The Efficacy and Safety of DWP14012 in Chinese Patients With Reflux Esophagitis

A Multicenter, Randomized, Double-Blind, Active-Parallel-Controlled, Phase 3 Clinical Study to Investigate the Efficacy and Safety of DWP14012 in the Treatment of Reflux Esophagitis

To evaluate the efficacy, safety, and cost-effectiveness of DWP14012 40 mg compared to esomeprazole magnesium enteric-coated tablets for the treatment of reflux esophagitis.

Study Overview

• Status: Completed
• Conditions: Reflux Esophagitis
• Intervention / Treatment: Drug: DWP14012

• Study Type: Interventional
• Enrollment (Actual): 332
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China
      • Minhu Chen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Subjects must meet all of the following inclusion criteria to be eligible for this study:

  1. Male or female subjects aged 18-75 years (inclusive);
  2. Subjects with a confirmed diagnosis of reflux esophagitis (Grade A-D according to LA classification) by esophagogastroduodenoscopy (EGD) at our site within 7 days prior to Visit 2 (date of randomization).
  3. Able to understand the information provided and to comply with protocol requirements;
  4. Voluntarily agreed to participate in this clinical study and signed the informed consent form (ICF).

Exclusion Criteria:

• 1）Subjects who were allergic to the investigational drug and any of its components or esomeprazole magnesium enteric-coated tablets, other benzimidazole compounds and their components; 2）Subjects who were unable to undergo esophagogastroduodenoscopy (EGD); 3）Subjects with eosinophilic esophagitis, Barrett's esophagus (≥ 3 cm), gastroesophageal varices, stricture of oesophagus, active peptic ulcer, active upper/lower gastrointestinal bleeding, or malignancies confirmed by EGD; 4）Subjects with Zollinger-Ellison syndrome, achalasia, irritable bowel syndrome, or inflammatory bowel disease; 5）Subjects with concomitant diseases that may affect esophageal motility (e.g., dermatosclerosis, viral infection or fungal infection, etc.), or a history of esophageal radiotherapy or esophageal cryotherapy; 6）Subjects who had undergone surgery to reduce gastric acid secretion, or any surgery that affected the structure or function of the esophagus, stomach, or duodenum (excluding benign tumor excision, endoscopic resection of benign polyps, and simple suture procedures such as gastric perforation); 7）Subjects with warning symptoms (e.g., odynophagia, severe dysphagia, bleeding, weight loss, anemia, or hematochezia) of gastrointestinal malignancies (excluding those who did not have any endoscopically confirmed anatomical abnormalities of the esophagus or stomach); 8）Subjects with a medical history of serious hepatic, renal, neurological, respiratory, endocrine, hematological, cardiovascular, or genitourinary diseases; 9）Subjects with a history of malignancies within 5 years prior to screening (excluding those who had recovered from non-digestive malignancies for 5 years and have not relapsed); 10）Subjects with a medical history of psychiatric disorders (excluding those with psychiatric disorders who were currently stable as judged by the investigator and were not receive treatment), or drug or alcohol abuse within 12 months prior to screening; 11）Subjects who required continuous treatment with nonsteroidal anti-inflammatory drugs (e.g., aspirin), systemic glucocorticoids, and antithrombotic drugs during the study (excluding those who used low-dose aspirin [≤ 100 mg/day] prophylactically); 12）Subjects who were taking anti-retroviral drugs such as atazanavir and nelfinavir at screening; 13）Subjects who used therapeutic doses of drugs for gastroesophageal reflux disease within 7 days prior to randomization, such as proton pump inhibitors, potassium competitive acid blockers, histamine H2 receptor antagonists, mucosal protective drugs, drugs promoting gastrointestinal motility, and traditional Chinese medicinal products for gastroesophageal reflux disease; 14）Subjects with alanine aminotransferase (ALT), aspartate aminotransferase (AST), or total bilirubin ≥ 2 × upper limit of normal (ULN); creatinine (Scr) ≥ 1.5 × ULN at screening; 15）Subjects who were positive for human immunodeficiency virus (HIV) or hepatitis B surface antigen (HBsAg) and/or hepatitis C virus (HCV) antibodies at screening; 16）Pregnant or lactating women; subjects of childbearing potential who were unable or unwilling to use adequate contraception from the time of signing the ICF until 30 days after the last dose or their partners were unwilling to use contraception; 17）Subjects who have participated and received treatment in clinical studies of other drugs, devices, etc. within 3 months prior to screening; 18）Subjects who were ineligible (for any reason) to participate in the study as judged by the investigator.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Lansoprazole	Drug: DWP14012; DWP14012 40mg
Experimental: DWP14012	Drug: DWP14012; DWP14012 40mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
mucosal healing within 8 weeks	The percentage of subjects with endoscopically confirmed mucosal healing within 8 weeks.	8weeks

Collaborators and Investigators

• Sponsor: Daewoong Pharmaceutical Co. LTD.
• Investigators: Study Chair: The First Affiliated Hospital of Sun Yat-sen University Chen, M.D., Ph.D., First Affiliated Hospital, Sun Yat-Sen University

Study record dates

Study Major Dates

• Study Start (Actual): December 30, 2021
• Primary Completion (Actual): July 23, 2022
• Study Completion (Actual): February 17, 2023

Study Registration Dates

• First Submitted: April 2, 2023
• First Submitted That Met QC Criteria: April 2, 2023
• First Posted (Actual): April 14, 2023

Study Record Updates

• Last Update Posted (Actual): April 14, 2023
• Last Update Submitted That Met QC Criteria: April 2, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Gastroenteritis; Intestinal Diseases; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Peptic Ulcer; Duodenal Diseases; Gastroesophageal Reflux; Esophagitis, Peptic; Esophagitis
• Other Study ID Numbers: DW_DWP14012306

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No