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

Phase 3

Completed

• Conditions: Laryngopharyngeal Reflux Disease
• Interventions: Drug: Placebo; Drug: Tegoprazan

• Registration Number: NCT05871398
• Lead Sponsor: Pusan National University Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-10-01
• Primary Completion: 2021-12-30
• Study Completion: 2023-02-28
• Status Verified: 2023-05
• Study First Submitted: 2023-05-02
• Study First Submitted QC: 2023-05-12
• Study First Posted: 2023-05-23
• Last Update Submitted: 2023-05-29
• Last Update Posted: 2023-06-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo group	Placebo	-
tegoprazan group	Tegoprazan	-

Primary Outcome Measures

Name	Time	Method
Reflux symptom index (RSI)	Week 8	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%.
Reflux finding score (RFS)	Week 8	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.

Trial Locations

Locations (1)

Pusan National University Hospital; 🇰🇷 Pusan, Korea, Republic of