Study to Evaluate the Efficacy and Safety of DWP14012 in Patients With Erosive Gastroesophageal Reflux Disease (Phase 2, Therapeutic Exploratory Study)

NCT03184324 — Phase 2, Completed, 211 participants, Daewoong Pharmaceutical Co. LTD.

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A Multi-Center, Randomized, Double-Blind, Active-controlled, Phase 2, Therapeutic Exploratory Study to Evaluate the Efficacy and Safety of DWP14012 in Patients With Erosive Gastroesophageal Reflux Disease.

Registry	NCT03184324
Status	Completed
Phase	Phase 2
Study type	Interventional; randomized, parallel, masking: quadruple, treatment
Enrollment	211 (Actual)
Sponsor	Daewoong Pharmaceutical Co. LTD. (Industry)
Conditions	Erosive Gastroesophageal Reflux Disease
Interventions	DWP14012, Esomeprazole, DWP14012 placebo, Esomeprazole placebo (Drug)
Dates	start 2017-08-28, primary completion 2018-04-18, completion 2018-04-18, first posted 2017-06-12, last updated 2020-09-03
Locations	1 site in South Korea

-Summary

The purpose of this study is to determine the efficacy and safety of DWP14012 compared to esomeprazole in the treatment of erosive gastroesophageal reflux disease classified as Los Angeles(LA) classification grades A to D.

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+Arms and interventions

Arm	Type	Interventions	Description
DWP14012 20mg	Experimental	Drug: DWP14012; Drug: DWP14012 placebo; Drug: Esomeprazole placebo	DWP14012 20mg, tablet, orally, once daily
DWP14012 40mg	Experimental	Drug: DWP14012; Drug: DWP14012 placebo; Drug: Esomeprazole placebo	DWP14012 40mg, tablet, orally, once daily
DWP14012 80mg	Experimental	Drug: DWP14012; Drug: DWP14012 placebo; Drug: Esomeprazole placebo	DWP14012 40mg*2, tablet, orally, once daily
Esomerpazole 40mg	Active comparator	Drug: Esomeprazole; Drug: DWP14012 placebo	Esomerpazole 40mg, tablet, orally, once daily

DWP14012 (Drug): tablet
Esomeprazole (Drug), also known as Nexium: tablet
DWP14012 placebo (Drug): tablet
Esomeprazole placebo (Drug): tablet

+Outcome measures

Primary outcomes

Ratio of subjects who were completely cured of mucosal defects by 8 weeks [8 weeks]

Secondary outcomes

Ratio of subjects who were completely cured of mucosal defects by 4 weeks [4 weeks]

+Eligibility

Sex: All, ages: 20 Years to 75 Years

Inclusion Criteria:

* Adults between 20 and 75 years old based on the date of written agreement
* Those who have been diagnosed with erosive gastroesophageal reflux disease(EGRD) of LA Grade A-D on the upper gastrointestinal endoscopy
* Those who experienced symptoms of heartburn or acid reflux within the last 7 days

Exclusion Criteria:

* Those who have undergone gastric acid suppression or gastric, esophageal surgery
* Those who with clinically significant liver, kidney, nervous system, respiratory, endocrine, hematologic, cardiovascular, urinary system disease

+Locations (1)

Facility	City	Country	Status
Hanyang University Medical Center	Sungdong-gu, Seoul	South Korea

My Notes

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