Study Evaluating Pantoprazole in Children With GERD | NCT00141817

ID	Type	Description	Link
B1791059

Status Module

Name	Type	Description	Arm Group Labels	Other Names
pantoprazole for approximately 9 weeks.	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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)]	AUC (0-t)= Area under the plasma concentration versus time curve from time zero (predose) to time of last quantifiable concentration (0-t).	Predose (0 hour), and 0.5, 1, 2, 4, 6, 12 hours postdose
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]	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 - ∞).	Predose (0 hour), and 0.5, 1, 2, 4, 6, 12 hours postdose
Plasma Decay Half-Life (t1/2)	Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.	Predose (0 hour), and 0.5, 1, 2, 4, 6, 12 hours postdose
Apparent Oral Clearance (CL/F)	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.	Predose (0 hour), and 0.5, 1, 2, 4, 6, 12 hours postdose

Name	Affiliation	Role
Medical Monitor	Wyeth is now a wholly owned subsidiary of Pfizer	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
		Little Rock	Arkansas	72205	United States

PubMed Identifier	Type	Citation	Retractions
21740077	Derived	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.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Pantoprazole 0.6 mg/kg Spheroids	Pantoprazole 0.6 mg/kg Spheroids for Participants Aged <6 years
FG001	Pantoprazole 1.2 mg/kg Spheroids	Pantoprazole 1.2 mg/kg Spheroids for Participants Aged <6 years

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

ID	Title	Description
BG000	Pantoprazole 0.6 mg/kg Spheroids	Pantoprazole 0.6 mg/kg Spheroids for Participants Aged <6 years
BG001	Pantoprazole 1.2 mg/kg Spheroids	Pantoprazole 1.2 mg/kg Spheroids for Participants Aged <6 years
BG002	Pantoprazole 0.6 mg/kg Tablets	Pantoprazole 0.6 mg/kg Tablets for Participants Aged >=6 years
BG003	Pantoprazole 1.2 mg/kg Tablets	Pantoprazole 1.2 mg/kg Tablets for Participants Aged >=6 years
BG004	Total	Total of all reporting groups

Units	Counts
Participants	BG0007 BG00110 BG00211 BG00313 BG00441

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Maximum Observed Plasma Concentration (Cmax)

Single-Dose Valid-for-Evaluation Population: Randomized participants who took 1 dose of pantoprazole and had at least 4 single-dose blood samples for pharmacokinetic (PK) analyses.

Posted

Mean

Standard Deviation

nanogram per milliliter (ng/mL)

Predose (0 hour), and 0.5, 1, 2, 4, 6, 12 hours postdose

ID	Title	Description
OG000	Pantoprazole 0.6 mg/kg Spheroids	Pantoprazole 0.6 mg/kg Spheroids for Participants Aged <6 years
OG001	Pantoprazole 1.2 mg/kg Spheroids	Pantoprazole 1.2 mg/kg Spheroids for Participants Aged <6 years
OG002	Pantoprazole 0.6 mg/kg Tablets	Pantoprazole 0.6 mg/kg Tablets for Participants Aged >=6 years
OG003	Pantoprazole 1.2 mg/kg Tablets	Pantoprazole 1.2 mg/kg Tablets for Participants Aged >=6 years

Units	Counts
Participants	OG0003 OG0017 OG00210 OG003

Title

Denominators

Categories

Title	Measurements
	OG000136± 127 OG001798± 729 OG0021643± 1229 OG003

Primary

Time to Reach Maximum Observed Plasma Concentration (Tmax)

Single-Dose Valid-for-Evaluation Population. Participants analyzed=number of participants with available data.

Posted

Mean

Standard Deviation

hours

Predose (0 hour), and 0.5, 1, 2, 4, 6, 12 hours postdose

ID	Title	Description
OG000	Pantoprazole 0.6 mg/kg Spheroids	Pantoprazole 0.6 mg/kg Spheroids for Participants Aged <6 years
OG001	Pantoprazole 1.2 mg/kg Spheroids	Pantoprazole 1.2 mg/kg Spheroids for Participants Aged <6 years
OG002	Pantoprazole 0.6 mg/kg Tablets	Pantoprazole 0.6 mg/kg Tablets for Participants Aged >=6 years
OG003	Pantoprazole 1.2 mg/kg Tablets	Pantoprazole 1.2 mg/kg Tablets for Participants Aged >=6 years

Units	Counts

Primary

Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)]

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

Single-Dose Valid-for-Evaluation Population.

