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

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorCarnot Laboratories

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Tegoprazan

    Drug

    Tegoprazan 50 mg daily for 28 days

  • Pantoprazole

    Drug

    Pantoprazole 40 mg daily for 28 days

Treatment groups

128 Participants
are divided into 4 treatment groups
Group A: Non-erosive GERD - Test productExperimental treatment 1 intervention
Group B: Non-erosive GERD - ComparatorActive comparator 1 intervention
Group C: Erosive GERD - Test productExperimental treatment 1 intervention
Group D: Erosive GERD - ComparatorActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Proportion of subjects with resolution of the main symptoms of gastroesophageal reflux disease

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.

Time frame
From enrollment to the end of treatment at 4 weeks

Secondary outcomes

Other outcomes

Sponsors and contacts

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