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PREA, PK And Safety PASS Study Of IV Pantoprazole In Pediatric Subjects

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ClinicalTrials.gov Identifier: NCT02401035
Recruitment Status : Recruiting
First Posted : March 27, 2015
Last Update Posted : July 19, 2019
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE December 15, 2014
First Posted Date  ICMJE March 27, 2015
Last Update Posted Date July 19, 2019
Actual Study Start Date  ICMJE May 9, 2017
Estimated Primary Completion Date April 11, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 27, 2018)
  • Volume of distribution of IV pantoprazole [ Time Frame: Day 1 ]
    Pharmacokinetic parameters will be summarized descriptively
  • Clearance of IV pantoprazole [ Time Frame: Day 1 ]
    Pharmacokinetic parameters will be summarized descriptively
  • Volume of distribution of IV pantoprazole [ Time Frame: Day 2 ]
    Pharmacokinetic parameters will be summarized descriptively
  • Clearance of IV pantoprazole [ Time Frame: Day 2 ]
    Pharmacokinetic parameters will be summarized descriptively
Original Primary Outcome Measures  ICMJE
 (submitted: March 23, 2015)
  • time to peak plasma concentration (Tmax) of iv pantoprazole [ Time Frame: Day 1 ]
    Pharmacokinetics parameters will be summarized descriptively
  • peak plasma concentration (Cmax) of iv pantoprazole [ Time Frame: Day 1 ]
    Pharmacokinetics parameters will be summarized descriptively
  • area under the concentration-time curve from time zero to last concentration (AUClast) of iv pantoprazole [ Time Frame: Day 1 ]
    Pharmacokinetics parameters will be summarized descriptively
  • area under the concentration-time curve from time zero to extrapolated infinite time (AUCinf) of iv pantoprazole [ Time Frame: Day 1 ]
    Pharmacokinetics parameters will be summarized descriptively
  • steady state volume of distribution (Vss) of iv pantoprazole [ Time Frame: Day 1 ]
    Pharmacokinetics parameters will be summarized descriptively
  • terminal phase half-life (T1/2) of iv pantoprazole [ Time Frame: Day 1 ]
    Pharmacokinetics parameters will be summarized descriptively
  • clearance (CL) of iv pantoprazole [ Time Frame: Day 1 ]
    Pharmacokinetics parameters will be summarized descriptively
  • time to peak plasma concentration (Tmax) of iv pantoprazole [ Time Frame: Day 7 ]
    Pharmacokinetics parameters will be summarized descriptively
  • peak plasma concentration (Cmax) of iv pantoprazole [ Time Frame: Day 7 ]
    Pharmacokinetics parameters will be summarized descriptively
  • area under the concentration-time curve from time zero to last concentration (AUClast) of iv pantoprazole [ Time Frame: Day 7 ]
    Pharmacokinetics parameters will be summarized descriptively
  • terminal phase half-life (T1/2) of iv pantoprazole [ Time Frame: Day 7 ]
    Pharmacokinetics parameters will be summarized descriptively
  • clearance (CL) of iv pantoprazole [ Time Frame: Day 7 ]
    Pharmacokinetics parameters will be summarized descriptively
Change History Complete list of historical versions of study NCT02401035 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 27, 2018)
  • CYP2C19 genotyping [ Time Frame: Day 1 ]
    CYP2C19 genotyping will be summarized descriptively
  • Maximum Plasma Concentration [ Time Frame: Day 1 ]
    Pharmacokinetic parameters will be summarized descriptively
  • Maximum Plasma Concentration [ Time Frame: Day 2 ]
    Pharmacokinetic parameters will be summarized descriptively
  • Area under plasma concentration-time profile from 0 to 24 hours [ Time Frame: Day 1 ]
    Pharmacokinetic parameters will be summarized descriptively
  • Area under plasma concentration-time profile from 0 to 24 hours [ Time Frame: Day 2 ]
    Pharmacokinetic parameters will be summarized descriptively
  • Area under plasma concentration-time profile from time 0 extrapolated to infinite time [ Time Frame: Day 1 ]
    Pharmacokinetic parameters will be summarized descriptively
  • Area under plasma concentration-time profile from time 0 extrapolated to infinite time [ Time Frame: Day 2 ]
    Pharmacokinetic parameters will be summarized descriptively
  • Terminal half-life [ Time Frame: Day 1 ]
    Pharmacokinetic parameters will be summarized descriptively
  • Terminal half-life [ Time Frame: Day 2 ]
    Pharmacokinetic parameters will be summarized descriptively
Original Secondary Outcome Measures  ICMJE
 (submitted: March 23, 2015)
CYP2C19 genotyping [ Time Frame: Day 1 ]
CYP2C19 genotyping will be summarized descriptively
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE PREA, PK And Safety PASS Study Of IV Pantoprazole In Pediatric Subjects
Official Title  ICMJE An Open-Label, Multicenter Study To Evaluate The Pharmacokinetics Of Single And Multiple Intravenous Doses Of Pantoprazole In Two Age Cohorts Of Hospitalized Pediatric Subjects 1 To 16 Years Of Age Who Are Candidates For Acid Suppression Therapy
Brief Summary The purpose of this study is to characterize the pharmacokinetics (PK) and safety of intravenous (IV) pantoprazole in patients 1 to 16 years old who are candidates for acid suppression therapy.
Detailed Description

