High Dose Pantoprazole (1.2 mg/kg)Total
Mean5.98 ± 2.985.91 ± 3.425.94 ± 3.19
Sex: Female, Male
Sex: Female, Male(Participants)Low Dose Pantoprazole (0.6 mg/kg)High Dose Pantoprazole (1.2 mg/kg)Total
Female131528.0
Male201939.0
08

Study locations

31 sites
  • Little Rock, Arkansas 72205, United States
  • Loma Linda, California 92351, United States
  • San Diego, California 92103, United States
  • Washington, District of Columbia 20010, United States
  • Miami, Florida 33101, United States
  • Pensacola, Florida 32504, United States
  • Chicago, Illinois 60614, United States
  • Park Ridge, Illinois 60068, United States
  • Louisville, Kentucky 40202, United States
  • Shreveport, Louisiana 71130, United States
  • Jackson, Mississippi 39216, United States
  • Kansas City, Missouri 64108, United States
  • New York, New York 10032, United States
  • Durham, North Carolina 27710, United States
  • Cleveland, Ohio 44106, United States
  • Temple, Texas 76508, United States
  • Brisbane, Australia
  • Antwerpen, B-2020, Belgium
  • Brussels, B-1090, Belgium
  • Gent, B-9000, Belgium
  • Paris, 75674, France
  • Aachen, D-52074, Germany
  • Osnabruck, D-49074, Germany
  • Brescia, 25123, Italy
  • Naples, 80131, Italy
  • Roma, 00161, Italy
  • Krakow, 30-663, Poland
  • Lodz, 91-738, Poland
  • Lublin, Poland
  • Warszaw, 04-730, Poland
  • Zurich, 8032, Switzerland
09

References and documents

Publications

  • Tammara BK, Sullivan JE, Adcock KG, Kierkus J, Giblin J, Rath N, Meng X, Maguire MK, Comer GM, Ward RM. Randomized, open-label, multicentre pharmacokinetic studies of two dose levels of pantoprazole granules in infants and children aged 1 month through <6 years with gastro-oesophageal reflux disease. Clin Pharmacokinet. 2011 Aug;50(8):541-50. doi: 10.2165/11591900-000000000-00000. PubMed 21740077 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 7, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00259012
Lead sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
Collaborators
Nycomed
First posted
Nov 28, 2005
Start date
Nov 2005
Primary completion
Mar 2008
Completion
Mar 2008
Results posted
May 7, 2010
Last update
May 7, 2010

Study contacts

Medical Monitor
study director · Wyeth is now a wholly owned subsidiary of Pfizer
Trial Manager
principal investigator · For Australia, medinfo@wyeth.com
Trial Manager
principal investigator · For Belgium, trials-BEL@wyeth.com
Trial Manager
principal investigator · For France, infomedfrance@wyeth.com
Trial Manager
principal investigator · For Germany, medinfoDEU@wyeth.com
Trial Manager
principal investigator · For Italy, descresg@wyeth.com
Trial Manager
principal investigator · For Poland, WPWZMED@wyeth.com
Trial Manager
principal investigator · For Switzerland, med@wyeth.com

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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