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
調査の概要
詳細な説明
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.
研究の種類
入学 (実際)
段階
- フェーズ2
連絡先と場所
研究場所
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Seoul、大韓民国、137-701
- Seoul St.Mary's Hospital
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：YH4808 A mg (Twice daily)
YH4808 A mg (Twice daily, Oral administration)
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1 tablet = YH4808 A mg
他の名前：
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実験的：YH4808 B mg (Once daily)
YH4808 B mg (Once daily, Oral administration)
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1 tablet = YH4808 B mg
他の名前：
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実験的：YH4808 B mg (Twice daily)
YH4808 B mg (Twice daily, Oral administration)
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1 tablet = YH4808 B mg
他の名前：
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実験的：YH4808 C mg (Once daily)
YH4808 C mg (Once daily, Oral administration)
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YH4808 C mg = 2 x YH4808 B mg
他の名前：
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アクティブコンパレータ：Esomeprazole 40mg (Once daily)
Esomeprazole 40mg (Once daily, Oral administration)
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1 tablet = Esomeprazole 40 mg
他の名前：
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
時間枠 |
|---|---|
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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
時間枠：Week 4
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Week 4
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二次結果の測定
結果測定 |
時間枠 |
|---|---|
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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
時間枠：Week 8
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Week 8
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Nocturnal Symptom Free Days & Symptom Free Days
時間枠：Treatment Period
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Treatment Period
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Sustained resolution of symptom & Time to first sustained symptom resolution
時間枠：Treatment Period
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Treatment Period
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Symptom Score
時間枠：Treatment Period
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Treatment Period
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Serum Gastrin Level
時間枠：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)
時間枠：Check at 4, and 8 weeks.
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Check at 4, and 8 weeks.
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Quality of Life
時間枠：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
時間枠：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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その他の成果指標
結果測定 |
時間枠 |
|---|---|
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Nocturnal Symptom Free Days & Symptom Free Days
時間枠：Follow-up period
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Follow-up period
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Sustained resolution of symptom
時間枠：Follow-up period
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Follow-up period
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Symptom Score
時間枠：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)
時間枠：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
時間枠：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
時間枠：Treatment & Follow-up period
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Treatment & Follow-up period
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協力者と研究者
スポンサー
捜査官
- 主任研究者：Myung Gyy Choi, M.D., Ph.D.、Catholic Univ. Seoul St. Mary Hospital
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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