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OpenTrials
Completed

NCT Number: NCT04022096

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

This study is designed to confirm the non-inferiority of Tegoprazan 25mg, compared to Lansoprazole 15mg as maintenance therapy in patients with healed erosive esophagitis confirmed by endoscopy following oral administration once daily(QD) for 6 months.

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Key information

Conditions

Healed Erosive Esophagitis

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hanyang University Seoul Hospital

Seoul, 133-792, South Korea

About this study

This is a double blind, randomized, active-controlled, phase 3 study. Subjects will be randomly assigned to one of the two treatment groups (tegoprazan 25mg, lansoprazole 15mg).

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Erosive eshophagitis(LA classification Grades A to D) within 12 weeks prior to Randomization
  • Healed erosive esophagitis within 7 days prior to Randomization
  • No heartburn and regurgitation within 7 days prior to Randomization

Exclusion criteria

  • Unable to undergo upper GI endoscopy
  • Presence of esophageal stricture, ulcerated stricture, gastroesophageal varix, long segment Barrett's esophagus with >3 cm length(LSBE), active digestive ulcer, gastric bleeding or malignant tumors on an upper GI endoscopy
  • Diagnosed with primary esophageal motility disorder, irritable bowel syndome(IBS) or inflammatory bowel disease(IBD)
  • History of acid-suppressive, esophageal or gastric surgeries

Treatment and study plan

Tegoprazan 25mg QD

Drug

Tegoprazan 25mg tablets will be orally administered, once daily, for up to 6 months.

Lansoprazole 15mg QD

Drug

Lansoprazole 15mg capsules will be orally administered, once daily, for up to 6 months.

Primary outcomes

  1. Endoscopic remission rate of EE at 24-week

    Time frame: 24-week

    Endoscopic remission: No endoscopic recurrence of erosion(LA grade A to D) during maintenance period(24 weeks)

Secondary outcomes

  1. Endoscopic remission rate of EE at 12-week

    Time frame: 12-week

    Endoscopic remission: No endoscopic recurrence of erosion(LA grades A to D) during maintenance period(12 weeks)

Sponsors and collaborators

Lead sponsor

HK inno.N Corporation

Industry

Registry information

Official study title

A Phase 3, Double-blind, Randomized, Active-controlled Study to Evaluate the Safety and Efficacy of Tegoprazan as Maintenance Therapy in Patients With Healed Erosive Esophagitis

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Jul 16, 2019
Registry last updated
Jan 27, 2023

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.