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

Sponsor

Daewoong Pharmaceutical Co. LTD. (Industry)

Overall Status

Completed

CT.gov ID

NCT03184324

Collaborator

(none)

211

Enrollment

Location

Arms

7.7

Actual Duration (Months)

27.6

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Erosive Gastroesophageal Reflux Disease	Drug: DWP14012 Drug: Esomeprazole Drug: DWP14012 placebo Drug: Esomeprazole placebo	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

211 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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.

Actual Study Start Date :

Aug 28, 2017

Actual Primary Completion Date :

Apr 18, 2018

Actual Study Completion Date :

Apr 18, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: DWP14012 20mg DWP14012 20mg, tablet, orally, once daily	Drug: DWP14012 tablet Drug: DWP14012 placebo tablet Drug: Esomeprazole placebo tablet
Experimental: DWP14012 40mg DWP14012 40mg, tablet, orally, once daily	Drug: DWP14012 tablet Drug: DWP14012 placebo tablet Drug: Esomeprazole placebo tablet
Experimental: DWP14012 80mg DWP14012 40mg*2, tablet, orally, once daily	Drug: DWP14012 tablet Drug: DWP14012 placebo tablet Drug: Esomeprazole placebo tablet
Active Comparator: Esomerpazole 40mg Esomerpazole 40mg, tablet, orally, once daily	Drug: Esomeprazole tablet Other Names: Nexium Drug: DWP14012 placebo tablet

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hanyang University Medical Center	Sungdong-gu	Seoul	Korea, Republic of	04763

Sponsors and Collaborators

Daewoong Pharmaceutical Co. LTD.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Daewoong Pharmaceutical Co. LTD.

ClinicalTrials.gov Identifier:

NCT03184324

Other Study ID Numbers:

DW_DWP14012002

First Posted:

Jun 12, 2017

Last Update Posted:

Sep 3, 2020

Last Verified:

Jun 1, 2018

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Gastroesophageal Reflux

Esophagitis, Peptic

Esomeprazole

Study Results

No Results Posted as of Sep 3, 2020