Posted

Mean

Standard Deviation

nanogram hour per milliliter (ng*h/mL)

Predose (0 hour), and 0.5, 1, 2, 4, 6, 12 hours postdose

ID	Title	Description
OG000	Pantoprazole 0.6 mg/kg Spheroids	Pantoprazole 0.6 mg/kg Spheroids for Participants Aged <6 years
OG001	Pantoprazole 1.2 mg/kg Spheroids	Pantoprazole 1.2 mg/kg Spheroids for Participants Aged <6 years
OG002	Pantoprazole 0.6 mg/kg Tablets	Pantoprazole 0.6 mg/kg Tablets for Participants Aged >=6 years
OG003	Pantoprazole 1.2 mg/kg Tablets	Pantoprazole 1.2 mg/kg Tablets for Participants Aged >=6 years

Primary

Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]

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 - ∞).

Single-Dose Valid-for-Evaluation Population. Participants analyzed=number of participants with available data.

Posted

Mean

Standard Deviation

ng*h/mL

Predose (0 hour), and 0.5, 1, 2, 4, 6, 12 hours postdose

ID	Title	Description
OG000	Pantoprazole 0.6 mg/kg Spheroids	Pantoprazole 0.6 mg/kg Spheroids for Participants Aged <6 years
OG001	Pantoprazole 1.2 mg/kg Spheroids	Pantoprazole 1.2 mg/kg Spheroids for Participants Aged <6 years
OG002	Pantoprazole 0.6 mg/kg Tablets	Pantoprazole 0.6 mg/kg Tablets for Participants Aged >=6 years
OG003	Pantoprazole 1.2 mg/kg Tablets	Pantoprazole 1.2 mg/kg Tablets for Participants Aged >=6 years

Primary

Plasma Decay Half-Life (t1/2)

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

Single-Dose Valid-for-Evaluation Population. Participants analyzed=number of participants with available data.

Posted

Mean

Standard Deviation

hours

Predose (0 hour), and 0.5, 1, 2, 4, 6, 12 hours postdose

ID	Title	Description
OG000	Pantoprazole 0.6 mg/kg Spheroids	Pantoprazole 0.6 mg/kg Spheroids for Participants Aged <6 years
OG001	Pantoprazole 1.2 mg/kg Spheroids	Pantoprazole 1.2 mg/kg Spheroids for Participants Aged <6 years
OG002	Pantoprazole 0.6 mg/kg Tablets	Pantoprazole 0.6 mg/kg Tablets for Participants Aged >=6 years
OG003	Pantoprazole 1.2 mg/kg Tablets	Pantoprazole 1.2 mg/kg Tablets for Participants Aged >=6 years

Primary

Apparent Oral Clearance (CL/F)

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.

Single-Dose Valid-for-Evaluation Population. Participants analyzed=number of participants with available data.

Posted

Mean

Standard Deviation

liter per hour per kilogram (L/h/kg)

Predose (0 hour), and 0.5, 1, 2, 4, 6, 12 hours postdose

ID	Title	Description
OG000	Pantoprazole 0.6 mg/kg Spheroids	Pantoprazole 0.6 mg/kg Spheroids for Participants Aged <6 years
OG001	Pantoprazole 1.2 mg/kg Spheroids	Pantoprazole 1.2 mg/kg Spheroids for Participants Aged <6 years
OG002	Pantoprazole 0.6 mg/kg Tablets	Pantoprazole 0.6 mg/kg Tablets for Participants Aged >=6 years
OG003	Pantoprazole 1.2 mg/kg Tablets

Primary

Terminal-Phase Volume of Distribution (Vz/F)

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

Single-Dose Valid-for-Evaluation Population. Participants analyzed=number of participants with available data.

