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

Pusan National University Hospital36 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Laryngopharyngeal Reflux Disease

Interventions

Eligibility

Sex: ALLMin age: 19 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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%.

Time frame: 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.