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

Sponsor
Daewoong Pharmaceutical Co. LTD. (Industry)
Overall Status
Completed
CT.gov ID
NCT05813561
Collaborator
(none)
332
1
2
13.6
24.4

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
332 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
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
Actual Study Start Date :
Dec 30, 2021
Actual Primary Completion Date :
Jul 23, 2022
Actual Study Completion Date :
Feb 17, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: DWP14012

Drug: DWP14012
DWP14012 40mg

Active Comparator: Lansoprazole

Drug: DWP14012
DWP14012 40mg

Outcome Measures

Primary Outcome Measures

  1. mucosal healing within 8 weeks [8weeks]

    The percentage of subjects with endoscopically confirmed mucosal healing within 8 weeks.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Minhu Chen Guangzhou Guangdong China

Sponsors and Collaborators

  • 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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Daewoong Pharmaceutical Co. LTD.
ClinicalTrials.gov Identifier:
NCT05813561
Other Study ID Numbers:
  • DW_DWP14012306
First Posted:
Apr 14, 2023
Last Update Posted:
Apr 14, 2023
Last Verified:
Apr 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 14, 2023