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

NCT02556021 | Completed Phase 3

• 1 other identifier: CJ_APA_302
• Study Type: interventional
• Target: 324
• Locations: 1 country
• Sites: 1

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

Conditions

Non-erosive Reflux Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Resolution of main symptoms(heartburn and regurgitation) at 2-week(for 7 consecutive days)

  2 week

• RDQ score change

  4 week

• Percentage of symptom free days

  4 week

Study Arms (3)

CJ-12420 50mg

EXPERIMENTAL

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

Drug: CJ-12420 50mg

CJ-12420 100mg

EXPERIMENTAL

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

Drug: CJ-12420 100mg

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

CJ-12420 50mg DRUG

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

Also known as: Not yet decided

CJ-12420 50mg

CJ-12420 100mg DRUG

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

Also known as: Not yet decided

CJ-12420 100mg

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects aged between 20 and 75 years
• Subjects who had experienced a minimum three-month history of main symptom(heartburn and regurgitation)
• Subjects were to have normal esophagus confirmed by endoscopy within 14 days prior to randomization
• Subjects who is able to understand and follow the instructions and is willing to participate throughout the entire study
• Subjects who voluntarily signed written informed consent form
• Subjects who agreed to use medically acceptable contraceptives during the period of study
• 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

You may not qualify if:

• Subjects who cannot undergo EGD
• Subjects who have esophageal stenosis, ulcer stenosis, gastroesophageal varices, Barrett's esophagus, active gastric ulcer, gastrointestinal bleeding or malignant tumor confirmed by EGD
• 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.
• Subjects who have warning symptoms of malignant gastrointestinal tract such as odynophagia, severe dysphagia, bleeding, weight loss, anemia, or bloody stool
• Subjects with eosinophilic esophagitis
• Subjects diagnosed with functional dyspepsia, primary esophageal motility disorder, IBS, IBD, etc. or with suspected IBS in the last 3 months
• Subjects who have a history of gastric acid suppression surgery or upper gastrointestinal, esophageal surgery
• Subjects who have bipolar disorder, anxiety disorder, panic disorder, somatoform disorder, personality disorder and psychiatric disorders.
• Subjects who are taking antipsychotic drugs, antidepressants or antianxiety medications
• Subjects who should continuously administer NSAIDs during the trial.
• Pregnant or lactating women
• Subjects with a history of clinically significant hepatic, renal, cardiovascular, respiratory, endocrine and CNS system disorder
• Subjects with a history of hypersensitivity to the active ingredient or excipients of the study drug, etc.
• Subjects who participated in the other clinical trial within 4 weeks prior to randomization

Sponsors & Collaborators

• HK inno.N Corporation: lead

Study Sites (1)

Yeouido St.Mary's Hospital

Seoul, South Korea

Location

Related Publications (1)

• 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.

  PMID: 34227708 DERIVED

MeSH Terms

Conditions

Non-Erosive Reflux Disease

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2015
• First Posted: September 22, 2015
• Study Start: September 22, 2015
• Primary Completion: November 1, 2016
• Study Completion: November 1, 2016
• Last Updated: April 4, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)