Comparison of 7-Day and 14-Day Bismuth Based Quadruple Therapy for Secondary Helicobacter Pylori Eradication
Information source: Asan Medical Center
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Helicobacter Infection
Intervention: pantoprazole (Drug); bismuth (Drug); metronidazole (Drug); tetracycline (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Asan Medical Center Official(s) and/or principal investigator(s):
Hwoon-Yong Jung, M.D, Principal Investigator, Affiliation: Asan Medical Center
Overall contact:
Jun-Won Chung, M.D., Phone: 82-2-3010-3188, Email: junwonchung@hanmail.net
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.
Clinical Details
Official title: Comparison of 7-Day and 14-Day Bismuth Based Quadruple Therapy for Secondary Helicobacter Pylori Eradication.
Study design: Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Efficacy Study
Primary outcome: Whether the two week group yield a higher eradication rate comparing to the one week group.
Secondary outcome: side effect
Eligibility
Minimum age: 18 Years.
Maximum age: 80 Years.
Gender(s): Both.
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
Locations and Contacts
Jun-Won Chung, M.D., Phone: 82-2-3010-3188, Email: junwonchung@hanmail.net
Asan Medical Center, Seoul 138-736, Korea, Republic of; Recruiting
Jun-Won Chung, M.D., Phone: 82-2-3010-3188, Email: junwonchung@hanmail.net
Additional Information
Starting date: June 2008
Ending date: November 2009
Last updated: February 10, 2009
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