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NCT05701540 | Recruiting | Gastroesophageal Reflux Disease

A Study to Evaluate the Efficacy and Safety of Tegoprazan in GERD Patients With Nighttime Heartburn
Sponsor:

HK inno.N Corporation

Brief Summary:

This study aims to compare the nighttime heartburn improvement effect of Tegoprazan 50mg and Esomeprazole 40mg(or 20mg) in patients with GERD.

Condition or disease

Gastroesophageal Reflux Disease

Intervention/treatment

Then empty

Esomeprazole

Phase

Phase 4

Detailed Description:

This is a multi-center, double-blind, randomized, active-controlled phase 4 study. Subjects will be randomly assigned to one of the two treatment groups (tegoprazan 50mg, esomeprazole 40mg or 20mg).}}

Study Type : Interventional
Estimated Enrollment : 338 participants
Masking : Quadruple
Primary Purpose : Treatment
Official Title : A Multicenter, Double-blind, Randomized, Active-controlled Phase 4 Study to Evaluate the Efficacy and Safety of Tegoprazan in GERD Patients With Nighttime Heartburn
Actual Study Start Date : March 24, 2023
Estimated Primary Completion Date : December 31, 2024
Estimated Study Completion Date : December 31, 2024
Arm Intervention/treatment

Experimental: Tegoprazan 50mg

Tegoprazan 50mg, once daily, oral administration for two weeks

Drug: Tegoprazan

Active Comparator: Esomeprazole 40mg or 20mg

In case of ERD patients: Esomeprazole 40mg, qd, oral administration for two weeks In case of NERD patients: Esomeprazole 20mg, qd, oral administration for two weeks

Drug: Esomeprazole
Ages Eligible for Study: 19 Years to 75 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Criteria
Inclusion Criteria
  • Subjects aged between 19 and 75 years
  • Subjects who have erosive reflux disease or non-erosive reflux disease
Exclusion Criteria
  • Unable to undergo upper GI endoscopy
  • Symptoms of primary or secondary esophageal movement disorders
  • Subjects who have undergone or are scheduled to undergo surgery that can affect gastric acid secretion(e.g. upper gastrectomy, vagotomy, etc)
A Study to Evaluate the Efficacy and Safety of Tegoprazan in GERD Patients With Nighttime Heartburn

Location Details

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A Study to Evaluate the Efficacy and Safety of Tegoprazan in GERD Patients With Nighttime Heartburn

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Recruiting

Korea, Republic of,

Severance Hospital

Seoul, Korea, Republic of, 03722