A Multicenter, Double-blind, Randomized, Investigator-initiated Trial to Evaluate the Degree of Symptom Relief of Zastaprazan and Esomeprazole in Patients With Erosive Reflux Disease With Night-time Heartburn Symptoms

Status: Recruiting
Location: See all (10) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY

Gastroesophageal reflux disease (GERD) is a condition caused by the reflux of stomach contents into the esophagus, presenting with typical symptoms such as heartburn and acid regurgitation. GERD is a chronic condition that affects quality of life, and patients with this condition are known to have a lower quality of life compared to healthy individuals. In particular, nocturnal heartburn can lead to sleep deprivation and affect daily life, as well as overall quality of life. This study aims to evaluate the efficacy of alleviating nocturnal heartburn symptoms in patients with erosive reflux disease (ERD).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 19
Healthy Volunteers: f
View:

• Korean adults aged 19 years or older as of the date of written consent

• Those diagnosed with erosive gastroesophageal reflux disease based on upper gastrointestinal endoscopy (EGD)

• Those who reported nighttime heartburn for more than 3 months at the time of screening (Visit 1)

• Those who voluntarily decided to participate and provide written informed consent

Locations
Other Locations
Republic of Korea
Korea University Ansan Hospital
RECRUITING
Ansan
Pusan National University Hospital
RECRUITING
Busan
Kyungpook National University Chilgok Hospital
RECRUITING
Chilgok
Hallym University Chuncheon Sacred Heart Hospital
RECRUITING
Chuncheon
Chonnam National University Hospital
RECRUITING
Gwangju
Catholic University of Korea, Incheon ST. Mary's Hospital
RECRUITING
Incheon
Gangnam Severance Hospital
RECRUITING
Seoul
Kyung Hee University Hospital
RECRUITING
Seoul
Soonchunhyang University Hospital
RECRUITING
Seoul
Pusan National University Yangsan Hospital
RECRUITING
Yangsan
Contact Information
Primary
Byung-Wook Kim
gastro@catholic.ac.kr
+82-1544-9004
Time Frame
Start Date: 2025-07-07
Estimated Completion Date: 2026-09-30
Participants
Target number of participants: 160
Treatments
Experimental: Zastaprazan
Zastaprazan 20 mg, once daily, preferably administered orally in the morning before breakfast for four weeks
Active_comparator: Esomeprazole
Esomeprazole 40 mg, once daily, preferably administered orally in the morning before breakfast for four weeks
Sponsors
Leads: Incheon St.Mary's Hospital

This content was sourced from clinicaltrials.gov