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

NCT05267743 | Completed Phase 4

• 1 other identifier: IN_APA_402
• Study Type: interventional
• Target: 218
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Erosive Reflux Disease

Outcome Measures

Primary Outcomes (1)

• 4 weeks cumulative ERD healing rate(%)

  Healing is defined as "not present" erosions or fissures according to the LA classification.

  4 weeks

Secondary Outcomes (5)

• 2 weeks ERD healing rate(%)

  2 weeks

• Healing rate(%) at 2 weeks and 4 weeks according to CYP2C19 genotype type

  2 weeks or 4 weeks

• Percentage of days without heartburn through the clinical trial subject dairy (%)

  2 weeks or 4 weeks

• RDQ (Reflux Disease Questionnaire) evaluation(mean change in severity)

  2 weeks or 4 weeks

• Incidence of Adverse Events [Safety]

  2 weeks or 4 weeks

Study Arms (2)

Tegoprazan 50mg QD

EXPERIMENTAL

Tegoprazan 50mg tablet, once daily, oral administration

Drug: Tegoprazan 50mg QD

Lansoprazole 30mg QD

ACTIVE COMPARATOR

Lansoprazole 30mg capsule, once dauly, oral administration

Drug: Lansoprazole 30mg QD

Interventions

Tegoprazan 50mg QD DRUG

Tegoprazan 50mg tablets will be orally administered, once daily, for up to 2 weeks or 4 weeks.

Tegoprazan 50mg QD

Lansoprazole 30mg QD DRUG

Lansoprazole 30mg tablets will be orally administered, once daily, for up to 2 weeks or 4 weeks.

Lansoprazole 30mg QD

Eligibility Criteria

• Age: 19 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Erosive eshophagitis(LA calssfication Grades A to D) with in 30 days prior to Randomization
• Those who have experienced heartburn symptoms within 7 days prior to Visit 1(screening date)

You may not qualify if:

• Unalbe to undergo upper GI endoscopy
• H. pylori positive
• Those who cannot write a clinical trial subject diary
• Presence of esophageal stricture, ulcerated stricture, gastroesophageal varix, long segment Barrett's esophagus with \>3cm length(LSBE), eosinophilic oesophagitis, active digestive ulcer or gastric bleeding on an upper GI endoscopy

Sponsors & Collaborators

• HK inno.N Corporation: lead

Study Sites (1)

Wonkwang University Hospital

Iksan, Muwang-ro 895, 54538, South Korea

Location

Related Publications (1)

• Shin CM, Choi SC, Cho JW, Kim SY, Lee OJ, Kim DH, Cho YK, Lee JY, Lee SK, Shin JE, Kim GH, Park SY, Hong SJ, Jung HK, Lee SJ, Youn YH, Jeon SW, Sung IK, Park MI, Lee OY. 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. Neurogastroenterol Motil. 2025 Jan;37(1):e14969. doi: 10.1111/nmo.14969. Epub 2024 Nov 25.

  PMID: 39587796 DERIVED

MeSH Terms

Interventions

tegoprazan; Lansoprazole

Intervention Hierarchy (Ancestors)

2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Suk Chae Choi

  Wonkwang University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2021
• First Posted: March 4, 2022
• Study Start: February 16, 2021
• Primary Completion: May 25, 2022
• Study Completion: May 25, 2022
• Last Updated: July 29, 2022

Record last verified: 2022-07

Locations

KR (1)