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
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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 females. The main question is What is the proportion of patients with resolution of the main symptoms of gastroesophageal reflux disease at four weeks of treatment with pantoprazole vs tegoprazan.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
Mexico
Saluz Investigación, S.C.
RECRUITING
Boca Del Río
Gastrologen S.A. de C.V.
RECRUITING
Mexico City
Time Frame
Start Date: 2024-07-30
Estimated Completion Date: 2025-11-30
Participants
Target number of participants: 128
Treatments
Experimental: Non-erosive GERD - Test product
Non-erosive GERD - Tegoprazan
Active_comparator: Non-erosive GERD - Comparator
Non-erosive GERD - Pantoprazole
Experimental: Erosive GERD - Test product
Erosive GERD - Tegoprazan
Active_comparator: Erosive GERD - Comparator
Erosive GERD - Pantoprazol
Related Therapeutic Areas
Sponsors
Leads: Carnot Laboratories