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

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
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06991348
Acronym
TOP-GERD
Enrollment
128
Registered
2025-05-27
Start date
2024-07-30
Completion date
2025-11-30
Last updated
2025-07-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastroesophageal Reflux Disease

Keywords

GERD, pantoprazole, tegoprazan, P-CAB, PPI

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.

Interventions

DRUGTegoprazan

Tegoprazan 50 mg daily for 28 days

DRUGPantoprazole

Pantoprazole 40 mg daily for 28 days

Sponsors

Carnot Laboratories
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
Proportion of subjects with resolution of the main symptoms of gastroesophageal reflux diseaseFrom enrollment to the end of treatment at 4 weeksCarlsson-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.

Countries

Mexico

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026