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

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HK inno.N

Status and phase

Completed
Phase 4

Conditions

Erosive Reflux Disease

Treatments

Drug: Tegoprazan 50mg QD
Drug: Lansoprazole 30mg QD

Study type

Interventional

Funder types

Industry

Identifiers

NCT05267743
IN_APA_402

Details and patient eligibility

About

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.

Full description

This is a double blind, radomized, active-controlled, phase 4 study. Subjects will be randomly assigned to one of the two treatment groups (Tegoprazan 50mg, Lansoprazole 30mg)

Enrollment

218 patients

Sex

All

Ages

19 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

  1. Unalbe to undergo upper GI endoscopy
  2. H. pylori positive
  3. Those who cannot write a clinical trial subject diary
  4. 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

218 participants in 2 patient groups

Tegoprazan 50mg QD
Experimental group
Description:
Tegoprazan 50mg tablet, once daily, oral administration
Treatment:
Drug: Tegoprazan 50mg QD
Lansoprazole 30mg QD
Active Comparator group
Description:
Lansoprazole 30mg capsule, once dauly, oral administration
Treatment:
Drug: Lansoprazole 30mg QD

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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