The Efficacy of Potassium-competitive Acid Blocker in Patients With Laryngopharyngeal Reflux Disease

Study Overview
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Brief Summary
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Background/Aims: Tegoprazan is a novel potassium-competitive acid blocker that has a fast onset of action and can control gastric pH for a prolonged period, which could offer clinical benefit in acid-related disorders. The investigators aimed to evaluate whether tegoprazan would be more effective in controlling symptoms than placebo in patients with laryngopharyngeal reflux disease (LPRD). Methods: This double-blind, randomized, placebo-controlled trial randomly assigned 35 patients suffering LPRD symptom to two groups: Tegoprazan50mg once daily and placebo. The primary end point was complete resolution rate of LPRD symptoms after 8-week medication, and the secondary endpoints were complete resolution rate of LPRD symptoms after 4-week medication, change of reflux symptom index (RSI) and reflux finding score (RFS) from baseline at 4- and 8-week medication.

Official Title
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The Efficacy of Potassium-competitive Acid Blocker (P-CAB) in Patients With Laryngopharyngeal Reflux Disease: a Double- Blind, Randomized, Placebo-controlled Pilot Study

Conditions
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Laryngopharyngeal Reflux Disease

Intervention / Treatment
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* Drug: Tegoprazan
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: At least one symptom of LPRD (hoarseness, globus, persistent throat discomfort, and frequent throat clearing) for at least 4 weeks Reflux symptom index > 13 and reflux finding score ≥ 7 Exclusion Criteria: Viral or bacterial laryngopharyngitis at present History of malignancy of head and neck region, esophagus and stomach Previous radiotherapy or endotracheal intubation within three months Previous anti-reflux surgery or gastroesophageal surgery Diagnosis of depression, anxiety, panic, somatoform or other psychotic disorder Taking anti-psychotics, anti-depressants or anti-anxiety drugs Anti-reflux medication such as proton-pump inhibitors (within 4 weeks before screening), histamine receptor 2 blockers, antacids or prokinetics (within 2 weeks before screening) Need for continuous therapy with non-steroidal anti-inflammatory drugs Pregnant or breastfeeding women, as well as female patients who were not willing to use contraception for the duration of the clinical trial period Abnormal laboratory test values at screening (blood urea nitrogen and serum creatine level >1.5 upper limit of normal [ULN]; total bilirubin levels and serum levels of alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase and gamma-glutamyl transferase > 2 ULN) or Any other conditions or disease that an investigator considered not appropriate for this study

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: placebo group<br> | Drug: Placebo<br>* Placebo<br>|
| Active Comparator: tegoprazan group<br> | Drug: Tegoprazan<br>* Novel, potent, and highly selective potassium-competitive acid blocker which was developed in Korea<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reflux symptom index (RSI) | RSI is a validated nine-item, self-administered questionnaire to assess the severity and responses to treatment of laryngopharyngeal reflux disease-associated symptoms. Each component is scored between 0 (no problem) and 5 (severe problem), with a maximum total score of 45. Non-response = RSI ≥ 13, Response = post-treatment RSI < 13 and change in RSI < 50%, Complete response = post-treatment RSI < 13 and change in RSI ≥ 50%. | Week 8 | 
| Reflux finding score (RFS) | RFS is a validated rating scale developed to quantify the degree of laryngeal involvement in laryngopharyngeal reflux disease during fiberoptic laryngoscopy. Scores range from 0 (no abnormal findings) to 26 (worst score possible). Normal < 7, Abnormal ≥ 7. | Week 8 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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: Laryngopharyngeal reflux disease, potassium-competitive acid blocker, treatment effectiveness