This trial is active, not recruiting.

Condition gastroesophageal reflux disease
Treatment pantoprazole
Phase phase 1
Sponsor Phillip Brian Smith
Collaborator The EMMES Corporation
Start date July 2014
End date July 2016
Trial size 40 participants
Trial identifier NCT02186652, Pro00048765


Multicenter, comparative single-dose pharmacokinetic (PK) study

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification bio-availability study
Intervention model single group assignment
Masking open label
Primary purpose basic science

Primary Outcomes

Pharmacokinetic Analysis in obese children after one single oral dose of Pantoprazole. The PK parameters for pantoprazole will be measured from Cmax, Tmax, Ka, Kel, AUC, VDss/F & CL/F
time frame: up to 12 hours

Secondary Outcomes

The CYP2C19 genotype and its association with CYP2C19 phenotype (PK) will be measured with the analysis of a blood sample
time frame: 12 hours

Eligibility Criteria

Male or female participants from 6 years up to 17 years old.

Inclusion Criteria: 1. Participant is between 6 and 17 (inclusive) years of age at the time of consent 2. BMI ≥95th percentile 3. Diagnosis of GERD established prior to 7 days before receipt of study drug dose defined as 1 or more of the following: 1. clinical symptoms consistent with GERD as determined by the investigator 2. a diagnosis of erosive esophagitis by endoscopy 3. esophageal biopsy with histopathology consistent with reflux esophagitis 4. abnormal pH-metry consistent with reflux esophagitis 5. other test result consistent with GERD 4. Written informed consent from the parent or legally authorized representative/guardian and participant assent per local IRB recommendation of age-appropriate consent and assent requirements Exclusion Criteria: 1. Use of pantoprazole, lansoprazole, omeprazole, esomeprazole or rabeprazole within 48 hours prior to dose of study drug 2. Use of fluoxetine, fluvoxamine, ketoconazole, ticlopidine, felbamate, topiramate, valproic acid, phenobarbital, carbamazepine, erythromycin, clarithromycin, grapefruit juice, verapamil, diltiazem, cimetidine, St. John's Wort, rifampin, rifapentine within seven days prior to dose of study drug 3. Consumption of food after midnight on the day of the baseline visit 4. Symptomatic asthma 5. Type I diabetes 6. History of adverse reaction to PPI 7. Impaired hepatic activity as defined as any of the following: AST ≥150 IU/L, ALT ≥150 IU/L, total bilirubin ≥2.0 mg/dl, or alkaline phosphatase ≥600 IU/L 8. Serum creatinine ≥2.0 mg/dL 9. For females of childbearing potential, a positive pregnancy test result 10. Known infection with hepatitis B, C, or HIV 11. Any other condition that, in the opinion of the principal investigator, makes participation unadvised or unsafe.

Additional Information

Official title The Effect of Obesity on the Pharmacokinetics of Pantoprazole in Children and Adolescents
Principal investigator Phillip B Smith, MD
Description Evaluate the pharmacokinetics of pantoprazole in obese children and adolescents with gastroesophageal reflux disease (GERD) following administration of an oral dose of pantoprazole.
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Duke University.