drugset / Trial / NCT05871398

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

NCT05871398

Phase 3 Completed 36 enrolled Pusan National University Hospital
RandomizedParallel-groupSingle-blindTreatment

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.

Timeline

Start
2019-10-01
Primary completion
2021-12-30
Completion
2023-02-28

Drugs

EvaluationDrugModalityDoseRoute
Comparator Tegoprazan Other / unclassified 50 mg