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Safety and Efficacy of Dexlansoprazole Delayed-Release Capsules in Treating Symptomatic Non-Erosive Gastroesophageal Reflux Disease in Adolescents

NCT01642602 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 104

Last updated 2014-08-06

Study results available
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Summary

The purpose of this study was to assess the safety and effectiveness of once daily oral administration of dexlansoprazole delayed-release capsules in adolescent participants with symptomatic non-erosive gastroesophageal reflux disease (GERD).

Conditions

  • Gastroesophageal Reflux Disease

Interventions

DRUG

Dexlansoprazole

Dexlansoprazole delayed-release capsules.

Sponsors & Collaborators

Principal Investigators

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

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2012-07-31
Primary Completion
2014-01-31
Completion
2014-01-31

Countries

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

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 NCT01642602 on ClinicalTrials.gov