PPI Infusion Versus Oral Acid Pump Inhibitors for Bleeding Peptic Ulcers

NCT05582174 | Recruiting Phase 4 DMC

• 1 other identifier: PPI vs VPZ study
• Study Type: interventional
• Target: 594
• Locations: 1 country
• Sites: 8

Brief Summary

Vonoprazan (VPZ), an oral potassium-competitive acid blocker (P-CAB) has emerged as an alternative potent acid-suppressant.It has a faster onset of action in 1 day (3-5 days in PPI), and is more stable in acidic condition than PPI. While many studies compared Vonoprazan against PPI in the treatment of reflux oesophagitis, H. Pylori eradication, and gastric ulcers; thus far, there is a paucity of data on use of Vonoprazan on bleeding peptic ulcers. We perform a multicenter randomized controlled trial (RCT) to compare the efficacy of oral Vonoprazan against standard high dose PPI therapy in bleeding peptic ulcers that had received successful endoscopic haemostasis We hypothesize that in patients with bleeding peptic ulcers, the use of acid pump inhibitors Vonoprazan would not be inferior to standard treatment of a bolus plus high dose PPI intravenous infusion at preventing recurrent bleeding after endoscopic haemostasis.

Conditions

Upper GI Bleeding; Proton Pump Inhibitors

Outcome Measures

Primary Outcomes (1)

• The number of recurrent bleeding

  The number of recurrent bleeding that occurred after 1st endoscopic hemostasis and confirmed by endoscopy

  within 30 days after randomization

Secondary Outcomes (2)

• further treatment for hemostasis

  within 30 days after randomization

• Total Days of hospital stay and intensive unit stay

  within 30 days after randomization

Study Arms (2)

PPI infusion

ACTIVE COMPARATOR

esomeprazole 80mg iv bolus followed by 8mg per hour for 72 hours

Drug: esomeprazole

Vonoprazan

EXPERIMENTAL

Vonoprazan 40 mg bid orally for 72 hours, and from day 4-30 VPZ 20 mg daily

Drug: Vonoprazan

Interventions

Vonoprazan DRUG

Vonoprazan 40 mg bid orally for 72 hours, and from day 4-30 VPZ 20 mg daily

Also known as: Takecab

Vonoprazan

esomeprazole DRUG

A high dose PPI infusion (esomeprazole 80mg iv bolus followed by 8mg per hour for 72 hours), and frorm day 4-30 oral esomeprazole daily

Also known as: nexium

PPI infusion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nanfang Hospital, Southern Medical University: collaborator
• Chinese University of Hong Kong: lead

Study Sites (8)

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

MeSH Terms

Conditions

Gastrointestinal Hemorrhage

Interventions

1-(5-(2-fluorophenyl)-1-(pyridin-3-ylsulfonyl)-1H-pyrrol-3-yl)-N-methylmethanamine; Esomeprazole

Condition Hierarchy (Ancestors)

Gastrointestinal Diseases; Digestive System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Omeprazole; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Side Liu, PhD

  Southern Medical University - Southern Hospital

  STUDY DIRECTOR

Central Study Contacts

xiaobei luo, PhD

CONTACT

86 17688881428; luoxiaobei63@126.com

bingyee suen, Bachelor

CONTACT

35052640; bingyeesuen@surgery.cuhk.edu.hk

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: random sequence was investigator-blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: October 13, 2022
• First Posted: October 17, 2022
• Study Start: May 18, 2023
• Primary Completion (Estimated): January 2, 2028
• Study Completion (Estimated): July 3, 2028
• Last Updated: March 18, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (8)