Status:
RECRUITING
Clinical Trial for the Comparative Evaluation of Acid Suppression and Symptom Management of Gastroesophageal Reflux Disease With the Administration of Tegoprazan or Pantoprazole
Lead Sponsor:
Carnot Laboratories
Conditions:
Gastroesophageal Reflux Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The objective of this clinical trial is to compare which of the two drugs best resolves symptoms in patients diagnosed with erosive and non-erosive gastroesophageal reflux disease, adult males and fem...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 30 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 30 2025
Estimated Enrollment :
128 Patients enrolled
Trial Details
Trial ID
NCT06991348
Start Date
July 30 2024
End Date
November 30 2025
Last Update
July 23 2025
Active Locations (2)
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1
Gastrologen S.A. de C.V.
Mexico City, Mexico City, Mexico, 01900
2
Saluz Investigación, S.C.
Boca del Río, Veracruz, Mexico, 94299