Empirical Rescue Therapies of Helicobacter Pylori Infection

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Dr. HONG LU, Shanghai Jiao Tong University School of Medicine

ClinicalTrials.gov Identifier:

NCT01668927

First received: August 16, 2012

Last updated: December 12, 2012

Last verified: December 2012

History of Changes

Purpose

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	Intervention	Phase
Functional Dyspepsia Scarred Peptic Ulcer	Drug: Proton Pump Inhibitor Drug: Bismuth Drug: Metronidazole Drug: Tetracycline Drug: Furazolidone Drug: Amoxicillin	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Helicobacter Pylori Treatment

Resource links provided by NLM:

Further study details as provided by Shanghai Jiao Tong University School of Medicine:

Primary Outcome Measures:

eradication rate of H. pylori [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]

Enrollment:	424
Study Start Date:	July 2012
Study Completion Date:	October 2012
Primary Completion Date:	September 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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 Other Name: tetracycline Drug: Furazolidone Other Name: 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 Other Name: tetracycline Drug: Amoxicillin Other Name: 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 Other Name: Furazolidone Drug: Amoxicillin Other Name: Amoxicillin
Active Comparator: tetracycline /metronidazole Classical rescue therapy	Drug: Proton Pump Inhibitor Other Name: Lansoprazole Drug: Bismuth Other Name: Bismuth potassium citrate Drug: Metronidazole Other Name: metronidazole Drug: Tetracycline Other Name: tetracycline

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT01668927

Locations

China, Shanghai
Renji Hospital
Shanghai, Shanghai, China, 200127

Sponsors and Collaborators

Shanghai Jiao Tong University School of Medicine

More Information

No publications provided

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
Study First Received:	August 16, 2012
Last Updated:	December 12, 2012
Health Authority:	China: Ethics Committee

Additional relevant MeSH terms:

Dyspepsia
Peptic Ulcer
Ulcer
Signs and Symptoms, Digestive
Signs and Symptoms
Duodenal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases
Pathologic Processes
Tetracycline
Amoxicillin
Lansoprazole
Furazolidone

Metronidazole
Bismuth
Potassium Citrate
Proton Pump Inhibitors
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Antacids
Anti-Infective Agents, Local
Anti-Infective Agents, Urinary
Renal Agents

ClinicalTrials.gov processed this record on May 19, 2013

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