Back to resultsComparison of 7-day and 14-day Bismuth Based Quadruple Therapy for Secondary Helicobacter Pylori Eradication
Primary Purpose
Helicobacter Infection
Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
pantoprazole
bismuth
metronidazole
tetracycline
Sponsored by
About this trial
This is an interventional treatment trial for Helicobacter Infection focused on measuring Helicobacter pylori, Bismuth, Salvage treatment, Metronidazole
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
Sites / Locations
- Asan Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
PBMT7
PBMT14
Arm Description
pantoprazole 40mg bid, bismuth 300mg qid, metronidazole 500mg tid,tetracycline 500mg qid for 7 days
pantoprazole 40mg bid, bismuth 300mg qid, metronidazole 500mg tid,tetracycline 500mg qid for 14 days
Outcomes
Primary Outcome Measures
Whether the two week group yield a higher eradication rate comparing to the one week group.
Secondary Outcome Measures
side effect
Full Information
NCT ID
NCT00841854
First Posted
February 10, 2009
Last Updated
December 4, 2016
Sponsor
Asan Medical Center
Collaborators
Inje University, Pacific Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT00841854
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.
Study Type
Interventional
2. Study Status
Record Verification Date
December 2016
Overall Recruitment Status
Completed
Study Start Date
June 2008 (undefined)
Primary Completion Date
May 2010 (Actual)
Study Completion Date
November 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Asan Medical Center
Collaborators
Inje University, Pacific Pharmaceuticals
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Helicobacter Infection
Keywords
Helicobacter pylori, Bismuth, Salvage treatment, Metronidazole
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
199 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PBMT7
Arm Type
Active Comparator
Arm Description
pantoprazole 40mg bid, bismuth 300mg qid, metronidazole 500mg tid,tetracycline 500mg qid for 7 days
Arm Title
PBMT14
Arm Type
Active Comparator
Arm Description
pantoprazole 40mg bid, bismuth 300mg qid, metronidazole 500mg tid,tetracycline 500mg qid for 14 days
Intervention Type
Drug
Intervention Name(s)
pantoprazole
Intervention Description
pantoprazole 40mg bid
Intervention Type
Drug
Intervention Name(s)
bismuth
Intervention Description
bismuth 300mg qid
Intervention Type
Drug
Intervention Name(s)
metronidazole
Intervention Description
metronidazole 500mg tid
Intervention Type
Drug
Intervention Name(s)
tetracycline
Intervention Description
tetracycline 500mg qid
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
side effect
Time Frame
four weeks after completion of medication
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hwoon-Yong Jung, M.D
Organizational Affiliation
Asan Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
138-736
Country
Korea, Republic of
12. IPD Sharing Statement
Citations:
PubMed Identifier
21762268
Citation
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.
Results Reference
derived
Learn more about this trial
Comparison of 7-day and 14-day Bismuth Based Quadruple Therapy for Secondary Helicobacter Pylori Eradication
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