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Efficacy and Safety of Dexlansoprazole MR and Lansoprazole on Healing of Erosive Esophagitis

NCT00251719 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 2054

Last updated 2012-02-03

Study results available
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Summary

This is a study to assess the efficacy and safety of 8 weeks of treatment with Dexlansoprazole modified release (MR)(60 mg daily and 90 mg daily) compared to Lansoprazole (30 mg daily) in healing subjects with endoscopically proven erosive esophagitis.

Conditions

  • Esophagitis, Reflux
  • Esophagitis, Peptic

Interventions

DRUG

Dexlansoprazole MR

Dexlansoprazole MR 60 mg, capsules, orally, once daily (QD) for up to 8 weeks.

DRUG

Dexlansoprazole MR

Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 8 weeks.

DRUG

Lansoprazole

Lansoprazole 30 mg, capsules, orally, once daily for up to 8 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
2005-12-31
Primary Completion
2007-01-31
Completion
2007-01-31

Countries

  • United States
  • Australia
  • Bulgaria
  • Canada
  • Colombia
  • Czechia
  • Germany
  • India
  • Latvia
  • Lithuania
  • New Zealand
  • Peru
  • Poland
  • Russia
  • Slovakia
  • South Africa

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 NCT00251719 on ClinicalTrials.gov