Comparison of 7-day and 14-day Bismuth Based Quadruple Therapy for Secondary Helicobacter Pylori Eradication
1 other identifier
interventional
199
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Jun 2008
Typical duration for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2008
CompletedFirst Submitted
Initial submission to the registry
February 10, 2009
CompletedFirst Posted
Study publicly available on registry
February 11, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2010
CompletedDecember 6, 2016
December 1, 2016
1.9 years
February 10, 2009
December 4, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Whether the two week group yield a higher eradication rate comparing to the one week group.
At least four week after completion of treatment
Secondary Outcomes (1)
side effect
four weeks after completion of medication
Study Arms (2)
PBMT7
ACTIVE COMPARATORpantoprazole 40mg bid, bismuth 300mg qid, metronidazole 500mg tid,tetracycline 500mg qid for 7 days
PBMT14
ACTIVE COMPARATORpantoprazole 40mg bid, bismuth 300mg qid, metronidazole 500mg tid,tetracycline 500mg qid for 14 days
Interventions
Eligibility Criteria
You may qualify if:
- H. pylori infection
- Aged between 18-80 years
- Are willing to received eradication therapy for H. pylori
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Asan Medical Centerlead
- Inje Universitycollaborator
- Pacific Pharmaceuticalscollaborator
Study Sites (1)
Asan Medical Center
Seoul, 138-736, South Korea
Related Publications (1)
Chung JW, Lee JH, Jung HY, Yun SC, Oh TH, Choi KD, Song HJ, Lee GH, Kim JH. Second-line Helicobacter pylori eradication: a randomized comparison of 1-week or 2-week bismuth-containing quadruple therapy. Helicobacter. 2011 Aug;16(4):289-94. doi: 10.1111/j.1523-5378.2011.00844.x.
PMID: 21762268DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hwoon-Yong Jung, M.D
Asan Medical Center
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- M.D.
Study Record Dates
First Submitted
February 10, 2009
First Posted
February 11, 2009
Study Start
June 1, 2008
Primary Completion
May 1, 2010
Study Completion
November 1, 2010
Last Updated
December 6, 2016
Record last verified: 2016-12