Efficacy of Vonoprazan Versus Intravenous Proton Pump Inhibitors for Prevention of Rebleeding in High Risk Peptic Ulcers Bleeding After Successful Endoscopic Hemostasis

NCT05005910 | Completed Early Phase 1 DMC

• 1 other identifier: 011/2563
• Study Type: interventional
• Target: 194
• Locations: 1 country
• Sites: 1

Brief Summary

Upper gastrointestinal hemorrhage (UGIH) is common urgency condition.The estimate mortality rate about 7 percent from peptic ulcers disease(PUD). A proton pump inhibitors (PPIs) intravenous infusion are standard treatment for high risk ulcer bleeding. Vonoprazan,subclass of potassium-competitive acid blockers (P-CABs), have beneficial effects including rapid, long-lasting and strong acid suppression.The investigators design a randomized-controlled trial comparison between 72 hours of intravenous PPIs infusion and oral vonoprazan in high risk ulcer UGIH after achieve endoscopic hemostasis. Outcome measurement are re-bleeding rate in 30 days as primary and re-bleeding rate in 3 days, 30 days mortality, rate of angioembolisation, unit of blood transfusion, hospital cost and length of stay as secondary outcome.

Conditions

Peptic Ulcer With Haemorrhage

Outcome Measures

Primary Outcomes (1)

• Rebleeding rate

  30 days

Secondary Outcomes (5)

• Rebleeding rate

  3 days

• Mortality rate

  30 days

• Number of blood transfusion unit

  30 days

• Rate of immobilisation or surgery

  30 days

• Length of stay

  Until discharge, assessed up to 30 days

Study Arms (2)

Vonoprazan

EXPERIMENTAL

Vonoprazan 20 mg oral every 12 hours (total 72 hours) then vonoprazan 20 mg oral once daily for 28 days

Drug: Vonoprazan

PPIs

ACTIVE COMPARATOR

PPIs IV infusion for 72 hours then oral PPIs twice per day for 28 days

Drug: PPIs IV infusion

Interventions

Vonoprazan DRUG

Vonoprazan 20 mg oral every 12 hours (total 72 hours)

Vonoprazan

PPIs IV infusion DRUG

Pantoprazole 80 mg IV loading then 8 mg/hr

PPIs

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• High risk peptic ulcers bleeding (Forrest class Ia,Ib,IIa,IIb)

You may not qualify if:

• Patients were not achieve endoscopic hemostasis
• End stage cancer disease
• Severe critical illness and ICU setting
• Uncorrectable coagulopathy
• Pregnancy or breast feeding
• Allergy to PPIs or Vonoprazan

Sponsors & Collaborators

• Uayporn Kaosombatwattana: lead

Study Sites (1)

Faculty of internal medicine siriraj hospital, Mahidol university

Bangkok Noi, Bangkok, 10700, Thailand

Location

Related Publications (7)

• Sung JJ, Suen BY, Wu JC, Lau JY, Ching JY, Lee VW, Chiu PW, Tsoi KK, Chan FK. Effects of intravenous and oral esomeprazole in the prevention of recurrent bleeding from peptic ulcers after endoscopic therapy. Am J Gastroenterol. 2014 Jul;109(7):1005-10. doi: 10.1038/ajg.2014.105. Epub 2014 Apr 29.

  PMID: 24777150 BACKGROUND

• Tsoi KK, Hirai HW, Sung JJ. Meta-analysis: comparison of oral vs. intravenous proton pump inhibitors in patients with peptic ulcer bleeding. Aliment Pharmacol Ther. 2013 Oct;38(7):721-8. doi: 10.1111/apt.12441. Epub 2013 Aug 5.

  PMID: 23915096 BACKGROUND

• Oshima T, Miwa H. Potent Potassium-competitive Acid Blockers: A New Era for the Treatment of Acid-related Diseases. J Neurogastroenterol Motil. 2018 Jul 30;24(3):334-344. doi: 10.5056/jnm18029.

  PMID: 29739175 BACKGROUND

• Kagami T, Sahara S, Ichikawa H, Uotani T, Yamade M, Sugimoto M, Hamaya Y, Iwaizumi M, Osawa S, Sugimoto K, Miyajima H, Furuta T. Potent acid inhibition by vonoprazan in comparison with esomeprazole, with reference to CYP2C19 genotype. Aliment Pharmacol Ther. 2016 May;43(10):1048-59. doi: 10.1111/apt.13588. Epub 2016 Mar 18.

  PMID: 26991399 BACKGROUND

• Miwa H, Uedo N, Watari J, Mori Y, Sakurai Y, Takanami Y, Nishimura A, Tatsumi T, Sakaki N. Randomised clinical trial: efficacy and safety of vonoprazan vs. lansoprazole in patients with gastric or duodenal ulcers - results from two phase 3, non-inferiority randomised controlled trials. Aliment Pharmacol Ther. 2017 Jan;45(2):240-252. doi: 10.1111/apt.13876. Epub 2016 Nov 27.

  PMID: 27891632 BACKGROUND

• Sugano K, Kontani T, Katsuo S, Takei Y, Sakaki N, Ashida K, Mizokami Y, Asaka M, Matsui S, Kanto T, Soen S, Takeuchi T, Hiraishi H, Hiramatsu N. Lansoprazole for secondary prevention of gastric or duodenal ulcers associated with long-term non-steroidal anti-inflammatory drug (NSAID) therapy: results of a prospective, multicenter, double-blind, randomized, double-dummy, active-controlled trial. J Gastroenterol. 2012 May;47(5):540-52. doi: 10.1007/s00535-012-0541-z. Epub 2012 Mar 3.

  PMID: 22388884 BACKGROUND

• Geeratragool T, Kaosombatwattana U, Boonchote A, Chatthammanat S, Preechakawin N, Srichot J, Sudcharoen A, Sirisunhirun P, Termsinsuk P, Rugivarodom M, Limsrivilai J, Maneerattanaporn M, Pausawasdi N, Leelakusolvong S. Comparison of Vonoprazan Versus Intravenous Proton Pump Inhibitor for Prevention of High-Risk Peptic Ulcers Rebleeding After Successful Endoscopic Hemostasis: A Multicenter Randomized Noninferiority Trial. Gastroenterology. 2024 Sep;167(4):778-787.e3. doi: 10.1053/j.gastro.2024.03.036. Epub 2024 Apr 5.

  PMID: 38582271 DERIVED

MeSH Terms

Conditions

Peptic Ulcer Hemorrhage

Interventions

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

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: December 12, 2020
• First Posted: August 16, 2021
• Study Start: September 1, 2021
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: October 27, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)