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Safety and Quality of Life Study of Dexlansoprazole Modified Release Formulation to Treat Heartburn

NCT00255190 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 591

Last updated 2016-07-27

Study results available
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Summary

The purpose of this study is to determine the long-term safety profile of daily treatment with dexlansoprazole MR in subjects with gastroesophageal reflux disease.

Conditions

  • Gastroesophageal Reflux Disease

Interventions

DRUG

Dexlansoprazole MR

Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 12 months.

DRUG

Dexlansoprazole MR

Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 12 months.

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Takeda

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-01-31
Primary Completion
2008-06-30
Completion
2008-06-30

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 NCT00255190 on ClinicalTrials.gov