- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04566211
Comparing the Efficacy of 10-day Reverse Hybrid Therapy and 10-day Triple Therapy Plus Bismuth Therapy.
September 22, 2020 updated by: Feng-Woei Tsay, Kaohsiung Veterans General Hospital.
Comparing 10-day Reverse Hybrid Therapy and 10-day Triple Therapy Plus Bismuth Therapy on Helicobacter Pylori Eradication
Reverse hybrid therapy achieves a higher eradication rate than triple therapy plus bismuth therapy remains unanswered.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
With the rising prevalence of antimicrobial resistance, the failure rate of the 7-day standard triple therapy has declined to unacceptable level (<80%) worldwide.
Several regimens were suggested to replace standard triple therapy in the area with high clarithromycin resistance, including sequential therapy, concomitant therapy, hybrid therapy and bismuth containing quadruple therapy.
A 14-day hybrid therapy invented by our study group appears very promising in H. pylori eradication, achieving eradication rates of 95%.
A clinical trial by Hsu et al from our hospital showed 12-day reverse hybrid therapy also achieved high eradication rate, and improved the compliance of patients.
Even prolong the treatment duration of standard triple therapy from 7 days to 12 days, the efficacy of eradication was still < 90% (85-88%).
The limitation of triple therapy in against resistant-stains was still existed.
The addition of bismuth (triple therapy plus bismuth) can improve cure rates despite a high prevalence of antimicrobial resistance.
The major bismuth effect is to add an additional 30%-40% to the success with resistant infections.
However the direct compare the efficacy between 10-day reverse hybrid therapy and 10-day triple therapy plus bismuth is still insufficiency in Taiwan and worldwide.
Choosing a navel therapy or a modifying triple therapy can get better efficacy, it is remained to be determined.
Besides genotyping polymorphism of CYP2C19 influenced the metabolism of proton pump inhibit, and could cause decreasing of eradication rate of standard triple therapy.
But the influence in 10-day reverse hybrid therapy and 10-day triple therapy plus bismuth is unclear.
Study Type
Interventional
Enrollment (Anticipated)
440
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Feng-Woei Tsay, Bachelor
- Phone Number: 72075 +886-7-342-2121
- Email: fwchaie@vghks.gov.tw
Study Locations
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-
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Kaohsiung, Taiwan, 813
- Recruiting
- Kaohsiung Veterans General Hospital
-
Contact:
- Feng-Woei Tsay, Bachelor
- Phone Number: 886-7346-8233
- Email: fwchaie@vghks.gov.tw
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 90 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Consecutive H pylori-infected outpatients, at least 20 years of age, with endoscopically proven peptic ulcer diseases or gastritis
Exclusion Criteria:
- previous H pylori-eradication therapy
- ingestion of antibiotics or bismuth within the prior 4 weeks
- patients with allergic history to the medications used
- patients with previous gastric surgery
- the coexistence of serious concomitant illness (for example, decompensated liver cirrhosis, uremia)
- pregnant women
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: (panto+amox+clar+metr)+(panto+amox)
a 7-day quadruple regimen with pantoprazole 40 mg twice daily, amoxicillin 1 g twice daily, clarithromycin 500 mg twice daily, and metronidazole 500 mg twice daily, followed by a 3-day dual regimen with pantoprazole 40 mg twice daily and amoxicillin 1 g twice daily
|
a 7-day quadruple regimen with pantoprazole 40 mg twice daily, amoxicillin 1 g twice daily, clarithromycin 500 mg twice daily, and metronidazole 500 mg twice daily, followed by a 3-day dual regimen with pantoprazole 40 mg twice daily and amoxicillin 1 g twice daily
Other Names:
|
ACTIVE_COMPARATOR: pantoprazole+bismuth+amox+clar
pantoprazole 40 mg twice daily, bismuth subcitrate 240 mg twice daily, and amoxicillin 1 g twice daily, clarithromycin 500 mg twice daily for 10 days
|
pantoprazole 40 mg twice daily, bismuth subcitrate 240 mg twice daily, and amoxicillin 1 g twice daily, clarithromycin 500 mg twice daily for 10 days
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants in Which H. Pylori Was Eradicated
Time Frame: sixth week after the end of anti- H. pylori therapy
|
To assess eradication efficacy,repeated endoscopy with rapid urease test, histological examination and culture or Urea breath test.
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sixth week after the end of anti- H. pylori therapy
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Feng-Woei Tsay, Bachelor, Kaohsiung Veterans General Hospital.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
January 1, 2020
Primary Completion (ANTICIPATED)
September 30, 2022
Study Completion (ANTICIPATED)
December 31, 2022
Study Registration Dates
First Submitted
September 22, 2020
First Submitted That Met QC Criteria
September 22, 2020
First Posted (ACTUAL)
September 28, 2020
Study Record Updates
Last Update Posted (ACTUAL)
September 28, 2020
Last Update Submitted That Met QC Criteria
September 22, 2020
Last Verified
September 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Enzyme Inhibitors
- Gastrointestinal Agents
- Anti-Bacterial Agents
- Cytochrome P-450 CYP3A Inhibitors
- Cytochrome P-450 Enzyme Inhibitors
- Protein Synthesis Inhibitors
- Antiprotozoal Agents
- Antiparasitic Agents
- Anti-Ulcer Agents
- Proton Pump Inhibitors
- Antacids
- Metronidazole
- Amoxicillin
- Clarithromycin
- Bismuth
- Pantoprazole
- Bismuth tripotassium dicitrate
Other Study ID Numbers
- VGHKS19-CT6-15
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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