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

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

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 Overview

• Status: Completed
• Conditions: Laryngopharyngeal Reflux Disease
• Intervention / Treatment: Drug: Placebo; Drug: Tegoprazan

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Phase 3

Contacts and Locations

Study Locations

• Korea, Republic of
  • Pusan, Korea, Republic of, 49241
    • Pusan National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reflux finding score (RFS)	Validated rating scale developed to quantify the degree of laryngeal involvement in laryngopharyngeal reflux disease during fiberoptic laryngoscopy	The primary efficacy endpoint was the complete resolution rate of LPRD symptoms after 8-week medication.

Collaborators and Investigators

• Sponsor: Pusan National University Hospital

Publications and helpful links

General Publications

• Lechien JR, Saussez S, Karkos PD. Laryngopharyngeal reflux disease: clinical presentation, diagnosis and therapeutic challenges in 2018. Curr Opin Otolaryngol Head Neck Surg. 2018 Dec;26(6):392-402. doi: 10.1097/MOO.0000000000000486.
• Katzka DA, Kahrilas PJ. Advances in the diagnosis and management of gastroesophageal reflux disease. BMJ. 2020 Nov 23;371:m3786. doi: 10.1136/bmj.m3786.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2019
• Primary Completion (Actual): December 30, 2021
• Study Completion (Actual): February 28, 2023

Study Registration Dates

• First Submitted: May 2, 2023
• First Submitted That Met QC Criteria: May 12, 2023
• First Posted (Actual): May 23, 2023

Study Record Updates

• Last Update Posted (Actual): June 1, 2023
• Last Update Submitted That Met QC Criteria: May 29, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: treatment effectiveness; : Laryngopharyngeal reflux disease; potassium-competitive acid blocker
• Additional Relevant MeSH Terms: Digestive System Diseases; Respiratory Tract Diseases; Gastrointestinal Diseases; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Laryngeal Diseases; Gastroesophageal Reflux; Laryngopharyngeal Reflux
• Other Study ID Numbers: H-1909-005-096

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No