NCT00141817

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
41

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Aug 2005

Geographic Reach
1 country

23 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2005

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

August 30, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 1, 2005

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2007

Completed
4.2 years until next milestone

Results Posted

Study results publicly available

December 28, 2011

Completed
Last Updated

December 28, 2011

Status Verified

November 1, 2011

Enrollment Period

2.3 years

First QC Date

August 30, 2005

Results QC Date

November 23, 2011

Last Update Submit

November 23, 2011

Conditions

Gastroesophageal Reflux

Keywords

Gastrointestinal Reflux Disease

Outcome Measures

Primary Outcomes (8)

  • 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

  • Terminal-Phase Volume of Distribution (Vz/F)

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

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

  • Plasma Concentrations After Multiple Doses

    Hours 2 and 4 on Day 7

Interventions

pantoprazole for approximately 9 weeks.DRUG

Eligibility Criteria

Age1 Year - 11 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • History of GI disorders, ie, unrepaired tracheal esophageal fistula, GI malabsorption, Eosinophilic esophagitis
  • Subjects 6-11 years old unable to swallow tablets

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (23)

Unknown Facility

Little Rock, Arkansas, 72205, United States

Location

Unknown Facility

Orange, California, 92868, United States

Location

Unknown Facility

San Diego, California, 92103, United States

Location

Unknown Facility

Washington D.C., District of Columbia, 20010, United States

Location

Unknown Facility

Gainesville, Florida, 32610, United States

Location

Unknown Facility

Miami, Florida, 33101, United States

Location

Unknown Facility

Pensacola, Florida, 32504, United States

Location

Unknown Facility

Park Ridge, Illinois, 60068, United States

Location

Unknown Facility

Indianapolis, Indiana, 46202, United States

Location

Unknown Facility

Louisville, Kentucky, 40202, United States

Location

Unknown Facility

Boston, Massachusetts, 02114, United States

Location

Unknown Facility

Boston, Massachusetts, 02115, United States

Location

Unknown Facility

Brockton, Massachusetts, 02302, United States

Location

Unknown Facility

Detroit, Michigan, 48201, United States

Location

Unknown Facility

Flint, Michigan, 48503, United States

Location

Unknown Facility

Jackson, Mississippi, 39216, United States

Location

Unknown Facility

Kansas City, Missouri, 64108, United States

Location

Unknown Facility

New York, New York, 10032, United States

Location

Unknown Facility

Cincinnati, Ohio, 45229, United States

Location

Unknown Facility

Memphis, Tennessee, 38105, United States

Location

Unknown Facility

Temple, Texas, 76508, United States

Location

Unknown Facility

Salt Lake City, Utah, 84108, United States

Location

Unknown Facility

Milwaukee, Wisconsin, 53226, United States

Location

Related Publications (1)

  • 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.

    PMID: 21740077DERIVED

MeSH Terms

Conditions

Gastroesophageal Reflux

Interventions

Pantoprazole

Condition Hierarchy (Ancestors)

Esophageal Motility DisordersDeglutition DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

2-PyridinylmethylsulfinylbenzimidazolesSulfoxidesSulfur CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsBenzimidazolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Results Point of Contact

Title
Pfizer ClinicalTrials.gov Call Center
Organization
Pfizer, Inc.
ClinicalTrials.gov_Inquiries@pfizer.com
1-800-718-1021

Study Officials

  • Medical Monitor

    Wyeth is now a wholly owned subsidiary of Pfizer

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 30, 2005

First Posted

September 1, 2005

Study Start

August 1, 2005

Primary Completion

November 1, 2007

Study Completion

November 1, 2007

Last Updated

December 28, 2011

Results First Posted

December 28, 2011

Record last verified: 2011-11

Locations

US(23)