Not yet recruitingInterventionalNot ApplicableUpdated May 8, 2026
Levofloxacin and Bismuth-containing Therapy Versus Quadruple Therapy as Second-line Treatment of Resistant Helicobacter Pylori Infection | NCT01742429 | Trialant
CompletedInterventionalPhase 4Updated Aug 29, 2014
Levofloxacin and Bismuth-containing Therapy Versus Quadruple Therapy as Second-line Treatment of Resistant Helicobacter Pylori Infection
ClinicalTrials.gov ID
NCT01742429
Lead Sponsor
Shanghai Jiao Tong University School of MedicineOTHER
Overall Status
Completed
Study Type
Interventional
Phase
Phase 4
Enrollment
200Actual
Last Update Posted
Aug 29, 2014Estimated
Start Date
Nov 2012
Primary Completion Date
Apr 2013Actual
Completion Date
Apr 2013Actual
Brief Summary
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.
Cure Rate of Helicobacter Pylori Infection
Proton pump inhibitor
Bismuth subsalicylate
Metronidazole
Tetracycline
Amoxicillin
Levofloxacin
Ages Eligible for Study
Adult (18-64)Older Adult (65+)
Sexes Eligible for Study
All
Accepts Healthy Volunteers
No
Eligibility 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.
Primary Purpose
Treatment
Allocation
Randomized
Interventional Model
Parallel Assignment
Masking
None (Open Label)
No central contacts
There are no central contacts for this study.
Renji Hospital, Shanghai Jiao-Tong University School of Medicine
Shanghai, Shanghai Municipality 200127, China
Lead Sponsor
Shanghai Jiao Tong University School of MedicineOTHER