- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01769365
Concomitant, Sequential, and Standard Triple Therapy for H. Pylori Infection
Comparison of 7-day Triple, 10-day Sequential, and 7-day Concomitant Therapies for Helicobacter Pylori Infection in Taiwan
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The purpose of this study is to compare the effectiveness of three H. pylori eradication regimens: 7-day standard triple therapy (pantoprazole, clarithromycin, and amoxicillin for 7 days), 10-day sequential therapy (pantoprazole and amoxicillin for 5 days, followed by pantoprazole, clarithromycin and metronidazole for a further 5 days) and 7-day quadruple therapy (pantoprazole, clarithromycin, amoxicillin and metronidazole for 7 days) in Taiwan.
A total of 306 subjects are enrolled into this study.
H. pylori-infected patients are randomized to a 7-day standard triple therapy, a 10-day sequential therapy, or a 7-day quadruple therapy. Eradication efficacy is assessed by a follow-up endoscopy with rapid urease test and histological examination eight weeks after the H. pylori therapy. The eradication rates of three groups will be compared.
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
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Kaohsiung, Taiwan, 813
- Kaohsiung Veterans General Hospital
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Kaohsiung city, Taiwan, 813
- Kaohsiung Veterans General Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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, bismuth, or proton pump inhibitors 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
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: 7-day quadruple therapy
|
pantoprazole 40 mg twice daily, clarithromycin 500 mg twice daily, amoxicillin 1 g twice daily and metronidazole 500 mg twice daily for 7 days
Other Names:
|
Experimental: 10-day sequential therapy
|
pantoprazole 40 mg twice daily and amoxicillin 1 g twice daily for 5 days, followed by pantoprazole 40 mg twice daily, clarithromycin 500 mg twice daily and metronidazole 500 mg twice daily for a further 5 days
Other Names:
|
Active Comparator: 7-day standard triple therapy
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pantoprazole 40 mg twice daily, clarithromycin 500 mg twice daily, 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 With Complete Eradication of Helicobacter Pylori
Time Frame: at the 6th week after the end of anti- H. pylori therapy
|
Evaluate eradication outcome by endoscopy urease test and histology or urea breath test
|
at the 6th week after the end of anti- H. pylori therapy
|
Collaborators and Investigators
Investigators
- Study Chair: Ping-I Hsu, MD, Kaohsiung Veterans General Hospital.
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Disease Attributes
- Gram-Negative Bacterial Infections
- Bacterial Infections
- Bacterial Infections and Mycoses
- Infections
- Communicable Diseases
- Helicobacter Infections
- 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
- Metronidazole
- Amoxicillin
- Clarithromycin
- Pantoprazole
Other Study ID Numbers
- VGHKS99-CT7-10
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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