A Phase 2 interventional study of Esomeprazole 40mg and YH4808 A mg in Reflux Esophagitis, sponsored by Yuhan Corporation. Completed at 1 site in Korea, Republic of. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2014-07-10.
Sponsored by Yuhan Corporation · Phase 2, Interventional, and Treatment
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.
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.
1,066 studies on the registry are indexed under Gastroesophageal Reflux; 188 are open to participants now.
This study's enrollment of 154 is above the median of 72 across 711 interventional studies indexed under Gastroesophageal Reflux.
Browse Gastroesophageal Reflux studies →Yuhan Corporation is the lead sponsor of 107 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
YH4808 A mg (Twice daily, Oral administration)
Drug: YH4808 A mg
YH4808 B mg (Once daily, Oral administration)
Drug: YH4808 B mg
YH4808 B mg (Twice daily, Oral administration)
Drug: YH4808 B mg
YH4808 C mg (Once daily, Oral administration)
Drug: YH4808 C mg
Esomeprazole 40mg (Once daily, Oral administration)
Drug: Esomeprazole 40mg
1 tablet = Esomeprazole 40 mg
Also known as: Nexium
1 tablet = YH4808 A mg
Also known as: Undecided
1 tablet = YH4808 B mg
Also known as: Undecided
YH4808 C mg = 2 x YH4808 B mg
Also known as: Undecided
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
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.
Nocturnal Symptom Free Days & Symptom Free Days
Time frame: Follow-up period
Sustained resolution of symptom
Time frame: Follow-up period
Symptom Score
Time frame: Follow-up period
Healing Rate of Reflux Esophagitis by Baseline According to Los Angeles Classification(LA Grade A~D Subgroup Analysis)
Time frame: Check at Baseline, Week 4 and Week 8
Healing Rate of Reflux Esophagitis and Symptom related endpoints by H.pylori positive or negative
Time frame: Treatement & Follow-up period
Adverse events, Physical examination results, ECG, Vital sign, Lab results
Time frame: Treatment & Follow-up period
This study is completed, as verified in Jul 2014. You cannot join it, but the record below documents what was studied.
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Yuhan Corporation