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NCT05871398

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

Completed Phase 3 Last updated 1 June 2023
What this trial tests

Phase 3 trial testing Tegoprazan in Laryngopharyngeal Reflux Disease in 36 participants. Completed in 28 February 2023.

Timeline
1 October 2019
Primary endpoint
30 December 2021
28 February 2023

Quick facts

Lead sponsorPusan National University Hospital
PhasePhase 3
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposetreatment
Enrollment36
Start date1 October 2019
Primary completion30 December 2021
Estimated completion28 February 2023
Sites1 location across South Korea

Drugs / interventions tested

Conditions studied

Sponsor

Pusan National University Hospital

Who can join

19 and older, any sex, with Laryngopharyngeal Reflux Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Efficacy of Tegoprazan in Patients with Laryngopharyngeal Reflux Disease: A Preliminary Feasibility Study.
    Jeon HK, Kim GH, Cheon YI, Shin SC, et al · · 2023 · cited 5× · PMID 37834761 · DOI 10.3390/jcm12196116

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Other trials of Tegoprazan

Trials testing the same drug.

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