A Multicenter, Double-blind, Randomized, Active-controlled Phase 4 Study to Evaluate the Efficacy and Safety of Tegoprazan in GERD Patients With Nighttime Heartburn
Status: Unknown
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY
This study aims to compare the nighttime heartburn improvement effect of Tegoprazan 50mg and Esomeprazole 40mg(or 20mg) in patients with GERD.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 19
Maximum Age: 75
Healthy Volunteers: f
View:
• Subjects aged between 19 and 75 years
• Subjects who have erosive reflux disease or non-erosive reflux disease
Locations
Other Locations
Republic of Korea
Severance Hospital
RECRUITING
Seoul
Contact Information
Primary
Tae Hoon Kim
luke.kim@inno-n.com
82-2-6477-0244
Backup
Jong Min Lee
jongmin.lee6@inno-n.com
82-2-6477-0251
Time Frame
Start Date: 2023-03-24
Completion Date: 2024-12-31
Participants
Target number of participants: 338
Treatments
Experimental: Tegoprazan 50mg
Tegoprazan 50mg, once daily, oral administration for two weeks
Active_comparator: Esomeprazole 40mg or 20mg
1. In case of ERD patients: Esomeprazole 40mg, qd, oral administration for two weeks~2. In case of NERD patients: Esomeprazole 20mg, qd, oral administration for two weeks
Related Therapeutic Areas
Sponsors
Leads: HK inno.N Corporation