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

• Status: Completed
• Trial end date: 2023-02-28
• Target enrollment: 0
• Participant gender: All

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. We 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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Pusan National University Hospital

Criteria

Inclusion Criteria:

At least one symptom of LPRD (hoarseness, globus, persistent throat discomfort, and frequent throat clearing) for at least 4 weeks

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-anxietydrugs Anti-reflux medication such as PPIs (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