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Study Evaluating Pantoprazole in Children With GERD

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00141817
Recruitment Status : Completed
First Posted : September 1, 2005
Results First Posted : December 28, 2011
Last Update Posted : December 28, 2011
Sponsor:
Information provided by (Responsible Party):
Wyeth is now a wholly owned subsidiary of Pfizer

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.

Condition or disease Intervention/treatment Phase
Gastroesophageal Reflux Drug: pantoprazole for approximately 9 weeks. Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 41 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : August 2005
Actual Primary Completion Date : November 2007
Actual Study Completion Date : November 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: GERD




Primary Outcome Measures :
  1. Maximum Observed Plasma Concentration (Cmax) [ Time Frame: Predose (0 hour), and 0.5, 1, 2, 4, 6, 12 hours postdose ]
  2. Time to Reach Maximum Observed Plasma Concentration (Tmax) [ Time Frame: Predose (0 hour), and 0.5, 1, 2, 4, 6, 12 hours postdose ]
  3. 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 ]
    AUC (0-t)= Area under the plasma concentration versus time curve from time zero (predose) to time of last quantifiable concentration (0-t).

  4. 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 ]
    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 - ∞).

  5. Plasma Decay Half-Life (t1/2) [ Time Frame: 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.

  6. Apparent Oral Clearance (CL/F) [ Time Frame: 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.

  7. Terminal-Phase Volume of Distribution (Vz/F) [ Time Frame: 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).

  8. Plasma Concentrations After Multiple Doses [ Time Frame: Hours 2 and 4 on Day 7 ]


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Ages Eligible for Study:   1 Year to 11 Years   (Child)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00141817


Locations
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United States, Arkansas
Little Rock, Arkansas, United States, 72205
United States, California
Orange, California, United States, 92868
San Diego, California, United States, 92103
United States, District of Columbia
Washington, District of Columbia, United States, 20010
United States, Florida
Gainesville, Florida, United States, 32610
Miami, Florida, United States, 33101
Pensacola, Florida, United States, 32504
United States, Illinois
Park Ridge, Illinois, United States, 60068
United States, Indiana
Indianapolis, Indiana, United States, 46202
United States, Kentucky
Louisville, Kentucky, United States, 40202
United States, Massachusetts
Boston, Massachusetts, United States, 02114
Boston, Massachusetts, United States, 02115
Brockton, Massachusetts, United States, 02302
United States, Michigan
Detroit, Michigan, United States, 48201
Flint, Michigan, United States, 48503
United States, Mississippi
Jackson, Mississippi, United States, 39216
United States, Missouri
Kansas City, Missouri, United States, 64108
United States, New York
New York, New York, United States, 10032
United States, Ohio
Cincinnati, Ohio, United States, 45229
United States, Tennessee
Memphis, Tennessee, United States, 38105
United States, Texas
Temple, Texas, United States, 76508
United States, Utah
Salt Lake City, Utah, United States, 84108
United States, Wisconsin
Milwaukee, Wisconsin, United States, 53226
Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
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Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier: NCT00141817    
Other Study ID Numbers: 3001B3-334
B1791059
First Posted: September 1, 2005    Key Record Dates
Results First Posted: December 28, 2011
Last Update Posted: December 28, 2011
Last Verified: November 2011
Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:
Gastrointestinal Reflux Disease
Additional relevant MeSH terms:
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Gastroesophageal Reflux
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Pantoprazole
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action