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Dexlansoprazole for Heartburn in Non-Erosive GERD
NCT02873689Phase 3
Key facts
- Status
- Completed
- Start
- Dec 2016
- Primary completion
- Mar 2018
- Countries
- 1
- Sponsor
- Takeda
- Modality
- Small Molecules
- Drugs
- dexlansoprazole
- Conditions
- Non-erosive Gastroesophageal Reflux Disease (NERD)
01
Overview
Phase 3, randomised, double-blind trial in Non-erosive Gastroesophageal Reflux Disease (NERD) comparing Dexlansoprazole 30 mg with Placebo (2 arms). Primary endpoint: Percentage of Days With Neither Daytime Nor Nighttime Heartburn During Treatment. Started Dec 2016; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Dexlansoprazole 30 mg
Dexlansoprazole 30 mg QD
Placebo
Placebo QD
03
Who it enrols
Chinese participants with symptomatic non-erosive GERD who have heartburn for 4 or more days in the week prior to screening and are responsive to acid-suppressive therapy.
04
Endpoints
Primary
Percentage of Days With Neither Daytime Nor Nighttime Heartburn During Treatment
Secondary
Percentage of Days Without Nighttime Heartburn During Treatment
05
Results
Not all primary endpoints met
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