The Efficacy of Potassium-competitive Acid Blocker in Patients With Laryngopharyngeal Reflux Disease
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
Publications
- Background 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.
- 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.
- 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Tegoprazan | Other / unclassified | 50 mg | — |