Study to Evaluate the Safety and Efficacy of CJ-12420 in Patients With Non Erosive Reflux Disease

Non-erosive Reflux Disease Clinical Trial

Official title:

A Multicenter, Double-blind, Randomized, Placebo-controlled Phase 3 Study to Evaluate the Efficacy and Safety of CJ-12420 in Patients With Non-erosive Reflux Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02556021
• Other study ID #: CJ_APA_302
• Status: Completed
• Phase: Phase 3
• First received: September 16, 2015
• Last updated: April 2, 2018
• Start date: September 22, 2015
• Est. completion date: November 1, 2016

Study information

• Verified date: April 2018
• Source: CJ HealthCare Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to demonstrate the superiority of efficacy of CJ-12420, once daily (QD), compared to placebo in patients with non-erosive reflux disease at Week 4

Description:

This is a double blind, randomized, placebo-controlled, phase 3 study. Subjects will be randomly assigned to one of the three treatment groups (CJ-12420 50 mg or 100 mg or placebo).

All subjects will be asked to take two tablets at the same time each day throughout the study, and also all subjects will be asked to record daily symptom in a subject diary on a daily basis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 324
• Est. completion date: November 1, 2016
• Est. primary completion date: November 1, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Subjects aged between 20 and 75 years

2. Subjects who had experienced a minimum three-month history of main symptom(heartburn and regurgitation)

3. Subjects were to have normal esophagus confirmed by endoscopy within 14 days prior to randomization

4. Subjects who is able to understand and follow the instructions and is willing to participate throughout the entire study

5. Subjects who voluntarily signed written informed consent form

6. Subjects who agreed to use medically acceptable contraceptives during the period of study

7. Subjects who had experienced heartburn and regurgitation within 7 days before randomization. Entry into study also required that patients had experienced at least mild upper gastrointestinal symptoms on at least 2 days/week or at least moderate upper gastrointestinal symptoms on at least 1 day/week

Exclusion Criteria:

1. Subjects who cannot undergo EGD

2. Subjects who have esophageal stenosis, ulcer stenosis, gastroesophageal varices, Barrett's esophagus, active gastric ulcer, gastrointestinal bleeding or malignant tumor confirmed by EGD

3. Subjects who have erosive esophagitis, acute upper gastrointestinal bleeding, gastric ulcers or duodenal ulcers, acute erosive gastritis within 2 months before randomization. Subjects with gastric or duodenal erosions are allowed to be included.

4. Subjects who have warning symptoms of malignant gastrointestinal tract such as odynophagia, severe dysphagia, bleeding, weight loss, anemia, or bloody stool

5. Subjects with eosinophilic esophagitis

6. Subjects diagnosed with functional dyspepsia, primary esophageal motility disorder, IBS, IBD, etc. or with suspected IBS in the last 3 months

7. Subjects who have a history of gastric acid suppression surgery or upper gastrointestinal, esophageal surgery

8. Subjects who have bipolar disorder, anxiety disorder, panic disorder, somatoform disorder, personality disorder and psychiatric disorders.

9. Subjects who are taking antipsychotic drugs, antidepressants or antianxiety medications

10. Subjects who should continuously administer NSAIDs during the trial.

11. Pregnant or lactating women

12. Subjects with a history of clinically significant hepatic, renal, cardiovascular, respiratory, endocrine and CNS system disorder

13. Subjects with a history of hypersensitivity to the active ingredient or excipients of the study drug, etc.

14. Subjects who participated in the other clinical trial within 4 weeks prior to randomization

Related Conditions & MeSH terms

• Gastroesophageal Reflux
• Non-erosive Reflux Disease

Intervention

Drug:
• CJ-12420 50mg
CJ-12420 50mg, tablet, once daily, oral administration for up to 4 weeks
• CJ-12420 100mg
CJ-12420 100mg, tablet, once daily, oral administration for up to 4 weeks
• Placebo
Placebo, tablet, once daily, oral administration for up to 4 weeks

Locations

Country	Name	City	State
Korea, Republic of	Yeouido St.Mary's Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
CJ HealthCare Corporation

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of patients with complete resolution of main symptoms (heartburn and regurgitation) at 4-week, defined as no episodes of symptom during the last 7 days of treatment, using Reflux Disease Questionnaire(RDQ)		4 week
Secondary	Resolution of main symptoms(heartburn and regurgitation) at 2-week(for 7 consecutive days)		2 week
Secondary	RDQ score change		4 week
Secondary	Percentage of symptom free days	Symptom will be collected by patient diary.	4 week