CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 908 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/NCT00251745
NCT00251745Phase 3Completed
CompareCT.gov

A Phase 3 Study to Evaluate the Efficacy and Safety of Dexlansoprazole MR (60 mg Once-Daily (QD) and 90 mg QD) Compared to Placebo on Symptom Relief in Subjects With Symptomatic Non-Erosive Gastroesophageal Reflux Disease (GERD)

Takeda·interventional·Posted Nov 10, 2005·Updated Apr 28, 2011

In Brief

A Phase 3 clinical trial evaluating Dexlansoprazole MR and Placebo for Gastroesophageal Reflux Disease. Completed, enrolled 908 participants across 95 sites.

Detailed Summary

The purpose of this study is to assess the efficacy and safety of daily treatment with Dexlansoprazole modified release (MR) (60 mg or 90 mg once daily \[QD\]) compared to placebo QD in relief of daytime and nighttime heartburn over 4 weeks in subjects with gastroesophageal reflux disease (GERD).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGastroesophageal Reflux Disease
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedNov 10, 2005
Enrollment StartDec 1, 2005
Primary CompletionMay 1, 2006
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 20.6 years ago

Interventions

Dexlansoprazole MRdrug

Dexlansoprazole MR 60 mg, capsules, orally, once daily for 4 weeks.

Dexlansoprazole MRdrug

Dexlansoprazole MR 90 mg, capsules, orally, once daily for 4 weeks.

Placebodrug

Dexlansoprazole placebo-matching capsules, orally, once daily for 4 weeks.