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Empirical Rescue Therapies of Helicobacter Pylori Infection

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ClinicalTrials.gov Identifier: NCT01668927
Recruitment Status : Completed
First Posted : August 20, 2012
Last Update Posted : June 4, 2013
Sponsor:
Information provided by (Responsible Party):

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  (Clinical Trial)
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 : July 2012
Primary Completion Date : September 2012
Study Completion Date : October 2012
Arms and Interventions

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


Outcome Measures

Primary Outcome Measures :
  1. eradication rate of H. pylori [ Time Frame: 2 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • H. 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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01668927


Locations
China, Shanghai
Renji Hospital
Shanghai, Shanghai, China, 200127
Sponsors and Collaborators
Shanghai Jiao Tong University School of Medicine
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr. HONG LU, professor of GI Division, Renji Hospital, Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier: NCT01668927     History of Changes
Other Study ID Numbers: rjkls_2012009
First Posted: August 20, 2012    Key Record Dates
Last Update Posted: June 4, 2013
Last Verified: June 2013

Additional relevant MeSH terms:
Dyspepsia
Peptic Ulcer
Signs and Symptoms, Digestive
Signs and Symptoms
Duodenal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases
Amoxicillin
Tetracycline
Metronidazole
Furazolidone
Lansoprazole
Proton Pump Inhibitors
Bismuth
Potassium Citrate
Anti-Bacterial Agents
Anti-Infective Agents
Antiprotozoal Agents
Antiparasitic Agents
Anti-Ulcer Agents
Gastrointestinal Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antacids
Protein Synthesis Inhibitors
Diuretics
Natriuretic Agents
Physiological Effects of Drugs