A Phase 4 interventional study of Vonoprazan and Esomeprazole in Ulcers, Gastric, sponsored by Shicai Ye. Not yet recruiting at 4 sites in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2024-07-29.
Sponsored by Shicai Ye · Phase 4, Interventional, and Treatment
The purpose of this clinical trial is to find out the effectiveness of voronasan in combination with aluminum phosphate gel in the treatment of post-operative ESD ulcers. It will also find out about the safety of vunorasan in combination with aluminum phosphate gel. The main questions it aims to answer are:
Participants will:
Intravenous lansoprazole 1-3 days after ESD and oral voronasan combined with aluminum phosphate gel or esomeprazole combined with aluminum phosphate gel 3-56 days after ESD.
Record their symptoms, endoscopic ulcer grading, ulcer size and Calculate ulcer healing rate at weeks 2 and 8.
112 studies on the registry are indexed under Stomach Ulcer; 13 are open to participants now.
This study's planned enrollment of 196 is below the median of 265 across 86 interventional studies indexed under Stomach Ulcer.
Browse Stomach Ulcer studies →This is the only study on the registry with Shicai Ye as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Vonorasan、tablet、20mg、qd、Days 3 to 56
Drug: Vonoprazan
Esomeprazole 、tablet、20mg、Days 3 to 56
Drug: Esomeprazole
oral drug 3-56 days after ESD.
oral drug 3-56 days after ESD.
Rate of ulcer reduction
Ulcer area = maximum diameter of the ulcer \* perpendicular line of the maximum diameter (mm2) The rate of ulcer reduction at 2 weeks = \[(area of the initial ulcer - area of the ulcer at 2 weeks)/area of the initial ulcer\]\*100% The rate of ulcer reduction at 8 weeks = \[ (area of the initial ulcer - area of the ulcer at 8 weeks)/area of the initial ulcer\]\*100% Ulcer area = maximum diameter of the ulcer \* perpendicular line of the maximum diameter (mm2) The rate of ulcer reduction at 2 weeks = \[(area of the initial ulcer - area of the ulcer at 2 weeks)/area of the initial ulcer\]\*100% The rate of ulcer reduction at 8 weeks = \[ (area of the initial ulcer - area of the ulcer at 8 weeks)/area of the initial ulcer\]\*100%
Time frame: 2nd and 8th week post-dose
Size of ulcer
Ulcer area = maximum diameter of the ulcer \* perpendicular line of the maximum diameter (mm2)
Time frame: 2nd and 8th week post-dose
Rate of ulcer healing
Healing rate = number of cases with scarring/total number of cases × 100 per cent
Time frame: 2nd and 8th week post-dose
Rate of bumpy
Rate of bumpy= number of cases that have occurred/total number of cases × 100 per cent
Time frame: 2nd and 8th week post-dose
Quality of ulcer healing
Scoring using the Ulcer Healing Scoring Scale，the highest score is 3 and the lowest is 1, with higher scores indicating better ulcer healing
Time frame: 2nd and 8th week post-dose
Rate of delayed hemorrhage
Rate of delayed hemorrhage=Number of haemorrhages/total
Time frame: 2th week post-dose
Postoperative symptom relief rate
Number of persons in remission/total
Time frame: 2th week post-dose
This study is not yet recruiting, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.
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