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pantoprazole enteric-coated spheroid

Phase 3

Gastroesophageal Reflux | Small molecule | Gastrointestinal |Pfizer, Inc.|Last Updated: May 19, 2010

Target and mechanism

ModalitySmall molecule

Also known as pantoprazole sodium enteric-coated spheroid suspension, pantoprazole sodium enteric-coated spheroid

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLED
Total Trials2
Total Enrollment127

FDA Designations

No designations recorded

Clinical trial landscape

pantoprazole enteric-coated spheroid · 2 trials · 1 indication

Phase 3 2
NCT00300755Study Evaluating Pantoprazole in Children With Gastroesophageal Reflux Disease (GERD)Gastroesophageal Reflux
COMPLETED60 Analytics
NCT00259012Study Evaluating Pantoprazole Sodium Enteric-Coated Spheroid Suspension In Infants With Presumed GERDGastroesophageal Reflux
COMPLETED67 Analytics
PHASE3COMPLETED
Study Evaluating Pantoprazole in Children With Gastroesophageal Reflux Disease (GERD)
Gastroesophageal RefluxUnlock trial analytics
PHASE3COMPLETED
Study Evaluating Pantoprazole Sodium Enteric-Coated Spheroid Suspension In Infants With Presumed GERD
Gastroesophageal RefluxUnlock trial analytics

Study Endpoints

Primary Endpoints

Change in Weekly Gastroesophageal Reflux Disease (GERD) Symptom Scores (WGSS)
Baseline and 8 weeks

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 in the treatment period.

Peak Concentration (Cmax)
1 day

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

Time to Peak Concentration (Tmax) Profile
1 day

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

Disposition Half-life
1 day

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.

Area Under the Concentration-time Curve (AUC)
1 day

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.

Apparent Oral Clearance (CL/F)
1 day

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.

Pantoprazole Plasma Concentration After Multiple-Dose Oral Administration
7 days

Plasma concentration of pantoprazole after multiple doses was measured to see if there was any accumulation of the drug.

Intragastric pH
7 days

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).

Median Intragastric pH
7 days

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).

Percentage of Time Intragastric pH Was >4
7 days

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).

Mean Intraesophageal pH
7 days

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).

Median Intraesophageal pH
7 days

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).

Percentage of Time That Intraesophageal pH Was <4
7 days

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
7 days

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
7 days

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.

Secondary Endpoints

Change in Individual Weekly Mean Frequency Score for Each Gastroesophageal Reflux Disease (GERD) Symptom Score From Baseline to Final Week
Baseline and 8 weeks
Change in Individual Weekly Mean Score For Each Respiratory Symptom From Baseline
Baseline and 8 weeks
Number of Patients With "Healed" Erosive Esophagitis (EE) at End of Study
8 weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1ACTIVE_COMPARATORArm 1- Low Dose pantoprazole
2ACTIVE_COMPARATORArm 2- Medium Dose pantoprazole
3ACTIVE_COMPARATORArm 3- High Dose pantoprazole
Low doseACTIVE_COMPARATOR -
High doseACTIVE_COMPARATOR -

Interventions

NameTypeDescription
pantoprazole sodium enteric-coated spheroidDRUGpediatric spheroids taken daily x 8 weeks
pantoprazole sodium enteric-coated spheroid suspensionDRUGpediatric suspension taken daily x 7 days
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Eligibility Criteria

Age Range1 Year to 5 Years
SexALL
Healthy VolunteersNo
Study Sites43

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...

Countries:United StatesCanadaAustraliaBelgiumFranceGermanyItalyPolandSwitzerland
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