Overview
Comparison of the Eradications Rates of Sequential Therapy Versus Concomitant Therapy
Status:
Unknown status
Unknown status
Trial end date:
2016-08-01
2016-08-01
Target enrollment:
0
0
Participant gender:
All
All
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) twice for 10 days 2. (pantoprazole 40 mg + amoxicillin 1.0g + clarithromycin 500 mg + metronidazole 500 mg) twice for 14 days 3. (pantoprazole 40 mg + amoxicillin 1.0g) twice for 5 days and subsequent pantoprazole 40mg + clarithromycin 500 mg + metronidazole 500 mg) twice for 5 days 4. (pantoprazole 40 mg + amoxicillin 1.0g) twice for 7 days and subsequent pantoprazole 40mg + clarithromycin 500 mg + metronidazole 500 mg) twice for 7 days 1st endpoint : Helicobacter pylori eradication rates (intention to treatment, per-protocol) 2nd endpoint : adverse event(nausea, vomiting, dizziness, bitter sense) drug compliancePhase:
Phase 4Accepts Healthy Volunteers?
Accepts Healthy VolunteersDetails
Lead Sponsor:
Incheon St.Mary's HospitalTreatments:
Amoxicillin
Clarithromycin
Metronidazole
Pantoprazole
Criteria
Inclusion Criteria:- 20~80 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