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Study to Evaluate the Pharmacokinetics and Safety of Dexlansoprazole in Pediatric Subjects With Symptomatic Gastroesophageal Reflux Disease

NCT01045096 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2012-04-05

Study results available
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Summary

The purpose of this study is to assess the pharmacokinetics and safety of dexlansoprazole, once daily (QD), in pediatric subjects with symptomatic Gastroesophageal Reflux Disease.

Conditions

  • Gastroesophageal Reflux

Interventions

DRUG

Dexlansoprazole

Dexlansoprazole 15 mg, delayed release capsules, orally, once daily for up to 7 days.

DRUG

Dexlansoprazole

Dexlansoprazole 30 mg, delayed release capsules, orally, once daily for up to 7 days

DRUG

Dexlansoprazole

Dexlansoprazole 60 mg, delayed release capsules, orally, once daily for up to 7 days

Sponsors & Collaborators

Principal Investigators

  • Medical Director, Clinical Science · Takeda

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
1 Year
Max Age
11 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-03-31
Primary Completion
2011-02-28
Completion
2011-02-28

Countries

  • United States

Study Locations

More Related Trials

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 NCT01045096 on ClinicalTrials.gov