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OpenTrials
Completed

NCT Number: NCT03736369

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

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.

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Key information

Conditions

Erosive Esophagitis

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hanyang University Medical Center

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

DWP14012 40mg

Drug

DWP14012 40mg, tablet, orally, once daily for up to 8 weeks

DWP14012 40mg placebo

Drug

DWP14012 40mg placebo-matching tablet, orally, once daily for up to 8 weeks

Esomeprazole 40mg

Drug

Esomeprazole 40mg tablet, orally, once daily for up to 8 weeks

Other names: Nexium 40mg

Esomeprazole 40mg placebo

Drug

Esomeprazole 40mg placebo-matching tablet, orally, once daily for up to 8 weeks

Other names: Nexium 40mg placebo

Primary outcomes

  1. Cumulative healing rate of erosive esophagitis at 8week by endoscopy

    Time frame: at 8week

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Daewoong Pharmaceutical Co. LTD.

Industry

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Nov 9, 2018
Registry last updated
Sep 3, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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