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Safety and Efficacy of Dexlansoprazole Modified Release Formulation to Treat Gastroesophageal Reflux Disease

NCT00321984 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 947

Last updated 2011-04-28

Study results available
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Summary

The purpose of this study is to assess the efficacy and safety of Dexlansoprazole modified release (MR) (30 mg once daily \[QD\] or 60 mg QD) compared to placebo in relief of daytime and nighttime heartburn over 4 weeks in subjects with symptomatic, nonerosive gastroesophageal reflux disease (GERD).

Conditions

  • Gastroesophageal Reflux Disease

Interventions

DRUG

Dexlansoprazole MR

Dexlansoprazole MR 30 mg, capsules, orally, once daily for 4 weeks.

DRUG

Dexlansoprazole MR

Dexlansoprazole MR 60 mg, capsules, orally, once daily for 4 weeks.

DRUG

Placebo

Dexlansoprazole placebo-matching capsules, orally, once daily for 4 weeks.

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Takeda

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-06-30
Primary Completion
2006-12-31
Completion
2006-12-31

Countries

  • United States

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 NCT00321984 on ClinicalTrials.gov