Comparison of the Eradications Rates of Sequential Therapy Versus Concomitant Therapy
Overview[ - collapse ][ - ]
Purpose | Comparison of the eradications rates of sequential therapy versus concomitant therapy of treatment of Helicobacter pylori infection in Korea. single center, randomized trial 1. (pantoprazole 40 mg + amoxicillin 1.0g + clarithromycin 500 mg + metronidazole 500 mg) bid for 10 days 2. (pantoprazole 40 mg + amoxicillin 1.0g + clarithromycin 500 mg + metronidazole 500 mg) bid for 14 days 3. (pantoprazole 40 mg + amoxicillin 1.0g) bid for 5 days and subsequent pantoprazole 40mg + clarithromycin 500 mg + metronidazole 500 mg) bid for 5 days 4. (pantoprazole 40 mg + amoxicillin 1.0g) bid for 7 days and subsequent pantoprazole 40mg + clarithromycin 500 mg + metronidazole 500 mg) bid for 7 days 1st endpoint : Helicobacter pylori eradication rates (intention to treatment, per-protocol) 2nd endpoint : adverse event(nausea, vomiting, dizziness, bitter sense) drug compliance |
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Condition | Helicobacter Pylori Infection |
Intervention | Drug: pantoprazole+ amoxicillin + clarithromycin + metronidazole |
Phase | Phase 4 |
Sponsor | Incheon St.Mary's Hospital |
Responsible Party | Incheon St.Mary's Hospital |
ClinicalTrials.gov Identifier | NCT02108184 |
First Received | February 26, 2014 |
Last Updated | April 5, 2014 |
Last verified | April 2014 |
Tracking Information[ + expand ][ + ]
First Received Date | February 26, 2014 |
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Last Updated Date | April 5, 2014 |
Start Date | February 2014 |
Estimated Primary Completion Date | January 2015 |
Current Primary Outcome Measures | Comparison of the eradications rates of sequential therapy versus concomitant therapy of treatment of Helicobacter pylori infection in Korea. [Time Frame: required average 10 weeks to assess Helicobacter pylori eradication rate from 1st visit] [Designated as safety issue: No]To assess Helicobacter pylori eradication rates |
Current Secondary Outcome Measures | Not Provided |
Descriptive Information[ + expand ][ + ]
Brief Title | Comparison of the Eradications Rates of Sequential Therapy Versus Concomitant Therapy |
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Official Title | Comparison of the Eradications Rates of Sequential Therapy Versus Concomitant Therapy of Treatment of Helicobacter Pylori Infection in Korea |
Brief Summary | Comparison of the eradications rates of sequential therapy versus concomitant therapy of treatment of Helicobacter pylori infection in Korea. single center, randomized trial 1. (pantoprazole 40 mg + amoxicillin 1.0g + clarithromycin 500 mg + metronidazole 500 mg) bid for 10 days 2. (pantoprazole 40 mg + amoxicillin 1.0g + clarithromycin 500 mg + metronidazole 500 mg) bid for 14 days 3. (pantoprazole 40 mg + amoxicillin 1.0g) bid for 5 days and subsequent pantoprazole 40mg + clarithromycin 500 mg + metronidazole 500 mg) bid for 5 days 4. (pantoprazole 40 mg + amoxicillin 1.0g) bid for 7 days and subsequent pantoprazole 40mg + clarithromycin 500 mg + metronidazole 500 mg) bid for 7 days 1st endpoint : Helicobacter pylori eradication rates (intention to treatment, per-protocol) 2nd endpoint : adverse event(nausea, vomiting, dizziness, bitter sense) drug compliance |
Detailed Description | Not Provided |
Study Type | Interventional |
Study Phase | Phase 4 |
Study Design | Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment |
Condition | Helicobacter Pylori Infection |
Intervention | Drug: pantoprazole+ amoxicillin + clarithromycin + metronidazole (pantoprazole 40 mg + amoxicillin 1.0 g) bid for the first 5 days, subsequently (pantoprazole 40 mg + clarithromycin 500 mg + metronidazole 500 mg )bid for the next 5 days (pantoprazole 40 mg + amoxicillin 1.0 g bid) for the first 7days, subsequently (pantoprazole 40 mg + clarithromycin 500 mg + metronidazole 500 mg bid) for the next 7 days (pantoprazole 40 mg + amoxicillin 1.0 g + clarithromycin 500 mg + metronidazole 500 mg )bid for 10 days (pantoprazole 40 mg +amoxicillin 1.0 g + clarithromycin 500 mg + metronidazole 500 mg bid) for 14 days |
Study Arm (s) | Experimental: pantoprazole, amoxicillin, clarithromycin, metronidazole (pantoprazole 40 mg + amoxicillin 1.0 g) bid for the first 5 days, subsequently (pantoprazole 40 mg + clarithromycin 500 mg + metronidazole 500 mg )bid for the next 5 days : Sequential therapy 1 (pantoprazole 40 mg + amoxicillin 1.0 g bid) for the first 7days, subsequently (pantoprazole 40 mg + clarithromycin 500 mg + metronidazole 500 mg bid) for the next 7 days : Sequential therpay 2 (pantoprazole 40 mg + amoxicillin 1.0 g + clarithromycin 500 mg + metronidazole 500 mg )bid for 10 days : Concomitant therapy 1 (pantoprazole 40 mg +amoxicillin 1.0 g + clarithromycin 500 mg + metronidazole 500 mg bid) for 14 days : Concomitant therapy 2 |
Recruitment Information[ + expand ][ + ]
Recruitment Status | Recruiting |
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Estimated Enrollment | 248 |
Estimated Completion Date | January 2015 |
Estimated Primary Completion Date | January 2015 |
Eligibility Criteria | Inclusion Criteria: - 20~70 patients - agreement of informed consent - H.pylori positive (biopsy, CLO) - Peptic ulcer disease, mucosa associated lymphoid tissue lymphoma, Post endoscopic submucosal dissection status due to early gastric cancer Exclusion Criteria: - H.pylori eradication history - severe hepatic, renal, cardiac failure - pregnancy, participant of other study |
Gender | Both |
Ages | 20 Years |
Accepts Healthy Volunteers | Accepts Healthy Volunteers |
Contacts | Contact: Sung min Park 082-032-280-5052 danson2000@hanmail.net |
Location Countries | Korea, Republic of |
Administrative Information[ + expand ][ + ]
NCT Number | NCT02108184 |
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Other Study ID Numbers | PSungmin |
Has Data Monitoring Committee | Yes |
Information Provided By | Incheon St.Mary's Hospital |
Study Sponsor | Incheon St.Mary's Hospital |
Collaborators | Not Provided |
Investigators | Not Provided |
Verification Date | April 2014 |
Locations[ + expand ][ + ]
Incheon St.Mary hospital | Incheon, Bupyung, Korea, Republic of, KSXX0009 Contact: Sungmin ParkRecruiting |
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