Clinical trial NCT05813561: The Efficacy and Safety of DWP14012 in Chinese Patients With Reflux Esophagitis
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Reflux Esophagitis
Lead sponsor: Daewoong Pharmaceutical Co. LTD.
Sponsor class: INDUSTRY
First posted: 2023-04-14
Enrollment: 332
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: mucosal healing within 8 weeks
timeFrame: 8weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Minhu Chen
state: Guangdong
Study officials:
affiliation: First Affiliated Hospital, Sun Yat-Sen University
name: The First Affiliated Hospital of Sun Yat-sen University Chen, M.D., Ph.D.
role: STUDY_CHAIR
References: