Trials / Completed
CompletedNCT03736369
Study to Evaluate the Efficacy and Safety of DWP14012 in Patients With Erosive Gastroesophageal Reflux Disease (Phase 3)
A Multi-Center, Randomized, Double-Blind, Active-controlled, Parallel-Group, Phase 3, Therapeutic Confirmatory Study to Evaluate the Efficacy and Safety of DWP14012 in Patients With Erosive Gastroesophageal Reflux Disease
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 263 (actual)
- Sponsor
- Daewoong Pharmaceutical Co. LTD. · Industry
- Sex
- All
- Age
- 20 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of study is to confirm the efficacy of DWP14012 Xmg, Once daily, compared to esomeprazole 40mg in patients with erosive gastroesophageal reflux disease.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | DWP14012 40mg | DWP14012 40mg, tablet, orally, once daily for up to 8 weeks |
| DRUG | DWP14012 40mg placebo | DWP14012 40mg placebo-matching tablet, orally, once daily for up to 8 weeks |
| DRUG | Esomeprazole 40mg | Esomeprazole 40mg tablet, orally, once daily for up to 8 weeks |
| DRUG | Esomeprazole 40mg placebo | Esomeprazole 40mg placebo-matching tablet, orally, once daily for up to 8 weeks |
Timeline
- Start date
- 2018-12-13
- Primary completion
- 2019-08-07
- Completion
- 2019-08-07
- First posted
- 2018-11-09
- Last updated
- 2020-09-03
Locations
1 site across 1 country: South Korea
Source: ClinicalTrials.gov record NCT03736369. Inclusion in this directory is not an endorsement.