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

NCT02401035 | Terminated Phase 4 Results FDA Drug

• 3 other identifiers: B17910892014-002182-29GERD
• Study Type: interventional
• Target: 19
• Locations: 9 countries
• Sites: 19

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.

Conditions

Gastroesophageal Reflux Disease

Keywords

candidate for acid suppression therapy; presumptive diagnosis of GERD; clinical diagnosis of suspected GERD; symptomatic GERD; endoscopically proven GERD

Outcome Measures

Primary Outcomes (2)

• Clearance (CL) of Pantoprazole

  Data reported below is combined for Days 1, 2 and 7.

  0.25, 1 to 2, 3 to 4, and 5 to 6 hours post-dose on Day 1; 0.25, 0.5, 1 to 2, 3 to 4, and 5 to 6, 8, and 12 hours post-dose on Day 2; 0.25, 0.5, 1, 2, 4, 8, and 12 hours post-dose on Day 7

• Volume of Distribution (Vd) of Pantoprazole

  Data reported below is combined for Days 1, 2 and 7.

  0.25, 1 to 2, 3 to 4, and 5 to 6 hours post-dose on Day 1; 0.25, 0.5, 1 to 2, 3 to 4, and 5 to 6, 8, and 12 hours post-dose on Day 2; 0.25, 0.5, 1, 2, 4, 8, and 12 hours post-dose on Day 7

Secondary Outcomes (13)

• Maximum Plasma Concentration (Cmax) of Pantoprazole: Single Dose

  0.25, 1, 2, 3 to 4, and 5 to 6 hours post-dose on Day 1

• Cmax of Pantoprazole: Multiple Dose

  0.25, 0.5, 1 to 2, 3 to 4, and 5 to 6, 8, and 12 hours post-dose on Day 2; 0.25, 0.5, 1, 2, 4, 8, and 12 hours post dose on Day 7

• Area Under the Plasma Concentration-time Profile From Time Zero to 24 Hour (AUC24) of Pantoprazole: Single Dose

  0.25, 1, 2, 3 to 4, and 5 to 6 hours post-dose on Day 1; 24 hours post dose on Day 1 (pre dose on Day 2)

• Area Under the Plasma Concentration-time Profile From Time Zero to 24 Hour (AUC24) of Pantoprazole: Multiple Dose

  0.25, 0.5, 1 to 2, 3 to 4, and 5 to 6, 8, and 12 hours post-dose on Day 2; 0.25, 0.5, 1, 2, 4, 8, and 12 hours post dose on Day 7

• Area Under the Plasma Concentration-time Profile From Time Zero Extrapolated to Infinite Time (AUCinf) of Pantoprazole: Single Dose

  0.25, 1, 2, 3 to 4, and 5 to 6 hours post-dose on Day 1

Study Arms (1)

IV pantoprazole

EXPERIMENTAL

Patients will receive 10 mg, 20 mg, or 40 mg IV pantoprazole determined by weight.

Drug: IV pantoprazole

Interventions

IV pantoprazole DRUG

Patients will receive 10 mg, 20 mg, or 40 mg IV pantoprazole determined by weight

IV pantoprazole

Eligibility Criteria

• Age: 1 Year - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (19)

Children's Health Specialty Center Dallas Campus

Dallas, Texas, 75207, United States

Location

Children's Medical Center Dallas

Dallas, Texas, 75235, United States

Location

Primary Children's Hospital

Salt Lake City, Utah, 84113, United States

Location

Hospital Militar Central "Cirujano Mayor Dr. Cosme Argerich"

CABA, Buenos Aires, C1426BOS, Argentina

Location

University clinical center of the Republic of Srpska

Banja Luka, 78000, Bosnia and Herzegovina

Location

JSC Evex Medical Corporation

Tbilisi, 0159, Georgia

Location

LTD Imedi Clinic

Tbilisi, 0159, Georgia

Location

Katholisches Klinikum Bochum

Bochum, 44791, Germany

Location

Zentralapotheke St. Josef-Hospital

Bochum, 44791, Germany

Location

Centro Trials - Dipartimento Pediatrico Universitario Ospedaliero Padiglione Salviati

Roma, 00165, Italy

Location

IRCCS Ospedale Pediatrico Bambino Gesù

Roma, 00165, Italy

Location

IRCCS-Ospedale Pediatrico Bambino Gesù Farmacia Ospedaliera

Roma, 00165, Italy

Location

University Children's Clinic

Belgrade, 11000, Serbia

Location

Institute for Child and Youth Health Care of Vojvodina

Novi Sad, 21000, Serbia

Location

Narodny ustav detskych chorob

Bratislava, 833 40, Slovakia

Location

Univerzitna nemocnica Martin

Martin, 036 59, Slovakia

Location

Komunalne pidpryiemstvo Dnipropetrovskyi spetsializovanyi klinichnyi medychnyi tsentr materi

Dnipro, 49006, Ukraine

Location

Komunalne nekomertsiine pidpryiemstvo Ivano-Frankivska oblasna dytiacha klinichna likarnia

Ivano-Frankivsk, 76018, Ukraine

Location

Komunalne nekomertsiine pidpryiemstvo "Khersonska dytiacha oblasna klinichna likarnia"

M. Kherson, 73013, Ukraine

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Gastroesophageal Reflux

Interventions

Pantoprazole

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2014
• First Posted: March 27, 2015
• Study Start: May 9, 2017
• Primary Completion: June 18, 2021
• Study Completion: June 18, 2021
• Last Updated: April 9, 2024
• Results First Posted: April 9, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share

Locations

IT (3); DE (2); US (3); GE (2); AR (1); BO (1); SL (2); SE (2); UA (3)