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Pantoprazole for approximately 9 weeks

Phase 3

Gastroesophageal Reflux | Small molecule | Gastrointestinal |Pfizer, Inc.|Last Updated: Feb 8, 2013

Target and mechanism

ModalitySmall molecule

Also known as pantoprazole for approximately 9 weeks.

Success Probability

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Market & Valuation

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Trial Design

RandomizedUNCONTROLLED
Total Trials2
Total Enrollment138

FDA Designations

No designations recorded

Clinical trial landscape

Pantoprazole for approximately 9 weeks · 2 trials · 2 indications

Phase 3 2
NCT00141817Study Evaluating Pantoprazole in Children With GERDGastroesophageal Reflux
COMPLETED41 Analytics
NCT00195208Study Comparing a Pantoprazole Formulation to the Currently Marketed Tablet for GERD and Erosive EsophagitisGastroesophageal Reflux
COMPLETED97 Analytics
PHASE3COMPLETED
Study Evaluating Pantoprazole in Children With GERD
Gastroesophageal RefluxUnlock trial analytics
PHASE3COMPLETED
Study Comparing a Pantoprazole Formulation to the Currently Marketed Tablet for GERD and Erosive Esophagitis
Gastroesophageal RefluxUnlock trial analytics

Study Endpoints

Primary Endpoints

Maximum Observed Plasma Concentration (Cmax)
Predose (0 hour), and 0.5, 1, 2, 4, 6, 12 hours postdose
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Predose (0 hour), and 0.5, 1, 2, 4, 6, 12 hours postdose
Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)]
Predose (0 hour), and 0.5, 1, 2, 4, 6, 12 hours postdose

AUC (0-t)= Area under the plasma concentration versus time curve from time zero (predose) to time of last quantifiable concentration (0-t).

Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]
Predose (0 hour), and 0.5, 1, 2, 4, 6, 12 hours postdose

AUC (0 - ∞)= Area under the plasma concentration versus time curve (AUC) from time zero (predose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).

Plasma Decay Half-Life (t1/2)
Predose (0 hour), and 0.5, 1, 2, 4, 6, 12 hours postdose

Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.

Apparent Oral Clearance (CL/F)
Predose (0 hour), and 0.5, 1, 2, 4, 6, 12 hours postdose

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. Clearance was estimated from population pharmacokinetic (PK) modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.

Terminal-Phase Volume of Distribution (Vz/F)
Predose (0 hour), and 0.5, 1, 2, 4, 6, 12 hours postdose

Vz/F was calculated as the ratio of clearance (CL) to terminal disposition rate constant (λz).

Plasma Concentrations After Multiple Doses
Hours 2 and 4 on Day 7
Comparison of MAO between the two formulations.

Secondary Endpoints

Comparison of BAO and pH parameters between the two formulations.
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Interventions

NameTypeDescription
pantoprazole for approximately 9 weeks.DRUG -
Pantoprazole for approximately 9 weeksDRUG -
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Eligibility Criteria

Age Range1 Year to 11 Years
SexALL
Healthy VolunteersNo
Study Sites23

Inclusion Criteria: * Endoscopically proven GERD diagnosed within 6 months before study entry. * Weight must be equal to or over 8.3 kg; for subjects 6 years or greater, weight must be equal to or under 25 kg Exclusion Criteria: * History of GI disorders, ie, unrepaired tracheal esophageal fistul...

Countries:United States
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