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Efficacy and Safety of Dexlansoprazole MR Compared to Placebo on Maintaining Healing in Subjects With Healed Erosive Esophagitis

NCT00321737 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 445

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) 30 mg and 60 mg or placebo in maintaining healing of erosive esophagitis (EE).

Conditions

  • Esophagitis, Reflux
  • Esophagitis, Peptic

Interventions

DRUG

Dexlansoprazole MR

Dexlansoprazole MR 30 mg, capsules, orally, once daily for up to six months.

DRUG

Dexlansoprazole MR

Dexlansoprazole MR 60 mg, 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
2006-05-31
Primary Completion
2007-05-31
Completion
2007-05-31

Countries

  • United States
  • Australia
  • Canada
  • Czechia
  • Estonia
  • Latvia
  • Lithuania
  • Slovakia

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 NCT00321737 on ClinicalTrials.gov