Comparing two medications for treating gastroesophageal reflux disease symptoms
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
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 |
| Enrollment | 128 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Carnot Laboratories Industry-sponsored |
| Locations | 2 sites (Mexico City, Mexico City and 1 other locations) |
| Trial ID | NCT06991348 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients with known hypersensitivity to the study medications or those with certain gastrointestinal conditions may not benefit from this study.
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 performed: Other studies have shown varying degrees of success with similar approaches, but this specific comparison of tegoprazan and pantoprazole is relatively novel.
Eligibility criteria
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 this trial is running
Mexico City, Mexico City and 1 other locations
- 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
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.