A RCT of Triple Therapy With Proton Pump Inhibitor vs Vonoprazan for Helicobacter Pylori Gastritis

NCT03908619 | Unknown Phase 4

• 1 other identifier: TRIVON
• Study Type: interventional
• Target: 252
• Locations: 1 country
• Sites: 1

Brief Summary

Helicobacter pylori (H. pylori) gastritis is a common bacterial infection among the elderly population. H. pylori infection causes chronic progressive gastric inflammation, peptic ulcer disease and gastric cancer. Gastric cancer is a significant contributor of cancer-related mortality. The eradication of H. pylori reduces the incidence of gastric cancer. However, the efficacy of H. pylori eradication has decreased dramatically because of antibiotic resistance. This study aims to (i) compare the eradication rates of H. pylori by triple therapy with vonoprazan for the treatment of H. pylori gastritis) (TTV regimen), with triple therapy with conventional proton pump inhibitor (PPI) (TTP regimen) in a multi-racial Asian cohort, (ii) evaluate the prevalence of antibiotic (klacid/amoxicillin/levofloxacin/tetracycline) resistance in H. pylori infected patients, and (iii) assess the safety of the TTV regimen. Diagnosed H. pylori-infected patients (n=252) will be enrolled and randomized 1:1 to TTV or TTP regimen. Gastric biopsies will be cultured and antibiotic sensitivity evaluated using E-test/agar dilution method. The safety of TTV regimen will be assessed using adverse effect questionnaire. This study may potentially impact on prescribing policies and management of H. pylori infections for improved therapeutic outcome.

Conditions

Helicobacter Pylori Infection

Keywords

Helicobacter pylori eradication; Triple therapy; Proton pump inhibitor; Vonoprazan

Outcome Measures

Primary Outcomes (1)

• Eradication rates of Helicobacter pylori determined by Carbon-13 urea breath test or biopsy

  Compare eradication rates of Helicobacter pylori by triple therapy with conventional proton pump inhibitor (Omeprazole/ Esomeprazole/ Rabeprazole) (TTP regimen) vs triple therapy with Vonoprazan (TTV regimen) in a multi-racial Asian cohort, using Carbon-13 urea breath test or biopsy

  6-8 weeks

Secondary Outcomes (3)

• Prevalence of antibiotic resistance based on E-test (Minimum Inhibitory Concentrations)

  6-8 weeks

• Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

  8 weeks

• Association of CYP2C19 genotypes with triple therapy efficacy

  Through study completion, an average of 2 years

Study Arms (4)

TTP (Group A)

ACTIVE COMPARATOR

Omeprazole 20mg bd/ Amoxicillin 1g bd/ Clarithromycin 500mg bd for 14 days

Drug: Omeprazole 20mg

TTP (Group B)

ACTIVE COMPARATOR

Esomperazole 20mg bd/ Amoxicillin 1g bd/ Clarithromycin 500mg bd for 14 days

Drug: Esomeprazole 20mg

TTP (Group C)

ACTIVE COMPARATOR

Rabeprazole 20mg bd/ Amoxicillin 1g bd/ Clarithromycin 500mg bd for 14 days

Drug: Rabeprazole Sodium 20mg

TTP (Group D)

EXPERIMENTAL

Vonoprazan 20mg bd/ Amoxicilllin 1g bd/ Clarithromycin 500mg bd for 7 days

Drug: Vonoprazan

Interventions

Omeprazole 20mg DRUG

Omeprazole 20mg bd/ Amoxicillin 1g bd/ Clarithromycin 500mg bd for 14 days

Also known as: Losec

TTP (Group A)

Esomeprazole 20mg DRUG

Esomperazole 20mg bd/ Amoxicillin 1g bd/ Clarithromycin 500mg bd for 14 days

Also known as: Nexium

TTP (Group B)

Rabeprazole Sodium 20mg DRUG

Rabeprazole 20mg bd/ Amoxicillin 1g bd/ Clarithromycin 500mg bd for 14 days

Also known as: Pariet

TTP (Group C)

