Comparison of 7-Day and 14-Day Bismuth Based Quadruple Therapy for Secondary Helicobacter Pylori Eradication | RxWiki

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)	Active Comparator: PBMT7 pantoprazole 40mg bid, bismuth 300mg qid, metronidazole 500mg tid,tetracycline 500mg qid for 7 days Active Comparator: PBMT14 pantoprazole 40mg bid, bismuth 300mg qid, metronidazole 500mg tid,tetracycline 500mg qid for 14 days

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

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