NA

Tahapan Penelitian : Recruit
Sponsor:
Mitra Pelaksana:
Daewoong Pharmaceutical, Co. Ltd.
No Registry
INA-DESON1D
Tanggal Input Registry : 26-09-2024

28-08-2024
Proportions of subjects with symptoms relief at week 4 measured by GERD-Q Score
Proportions of subjects with symptoms relief at week 8 measured by GERD-Q Score
 
NA
A Multi-Center, Randomized, Open-Label Study to Evaluate Symptom Relief and Safety after Using Fexuprazan 40 Mg Compared to Esomeprazole 40 Mg in Patients with Gastroesophageal Reflux Disease (GERD).
Interventional
Fexuprazan tablet 40 mg
134
 

Inclusion Criteria:

Subjects must meet all the following criteria: 1) Male and female adults aged 18 to 60 years at the date of the written informed consent form. 2) Those who had experienced heartburn and/or acid regurgitation confirmed with: a. GERD-Q Score >7 and b. People who have experienced heartburn symptoms > 3 days within the last 7 days, or c. People who have experienced acid reflux (symptom of acid reflux or back flowing of contents from stomach into the esophagus) > 3 days within the last 7 days 3) Those who could understand the provided information and able to fill out the questionnaire and subject diary. 4) Those who voluntarily decided to participate in the study and wrote the informed consent form.

Exclusion Criteria:

[Digestive system related] 1) Those who have been diagnosed with inflammatory bowel disease (Crohn disease, ulcerative colitis, etc.), primary esophageal motility, or pancreatitis. 2) Those who had a surgery to reduce gastric acid secretion or gastric or esophageal surgery (e.g., gastrotomy, mucosal resection, etc.), except appendectomy, cholecystectomy, or endoscopic polypectomy of benign polyps. 3) Those who had warning symptoms of malignant gastrointestinal tract such as odynophagia, severe dysphagia, bleeding, weight loss, anemia, or bloody stool. (But those who have additional warning symptoms besides typical symptoms of gastroesophageal reflux disease may be included if the result of endoscopy for verifying whether to have tumor is negative.) [Medical history] 4) Those who had a history of clinically significant disease of hepatic, renal, endocrine, hemato-oncologic, or urinary system. 5) Those who had history malignant tumor in the last 5 years. (But in case of malignant tumors except digestive malignant tumor, subjects completely healed for 5 years without recurrence are allowed to enroll.) 6) Those who had a history of psychosis, illegal drug or alcohol abuse. 7) Those who had a known acquired immunodeficiency syndrome (AIDS) or hepatitis infection, including HBsAg+ or hepatitis C virus (HCV)-antibody-positive or virus carriers. (But the participant may be included in the study if he/she is HCV-RNA-negative). Rapid test screening will be done if there are no previous result. 8) Those who had hypersensitivity or history of clinically significant hypersensitivity reaction to investigational product. [Medication history/treatment history] 9) Those who received concomitant prohibition drugs within 2 weeks prior or need continuous treatment during the clinical study*) *)Those who meet the inclusion criteria following a sufficient wash-out period (2 weeks for NSAIDs with a half-life of> 24 hours) after taking the following drugs can be enrolled) a. Non-steroidal anti-inflammatory drugs (aspirin, etc.) and acetaminophen: a low dose of aspirin (≤100 mg/day) which has been administered for the purpose of prevention before participating in the study is allowed: acetaminophen administration is allowed up to 4 g/day and does not exceed 5 days in 4 weeks. b. Acid suppressive drugs: Proton pump inhibitors (PPIs), PCAB, H2 receptor antagonists, anti-gastrin agents c. Cholinergic drugs, anticholinergic drugs, and antispasmodics d. Psychotropic drugs: Antipsychotics drugs, antidepressants, antimanic drugs, antianxiety drugs, and hallucinogenic agents, etc. e. Steroids (allowed if used in a local application) f. Antithrombotic drugs (antiplatelet drugs and anticoagulants) g. Mucoprotective drugs 10) Those who need to take any prohibited concomitant medication during clinical study. (Only Antacid and Prokinetic permitted as rescue drug. The use of Antacid and Prokinetic during the study period will be recorded as subject's prior/concomitant medication) 11) Those who took the other investigational product within 4 weeks prior to administration of investigational product. (But it is possible to enroll in the study [i.e., observational study, retrospective study] that doesn‟t affect this study's efficacy and safety as determined by the investigator.) [Laboratory tests] 12) At screening, those who had a. serum alanine aminotransferase (ALT), aspartate aminotransferase (AST), or total bilirubin levels ≥ 2 X upper limit of normal b. serum creatinine or BUN ≥ 2 X upper limit of normal [Others] 13) Pregnant or breast-feeding women 14) Those who do not consent to use appropriate contraceptive methods during the study. Appropriate contraceptive methods for patients or their partners: - For Male subject: to use barrier method such as male condom and surgical sterilization such as vasectomy; - For Female subject: to use 1) hormonal contraceptive such as Intraurine system : intrauterine hormone-containing system, implant, injection, contraceptive pills, or 2) non hormonal contraceptive such as Intraurine system : copper loop, barrier method : female condom, diaphragm or cervical cap, or surgical strerilization : tubectomy. 15) In the opinion of the investigator, those who were unsuitable for any reason.
 
KET-354/UN2.F1/ETIK/PPM.00.02/2024
Not applicable
PPUK/PPUB number
NA
Stephanie