Empirical Rescue Therapies of Helicobacter Pylori Infection

Sponsor

Shanghai Jiao Tong University School of Medicine (Other)

Overall Status

Completed

CT.gov ID

NCT01668927

Collaborator

(none)

424

Enrollment

Location

Arms

Duration (Months)

140.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The increase of antibiotic resistance to H. pylori causes failure of treatment. Furazolidone, amoxicillin and tetracycline are good candidates for rescue therapy since resistance to these three antimicrobials was rare. It is necessary to assess the efficacy and safety of these four bismuth-containing quadruple regimens with above antibiotics as empirical rescue therapies for H. pylori eradication.

Condition or Disease	Intervention/Treatment	Phase
Functional Dyspepsia Scarred Peptic Ulcer	Drug: Proton Pump Inhibitor Drug: Bismuth Drug: Metronidazole Drug: Tetracycline Drug: Furazolidone Drug: Amoxicillin	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

424 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Helicobacter Pylori Treatment

Study Start Date :

Jul 1, 2012

Actual Primary Completion Date :

Sep 1, 2012

Actual Study Completion Date :

Oct 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: tetracycline/furazolidone one of the four empirical rescue therapies	Drug: Proton Pump Inhibitor Other Names: Lansoprazole Drug: Bismuth Other Names: Bismuth potassium citrate Drug: Tetracycline Drug: Furazolidone
Experimental: amoxicillin/tetracycline one of the four empirical rescue therapies	Drug: Proton Pump Inhibitor Other Names: Lansoprazole Drug: Bismuth Other Names: Bismuth potassium citrate Drug: Tetracycline Drug: Amoxicillin
Experimental: amoxicillin/furazolidone one of the four empirical rescue therapies	Drug: Proton Pump Inhibitor Other Names: Lansoprazole Drug: Bismuth Other Names: Bismuth potassium citrate Drug: Furazolidone Drug: Amoxicillin
Active Comparator: tetracycline /metronidazole Classical rescue therapy	Drug: Proton Pump Inhibitor Other Names: Lansoprazole Drug: Bismuth Other Names: Bismuth potassium citrate Drug: Metronidazole Drug: Tetracycline

Outcome Measures

Primary Outcome Measures

eradication rate of H. pylori [2 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

1. pylori -positive patients with functional dyspepsia and scarred peptic ulcers who had previously failed one or more eradication regimens containing clarithromycin, metronidazole and/or amoxicillin.

Exclusion Criteria:

less than 18 years old, never receiving eradication treatment before, with previous gastric surgery, pregnancy, lactation, major systemic diseases, administration of antibiotics, bismuth, antisecretory drugs in the preceding 8 weeks