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

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

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

188 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-15

Study Completion Date

2020-12-11

Brief Summary

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

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Detailed Description

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Conditions

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GERD

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Intervention Type DRUG

Esomeprazole 40mg, QD

Interventions

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JP-1366

JP-1366, QD

Intervention Type DRUG

JP-1366 placebo

JP-1366 placebo, QD

Intervention Type DRUG

Esomeprazole 40mg

Esomeprazole 40mg, QD

Intervention Type DRUG

Esomeprazole placebo

Esomeprazole placebo, QD

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

19 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No