PREA, PK And Safety PASS Study Of IV Pantoprazole In Pediatric Subjects
NCT02401035
ABOUT THIS STUDY
FOR MORE INFORMATION
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- 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.
- 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.
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Descriptive Information | |||||||
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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 | Allocation: N/A 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 | 24 | ||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||
Estimated Study Completion Date ICMJE | January 30, 2023 | ||||||
Estimated Primary Completion Date | January 2, 2023 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 1 Year to 16 Years (Child) | ||||||
Accepts Healthy Volunteers ICMJE | No | ||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | Argentina, Bosnia and Herzegovina, Georgia, Germany, Italy, Puerto Rico, Serbia, Slovakia, Ukraine, 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 |
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IPD Sharing Statement ICMJE |
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Responsible Party | Pfizer | ||||||
Study Sponsor ICMJE | Pfizer | ||||||
Collaborators ICMJE | Not Provided | ||||||
Investigators ICMJE |
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PRS Account | Pfizer | ||||||
Verification Date | March 2021 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |