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Completed

NCT Number: NCT04282954

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

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

Completed

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Key information

Conditions

GERD Deglutition Disorders Digestive System Diseases Esophageal Diseases Esophageal Motility Disorders Gastroesophageal Reflux Gastrointestinal Diseases

Age range

19 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Severance Hospital and 19 hospitals

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

JP-1366

Drug

JP-1366, QD

JP-1366 placebo

Drug

JP-1366 placebo, QD

Esomeprazole 40mg

Drug

Esomeprazole 40mg, QD

Esomeprazole Placebo

Drug

Esomeprazole placebo, QD

Primary outcomes

  1. Accumulated mucosal defect cure rate*(%) at Week 8 following study drug administration (%)

    Time frame: 8 weeks

    • Erosion recovered to normal mucous membrane on upper gastrointestinal endoscopy

Sponsors and collaborators

Lead sponsor

Onconic Therapeutics Inc.

Industry

Registry information

Official study title

A Randomized, Double-blind, Active-controlled, Multi-center Phase II Clinical Trial to Evaluate the Safety and Efficacy of JP-1366 in Patients With Erosive Gastroesophageal Reflux Disease

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Feb 25, 2020
Registry last updated
Jul 13, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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