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: June 1, 2013
Last verified: June 2013
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: June 1, 2013
Health Authority: China: Ethics Committee

Additional relevant MeSH terms:
Peptic Ulcer
Duodenal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases
Amoxicillin
Tetracycline
Metronidazole
Furazolidone
Proton Pump Inhibitors
Bismuth
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antiprotozoal Agents
Antiparasitic Agents
Radiation-Sensitizing Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antacids
Protein Synthesis Inhibitors
Anti-Infective Agents, Local
Anti-Infective Agents, Urinary
Renal Agents
Antitrichomonal Agents
Monoamine Oxidase Inhibitors

ClinicalTrials.gov processed this record on September 18, 2014