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A Study to Evaluate Tegoprazan as a Diagnostic Tool for GERD

ConditionGERD (Gastroesophageal Reflux Disease)
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age19-75
SponsorHK inno.N Corporation

About this trial

The purpose of this study is to evaluate the diagnostic value of tegoprazan for GERD.

Patients experiencing typical GERD symptoms, such as heartburn and acid regurgitation, will take either tegoprazan or a placebo once daily for 1 week.

Investigators will compare the short-term symptom improvement between the two groups to determine if an early response to tegoprazan can help diagnose GERD.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients aged 19 to 75 years who have experienced symptoms of acid regurgitation or heartburn at least twice a week starting at least 3 months prior to screening.

Baseline Symptom Assessment Questionnaire score of at least 6 at screening.

7-Day Symptom Assessment Questionnaire score of at least 4 at randomization.

Disqualifiers

Known hypersensitivity to Potassium-Competitive Acid Blockers (P-CABs) or benzimidazoles.

Presence of gastrointestinal warning symptoms (e.g., progressive dysphagia, bleeding, unintentional weight loss within 3 months, hematemesis, anemia, hematochezia, or rectal bleeding) without a confirmed negative tumor finding on endoscopy.

History of or planned gastrointestinal surgery that potentially affects gastric acid secretion.

Diagnosed with Zollinger-Ellison syndrome or other gastric acid secretion disorders.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Tegoprazan 50 mg

    Drug

    Tegoprazan 50 mg tablet will be orally administered once daily for 7 days.

  • Placebo

    Drug

    Placebo tablet will be orally administered once daily for 7 days.

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Tegoprazan 50 mgExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Diagnostic accuracy (Sensitivity, Specificity, Positive Predictive Value, and Negative Predictive Value) of GERD based on total symptom score

Time frame
Day 7

Secondary outcomes

1

Diagnostic accuracy (Sensitivity, Specificity, Positive Predictive Value, and Negative Predictive Value) of GERD based on individual symptoms of heartburn and acid regurgitation

Time frame
Day 7
2

Diagnostic accuracy (Sensitivity, Specificity, Positive Predictive Value, and Negative Predictive Value) of GERD based on total symptom score

Time frame
Day 3
3

Diagnostic accuracy (Sensitivity, Specificity, Positive Predictive Value, and Negative Predictive Value) of GERD based on individual symptoms of heartburn and acid regurgitation

Time frame
Day 3
4

Change from baseline in the 7-day symptom assessment questionnaire score at the end of visit

Time frame
Baseline and Day 7 (End of Visit)

Other outcomes

1

Daily sensitivity and specificity of GERD diagnosis

Time frame
Daily for 7 days

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

HK inno.N Corporation

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: