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
Trial Snapshot
- Phase
- Phase 4
- Status
- Recruiting
- Sponsor
- Enrollment
- 128
- Locations
- 2
- Primary Endpoint
- Proportion of subjects with resolution of the main symptoms of gastroesophageal reflux disease
Study Overview
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 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Non-erosive GERD - Test product
Non-erosive GERD - Tegoprazan
Intervention: Tegoprazan (Drug)
Non-erosive GERD - Comparator
Non-erosive GERD - Pantoprazole
Intervention: Pantoprazole (Drug)
Erosive GERD - Test product
Erosive GERD - Tegoprazan
Intervention: Tegoprazan (Drug)
Erosive GERD - Comparator
Erosive GERD - Pantoprazol
Intervention: Pantoprazole (Drug)
Outcomes
Primary Outcomes
Proportion of subjects with resolution of the main symptoms of gastroesophageal reflux disease
Time Frame: From enrollment to the end of treatment at 4 weeks
Carlsson-Dent Questionnaire. These tool consists of 7 multiple-choice questions, using a cut-off point ≥ 4 to be considered positive, which qualitatively assesses symptoms associated with GERD and triggering factors such as diet, posture and medications used.
Secondary Outcomes
No secondary outcomes reported