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

Laryngopharyngeal Reflux Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05871398
• Other study ID #: H-1909-005-096
• Status: Completed
• Phase: Phase 3
• Start date: October 1, 2019
• Est. completion date: February 28, 2023

Study information

• Verified date: May 2023
• Source: Pusan National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: February 28, 2023
• Est. primary completion date: December 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Gastroesophageal Reflux
• Laryngopharyngeal Reflux
• Laryngopharyngeal Reflux Disease

Intervention

Drug:
• Tegoprazan
Novel, potent, and highly selective potassium-competitive acid blocker which was developed in Korea
• Placebo
Placebo

Locations

Country	Name	City	State
Korea, Republic of	Pusan National University Hospital	Pusan

Sponsors (1)

Lead Sponsor	Collaborator
Pusan National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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