Vonoprazan DRUG

Vonoprazan 20mg bd/ Amoxicilllin 1g bd/ Clarithromycin 500mg bd for 7 days

Also known as: Vocinti

TTP (Group D)

Eligibility Criteria

• Age: 21 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Newly diagnosed to have H. pylori infection from the Gastroenterology and Hepatology Clinic or ward from Changi General Hospital, The diagnosis of H. pylori infection is established based on either a positive carbon urea breath test (CUBT), a positive rapid urease test, or histology in patients who undergo a diagnostic upper gastrointestinal endoscopy.
• Asian (Chinese, Malay or Indian) ancestry as defined by NRIC,
• Aged ≥ 21 years of age,
• Provision of written informed consent,
• Willing to provide a blood sample for genotyping,
• Ability to communicate with the investigator and to understand and comply with all requirements of study participation.

You may not qualify if:

• Known allergy to any of the treatment drugs,
• Inability to undergo routine test to confirm success of H. pylori eradication,
• Previous failed H. pylori therapy,
• Pregnancy or lactation,
• Declare themselves positive for HIV or viral hepatitis (Hepatitis A, B, C),
• Treatment within the previous 3 months with antibiotics.

Sponsors & Collaborators

• Changi General Hospital: lead

Study Sites (1)

Clinical Trials & Research Unit

Singapore, 529889, Singapore

RECRUITING

Related Publications (2)

• Li M, Oshima T, Horikawa T, Tozawa K, Tomita T, Fukui H, Watari J, Miwa H. Systematic review with meta-analysis: Vonoprazan, a potent acid blocker, is superior to proton-pump inhibitors for eradication of clarithromycin-resistant strains of Helicobacter pylori. Helicobacter. 2018 Aug;23(4):e12495. doi: 10.1111/hel.12495. Epub 2018 Jun 6.

  PMID: 29873436 BACKGROUND

• Sue S, Kuwashima H, Iwata Y, Oka H, Arima I, Fukuchi T, Sanga K, Inokuchi Y, Ishii Y, Kanno M, Terada M, Amano H, Naito M, Iwase S, Okazaki H, Komatsu K, Kokawa A, Kawana I, Morimoto M, Saito T, Kunishi Y, Ikeda A, Takahashi D, Miwa H, Sasaki T, Tamura T, Kondo M, Shibata W, Maeda S. The Superiority of Vonoprazan-based First-line Triple Therapy with Clarithromycin: A Prospective Multi-center Cohort Study on Helicobacter pylori Eradication. Intern Med. 2017;56(11):1277-1285. doi: 10.2169/internalmedicine.56.7833. Epub 2017 Jun 1.

  PMID: 28566587 BACKGROUND

MeSH Terms

Interventions

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

Intervention Hierarchy (Ancestors)

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

• Daphne Shih Wen Ang, MD

  Changi General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Seok Hwee Koo, PhD

CONTACT

6568504929; seok_hwee_koo@cgh.com.sg

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Diagnosed H. pylori positive patients (n=252) will be randomized into four study groups: * Group A: Omeprazole 20mg bd/ Amoxicillin 1g bd/ Clarithromycin 500mg bd for 14 days (n=42) * Group B: Esomperazole 20mg bd/ Amoxicillin 1g bd/ Clarithromycin 500mg bd for 14 days (n=42) * Group C: Rabeprazole 20mg bd/ Amoxicillin 1g bd/ Clarithromycin 500mg bd for 14 days(n=42) * Group D: Vonoprazan 20mg bd/ Amoxicilllin 1g bd/ Clarithromycin 500mg bd for 7 days (n=42)

Study Record Dates

• First Submitted: April 5, 2019
• First Posted: April 9, 2019
• Study Start: April 16, 2019
• Primary Completion: March 31, 2021
• Study Completion: March 31, 2021
• Last Updated: October 8, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)