Evaluating Tegoprazan for Nighttime Heartburn in GERD Patients
A Multicenter, Double-blind, Randomized, Active-controlled Phase 4 Study to Evaluate the Efficacy and Safety of Tegoprazan in GERD Patients With Nighttime Heartburn
This study is testing whether Tegoprazan can help people with GERD feel better at night compared to another heartburn medication called Esomeprazole.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 338 (estimated) |
| Ages | 19 Years to 75 Years |
| Sex | All |
| Sponsor | HK inno.N Corporation Industry-sponsored |
| Locations | 1 site (Seoul) |
| Trial ID | NCT05701540 on ClinicalTrials.gov |
What this trial studies
This study compares the effectiveness of Tegoprazan 50mg versus Esomeprazole 40mg or 20mg in improving nighttime heartburn symptoms in patients with Gastroesophageal Reflux Disease (GERD). It is a multi-center, double-blind, randomized, active-controlled phase 4 study where participants will be assigned to one of the two treatment groups. The aim is to determine which medication provides better relief from nighttime heartburn.
Who should consider this trial
Good fit: Ideal candidates are adults aged 19 to 75 with either erosive or non-erosive reflux disease.
Not a fit: Patients who have undergone surgery affecting gastric acid secretion or have esophageal movement disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could offer a more effective treatment option for patients suffering from nighttime heartburn associated with GERD.
How similar studies have performed: Other studies have shown success with similar approaches in treating GERD, making this a promising area of investigation.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Subjects aged between 19 and 75 years 2. Subjects who have erosive reflux disease or non-erosive reflux disease Exclusion Criteria: 1. Unable to undergo upper GI endoscopy 2. Symptoms of primary or secondary esophageal movement disorders 3. Subjects who have undergone or are scheduled to undergo surgery that can affect gastric acid secretion(e.g. upper gastrectomy, vagotomy, etc)
Where this trial is running
Seoul
- Severance Hospital — Seoul, Korea, Republic of (Recruiting)
Study contacts
- Principal investigator: Sang Kil Lee, Ph.D — Severance Hospital
- Study coordinator: Tae Hoon Kim
- Email: luke.kim@inno-n.com
- Phone: 82-2-6477-0244
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.