Comparing Vonoprazan and oral PPIs for bleeding peptic ulcers
A Comparison Between a High Dose PPI Intravenous Infusion and Oral Acid Pump Inhibitors After Endoscopic Haemostasis to Bleeding Peptic Ulcers
This study tests whether a new medication called Vonoprazan is as good as standard proton pump inhibitors in preventing bleeding from peptic ulcers after treatment.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 594 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Chinese University of Hong Kong Academic / other |
| Locations | 8 sites (Guangzhou, Guangdong and 7 other locations) |
| Trial ID | NCT05582174 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to compare the effectiveness of oral Vonoprazan, a potassium-competitive acid blocker, against standard high-dose proton pump inhibitors (PPIs) in patients with bleeding peptic ulcers who have undergone successful endoscopic treatment. The study is a multicenter randomized controlled trial that hypothesizes that Vonoprazan will not be inferior to intravenous PPI therapy in preventing recurrent bleeding. The trial will assess outcomes such as rebleeding rates and overall patient recovery following treatment. By evaluating these two treatment options, the study seeks to provide insights into optimal management strategies for upper gastrointestinal bleeding.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who have experienced upper gastrointestinal bleeding due to non-variceal causes and have undergone endoscopic treatment.
Not a fit: Patients with variceal bleeding or those who do not meet the inclusion criteria for endoscopic treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective oral treatment option for patients with bleeding peptic ulcers, potentially reducing the risk of recurrent bleeding.
How similar studies have performed: While many studies have compared Vonoprazan to PPIs for other conditions, this specific comparison for bleeding peptic ulcers is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * \- Patients aged ≥18 years who had undergone oesophagogastroduodenoscopy (OGD) for sign and symptoms of aneamia or upper GI bleeding including haematochezia, melaena or haematemesis, and found to a non-variceal upper GI cause of bleeding (peptic ulcers, dieulafoy's lesions, Mallory Weiss tear with active bleeding or major stigmata of haemorrhage * Major stigmata of recent haemorrhage includes peptic ulcers with spurting or oozing bleeding (Forrest classification Ia and Ib, respectively) ,with a nonbleeding visible vessel (Forrest classification IIa) or an adherent clot (Forrest classification IIb). For peptic ulcers with an adherent clot (Forrest classification IIb), the clot would be lifted (by irrigation using syringe boluses or water pump device, or manipulation with a snare or alligator etc.) and ulcer base examined to look for underlying vessels. Once the clot is removed, any identified underlying active bleeding or nonbleeding visible vessel should receive endoscopic haemostasis * Patients who had undergone endoscopic hemostatic treatment (a combination of hemoclipping therapy or contact thermocoagulation using multipolar/bipolar electrocautery probes or haemostatic forceps, with or without preinjection of diluted epinephrine. Endoscopic haemostasis is defined as no evidence of bleeding after irrigation and 3 minutes of observation Exclusion Criteria: * No consent * Patients under the age of 18 * Patients who were pregnant or in lactation * Hypersensitivity to PPI or Vonoprazan or any component of the formulation * Patients who were found to have tumour bleeding, oesophageal varices as the cause of the NVGIB * NVGIB due to post therapeutic endoscopic treatment such as gastric polypectomy, endoscopic mucosal resection, endoscopic submucosal dissection etc.
Where this trial is running
Guangzhou, Guangdong and 7 other locations
- Nanfang Hospital Southern Medical University — Guangzhou, Guangdong, China (Recruiting)
- The Second Affiliated Hospital of Guangzhou Medical University — Guangzhou, Guangdong, China (Not_yet_recruiting)
- The Second Affiliated Hospital of Guangzhou University of Chinese Medicine — Guangzhou, Guangdong, China (Not_yet_recruiting)
- Shenzhen Pingshan District People's Hospital — Shenzhen, Guangdong, China (Not_yet_recruiting)
- The Second Affiliated Hospital The Chinese University of Hong Kong, Shenzhen & Longgang District People's Hospital of Shenzhen — Shenzhen, Guangdong, China (Not_yet_recruiting)
- Yangjiang People's Hospital of Guangdong Medical University — Yangjiang, Guangdong, China (Not_yet_recruiting)
- Zhuhai People's Hospital (Zhuhai Hospital Affiliated to Jinan University) — Zhuhai, Guangdong, China (Not_yet_recruiting)
- Prince of Wales Hospital — Hong Kong, Hong Kong SAR, China (Not_yet_recruiting)
Study contacts
- Study coordinator: xiaobei luo, PhD
- Email: luoxiaobei63@126.com
- Phone: 86 17688881428
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.