A study to evaluate the pharmacokinetics (the way the body absorbs, distributes and eliminates the drug) of the study drug pantoprazole in hospitalized children aged 1-16 years old who are candidates for acid suppression therapy.
- Conditions
- Gastroesophageal Reflux Disease (GERD)Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
- Registration Number
- EUCTR2014-002182-29-ES
- Lead Sponsor
- Pfizer Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 24
1. Evidence of a personally signed and dated informed consent document indicating that the parent/legal guardian has been informed of all pertinent aspects of the study.
2. Evidence of a personally signed and dated assent, indicating that the subject understands the nature of all pertinent aspects of the study, and is willing to participate in the study activities, if applicable, as consistent with the subject's age and ability to provide assent.
3. The subject (to degree appropriate for age) and parent or legal guardian are able to understand and comply with protocol requirements, instructions and protocol-stated restrictions and are likely to complete the study as planned.
4. Hospitalized subjects 1 to 16 years who in the judgment of the investigator are candidates for acid suppression therapy (ie, those with a presumptive diagnosis of GERD, a clinical diagnosis of suspected GERD, symptomatic GERD, or endoscopically proven GERD).
5. Physical examination and clinical laboratory evaluations within normal limits unless the investigator documents that the deviations are not clinically significant or are directly related to the reason for acid suppression therapy or to the subject's underlying disease process.
6. Body weight >5th percentile for subject's age.
7. Y-site or dedicated IV line for administration of pantoprazole.
8. Expected survival for at least 30 days.
9. The subject (to degree appropriate for age) and parent or legal guardian are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
10. Male and female subjects of childbearing potential and 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.
a. If subject is a female of childbearing potential, she must agree to use adequate contraception and must have a negative serum pregnancy test within 24 hours prior to administration of investigational product.
Are the trial subjects under 18? yes
Number of subjects for this age range: 24
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
1. Subjects who are investigational site staff members directly involved in the conduct of the trial and their family members, site staff members otherwise supervised by the Investigator, or subjects who are Pfizer employees directly involved in the conduct of the trial.
2. Participation in other studies involving investigational drug(s) (Phases 1-4) or treatment with an investigational drug within 30 days or 5 half-lives before the first dose of the investigational product and/or during study participation.
3. 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.
4. Pregnant females; breastfeeding females; males and females of childbearing potential who are unwilling or unable to use a highly effective method of contraception as outlined in this protocol for the duration of the study and for at least 28 days after last dose of investigational product.
5. Serum creatine kinase levels >3x upper limit of normal.
6. Known history of human immunodeficiency virus (HIV) or clinical manifestations of acquired immune deficiency syndrome (AIDS).
7. History or presence of upper gastrointestinal anatomic or motor disorders, including the following:
a. Esophageal strictures, webs, or diverticulae.
b. Gastrointestinal strictures of any kind.
c. Esophageal or gastric motor disorders (eg, scleroderma).
d. Barrett's esophagus.
e. Peptic ulcer disease, erosive gastritis and/or erosive duodenitis.
f. Known eosinophilic esophagitis by histology.
g. Gastrointestinal malabsorption.
h. Known active Helicobacter pylori infection.
8. Known hypersensitivity to proton pump inhibitors (PPIs), including pantoprazole or to any substituted benzimidazole or to any of the excipients.
9. History of treatment with any PPI (eg, omeprazole, esomeprazole, lansoprazole, rabeprazole, or pantoprazole) within 2 weeks (14 days) before Day 1.
10. Use of Histamine 2 Receptor Blockers (H2RAs) (eg, cimetidine, famotidine, ranitidine or nizatidine), sucralfate, misoprostol, or prokinetic agents (eg, cisapride, urecholine, erythromycin or metoclopramide), and bismuth preparations within 2 weeks (14 days) before Day 1.
11. Any disorder requiring chronic (every day) use of warfarin, carbamazepine, or phenytoin, methotrexate, atazanavir or nelfinavir, clopidogrel, and potent inhibitors and inducers of CYP2C19.
12. Chronic (daily) use of glucocorticoids (eg, prednisone, prednisolone, dexamethasone). Steroid inhalers and topical steroids may be used.
13. 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).
14. Diagnosed as having or has received treatment for esophageal, gastric, pyloric channel, or duodenal ulceration within 30 days before Screening.
15. Alanine aminotransferase (ALT) or Blood urea nitrogen (BUN) >2.0 Upper limit of normal (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.
16. In the Investigator?s opinion, a chronic condition (eg, d
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Secondary Objective: To determine the safety and tolerability of single and multiple doses of IV pantoprazole in each of the two independent age cohorts over 7 days.<br><br>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.;Primary end point(s): Day 1: Tmax, Cmax, AUClast, AUCinf, Vss, T1/2 and CL of pantoprazole following a single IV dose.<br><br>Day 7: Tmax, Cmax, AUClast, T1/2 and CL of pantoprazole following multiple IV doses.;Timepoint(s) of evaluation of this end point: Day 1 and Day 7.;Main Objective: To characterize the PK profile of single and repeated IV doses of pantoprazole in pediatric subjects aged 1 to less than 2 years old.<br><br>To characterize the PK profile of single and repeated IV doses of pantoprazole in pediatric subjects aged 2 to 16 years old.
- Secondary Outcome Measures
Name Time Method Timepoint(s) of evaluation of this end point: 1. Throughout the trial. <br><br>2. Samples for CYP2C19 genotype analysis will be collected pre-dose.;Secondary end point(s): 1. Safety and tolerability of single and multiple doses of IV pantoprazole for each of the two age cohorts will be assessed by physical examinations, adverse event (AE) monitoring, clinical laboratory measurements, blood pressure, and pulse rate.<br><br>2. CYP2C19 genotype to determine the presence of the gene for the major enzyme responsible for metabolism of pantoprazole.