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Safety and Efficacy of Dexlansoprazole Delayed-Release Capsules for Healing of Erosive Esophagitis and Maintenance of Healed Erosive Esophagitis and Relief of Heartburn in Adolescents

NCT01642615 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 63

Last updated 2015-05-27

Study results available
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Summary

The purpose of this study is to assess the safety and effectiveness of treatment with once daily oral administration of dexlansoprazole delayed-release capsules in adolescents with erosive esophagitis (EE) and for maintenance of healed EE and relief of heartburn.

Conditions

  • Gastroesophageal Reflux Disease
  • Erosive Esophagitis

Interventions

DRUG

Dexlansoprazole

Dexlansoprazole capsules

DRUG

Dexlansoprazole

Dexlansoprazole capsules

DRUG

Placebo

Dexlansoprazole placebo-matching capsules

Sponsors & Collaborators

Principal Investigators

  • Medical Director, Clinical Science · Takeda Global Research and Development Center, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2012-07-31
Primary Completion
2014-11-30
Completion
2014-11-30

Countries

  • United States
  • Belgium
  • Brazil
  • Hungary
  • Italy
  • Mexico
  • Poland
  • Portugal

Study Locations

More Related Trials

Entities

Drugs
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 NCT01642615 on ClinicalTrials.gov