Comparing two medications for treating gastroesophageal reflux disease symptoms
Official title: Multicenter, Active-controlled, Randomized, Double-blind, Clinical Trial for the Comparative Evaluation of Acid Suppression and Symptom Management of Gastroesophageal Reflux Disease With the Administration of Tegoprazan or Pantoprazole: TOP-GERD
Run by Carnot Laboratories · NCT06991348 · Data updated 2026-11-12
This study is testing whether tegoprazan works better than pantoprazole in helping adults with gastroesophageal reflux disease (GERD) feel better after four weeks of treatment.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 128 (estimated) |
| Sponsor | Carnot Laboratories Industry-sponsored |
| Locations | 2 sites (Mexico City, Mexico City and 1 other locations) |
| Status | Recruiting |
| Started | July 30, 2024 |
| Main results expected | November 30, 2025 |
| Study ends | November 30, 2025 |
| Registry record updated | July 23, 2025 |
| Trial ID | NCT06991348 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are adults diagnosed with erosive or non-erosive gastroesophageal reflux disease who have experienced recurrent heartburn and regurgitation for at least three months.
✕Probably not a fit
Patients with known hypersensitivity to the study medications or those with certain gastrointestinal conditions may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial aims to evaluate the effectiveness of tegoprazan versus pantoprazole in resolving symptoms of gastroesophageal reflux disease (GERD) in adult patients. Participants will be assessed for symptom resolution after four weeks of treatment with either medication. The study includes patients with both erosive and non-erosive forms of GERD, ensuring a comprehensive comparison of the two drugs. The trial will utilize endoscopic diagnoses and impedance pHmetry results to confirm eligibility and monitor outcomes.
Why it matters
Potential benefit: If successful, this study could provide patients with a more effective treatment option for managing GERD symptoms.
How similar studies have gone: Other studies have shown varying degrees of success with similar approaches, but this specific comparison of tegoprazan and pantoprazole is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * With endoscopic diagnosis of GERD or NERD (endoscopy ≤ 15 days old) * With positive impedance pHmetry results (pHmetry ≤ 15 days old) * With recurrent symptoms of heartburn and regurgitation for a previous period ≥ 3 months old Exclusion Criteria: * With known hypersensitivity to tegoprazan, pantoprazole, or any of the components of each formulation * Subjects with concomitant administration of atazanavir, nelfinavir or rilpivirine * Nephropathic and/or hepatopathic subjects (including non-alcoholic hepatitis) * Subjects with upper gastrointestinal tract bleeding * Subjects with gastric and/or duodenal ulcer 2 months prior to screening * Subjects with a history of esophageal or gastric surgery
Where it's running
-
Gastrologen S.A. de C.V.
Mexico City, Mexico City, Mexico Recruiting -
Saluz Investigación, S.C.
Boca del Río, Veracruz, Mexico Recruiting
Study contacts
- Principal investigator: Jose M Remes-Troche, Dr — Digestive Physiology and Motility Lab, Instituto de Investigaciones Médico Biológicas, Veracruz , México
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Predictors of symptom improvement after laparoscopic fundoplication
This study tests what preoperative factors help predict which GERD patients will feel better after laparoscopic fundoplication.
-
Thread-Embedding Acupuncture plus a Proton Pump Inhibitor for GERD
This study tests whether adding thread-embedding acupuncture to standard omeprazole treatment helps people with GERD who have a traditional Liver-Stomach constraint-heat pattern.
-
Managing GERD with personalized dietary changes and guided education
A dietary plan and written education are being tested to see if they help adults with chronic GERD reduce symptoms.
-
GERD patient registry study using a large prospective clinical database
A large group of adults with gastroesophageal reflux disease are being looked at in real-world care to see who they are, what treatments they get, and how symptoms and well-being change after treatment.
-
Mindfulness Intervention for Emotional Distress in GERD
This online mindfulness program is being tested to see if it can help adults with GERD feel less emotional distress and experience fewer reflux symptoms.
-
A new surgical approach to reduce GERD after weight loss surgery
This study is testing a new type of weight loss surgery to see if it can help reduce acid reflux in people who have had weight loss surgery.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.