Posted

Mean

Standard Deviation

liter per kilogram (L/kg)

Predose (0 hour), and 0.5, 1, 2, 4, 6, 12 hours postdose

ID	Title	Description
OG000	Pantoprazole 0.6 mg/kg Spheroids	Pantoprazole 0.6 mg/kg Spheroids for Participants Aged <6 years
OG001	Pantoprazole 1.2 mg/kg Spheroids	Pantoprazole 1.2 mg/kg Spheroids for Participants Aged <6 years
OG002	Pantoprazole 0.6 mg/kg Tablets	Pantoprazole 0.6 mg/kg Tablets for Participants Aged >=6 years
OG003	Pantoprazole 1.2 mg/kg Tablets	Pantoprazole 1.2 mg/kg Tablets for Participants Aged >=6 years

Primary

Plasma Concentrations After Multiple Doses

Multiple-Dose Valid-for-Evaluation Population: Randomized participants who had concentration evaluations of pantoprazole either at 2 hours or at 4 hours after single dose and after at least 5 consecutive doses. n=participants who had data available at that specific time point.

Posted

Mean

Standard Deviation

ng/mL

Hours 2 and 4 on Day 7

ID	Title	Description
OG000	Pantoprazole 0.6 mg/kg Spheroids	Pantoprazole 0.6 mg/kg Spheroids for Participants Aged <6 years
OG001	Pantoprazole 1.2 mg/kg Spheroids	Pantoprazole 1.2 mg/kg Spheroids for Participants Aged <6 years
OG002	Pantoprazole 0.6 mg/kg Tablets	Pantoprazole 0.6 mg/kg Tablets for Participants Aged >=6 years
OG003	Pantoprazole 1.2 mg/kg Tablets	Pantoprazole 1.2 mg/kg Tablets for Participants Aged >=6 years

