At a glance

ClinicalIndex Comparison Record

Phase 3Completed· 2,054 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/NCT00251719

NCT00251719Phase 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 2,054 participants across 144 sites in 16 countries.

Detailed 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.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsEsophagitis, Reflux, Esophagitis, Peptic

CountriesAustralia, Bulgaria, Canada, Colombia, Czechia, Germany, India, Latvia, Lithuania, New Zealand, Peru, Poland, Russia, 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.