CompletedPhase 1

PK Study With Pantoprazole in Obese Children and Adolescents

United States41 participantsStarted 2014-06-04

Plain-language summary

Multicenter, comparative single-dose pharmacokinetic (PK) study

Who can participate

Age range6 Years – 17 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Participant is between 6 and 17 (inclusive) years of age at the time of consent
✓. BMI ≥95th percentile
✓. Diagnosis of GERD established prior to 7 days before receipt of study drug dose defined as 1 or more of the following:
✓. clinical symptoms consistent with GERD as determined by the investigator
✓. a diagnosis of erosive esophagitis by endoscopy
✓. esophageal biopsy with histopathology consistent with reflux esophagitis
✓. abnormal pH-metry consistent with reflux esophagitis
✓. other test result consistent with GERD

Exclusion criteria

✕. Use of pantoprazole, lansoprazole, omeprazole, esomeprazole or rabeprazole within 48 hours prior to dose of study drug
✕. 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
✕. Consumption of food after midnight on the day of the baseline visit
✕. Symptomatic asthma
✕. Type I diabetes
✕. History of adverse reaction to PPI
✕. 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
✕. Serum creatinine ≥2.0 mg/dL

What they're measuring

Pharmacokinetic Analysis in Obese Children After One Single Oral Dose of Pantoprazole (Cmax).

Timeframe: pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, & 8 hours

Pharmacokinetic Analysis in Obese Children After One Single Oral Dose of Pantoprazole (Tmax).

Timeframe: pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, & 8 hours

PK Sampling

Timeframe: Pre-dose (within 30 minutes), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours (±10 minutes) after dosing

Drug Concentration in Plasma Samples

Timeframe: Pre-dose (within 30 minutes), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours (±10 minutes) after dosing

Pharmacokinetic Analysis in Obese Children After One Single Oral Dose of Pantoprazole (AUC).

Timeframe: pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, & 8 hours

Pharmacokinetic Analysis in Obese Children After One Single Oral Dose of Pantoprazole (AUC).

Timeframe: pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, & 8 hours

Pharmacokinetic Analysis in Obese Children After One Single Oral Dose of Pantoprazole (CL/F).

Timeframe: pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, & 8 hours

Trial details

NCT IDNCT02186652

SponsorPhillip Brian Smith

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2015-09-13

Results submitted2018-09-24

View on ClinicalTrials.gov More Gastroesophageal Reflux Disease trials

Who can participate

Age range6 Years – 17 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Participant is between 6 and 17 (inclusive) years of age at the time of consent
✓. BMI ≥95th percentile
✓. Diagnosis of GERD established prior to 7 days before receipt of study drug dose defined as 1 or more of the following:
✓. clinical symptoms consistent with GERD as determined by the investigator
✓. a diagnosis of erosive esophagitis by endoscopy
✓. esophageal biopsy with histopathology consistent with reflux esophagitis
✓. abnormal pH-metry consistent with reflux esophagitis
✓. other test result consistent with GERD

Exclusion criteria

✕. Use of pantoprazole, lansoprazole, omeprazole, esomeprazole or rabeprazole within 48 hours prior to dose of study drug
✕. 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
✕. Consumption of food after midnight on the day of the baseline visit
✕. Symptomatic asthma
✕. Type I diabetes
✕. History of adverse reaction to PPI
✕. 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
✕. Serum creatinine ≥2.0 mg/dL

What they're measuring

Pharmacokinetic Analysis in Obese Children After One Single Oral Dose of Pantoprazole (Cmax).

Timeframe: pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, & 8 hours

Pharmacokinetic Analysis in Obese Children After One Single Oral Dose of Pantoprazole (Tmax).

Timeframe: pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, & 8 hours

PK Sampling

Timeframe: Pre-dose (within 30 minutes), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours (±10 minutes) after dosing

Drug Concentration in Plasma Samples

Timeframe: Pre-dose (within 30 minutes), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours (±10 minutes) after dosing

Pharmacokinetic Analysis in Obese Children After One Single Oral Dose of Pantoprazole (AUC).

Timeframe: pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, & 8 hours

Pharmacokinetic Analysis in Obese Children After One Single Oral Dose of Pantoprazole (AUC).

Timeframe: pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, & 8 hours

Pharmacokinetic Analysis in Obese Children After One Single Oral Dose of Pantoprazole (CL/F).

Timeframe: pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, & 8 hours