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
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Réel)
Phase
- Phase 2
Contacts et emplacements
Lieux d'étude
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-
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Seoul, Corée, République de, 137-701
- Seoul St.Mary's Hospital
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: YH4808 A mg (Twice daily)
YH4808 A mg (Twice daily, Oral administration)
|
1 tablet = YH4808 A mg
Autres noms:
|
|
Expérimental: YH4808 B mg (Once daily)
YH4808 B mg (Once daily, Oral administration)
|
1 tablet = YH4808 B mg
Autres noms:
|
|
Expérimental: YH4808 B mg (Twice daily)
YH4808 B mg (Twice daily, Oral administration)
|
1 tablet = YH4808 B mg
Autres noms:
|
|
Expérimental: YH4808 C mg (Once daily)
YH4808 C mg (Once daily, Oral administration)
|
YH4808 C mg = 2 x YH4808 B mg
Autres noms:
|
|
Comparateur actif: Esomeprazole 40mg (Once daily)
Esomeprazole 40mg (Once daily, Oral administration)
|
1 tablet = Esomeprazole 40 mg
Autres noms:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
|---|---|
|
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
Délai: Week 4
|
Week 4
|
Mesures de résultats secondaires
Mesure des résultats |
Délai |
|---|---|
|
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
Délai: Week 8
|
Week 8
|
|
Nocturnal Symptom Free Days & Symptom Free Days
Délai: Treatment Period
|
Treatment Period
|
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Sustained resolution of symptom & Time to first sustained symptom resolution
Délai: Treatment Period
|
Treatment Period
|
|
Symptom Score
Délai: Treatment Period
|
Treatment Period
|
|
Serum Gastrin Level
Délai: Check at Baseline(Pre-dose), 2, 4, and 8 weeks.
|
Check at Baseline(Pre-dose), 2, 4, and 8 weeks.
|
|
Global Impression of Change (Patient, Investigator)
Délai: Check at 4, and 8 weeks.
|
Check at 4, and 8 weeks.
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Quality of Life
Délai: 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
Délai: Check at Baseline(Pre-dose), 2, 4, and 8 weeks.
|
Check at Baseline(Pre-dose), 2, 4, and 8 weeks.
|
Autres mesures de résultats
Mesure des résultats |
Délai |
|---|---|
|
Nocturnal Symptom Free Days & Symptom Free Days
Délai: Follow-up period
|
Follow-up period
|
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Sustained resolution of symptom
Délai: Follow-up period
|
Follow-up period
|
|
Symptom Score
Délai: Follow-up period
|
Follow-up period
|
|
Healing Rate of Reflux Esophagitis by Baseline According to Los Angeles Classification(LA Grade A~D Subgroup Analysis)
Délai: Check at Baseline, Week 4 and Week 8
|
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
Délai: 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
Délai: Treatment & Follow-up period
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Treatment & Follow-up period
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Myung Gyy Choi, M.D., Ph.D., Catholic Univ. Seoul St. Mary Hospital
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
- Maladies du système digestif
- Maladies gastro-intestinales
- Maladies de l'estomac
- Gastro-entérite
- Maladies intestinales
- Troubles de la motricité oesophagienne
- Troubles de la déglutition
- Maladies de l'oesophage
- Ulcère peptique
- Maladies duodénales
- Reflux gastro-oesophagien
- Oesophagite, peptique
- Oesophagite
- Mécanismes moléculaires de l'action pharmacologique
- Inhibiteurs d'enzymes
- Agents gastro-intestinaux
- Agents anti-ulcéreux
- Les inhibiteurs de la pompe à protons
- Ésoméprazole
Autres numéros d'identification d'étude
- YH4808-201
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