In hospitalized pediatric subjects, age 1 to 16 years who in the judgment of the investigator are candidates for acid suppression therapy, the following are the objectives of this trial:

Primary Objectives To characterize the PK of single and multiple IV doses of pantoprazole in pediatric subjects aged 1 to less than 2 years old.

To characterize the PK of single and multiple IV doses of pantoprazole in pediatric subjects aged 2 to 16 years old.

Secondary Objectives To determine the safety, tolerability, and PK of single and multiple IV doses of pantoprazole in each of the independent age cohorts.

To assess the CYP2C19 genotype in pediatric subjects receiving IV pantoprazole, to determine the presence of the gene for the major enzyme responsible for metabolism of pantoprazole.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Gastroesophageal Reflux Disease
Intervention  ICMJE Drug: IV pantoprazole
Patients will receive 10 mg, 20 mg, or 40 mg IV pantoprazole determined by weight
Study Arms  ICMJE Experimental: IV pantoprazole
Patients will receive 10 mg, 20 mg, or 40 mg IV pantoprazole determined by weight.
Intervention: Drug: IV pantoprazole
Publications * Not Provided

*   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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 23, 2015)
24
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 9, 2022
Estimated Primary Completion Date April 11, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Subjects aged 1 to 16 years who in the judgment of the investigator are candidates for gastric acid suppression therapy (ie, those with a presumptive diagnosis of GERD, a clinical diagnosis of suspected GERD, symptomatic GERD, or endoscopically proven GERD) and whom the investigator judges would need to receive IV PPI therapy for at least 4 days.
  • Body weight > 5th percentile for age.
  • Y-site or dedicated IV line for administration of pantoprazole sodium.
  • Expected survival for at least 30 days.
  • Fertile male and female subjects of childbearing potential at risk for pregnancy must agree to use a highly effective method of contraception throughout the study and for at least 28 days after the last dose of assigned treatment. Female subjects of non-childbearing potential must be premenarchal, have undergone hysterectomy with bilateral oophorectomy, have medically confirmed ovarian failure, or achieved post-menopausal status.

Exclusion Criteria:

  • Participation in other studies involving investigational drug(s) or treatment with an investigational drug within 30 days or 5 half lives prior to study entry and/or during study participation.
  • Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
  • Pregnant females; breastfeeding females; fertile male subjects, and female subjects of childbearing potential who are unwilling or unable to use a highly effective method of contraception for the duration of the study and for at least 28 days after last dose of investigational product.
  • Serum CK levels >3x ULN.
  • Known history of HIV or clinical manifestations of AIDS.
  • Known hypersensitivity to PPIs or to any substituted benzimidazole or to any of the excipients.
  • History of treatment with any PPI within 2 days (48 hours) before investigational product dosing on Day 1.
  • Use of H2RAs, sucralfate, misoprostol, or prokinetic agents, and bismuth preparations within 1 day (24 hours) before investigational product dosing on Day 1.
  • Any disorder requiring chronic (every day) use of warfarin, carbamazepine, or phenytoin, methotrexate, atazanavir or nelfinavir, clopidogrel, and potent inhibitors and inducers of CYP2C19.
  • Chronic (daily) use of glucocorticoids. Steroid inhalers and topical steroids may be used.
  • Active malignancy of any type, or history of a malignancy (Subject with a history of malignancies that have been surgically removed or eradicated by irradiation or chemotherapy and who have no evidence of recurrence for at least 5 years before Screening are acceptable).
  • ALT or BUN >2.0 ULN or estimated creatinine >1.5 X ULN for age or any other laboratory abnormality considered by the Investigator to be clinically significant within 14 days before Screening.
  • In the Investigator's opinion, a chronic condition (eg, diabetes, epilepsy), which is either not stable or well controlled and may interfere with the conduct of the study.
  • History of sensitivity to heparin or heparin induced thrombocytopenia.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 1 Year to 16 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Pfizer CT.gov Call Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com
Listed Location Countries  ICMJE Argentina,   Bosnia and Herzegovina,   Georgia,   Germany,   Italy,   Serbia,   Slovakia,   United States
Removed Location Countries Spain
 
Administrative Information
NCT Number  ICMJE NCT02401035
Other Study ID Numbers  ICMJE B1791089
2014-002182-29 ( EudraCT Number )
B1791089 ( Other Identifier: Study Number )
GERD ( Other Identifier: Alias Study Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
URL: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date July 2019

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