Clinical Trial to Evaluate the Safety and Efficacy of JP-1366 in Patients With Erosive Gastroesophageal Reflux Disease

Onconic Therapeutics

Status and phase: Completed; Phase 2

Conditions: GERD

Treatments: Drug: Esomeprazole 40mg; Drug: JP-1366 placebo; Drug: Esomeprazole placebo; Drug: JP-1366

Study type: Interventional

Funder types: Industry

Identifiers

NCT04282954

JP-1366-201

Details and patient eligibility

About

Clinical trial to evaluate the safety and efficacy of JP-1366 in patients with erosive gastroesophageal reflux disease

Enrollment: 188 patients

Sex: All

Ages: 19 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adults between 19 and 75 years old based on the date of written agreement
• Those who have been diagnosed with erosive gastroesophageal reflux disease(EGRD) of LA Grade A-D on the upper gastrointestinal endoscopy
• Those who experienced symptoms of heartburn or acid reflux within the last 7 days

Exclusion criteria

• Those who have undergone gastric acid suppression or gastric, esophageal surgery
• Those who with clinically significant liver, kidney, nervous system, respiratory, endocrine, hematologic, cardiovascular, urinary system disease
• Clinically significant abnormal laboratory values during screening

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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188 participants in 4 patient groups

Group 1

Experimental group

Description:

JP-1366 A mg

Treatment:

Drug: JP-1366 placebo

Drug: JP-1366

Drug: Esomeprazole placebo

Group 2

Experimental group

Description:

JP-1366 B mg

Treatment:

Drug: JP-1366 placebo

Drug: JP-1366

Drug: Esomeprazole placebo

Group 3

Experimental group

Description:

JP-1366 C mg

Treatment:

Drug: JP-1366 placebo

Drug: JP-1366

Drug: Esomeprazole placebo

Goup 4

Active Comparator group

Description:

Esomeprazole 40 mg

Treatment:

Drug: JP-1366 placebo

Drug: Esomeprazole 40mg