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Completed

NCT Number: NCT02028663

Study to Evaluate the Safety and Efficacy of CJ-12420 in Patients With Erosive Esophagitis

The purpose of this study is to investigate the optimal dose and administration methods of CJ-12420 in patients with erosive esophagitis by comparing the safety and efficacy of orally administered CJ-12420 to esomeprazole 40mg.

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Key information

Conditions

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

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Seoul National University Hospital and 11 others

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Aged between 20-70
  • Diagnosed with Erosive Esophagitis by Esophagogastroduodenoscopy (EGD) and classified into LA Grade A to D within 14 days before randomization to treatment

Exclusion criteria

  • Patients who cannot undergo EGD
  • Patients diagnosed with irritable bowel syndrome (IBS), inflammatory bowel disease (IBD), or suspected IBS
  • Patients who took PPIs within 2 weeks prior to study drug administration
  • Long-term use of nonsteroidal anti-inflammatory drugs throughout the study
  • Clinically significant abnormal laboratory values during screening

Treatment and study plan

CJ-12420

Drug

Once daily, Oral administration

Other names: Undecided

Esomeprazole

Drug

Once daily, Oral administration

Other names: Nexium

Primary outcomes

  1. Cumulative healing rate of erosive esophagitis at 8-week

    Time frame: 8 week

Secondary outcomes

  1. Healing rate of erosive esophagitis at 4-week

    Time frame: 4 week

Sponsors and collaborators

Lead sponsor

HK inno.N Corporation

Industry

Registry information

Official study title

A Double-Blind, Randomized, Dose-finding Study to Evaluate the Safety and Efficacy of CJ-12420 in Patients With Erosive Esophagitis

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jan 7, 2014
Registry last updated
Aug 8, 2014

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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