Study Evaluating Pantoprazole in Children With GERD - Full Text View

Sponsor:	Wyeth is now a wholly owned subsidiary of Pfizer
Information provided by (Responsible Party):	Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:	NCT00141817

Purpose

The purpose of this study is to characterize the PK profile, safety and tolerability of single and multiple doses of pantoprazole in children aged 1 through 11 years with endoscopically proven GERD.

Condition	Intervention	Phase
Gastroesophageal Reflux	Drug: pantoprazole for approximately 9 weeks.	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Multicenter, Randomized, Open Label, Single, and Multiple Dose Study of the Safety and Pharmacokinetics of 2 Dose Levels of Pantoprazole Sodium in Children Aged 1 Through 11 Years With Endoscopically Proven GERD

Resource links provided by NLM:

MedlinePlus related topics: GERD

Drug Information available for: Pantoprazole Pantoprazole sodium

U.S. FDA Resources

Further study details as provided by Wyeth is now a wholly owned subsidiary of Pfizer:

Primary Outcome Measures:

Maximum Observed Plasma Concentration (Cmax) [ Time Frame: Predose (0 hour), and 0.5, 1, 2, 4, 6, 12 hours postdose ] [ Designated as safety issue: No ]
Time to Reach Maximum Observed Plasma Concentration (Tmax) [ Time Frame: Predose (0 hour), and 0.5, 1, 2, 4, 6, 12 hours postdose ] [ Designated as safety issue: No ]
Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)] [ Time Frame: Predose (0 hour), and 0.5, 1, 2, 4, 6, 12 hours postdose ] [ Designated as safety issue: No ]
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 - ∞)] [ Time Frame: Predose (0 hour), and 0.5, 1, 2, 4, 6, 12 hours postdose ] [ Designated as safety issue: No ]
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) [ Time Frame: Predose (0 hour), and 0.5, 1, 2, 4, 6, 12 hours postdose ] [ Designated as safety issue: No ]
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
Apparent Oral Clearance (CL/F) [ Time Frame: Predose (0 hour), and 0.5, 1, 2, 4, 6, 12 hours postdose ] [ Designated as safety issue: No ]
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) [ Time Frame: Predose (0 hour), and 0.5, 1, 2, 4, 6, 12 hours postdose ] [ Designated as safety issue: No ]
Vz/F was calculated as the ratio of clearance (CL) to terminal disposition rate constant (λz).
Plasma Concentrations After Multiple Doses [ Time Frame: Hours 2 and 4 on Day 7 ] [ Designated as safety issue: No ]

Enrollment:	41
Study Start Date:	August 2005
Study Completion Date:	November 2007
Primary Completion Date:	November 2007 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	1 Year to 11 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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 fistula, GI malabsorption, Eosinophilic esophagitis
Subjects 6-11 years old unable to swallow tablets

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00141817

Show 23 Study Locations

Sponsors and Collaborators

Wyeth is now a wholly owned subsidiary of Pfizer

Investigators

Study Director:

Medical Monitor

Wyeth is now a wholly owned subsidiary of Pfizer

More Information

No publications provided by Wyeth is now a wholly owned subsidiary of Pfizer

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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 1;50(8):541-50.

Responsible Party:	Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:	NCT00141817 History of Changes
Other Study ID Numbers:	3001B3-334, B1791059
Study First Received:	August 30, 2005
Results First Received:	November 23, 2011
Last Updated:	November 23, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:

Gastrointestinal Reflux Disease

Additional relevant MeSH terms:

Gastroesophageal Reflux
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Pantoprazole

Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Ulcer Agents
Gastrointestinal Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 21, 2012