A Multi-Center, Prospective, Randomized, Double-Blind, Active-Controlled, Exploratory Clinical Trial to Evaluate the Efficacy and Safety of Fexuprazan in Patients with Laryngopharyngeal Reflux Disease
- Conditions
- Diseases of the respiratory system
- Registration Number
- KCT0007251
- Lead Sponsor
- Asan Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 150
1. In visit 1, Age = 19
2. In visit 1, Symptoms of LPRD = 1 month
3. In visit 1, Patients with sore throat reflux
4. In visit 1, RSI = 13
5. In visit 1, RFS = 7
6. In visit 1, Patients who understand given information and write questionnaire
7. In visit 1, Those who voluntarily decide to participate in this clinical trial and give written consent
[Past medical history]
1. Based on Visit 1, A person who has a history of malignant tumors within 5 years, (except Pharyngeal cancer, esophageal cancer, stomach cancer. but Malignant tumors can be participated if more than 5 years have elapsed without recurrence after being diagnosed with complete recovery.
2. Based on Visit 1, A person who has had a bronchial intubation within the last 3 months.
3. A person who has had radiation therapy in the neck area
4. Those who have undergone gastric acid suppression surgery or gastric and esophageal surgery (except simple perforation surgery, appendectomy, and benign tumor resection using an endoscope)
5. Those who have rare genetic problems such as fructose intolerance, poor absorption of glucose-galactose, or sucrose-isomaltase deficiency.
6. A person who has a history of overreacting of investigator product or same drugs (P-CAB, benzimidazole)
[Current medical history]
7. Those with diseases in the liver, kidney, cardiovascular system, respiratory system, internal branch system, and central nervous system that can affect the interpretation of clinical trial results under the judgment of the tester.
8. Patients with clinically significant psychiatric disorders
9. Those who have upper respiratory tract infections and allergies.
10. A person who has viral or bacterial laryngopharyngitis
11. Those who have gastrointestinal diseases as below.
A. Those who have been diagnosed with erosive gastroesophageal reflux disease or have the main symptoms of erosive gastroesophageal reflux disease (chest fever and/or reflux symptoms of body or bitter water flowing into the mouth).
B. People with esophageal diseases such as erosive esophagitis, esophageal stenosis, Barrett'sesophagus, and esophageal varicose veins.
C. People with peptic ulcers and gastrointestinal bleeding.
D. Those with Zollinger-Ellison syndrome, inflammatory diseases (cron disease or ulcerative colitis, etc.).
[Drug administration and treatment]
13.Based on Visit 1, those who are or are scheduled to take drugs related to the treatment (H2 receptor antagonists, prostaglandin drugs, gastric mucosal protectors, gastrointestinal motility promoters) of gastroesophageal reflux disease within the last two weeks.
14. A person who has administered the following drugs or needs continuous administration during the clinical trial period.
? Gastric acid Inhibitor : H2 receptor antagonists, proton pump inhibitors (PPI), potassium-competitive gastric acid secretion inhibitors (P-CAB), and anti-gasstrin agents
? Gastric mucosal protector
? Antacids
? Gastrointestinal motility booster.
? Digestive machine Jin Economy
? Choline (however, local administration is allowed)
? Glucocorticosteroid (however, local administration is allowed)
Forbidden during clinical trial.
? Nonsteroidal anti-inflammatory analgesics.
? Antiviral drugs such as lilpivirin, Atazanavir, and Nelpinavir.
? Antipsychotics, antidepressants, anti-anxiety drugs.
? Antithrombotic (anticoagulant or antiplatelet)
15. A person who participated in another clinical trial within 4 weeks of Visit 1 and was administered or applied to a clinical trial drug or medical device at least once.
[Laboratory test]
16. Among the blood chemistry test results of Visit 1, who meets the following criteria.
alanine aminotransferase (ALT)= ULN (Upper limit of normal) X2
aspartate aminotransferase (AST)
alkaline phosphatase (ALP)
gamma-glutamyl transferase (G
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method RSI changes after 8 weeks.
- Secondary Outcome Measures
Name Time Method RSI changes after 4 weeks.;RFS changes after 4 and 8 weeks ;RSI change rate after 4weeks and 8weeks;RFS change rate after 4weeks and 8weeks;RSI efficacy after 4 weeks and 8 weeks (percentage of patients with 50% or more improvement);RFS efficacy after 4 weeks and 8 weeks (percentage of patients with 50% or more improvement);RSS-12 total score and change of QoL Score after 4weeks and 8weeks;The amount of change in LPR-HRQL by domain after 4 and 8 weeks.