Keverprazan vs Pantoprazole for the Treatment of ANVUGIB
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorGeneral Hospital of Shenyang Military Region
About this trial
Acute non-variceal upper gastrointestinal bleeding (ANVUGIB) is a common medical emergency requiring hospitalization. The cornerstone of ANVUGIB management is effective gastric acid suppression. Potassium-competitive acid blockers (P-CABs) represent a novel class of gastric acid secretion inhibitors, which can rapidly and consistently increase intragastric pH. Keverprazan, a novel P-CAB, has been shown to be effective in treating duodenal ulcers and erosive esophagitis. Herein, we have designed a multicenter randomized controlled trial (RCT) to determine whether keverprazan is noninferior to pantoprazole in preventing rebleeding after successful initial hemostasis in patients with ANVUGIB.
Eligibility criteria
Qualifiers
Participants presented with hematemesis, melena, or other clinical manifestations suggestive of upper gastrointestinal bleeding within 5 days before screening.
Participants have endoscopic confirmation of a non-variceal source of upper gastrointestinal bleeding.
Participants are aged between 18 and 75 years.
Participants who are willing to participate in this clinical trial and sign the written informed consent.
Disqualifiers
Participants have experienced failure of endoscopic hemostasis, rebleeding before randomization, or a requirement for immediate transcatheter arterial embolization or surgery at the time of eligibility assessment.
Participants have an active malignancy or malignancy expected to interfere with survival, outcome assessment, treatment adherence, or follow-up.
Participants have esophageal or gastric varices or portal hypertensive gastropathy identified during endoscopic examination.
Participants who are unable to swallow the study medication.
Trial design
Treatments tested in this trial
- Pantoprazole
- Keverprazan
Treatment groups
908 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov