At a glance

ClinicalIndex Comparison Record

Phase 3Completed· 2,038 enrolled

Drug / intervention

Dexlansoprazole MR +2 moredrug

Likely dose

Dexlansoprazole MR 60 mgfrom record

Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00251693

NCT00251693Phase 3Completed

Compare CT.gov

A Phase 3 Study to Evaluate the Efficacy and Safety of TAK-390MR (60 mg Once- Daily [QD] and 90 mg QD) and an Active Comparator, Lansoprazole (30 mg QD) on Healing of Erosive Esophagitis

Takeda·interventional·Posted Nov 10, 2005·Updated Feb 3, 2012

In Brief

A Phase 3 clinical trial evaluating Dexlansoprazole MR and Lansoprazole for Esophagitis, Reflux and Esophagitis, Peptic. Completed, enrolled 2,038 participants across 140 sites in 15 countries.

Detailed Summary

The purpose of this study is to assess the efficacy and safety of 8 weeks of once-daily (QD) treatment with dexlansoprazole modified release (MR) 60 mg or 90 mg or lansoprazole 30 mg in healing subjects with endoscopically proven erosive esophagitis.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsEsophagitis, Reflux, Esophagitis, Peptic

CountriesAustralia, Bulgaria, Canada, Czechia, Germany, Hungary, India, Latvia, Lithuania, New Zealand, Peru, Poland, Slovakia, South Africa, United States

Collaborators--

Timeline

Phase 3CompletedFinished

2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027

First PostedNov 2005

Enrollment StartDec 2005

Primary CompletionJan 2007

TodayJul 2026

First PostedNov 10, 2005

Enrollment StartDec 1, 2005

Primary CompletionJan 1, 2007

TodayJul 2, 2026

Enrollment to primary: 1.1 yearsPosted 20.6 years ago

Interventions

Dexlansoprazole MRdrug

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

Dexlansoprazole MRdrug

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

Lansoprazoledrug

Lansoprazole 30 mg, capsules, orally, once daily for up to 8 weeks.