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Trial record 1 of 1 for:    NCT00141817
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Study Evaluating Pantoprazole in Children With GERD

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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

Tracking Information
First Submitted Date  ICMJE August 30, 2005
First Posted Date  ICMJE September 1, 2005
Results First Submitted Date  ICMJE November 23, 2011
Results First Posted Date  ICMJE December 28, 2011
Last Update Posted Date December 28, 2011
Study Start Date  ICMJE August 2005
Actual Primary Completion Date November 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 23, 2011)
  • Maximum Observed Plasma Concentration (Cmax) [ Time Frame: Predose (0 hour), and 0.5, 1, 2, 4, 6, 12 hours postdose ]
  • Time to Reach Maximum Observed Plasma Concentration (Tmax) [ Time Frame: 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)] [ 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).
  • 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 - ∞).
  • 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.
  • 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.
  • 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).
  • Plasma Concentrations After Multiple Doses [ Time Frame: Hours 2 and 4 on Day 7 ]
Original Primary Outcome Measures  ICMJE
 (submitted: August 30, 2005)
Characterization of the PK profile of single and multiple doses of pantoprazole.
Change History Complete list of historical versions of study NCT00141817 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: August 30, 2005)
Assessment of safety and tolerability of pantoprazole and assessment of growth parameters
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study Evaluating Pantoprazole in Children With GERD
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Gastroesophageal Reflux
Intervention  ICMJE Drug: pantoprazole for approximately 9 weeks.
Study Arms  ICMJE Not Provided
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 23, 2011)
41
Original Enrollment  ICMJE
 (submitted: August 30, 2005)
30
Actual Study Completion Date  ICMJE November 2007
Actual Primary Completion Date November 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 1 Year to 11 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00141817
Other Study ID Numbers  ICMJE 3001B3-334
B1791059
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Wyeth is now a wholly owned subsidiary of Pfizer
Study Sponsor  ICMJE Wyeth is now a wholly owned subsidiary of Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
PRS Account Wyeth is now a wholly owned subsidiary of Pfizer
Verification Date November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP