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)

Carnot Laboratories

Status and phase: Enrolling; Phase 4

Conditions: Gastroesophageal Reflux Disease

Treatments: Drug: Pantoprazole; Drug: Tegoprazan

Study type: Interventional

Funder types: Industry

Identifiers

NCT06991348

CRN-GA-01-2022

Details and patient eligibility

About

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.

Enrollment: 128 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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128 participants in 4 patient groups

Non-erosive GERD - Test product

Experimental group

Description:

Non-erosive GERD - Tegoprazan

Treatment:

Drug: Tegoprazan

Non-erosive GERD - Comparator

Active Comparator group

Description:

Non-erosive GERD - Pantoprazole

Treatment:

Drug: Pantoprazole

Erosive GERD - Test product

Experimental group

Description:

Erosive GERD - Tegoprazan

Treatment:

Drug: Tegoprazan

Erosive GERD - Comparator

Active Comparator group

Description:

Erosive GERD - Pantoprazol

Treatment:

Drug: Pantoprazole