Study to Investigate the Safety, Tolerability and Efficacy of YH4808 in Patients With Reflux Esophagitis
Randomized, Double-blind, Active-controlled, Multi-center Clinical Trial to Investigate the Safety, Tolerability and Efficacy of YH4808 in Patients With Reflux Esophagitis
연구 개요
상세 설명
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.
연구 유형
등록 (실제)
단계
- 2 단계
연락처 및 위치
연구 장소
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Seoul, 대한민국, 137-701
- Seoul St.Mary's Hospital
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Subject who has signed on the written consent
- Male and female aged 20 and over
- Endoscopically verified Reflux Esophagitis classified into Los Angeles classification Grade A, B, C or D within 2 weeks before randomisation
Exclusion Criteria:
- History or presence of upper gastrointestinal anatomic or motor disorders
- Other exclusions apply.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: YH4808 A mg (Twice daily)
YH4808 A mg (Twice daily, Oral administration)
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1 tablet = YH4808 A mg
다른 이름들:
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실험적: YH4808 B mg (Once daily)
YH4808 B mg (Once daily, Oral administration)
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1 tablet = YH4808 B mg
다른 이름들:
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실험적: YH4808 B mg (Twice daily)
YH4808 B mg (Twice daily, Oral administration)
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1 tablet = YH4808 B mg
다른 이름들:
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실험적: YH4808 C mg (Once daily)
YH4808 C mg (Once daily, Oral administration)
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YH4808 C mg = 2 x YH4808 B mg
다른 이름들:
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활성 비교기: Esomeprazole 40mg (Once daily)
Esomeprazole 40mg (Once daily, Oral administration)
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1 tablet = Esomeprazole 40 mg
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
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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
기간: Week 4
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Week 4
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2차 결과 측정
결과 측정 |
기간 |
|---|---|
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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
기간: Week 8
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Week 8
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Nocturnal Symptom Free Days & Symptom Free Days
기간: Treatment Period
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Treatment Period
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Sustained resolution of symptom & Time to first sustained symptom resolution
기간: Treatment Period
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Treatment Period
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Symptom Score
기간: Treatment Period
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Treatment Period
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Serum Gastrin Level
기간: Check at Baseline(Pre-dose), 2, 4, and 8 weeks.
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Check at Baseline(Pre-dose), 2, 4, and 8 weeks.
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Global Impression of Change (Patient, Investigator)
기간: Check at 4, and 8 weeks.
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Check at 4, and 8 weeks.
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Quality of Life
기간: Check at Baseline(Pre-dose), 4, and 8 weeks.
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Check at Baseline(Pre-dose), 4, and 8 weeks.
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Epworth Sleepiness Scale
기간: Check at Baseline(Pre-dose), 2, 4, and 8 weeks.
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Check at Baseline(Pre-dose), 2, 4, and 8 weeks.
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기타 결과 측정
결과 측정 |
기간 |
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Nocturnal Symptom Free Days & Symptom Free Days
기간: Follow-up period
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Follow-up period
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Sustained resolution of symptom
기간: Follow-up period
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Follow-up period
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Symptom Score
기간: Follow-up period
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Follow-up period
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Healing Rate of Reflux Esophagitis by Baseline According to Los Angeles Classification(LA Grade A~D Subgroup Analysis)
기간: Check at Baseline, Week 4 and Week 8
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Check at Baseline, Week 4 and Week 8
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Healing Rate of Reflux Esophagitis and Symptom related endpoints by H.pylori positive or negative
기간: Treatement & Follow-up period
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Treatement & Follow-up period
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Adverse events, Physical examination results, ECG, Vital sign, Lab results
기간: Treatment & Follow-up period
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Treatment & Follow-up period
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공동 작업자 및 조사자
수사관
- 수석 연구원: Myung Gyy Choi, M.D., Ph.D., Catholic Univ. Seoul St. Mary Hospital
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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YH4808 A mg에 대한 임상 시험
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Seoul National University Hospital완전한
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Laboratorios Silanes S.A. de C.V.완전한
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Novo Nordisk A/S완전한