Study to Investigate the Safety, Tolerability and Efficacy of YH4808 in Patients With Reflux Esophagitis

Overview

This study is to investigate the optimal clinical dose and administration methods of YH4808 in patients with reflux esophagitis by evaluating the safety and efficacy after YH4808 oral administration.

Full Title of Study: “Randomized, Double-blind, Active-controlled, Multi-center Clinical Trial to Investigate the Safety, Tolerability and Efficacy of YH4808 in Patients With Reflux Esophagitis”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: November 2013

Detailed Description

In the result of recent meta-analysis, there was no improvement in symptoms with the first administration of PPI in about 75% of GERD patients, and symptoms were still sustained in about 50% of patients after administration of more than 3 days. Especially the nocturnal secretion of gastric acid was not effectively inhibited, and about 25% of GERD patients could not achieve the proper therapeutic effects even after PPI treatment twice daily for 4-8 weeks. YH4808, as a selective K+- competitive acid blocker (P-CAB), is no need for activation by gastric acid since it competitively inhibits proton pump with K+. Thus, the inhibition of gastric acid secretion by YH4808 is prompt and effective. In addition, the inhibitive effect of gastric acid secretion by stimulation of histamine is proved to be more powerful than PPI (esomeprazole) and sustained in in-vitro/in-vivo model, and 24-h inhibition of gastric acid secretion and especially nocturnal inhibition of gastric acid secretion was observed to be superior to esomeprazole with repeat doses for 7 days in healthy volunteers. Based on these nonclinical and clinical outcomes, an exploratory phase-II clinical trial is to be conducted to determine the proper treatment dose and administration method of YH48084 for GERD patients.

Interventions

  • Drug: Esomeprazole 40mg
    • 1 tablet = Esomeprazole 40 mg
  • Drug: YH4808 A mg
    • 1 tablet = YH4808 A mg
  • Drug: YH4808 B mg
    • 1 tablet = YH4808 B mg
  • Drug: YH4808 C mg
    • YH4808 C mg = 2 x YH4808 B mg

Arms, Groups and Cohorts

  • Experimental: YH4808 A mg (Twice daily)
    • YH4808 A mg (Twice daily, Oral administration)
  • Experimental: YH4808 B mg (Once daily)
    • YH4808 B mg (Once daily, Oral administration)
  • Experimental: YH4808 B mg (Twice daily)
    • YH4808 B mg (Twice daily, Oral administration)
  • Experimental: YH4808 C mg (Once daily)
    • YH4808 C mg (Once daily, Oral administration)
  • Active Comparator: Esomeprazole 40mg (Once daily)
    • Esomeprazole 40mg (Once daily, Oral administration)

Clinical Trial Outcome Measures

Primary Measures

  • Number of Participants With Healing of Reflux Esophagitis (RE) Who Were “Normal(including minimal change)” at Week 4 Out of Patients Who Were Graded “A, B, C or D” at Baseline According to Los Angeles Classification
    • Time Frame: Week 4

Secondary Measures

  • Number of Participants With Healing of Reflux Esophagitis (RE) Who Were “Normal(including minimal change)” at Week 8 Out of Patients Who Were Graded “A, B, C or D” at Baseline According to Los Angeles Classification
    • Time Frame: Week 8
  • Nocturnal Symptom Free Days & Symptom Free Days
    • Time Frame: Treatment Period
  • Sustained resolution of symptom & Time to first sustained symptom resolution
    • Time Frame: Treatment Period
  • Symptom Score
    • Time Frame: Treatment Period
  • Serum Gastrin Level
    • Time Frame: Check at Baseline(Pre-dose), 2, 4, and 8 weeks.
  • Global Impression of Change (Patient, Investigator)
    • Time Frame: Check at 4, and 8 weeks.
  • Quality of Life
    • Time Frame: Check at Baseline(Pre-dose), 4, and 8 weeks.
  • Epworth Sleepiness Scale
    • Time Frame: Check at Baseline(Pre-dose), 2, 4, and 8 weeks.

Participating in This Clinical Trial

Inclusion Criteria

1. Subject who has signed on the written consent 2. Male and female aged 20 and over 3. Endoscopically verified Reflux Esophagitis classified into Los Angeles classification Grade A, B, C or D within 2 weeks before randomisation Exclusion Criteria:

1. History or presence of upper gastrointestinal anatomic or motor disorders 2. Other exclusions apply.

Gender Eligibility: All

Minimum Age: 20 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Yuhan Corporation
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Myung Gyy Choi, M.D., Ph.D., Principal Investigator, Catholic Univ. Seoul St. Mary Hospital

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