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Pharmacokinetic and Safety of Dexlansoprazole in Adolescents With Gastroesophageal Reflux Disease

NCT00847210 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2012-02-02

Study results available
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Summary

The purpose of this study is to asses the pharmacokinetics and safety of dexlansoprazole modified release (MR), once daily (QD), in adolescent subjects (age 12-17 years old) with Symptomatic Gastroesophageal Reflux Disease.

Conditions

  • Gastroesophageal Reflux

Interventions

DRUG

Dexlansoprazole MR

Dexlansoprazole MR 30 mg, capsules, orally, once daily for up to 7 days.

DRUG

Dexlansoprazole MR

Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 7 days.

Sponsors & Collaborators

Principal Investigators

  • Medical Director Pharmacovigilance · Takeda

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-05-31
Primary Completion
2009-09-30
Completion
2009-09-30

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00847210 on ClinicalTrials.gov