Clinical Trial for the Comparative Evaluation of Acid Suppression and Symptom Management of Gastroesophageal Reflux Disease With the Administration of Tegoprazan or Pantoprazole

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

128 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-30

Study Completion Date

2025-11-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Gastroesophageal Reflux Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Non-erosive GERD - Test product

Non-erosive GERD - Tegoprazan

Group Type EXPERIMENTAL

Tegoprazan

Intervention Type DRUG

Tegoprazan 50 mg daily for 28 days

Non-erosive GERD - Comparator

Non-erosive GERD - Pantoprazole

Group Type ACTIVE_COMPARATOR

Pantoprazole

Intervention Type DRUG

Pantoprazole 40 mg daily for 28 days

Erosive GERD - Test product

Erosive GERD - Tegoprazan

Group Type EXPERIMENTAL

Tegoprazan

Intervention Type DRUG

Tegoprazan 50 mg daily for 28 days

Erosive GERD - Comparator

Erosive GERD - Pantoprazol

Group Type ACTIVE_COMPARATOR

Pantoprazole

Intervention Type DRUG

Pantoprazole 40 mg daily for 28 days

Interventions

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Tegoprazan

Tegoprazan 50 mg daily for 28 days

Intervention Type DRUG

Pantoprazole

Pantoprazole 40 mg daily for 28 days

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No