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Abdominal pain	General disorders	COSTART	Non-systematic Assessment	EG0001 affected7 at risk EG0011 affected10 at risk EG0023 affected11 at risk EG0031 affected13 at risk
Accidental injury	General disorders	COSTART	Non-systematic Assessment	EG0001 affected7 at risk EG0011 affected10 at risk EG0021 affected11 at risk EG003
Fever	General disorders	COSTART	Non-systematic Assessment	EG0000 affected7 at risk EG0011 affected10 at risk EG0021 affected11 at risk EG003
Hypotension	Cardiac disorders	COSTART	Non-systematic Assessment	EG0000 affected7 at risk EG0011 affected10 at risk EG0020 affected11 at risk EG003
Diarrhea	Gastrointestinal disorders	COSTART	Non-systematic Assessment	EG0001 affected7 at risk EG0013 affected10 at risk EG0021 affected11 at risk EG003
Nausea	Gastrointestinal disorders	COSTART	Non-systematic Assessment	EG0000 affected7 at risk EG0012 affected10 at risk EG0020 affected11 at risk EG003
Vomiting	Gastrointestinal disorders	COSTART	Non-systematic Assessment	EG0001 affected7 at risk EG0013 affected10 at risk EG0020 affected11 at risk EG003
Creatine phosphokinase increased	Metabolism and nutrition disorders	COSTART	Non-systematic Assessment	EG0000 affected7 at risk EG0011 affected10 at risk EG0020 affected11 at risk EG003
Thirst	Metabolism and nutrition disorders	COSTART	Non-systematic Assessment	EG0000 affected7 at risk EG0011 affected10 at risk EG0020 affected11 at risk EG003
Weight loss	Metabolism and nutrition disorders	COSTART	Non-systematic Assessment	EG0001 affected7 at risk EG0010 affected10 at risk EG0020 affected11 at risk EG003
Abnormal/changed behavior	Nervous system disorders	COSTART	Non-systematic Assessment	EG0001 affected7 at risk EG0010 affected10 at risk EG0020 affected11 at risk EG003
Cough increased	Respiratory, thoracic and mediastinal disorders	COSTART	Non-systematic Assessment	EG0000 affected7 at risk EG0012 affected10 at risk EG0020 affected11 at risk EG003
Maculopapular rash	Skin and subcutaneous tissue disorders	COSTART	Non-systematic Assessment	EG0001 affected7 at risk EG0010 affected10 at risk EG0020 affected11 at risk EG003
Otitis media	Ear and labyrinth disorders	COSTART	Non-systematic Assessment	EG0000 affected7 at risk EG0011 affected10 at risk EG0022 affected11 at risk EG003
Urinary tract infection	Renal and urinary disorders	COSTART	Non-systematic Assessment	EG0000 affected7 at risk EG0011 affected10 at risk EG0020 affected11 at risk EG003
Upper respiratory infection	Respiratory, thoracic and mediastinal disorders	COSTART	Non-systematic Assessment	EG0001 affected7 at risk EG0011 affected10 at risk EG0022 affected11 at risk EG003
Headache	General disorders	COSTART	Non-systematic Assessment	EG0000 affected7 at risk EG0010 affected10 at risk EG0021 affected11 at risk EG003
Injection site hemorrhage	General disorders	COSTART	Non-systematic Assessment	EG0000 affected7 at risk EG0010 affected10 at risk EG0020 affected11 at risk EG003
Injection site pain	General disorders	COSTART	Non-systematic Assessment	EG0000 affected7 at risk EG0010 affected10 at risk EG0021 affected11 at risk EG003
Pain	General disorders	COSTART	Non-systematic Assessment	EG0000 affected7 at risk EG0010 affected10 at risk EG0020 affected11 at risk EG003
Eructation	Gastrointestinal disorders	COSTART	Non-systematic Assessment	EG0000 affected7 at risk EG0010 affected10 at risk EG0020 affected11 at risk EG003
Gastroenteritis	Gastrointestinal disorders	COSTART	Non-systematic Assessment	EG0000 affected7 at risk EG0010 affected10 at risk EG0020 affected11 at risk EG003
Hyperlipemia	Metabolism and nutrition disorders	COSTART	Non-systematic Assessment	EG0000 affected7 at risk EG0010 affected10 at risk EG0020 affected11 at risk EG003
Hyperuricemia	Metabolism and nutrition disorders	COSTART	Non-systematic Assessment	EG0000 affected7 at risk EG0010 affected10 at risk EG0020 affected11 at risk EG003
Hypoglycemia	Metabolism and nutrition disorders	COSTART	Non-systematic Assessment	EG0000 affected7 at risk EG0010 affected10 at risk EG0020 affected11 at risk EG003
Rhinitis	Respiratory, thoracic and mediastinal disorders	COSTART	Non-systematic Assessment	EG0000 affected7 at risk EG0010 affected10 at risk EG0021 affected11 at risk EG003
Sinus congestion	Respiratory, thoracic and mediastinal disorders	COSTART	Non-systematic Assessment	EG0000 affected7 at risk EG0010 affected10 at risk EG0021 affected11 at risk EG003
Contact dermatitis	Skin and subcutaneous tissue disorders	COSTART	Non-systematic Assessment	EG0000 affected7 at risk EG0010 affected10 at risk EG0020 affected11 at risk EG003
Eye disorder	Eye disorders	COSTART	Non-systematic Assessment	EG0000 affected7 at risk EG0010 affected10 at risk EG0021 affected11 at risk EG003

ID	Term
D015154	Esophageal Motility Disorders
D003680	Deglutition Disorders
D004935	Esophageal Diseases
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases

ID	Term
D053799	2-Pyridinylmethylsulfinylbenzimidazoles
D013454	Sulfoxides
D013457	Sulfur Compounds
D009930	Organic Chemicals
D011725	Pyridines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D001562	Benzimidazoles
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring

ID	Title	Description	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Pantoprazole 0.6 mg/kg Spheroids	Pantoprazole 0.6 mg/kg Spheroids for Participants Aged <6 years	7	4	7
EG001	Pantoprazole 1.2 mg/kg Spheroids	Pantoprazole 1.2 mg/kg Spheroids for Participants Aged <6 years	10	7	10
EG002	Pantoprazole 0.6 mg/kg Tablets	Pantoprazole 0.6 mg/kg Tablets for Participants Aged >=6 years	11	9	11
EG003	Pantoprazole 1.2 mg/kg Tablets	Pantoprazole 1.2 mg/kg Tablets for Participants Aged >=6 years	13	7	13