CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 947 enrolled
Drug / intervention
Dexlansoprazole MR +2 moredrug
Likely dose
Dexlansoprazole MR 30 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/NCT00321984
NCT00321984Phase 3Completed
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A Phase 3 Study to Evaluate the Efficacy and Safety of Dexlansoprazole MR (30 mg QD and 60 mg QD) Compared to Placebo on Symptom Relief in Subjects With Symptomatic Nonerosive Gastroesophageal Reflux Disease (GERD)

Takeda·interventional·Posted May 4, 2006·Updated Apr 28, 2011

In Brief

A Phase 3 clinical trial evaluating Dexlansoprazole MR and Placebo for Gastroesophageal Reflux Disease. Completed, enrolled 947 participants across 153 sites.

Detailed Summary

The purpose of this study is to assess the efficacy and safety of Dexlansoprazole modified release (MR) (30 mg once daily \[QD\] or 60 mg QD) compared to placebo in relief of daytime and nighttime heartburn over 4 weeks in subjects with symptomatic, nonerosive gastroesophageal reflux disease (GERD).

Study Details

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

Timeline

Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 4, 2006
Enrollment StartJun 1, 2006
Primary CompletionDec 1, 2006
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 20.2 years ago

Interventions

Dexlansoprazole MRdrug

Dexlansoprazole MR 30 mg, capsules, orally, once daily for 4 weeks.

Dexlansoprazole MRdrug

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

Placebodrug

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