Comparison of 7-Day and 14-Day Bismuth Based Quadruple Therapy for Secondary Helicobacter Pylori Eradication
Overview[ - collapse ][ - ]
Purpose | At present, triple therapy are recommended by various guidelines for the treatment of Helicobacter pylori (H. pylori) infection. Recent studies have shown worldwide high treatment failure rates with one week first line clarithromycin based triple therapy necessitating salvage strategy to eradicate H. pylori in primary treatment failure. However, the exact duration of bismuth based second line treatment is not determined. Therefore, the investigators performed this study to evaluate the eradication rate of 1 or 2-week quadruple regimen as a second-line therapy. |
---|---|
Condition | Helicobacter Infection |
Intervention | Drug: pantoprazole Drug: bismuth Drug: metronidazole Drug: tetracycline |
Phase | Phase 4 |
Sponsor | Asan Medical Center |
Responsible Party | Asan Medical Center |
ClinicalTrials.gov Identifier | NCT00841854 |
First Received | February 10, 2009 |
Last Updated | February 10, 2009 |
Last verified | February 2009 |
Tracking Information[ + expand ][ + ]
First Received Date | February 10, 2009 |
---|---|
Last Updated Date | February 10, 2009 |
Start Date | June 2008 |
Estimated Primary Completion Date | November 2009 |
Current Primary Outcome Measures | Whether the two week group yield a higher eradication rate comparing to the one week group. [Time Frame: At least four week after completion of treatment] [Designated as safety issue: No] |
Current Secondary Outcome Measures | side effect [Time Frame: four weeks after completion of medication] [Designated as safety issue: Yes] |
Descriptive Information[ + expand ][ + ]
Brief Title | Comparison of 7-Day and 14-Day Bismuth Based Quadruple Therapy for Secondary Helicobacter Pylori Eradication |
---|---|
Official Title | Comparison of 7-Day and 14-Day Bismuth Based Quadruple Therapy for Secondary Helicobacter Pylori Eradication. |
Brief Summary | At present, triple therapy are recommended by various guidelines for the treatment of Helicobacter pylori (H. pylori) infection. Recent studies have shown worldwide high treatment failure rates with one week first line clarithromycin based triple therapy necessitating salvage strategy to eradicate H. pylori in primary treatment failure. However, the exact duration of bismuth based second line treatment is not determined. Therefore, the investigators performed this study to evaluate the eradication rate of 1 or 2-week quadruple regimen as a second-line therapy. |
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 Infection |
Intervention | Drug: pantoprazole pantoprazole 40mg bid Drug: bismuth bismuth 300mg qid Drug: metronidazole metronidazole 500mg tid Drug: tetracycline tetracycline 500mg qid |
Study Arm (s) |
|
Recruitment Information[ + expand ][ + ]
Recruitment Status | Recruiting |
---|---|
Estimated Enrollment | 150 |
Estimated Completion Date | November 2009 |
Estimated Primary Completion Date | July 2009 |
Eligibility Criteria | Inclusion Criteria: - H. pylori infection - Aged between 18-80 years - Are willing to received eradication therapy for H. pylori Exclusion Criteria: - Children and teenagers aged less than 18 years or over 80 years - Previous eradication therapy for H. pylori - History of gastrectomy - Previous allergic reaction to antibiotics - Use of prompt pump inhibitors and antibiotics in the recent 4 weeks - Active upper GI bleeding in the recent 1 week - Contraindication to treatment drugs - Pregnant or lactating women - Severe concurrent disease or malignancy |
Gender | Both |
Ages | 18 Years |
Accepts Healthy Volunteers | No |
Contacts | Contact: Jun-Won Chung, M.D. 82-2-3010-3188 junwonchung@hanmail.net |
Location Countries | Korea, Republic of |
Administrative Information[ + expand ][ + ]
NCT Number | NCT00841854 |
---|---|
Other Study ID Numbers | 2008-0088 |
Has Data Monitoring Committee | No |
Information Provided By | Asan Medical Center |
Study Sponsor | Asan Medical Center |
Collaborators | Inje University Pacific Pharmaceuticals |
Investigators | Principal Investigator: Hwoon-Yong Jung, M.D Asan Medical Center |
Verification Date | February 2009 |
Locations[ + expand ][ + ]
Asan Medical Center | Seoul, Korea, Republic of, 138-736 Contact: Jun-Won Chung, M.D. | 82-2-3010-3188 | junwonchung@hanmail.netRecruiting |
---|