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NCT05267743

Study to Confirm the Safety and Efficacy of Tegoprazan in Patients With Healed Erosive Reflux Disease

Completed Phase 4 Last updated 29 July 2022
What this trial tests

Phase 4 trial testing Tegoprazan 50mg QD in Erosive Reflux Disease in 218 participants. Completed in 25 May 2022.

Timeline
16 February 2021
Primary endpoint
25 May 2022
25 May 2022

Quick facts

Lead sponsorHK inno.N Corporation
PhasePhase 4
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingquadruple
Primary purposetreatment
Enrollment218
Start date16 February 2021
Primary completion25 May 2022
Estimated completion25 May 2022
Sites1 location across South Korea

Drugs / interventions tested

Conditions studied

Sponsor

HK inno.N Corporation — full company profile →

Who can join

Adults 19 to 80, any sex, with Erosive Reflux Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study is designed to evaluate the efficacy and safety of Tegoprazan 50mg, compared to Lansoprazole 30mg in patients with healed erosive reflux disease confirmed by endoscopy following oral administration once daily(QD) of 2 weeks or 4 weeks.

Publications & conference data

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

  1. Comparison of Tegoprazan and Lansoprazole in Patients With Erosive Esophagitis up to 4 Weeks: A Multi-Center, Randomized, Double-Blind, Active-Comparator Phase 4 Trial.
    Shin CM, Choi SC, Cho JW, Kim SY, et al · · 2025 · cited 8× · PMID 39587796 · DOI 10.1111/nmo.14969

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Other HK inno.N Corporation trials

Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05267743.

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