PK Study With Pantoprazole in Obese Children and Adolescents

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-04

Study Completion Date

2015-09-13

Brief Summary

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Multicenter, comparative single-dose pharmacokinetic (PK) study

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Detailed Description

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Evaluate the pharmacokinetics of pantoprazole in obese children and adolescents with gastroesophageal reflux disease (GERD) following administration of an oral dose of pantoprazole.

Conditions

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Gastroesophageal Reflux Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Pantoprazole

Group Type OTHER

Pantoprazole

Intervention Type DRUG

Interventions

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Pantoprazole

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

6 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No