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Trial record 13 of 21 for:    "Gastritis" | "Clarithromycin"

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

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ClinicalTrials.gov Identifier: NCT03908619
Recruitment Status : Not yet recruiting
First Posted : April 9, 2019
Last Update Posted : April 9, 2019
Sponsor:
Information provided by (Responsible Party):
Ang Shih Wen Daphne, Changi General Hospital

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.

Condition or disease Intervention/treatment Phase
Helicobacter Pylori Infection Drug: Omeprazole 20mg Drug: Esomeprazole 20mg Drug: Rabeprazole Sodium 20mg Drug: Vonoprazan Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 252 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

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)
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial of Triple Therapy With Conventional Proton Pump Inhibitor vs Triple Therapy With Vonoprazan as First Line Therapy for Helicobacter Pylori Gastritis
Estimated Study Start Date : April 1, 2019
Estimated Primary Completion Date : March 31, 2021
Estimated Study Completion Date : March 31, 2021

Arm Intervention/treatment
Active Comparator: TTP (Group A)
Omeprazole 20mg bd/ Amoxicillin 1g bd/ Clarithromycin 500mg bd for 14 days
Drug: Omeprazole 20mg
Omeprazole 20mg bd/ Amoxicillin 1g bd/ Clarithromycin 500mg bd for 14 days
Other Name: Losec

Active Comparator: TTP (Group B)
Esomperazole 20mg bd/ Amoxicillin 1g bd/ Clarithromycin 500mg bd for 14 days
Drug: Esomeprazole 20mg
Esomperazole 20mg bd/ Amoxicillin 1g bd/ Clarithromycin 500mg bd for 14 days
Other Name: Nexium

Active Comparator: TTP (Group C)
Rabeprazole 20mg bd/ Amoxicillin 1g bd/ Clarithromycin 500mg bd for 14 days
Drug: Rabeprazole Sodium 20mg
Rabeprazole 20mg bd/ Amoxicillin 1g bd/ Clarithromycin 500mg bd for 14 days
Other Name: Pariet

Experimental: TTP (Group D)
Vonoprazan 20mg bd/ Amoxicilllin 1g bd/ Clarithromycin 500mg bd for 7 days
Drug: Vonoprazan
Vonoprazan 20mg bd/ Amoxicilllin 1g bd/ Clarithromycin 500mg bd for 7 days
Other Name: Vocinti




Primary Outcome Measures :
  1. Eradication rates of Helicobacter pylori determined by Carbon-13 urea breath test or biopsy [ Time Frame: 6-8 weeks ]
    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


Secondary Outcome Measures :
  1. Prevalence of antibiotic resistance based on E-test (Minimum Inhibitory Concentrations) [ Time Frame: 6-8 weeks ]
    Evaluate the prevalence of antibiotic (clarithromycin/ amoxicillin/ levofloxacin/ tetracycline) resistance in H. pylori-infected patients of both treatment groups using E-test

  2. Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] [ Time Frame: 8 weeks ]
    Assess the safety of triple therapy for eradication of H. pylori in the local population using adverse effect questionnaire

  3. Association of CYP2C19 genotypes with triple therapy efficacy [ Time Frame: Through study completion, an average of 2 years ]
    Perform CYP2C19 using sequencing or restriction fragment length polymorphism methods



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03908619


Contacts
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Contact: Seok Hwee Koo, PhD 6568504929 seok_hwee_koo@cgh.com.sg

Locations
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Singapore
Clinical Trials & Research Unit Not yet recruiting
Singapore, Singapore, 529889
Contact: Lay Hwa Yew    65-68502375    yew.lay.hwa@singhealth.com.sg   
Sub-Investigator: Kim Wei Lim, MRCP         
Sub-Investigator: Tiing Leong Ang, MD         
Sub-Investigator: Seok Hwee Koo, PhD         
Sub-Investigator: Thean Yen Tan, MD         
Sponsors and Collaborators
Changi General Hospital
Investigators
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Principal Investigator: Daphne Shih Wen Ang, MD Changi General Hospital

Publications:
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Responsible Party: Ang Shih Wen Daphne, Senior Consultant, Changi General Hospital
ClinicalTrials.gov Identifier: NCT03908619     History of Changes
Other Study ID Numbers: TRIVON
First Posted: April 9, 2019    Key Record Dates
Last Update Posted: April 9, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Ang Shih Wen Daphne, Changi General Hospital:
Helicobacter pylori eradication
Triple therapy
Proton pump inhibitor
Vonoprazan

Additional relevant MeSH terms:
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Gastritis
Clarithromycin
Helicobacter Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases
Amoxicillin
Omeprazole
Esomeprazole
Rabeprazole
Proton Pump Inhibitors
Anti-Bacterial Agents
Anti-Infective Agents
Anti-Ulcer Agents
Gastrointestinal Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Protein Synthesis Inhibitors
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors