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 : November 9, 2022
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Tracking Information | |||||||
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First Submitted Date ICMJE | December 15, 2014 | ||||||
First Posted Date ICMJE | March 27, 2015 | ||||||
Last Update Posted Date | November 9, 2022 | ||||||
Actual Study Start Date ICMJE | May 9, 2017 | ||||||
Estimated Primary Completion Date | April 20, 2027 (Final data collection date for primary outcome measure) | ||||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE |
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Change History | |||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
CYP2C19 genotyping [ Time Frame: Day 1 ] CYP2C19 genotyping will be summarized descriptively
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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. |
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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 |
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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
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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
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Publications * | Not Provided | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||
Recruitment Status ICMJE | Recruiting | ||||||
Estimated Enrollment ICMJE |
24 | ||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||
Estimated Study Completion Date ICMJE | May 18, 2027 | ||||||
Estimated Primary Completion Date | April 20, 2027 (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, Serbia, Slovakia, Ukraine, United States | ||||||
Removed Location Countries | Puerto Rico, 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 ) |
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Has Data Monitoring Committee | No | ||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Current Responsible Party | Pfizer | ||||||
Original Responsible Party | Same as current | ||||||
Current Study Sponsor ICMJE | Pfizer | ||||||
Original Study Sponsor ICMJE | Same as current | ||||||
Collaborators ICMJE | Not Provided | ||||||
Investigators ICMJE |
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PRS Account | Pfizer | ||||||
Verification Date | November 2022 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |