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

Last updated on July 5, 2018

FOR MORE INFORMATION
Study Location
Children's Hospital of Michigan
Detroit, Michigan, 48201 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Gastroesophageal Reflux Disease
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
1-16 year
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Hospitalized subjects 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)

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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.

NCT02401035
Pfizer
Recruiting
PREA, PK And Safety PASS Study Of IV Pantoprazole In Pediatric Subjects

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

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 profile of single and repeated IV doses of pantoprazole in pediatric subjects aged 1 < to less than 2 years old.

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

Secondary Objectives To determine the safety and tolerability of single and multiple doses of IV pantoprazole in each of the independent age cohorts over 7 days.

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.

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


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
24
March 16, 2020
February 17, 2020   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Hospitalized subjects 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)
  • 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.
Sexes Eligible for Study: All
1 Year to 16 Years   (Child)
No

Contact: Pfizer CT.gov Call Center 1-800-718-1021 [email protected]
Germany,   Italy,   Serbia,   Slovakia,   Spain,   United States
 
 
NCT02401035
B1791089
2014-002182-29 ( EudraCT Number )
B1791089 ( Other Identifier: Study Number )
GERD ( Other Identifier: Alias Study Number )
No
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: Yes
Plan Description: Information relating to our policy on data sharing and the process for requesting data can be found at the following link: http://www.pfizer.com/research/clinical_trials/trial_data_and_results/da...
URL: http://
Pfizer
Pfizer
Parexel
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
November 2017

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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