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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-01

Study Completion Date

2023-02-28

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.

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Detailed Description

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Conditions

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Laryngopharyngeal Reflux Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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placebo group

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo

tegoprazan group

Group Type ACTIVE_COMPARATOR

Tegoprazan

Intervention Type DRUG

Novel, potent, and highly selective potassium-competitive acid blocker which was developed in Korea

Interventions

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Tegoprazan

Novel, potent, and highly selective potassium-competitive acid blocker which was developed in Korea

Intervention Type DRUG

Placebo

Intervention Type DRUG

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

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes