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Study to Evaluate the Efficacy and Safety of DWP14012 in Patients With Erosive Gastroesophageal Reflux Disease (Phase 3)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03736369
Recruitment Status : Completed
First Posted : November 9, 2018
Last Update Posted : September 3, 2020
Sponsor:
Information provided by (Responsible Party):
Daewoong Pharmaceutical Co. LTD.

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Erosive Esophagitis Drug: DWP14012 40mg Drug: DWP14012 40mg placebo Drug: Esomeprazole 40mg Drug: Esomeprazole 40mg placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 263 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, Parallel-Group, Phase 3, Therapeutic Confirmatory Study to Evaluate the Efficacy and Safety of DWP14012 in Patients With Erosive Gastroesophageal Reflux Disease
Actual Study Start Date : December 13, 2018
Actual Primary Completion Date : August 7, 2019
Actual Study Completion Date : August 7, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: GERD

Arms and Interventions
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Arm Intervention/treatment
Experimental: DWP14012 40mg
Orally, once daily
 Drug: DWP14012 40mg
DWP14012 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
Other Name: Nexium 40mg placebo
Active Comparator: Esomeprazole 40mg
Orally, once daily
 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
Other Name: Nexium 40mg


Outcome Measures
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Primary Outcome Measures :
  1. Cumulative healing rate of erosive esophagitis at 8week by endoscopy [ Time Frame: at 8week ]

Secondary Outcome Measures :
  1. Cumulative healing rate of erosive esophagitis at 4week by endoscopy [ Time Frame: at 4week ]
  2. Reflux disease symptom assessment using RDQ(Reflux disease questionnaire) [ Time Frame: at 4week and 8week ]
    Mean change of the frequency or severity of main symptoms

  3. Quality of Life assessment using GERD-HRQL(GERD-Health related quality life) [ Time Frame: at 4week and 8week ]
    Mean change of the total score of GERD-HRQL


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 regurgitation 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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03736369


Locations
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Korea, Republic of
Hanyang University Medical Center
Seoul, Korea, Republic of
Sponsors and Collaborators
Daewoong Pharmaceutical Co. LTD.
More Information
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Responsible Party: Daewoong Pharmaceutical Co. LTD.
ClinicalTrials.gov Identifier: NCT03736369    
Other Study ID Numbers: DW_DWP14012301
First Posted: November 9, 2018    Key Record Dates
Last Update Posted: September 3, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Gastroesophageal Reflux
Esophagitis
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
 Gastroenteritis
Esomeprazole
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action