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

NCT ID: NCT02556021

Last Updated: 2018-04-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 324 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-09-22
• Study Completion Date: 2016-11-01

Brief 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

Detailed 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.

Conditions

Non-erosive Reflux Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

CJ-12420 50mg

CJ-12420 50 mg, tablet, once daily, oral administration for up to 4 weeks

Group Type: EXPERIMENTAL

CJ-12420 50mg

Intervention Type: DRUG

CJ-12420 50mg, tablet, once daily, oral administration for up to 4 weeks

CJ-12420 100mg

CJ-12420 100 mg, tablet, once daily, oral administration for up to 4 weeks

Group Type: EXPERIMENTAL

CJ-12420 100mg

Intervention Type: DRUG

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo, tablet, once daily, oral administration for up to 4 weeks

Interventions

CJ-12420 50mg

CJ-12420 50mg, tablet, once daily, oral administration for up to 4 weeks

Intervention Type: DRUG

CJ-12420 100mg

CJ-12420 100mg, tablet, once daily, oral administration for up to 4 weeks

Intervention Type: DRUG

Placebo

Placebo, tablet, once daily, oral administration for up to 4 weeks

Intervention Type: DRUG

Other Intervention Names

Not yet decided; Not yet decided

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

HK inno.N Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Yeouido St.Mary's Hospital

Seoul, , South Korea

Countries

South Korea

References

Kim SH, Cho KB, Chun HJ, Lee SW, Kwon JG, Lee DH, Kim SG, Jung HY, Kim JW, Lee JS, Park H, Choi SC, Jee SR, Kim HS, Ko KH, Park SJ, Lee YC, Park SH, Kim AR, Kim EJ, Park HW, Kim BT, Song GS. Randomised clinical trial: comparison of tegoprazan and placebo in non-erosive reflux disease. Aliment Pharmacol Ther. 2021 Aug;54(4):402-411. doi: 10.1111/apt.16477. Epub 2021 Jul 6.

Reference Type: DERIVED

PMID: 34227708 (View on PubMed)

Other Identifiers

CJ_APA_302

Identifier Type: -

Identifier Source: org_study_id