- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03321773
Comparing the Efficacy of 14-day Reverse Hybrid Therapy and 14-day Triple Therapy Plus Bismuth Therapy
March 12, 2019 updated by: Feng-Woei Tsay, Kaohsiung Veterans General Hospital.
Compare 14-day Reverse Hybrid Therapy and 14-day Triple Therapy Plus Bismuth on Helicobacter Pylori Eradication
Reverse hybrid therapy achieves a higher eradication rate than bismuth (triple therapy plus bismuth) 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 14-day reverse hybrid therapy and 14-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 14-day reverse hybrid therapy and 14-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: Ping-I Hsu, Bachelor
- Phone Number: 8078 +886-7-342-2121
- Email: pihsu@vghks.gov.tw
Study Locations
-
-
-
Kaohsiung, Taiwan, 813
- Recruiting
- Kaohsiung Veterans General Hospital
-
Contact:
- Feng-Woei Tsay, Bachelor
- Phone Number: 2074 886-7346-2121
- Email: fwchiae@vghks.gov.tw
-
Contact:
- Ping-I Hsu, MD
- Phone Number: 886-7346-8233
- Email: pihsu@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
18 years to 88 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 Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: triple therapy plus bismuth therapy
pantoprazole 40mg twice daily for 14 days, amoxicillin 1g twice daily for 14 days, clarithromycin 500mg twice daily for 14 days, bismuth subcitrate 240mg twice daily for 14 days.
|
pantoprazole 40mg twice daily for 14 days, amoxicillin 1g twice daily for 14 days, clarithromycin 500mg twice daily for 14 days, bismuth subcitrate 240mg twice daily for 14 days.
Other Names:
|
Active Comparator: reverse hybrid therapy
(pantoprazole 40mg twice daily for 7 days, amoxicillin 1 g twice dailyfor 7 days, clarithromycin 500 mg twice daily for 7 days, and metronidazole 500 mg twice daily for 7 days) followed by (pantoprazole 40mg twice daily for 7 days and amoxicillin 1 g twice daily for 7 days)
|
(pantoprazole 40mg twice daily for 7 days, amoxicillin 1 g twice dailyfor 7 days, clarithromycin 500 mg twice daily for 7 days, and metronidazole 500 mg twice daily for 7 days) followed by (pantoprazole 40mg twice daily for 7 days and amoxicillin 1 g twice daily for 7 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.
|
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
- Study Chair: 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, 2017
Primary Completion (Anticipated)
December 1, 2020
Study Completion (Anticipated)
December 1, 2020
Study Registration Dates
First Submitted
October 20, 2017
First Submitted That Met QC Criteria
October 23, 2017
First Posted (Actual)
October 26, 2017
Study Record Updates
Last Update Posted (Actual)
March 14, 2019
Last Update Submitted That Met QC Criteria
March 12, 2019
Last Verified
March 1, 2019
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
- VGHKS16-CT10-17
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.
Clinical Trials on Helicobacter Pylori Infection
-
Bangabandhu Sheikh Mujib Medical University, Dhaka...RecruitingHelicobacter Pylori Infection | Helicobacter Pylori EradicationBangladesh
-
Shandong UniversityRecruitingHelicobacter Pylori Infection | Patient Education | Helicobacter Pylori EradicationChina
-
Shandong UniversityCompletedHelicobacter Pylori Infection Helicobacter Pylori Eradication Patient EducationChina
-
Shanghai Jiao Tong University School of MedicineCompletedCure Rate of Helicobacter Pylori InfectionChina
-
Seoul National University Bundang HospitalRecruitingHelicobacter Pylori Infection | Helicobacter Pylori 23S rRNA Clarithromycin Resistance Mutation | Helicobacter Pylori Associated Gastrointestinal Disease | Helicobacter Pylori Infection, Susceptibility toKorea, Republic of
-
The First Affiliated Hospital of Nanchang UniversityUnknownBacterial Infection Due to Helicobacter Pylori (H. Pylori) | Eradication Therapy of Helicobacter Pylori | Detection of Helicobacter PyloriChina
-
Tanta UniversityNot yet recruitingPersistent Helicobacter Pylori InfectionEgypt
-
Nanjing First Hospital, Nanjing Medical UniversityCompletedHelicobacter Pylori 23S rRNA/gyrA Gene Mutation Detection Kit (Fluorescence PCR Fusion Curve Method)Helicobacter Pylori Infection | Helicobacter Pylori gyrA Levofloxacin Resistance Mutation | Fecal Drug Resistance Gene Detection | Helicobacter Pylori Infection, Susceptibility toChina
-
National University Hospital, SingaporeUnknownHELICOBACTER PYLORI INFECTIONSSingapore
-
Kaohsiung Veterans General Hospital.Kaohsiung Medical University Chung-Ho Memorial HospitalCompletedHelicobacter Pylori InfectionTaiwan
Clinical Trials on triple therapy plus bismuth therapy
-
National Cancer Center, KoreaCompletedHelicobacter Pylori Infection | Family History of Stomach CancerKorea, Republic of
-
Ying HUANGTang-Du Hospital; Beijing Children's Hospital; Guangzhou Women and Children's... and other collaboratorsRecruitingHelicobacter InfectionsChina
-
National Taiwan University HospitalUnknownTriple Therapy Versus Quadruple Therapies in the First Line Therapy of Helicobacter Pylori InfectionHelicobacter Pylori InfectionTaiwan
-
National Cheng-Kung University HospitalMinistry of Health and Welfare, TaiwanEnrolling by invitationMedication Adherence | Helicobacter Pylori Infection | Patient Compliance | Comorbidities and Coexisting Conditions | Real-world Outcome | Patient DropoutsTaiwan
-
Chengdu University of Traditional Chinese MedicineCompletedFailure After Assisted Reproductive TechnologyChina
-
Chengdu University of Traditional Chinese MedicineCompletedFailure After Assisted Reproductive TechnologyChina
-
University of LatviaNational Institute of Public Health, Slovenia; Iuliu Hatieganu University of... and other collaboratorsRecruitingGastric Cancer | H Pylori Infection | H Pylori Eradication | H-pyloriPoland, Croatia, Ireland, Latvia, Romania, Slovenia
-
Federal University of São PauloFundação de Amparo à Pesquisa do Estado de São PauloCompletedHelicobacter Pylori Infection | Immune Thrombocytopenic PurpuraBrazil
-
Kaohsiung Medical UniversityCompletedHelicobacter Pylori InfectionTaiwan
-
Fundacion SEIMC-GESIDACompleted