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

NCT05871398 | Completed Phase 3

• 1 other identifier: H-1909-005-096
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Laryngopharyngeal Reflux Disease

Keywords

: Laryngopharyngeal reflux disease; potassium-competitive acid blocker; treatment effectiveness

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

placebo group

PLACEBO COMPARATOR

Drug: Placebo

tegoprazan group

ACTIVE COMPARATOR

Drug: Tegoprazan

Interventions

Tegoprazan DRUG

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

tegoprazan group

Placebo DRUG

Placebo

placebo group

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pusan National University Hospital: lead

Study Sites (1)

Pusan National University Hospital

Pusan, 49241, South Korea

Location

Related Publications (3)

• 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.

  PMID: 30234664 BACKGROUND

• 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.

  PMID: 33229333 BACKGROUND

• Jeon HK, Kim GH, Cheon YI, Shin SC, Lee BJ. Efficacy of Tegoprazan in Patients with Laryngopharyngeal Reflux Disease: A Preliminary Feasibility Study. J Clin Med. 2023 Sep 22;12(19):6116. doi: 10.3390/jcm12196116.

  PMID: 37834761 DERIVED

MeSH Terms

Interventions

tegoprazan

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 2, 2023
• First Posted: May 23, 2023
• Study Start: October 1, 2019
• Primary Completion: December 30, 2021
• Study Completion: February 28, 2023
• Last Updated: June 1, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)