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Completed

NCT Number: NCT05267743

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

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.

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Key information

Conditions

Erosive Reflux Disease

Age range

19 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Wonkwang University Hospital

Iksan, Muwang-ro 895, 54538, South Korea

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

Exclusion criteria

  • 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

Treatment and study plan

Tegoprazan 50mg QD

Drug

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

Lansoprazole 30mg QD

Drug

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

Primary outcomes

  1. 4 weeks cumulative ERD healing rate(%)

    Time frame: 4 weeks

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

Secondary outcomes

  1. 2 weeks ERD healing rate(%)

    Time frame: 2 weeks

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

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

    Time frame: 2 weeks or 4 weeks

    Extensive Metaboliser (EM), Intermediate Metaboliser (IM), Poor Metaboliser (PM)

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

    Time frame: 2 weeks or 4 weeks

    On days with no symptoms of heartburn, '0. It is defined as a case assessed as having no symptoms.

  4. RDQ (Reflux Disease Questionnaire) evaluation(mean change in severity)

    Time frame: 2 weeks or 4 weeks

    Average scale change in RDQ severity and frequency at 2 weeks and 4 weeks after administration compared to before administration of investigational drugs for each category (heartburn, indigestion, acid reflux)

  5. Incidence of Adverse Events [Safety]

    Time frame: 2 weeks or 4 weeks

    Physical examination(weight-kg)(height-cm), vital signs(SBP, DBP, heart rate, body temperature), adverse reactions, blood chemistry test

Sponsors and collaborators

Lead sponsor

HK inno.N Corporation

Industry

Registry information

Official study title

A Multicenter, Double-blind, Randomized, Active-controlled Phase 4 Study to Evaluate the Efficacy and Safety of Tegoprazan in Patients With Erosive Reflux Disease

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Mar 4, 2022
Registry last updated
Jul 29, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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