Comparison of the Eradications Rates of Sequential Therapy Versus Concomitant Therapy
Information source: Incheon St.Mary's Hospital
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Helicobacter Pylori Infection
Intervention: pantoprazole, amoxicillin, clarithromycin, metronidazole (Drug); pantoprazole, amoxicillin, clarithromycin, metronidazole (Drug); pantoprazole, amoxicillin, clarithromycin, metronidzole (Drug); pantoprazole, amoxicillin, clarithromycin, metronidazole (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Incheon St.Mary's Hospital Overall contact: Sung min Park, Phone: 082-032-280-5052, Email: danson2000@hanmail.net
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
Clinical Details
Official title: Comparison of the Eradications Rates of Sequential Therapy Versus Concomitant Therapy of Treatment of Helicobacter Pylori Infection in Korea
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Comparison of the eradications rates of sequential therapy versus concomitant therapy of treatment of Helicobacter pylori infection in Korea.
Eligibility
Minimum age: 20 Years.
Maximum age: 70 Years.
Gender(s): Both.
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
Locations and Contacts
Sung min Park, Phone: 082-032-280-5052, Email: danson2000@hanmail.net
Incheon St.Mary hospital, Incheon, Bupyung KSXX0009, Korea, Republic of; Recruiting Sungmin Park
Additional Information
Related publications: Lim JH, Lee DH, Choi C, Lee ST, Kim N, Jeong SH, Kim JW, Hwang JH, Park YS, Lee SH, Shin CM, Jo HJ, Jang ES, Song Is, Jung HC. Clinical outcomes of two-week sequential and concomitant therapies for Helicobacter pylori eradication: a randomized pilot study. Helicobacter. 2013 Jun;18(3):180-6. doi: 10.1111/hel.12034. Epub 2013 Jan 11.
Starting date: February 2014
Last updated: May 10, 2014
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