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Comparison of Dexlansoprazole MR to Placebo on the Ability to Maintain Healing in Subjects With Healed Erosive Esophagitis

NCT00255151 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 451

Last updated 2012-02-03

Study results available
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Summary

The purpose of this study is to assess the ability of once-daily (QD) treatment with Dexlansoprazole modified-release (MR) 60 mg and 90 mg and placebo in maintaining healing of erosive esophagitis (EE).

Conditions

  • Esophagitis, Reflux
  • Esophagitis, Peptic

Interventions

DRUG

Dexlansoprazole MR

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

DRUG

Dexlansoprazole MR

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

DRUG

Placebo

Dexlansoprazole placebo-matching capsules, orally, once daily for up to six months.

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
2006-01-31
Primary Completion
2006-11-30
Completion
2006-11-30

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 NCT00255151 on ClinicalTrials.gov