Levofloxacin and Bismuth-containing Therapy Versus Quadruple Therapy as Second-line Treatment of Resistant Helicobacter Pylori Infection
This study is currently recruiting participants.
Verified February 2013 by Shanghai Jiao Tong University School of Medicine
Sponsor:
Shanghai Jiao Tong University School of Medicine
Information provided by (Responsible Party):
Dr. HONG LU, Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier:
NCT01742429
First received: December 2, 2012
Last updated: February 10, 2013
Last verified: February 2013
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Purpose
To test the efficacy of 14 day levofloxacin and bismuth-containing second-line therapy for resistant Helicobacter pylori infection, to compare with the classical quadruple therapy.
| Condition | Intervention | Phase |
|---|---|---|
|
Cure Rate of Helicobacter Pylori Infection |
Drug: Proton pump inhibitor Drug: Bismuth subsalicylate Drug: Metronidazole Drug: Tetracycline Drug: Amoxicillin Drug: Levofloxacin |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
Resource links provided by NLM:
Drug Information available for:
Tetracycline
Tetracycline hydrochloride
Docusate calcium
Metronidazole
Docusate sodium
Metronidazole benzoate
Bismuth subsalicylate
Amoxicillin
Amoxicillin sodium
Metronidazole hydrochloride
Ofloxacin
Levofloxacin
Ofloxacin hydrochloride
U.S. FDA Resources
Further study details as provided by Shanghai Jiao Tong University School of Medicine:
Primary Outcome Measures:
- eradication rate [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]urease breath test
| Estimated Enrollment: | 100 |
| Study Start Date: | November 2012 |
| Estimated Study Completion Date: | March 2013 |
| Estimated Primary Completion Date: | February 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Levofloxacin-bismuth therapy
14 day levofloxacin and bismuth-containing therapy:PPI,bismuth, amoxicillin, levofloxacin
|
Drug: Proton pump inhibitor
Drug: Bismuth subsalicylate
Drug: Amoxicillin
antibiotic
Drug: Levofloxacin
antibiotic
|
|
Active Comparator: classical quadruple therapy
14 day classical quadruple therapy:PPI,bismuth, metronidazole, tetracycline
|
Drug: Proton pump inhibitor
Drug: Bismuth subsalicylate
Drug: Metronidazole
antibiotic
Drug: Tetracycline
antibiotic
|
Eligibility| Ages Eligible for Study: | 19 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- all patients had failed H.pylori therapies including clarithromycin, metronidazole and/or amoxicillin (if not allergic) before.
Exclusion Criteria:
- patients less than 18 years old,
- previous gastric surgery,
- pregnancy,
- lactation,
- major systemic diseases,
- administration of antibiotics,
- bismuth,
- antisecretory drugs in the preceding 8 weeks, or
- allergy to any one of the medication used in the quadruple regimens.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01742429
Contacts
| Contact: Hong Lu, M.D. | 86-21-5875234 ext 3111 | honglu02@yahoo.com |
Locations
| China, Shanghai | |
| Renji Hospital, Shanghai Jiao-Tong University School of Medicine | Recruiting |
| Shanghai, Shanghai, China, 200127 | |
| Contact: Huili Dai, Ph.D. 86-21-58752345 | |
| Principal Investigator: Hong Lu, M.D.,Ph.D. | |
Sponsors and Collaborators
Shanghai Jiao Tong University School of Medicine
More Information
No publications provided
| Responsible Party: | Dr. HONG LU, Prof. of Medicine, Shanghai Jiao Tong University School of Medicine |
| ClinicalTrials.gov Identifier: | NCT01742429 History of Changes |
| Other Study ID Numbers: | rjkls2012008 |
| Study First Received: | December 2, 2012 |
| Last Updated: | February 10, 2013 |
| Health Authority: | China: Ethics Committee |
Keywords provided by Shanghai Jiao Tong University School of Medicine:
|
Helicobacter pylori second line treatment |
Additional relevant MeSH terms:
|
Helicobacter Infections Gram-Negative Bacterial Infections Bacterial Infections Tetracycline Amoxicillin Ofloxacin Metronidazole Bismuth Bismuth subsalicylate Proton Pump Inhibitors Protein Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions |
Anti-Bacterial Agents Anti-Infective Agents Therapeutic Uses Antacids Antidiarrheals Gastrointestinal Agents Radiation-Sensitizing Agents Physiological Effects of Drugs Antiprotozoal Agents Antiparasitic Agents Nucleic Acid Synthesis Inhibitors Anti-Infective Agents, Urinary Renal Agents |
ClinicalTrials.gov processed this record on May 23, 2013