Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 73 of 150 for:    tetracycline

Empirical Rescue Therapies of Helicobacter Pylori Infection

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01668927
Recruitment Status : Completed
First Posted : August 20, 2012
Last Update Posted : June 4, 2013
Sponsor:
Information provided by (Responsible Party):
Dr. HONG LU, Shanghai Jiao Tong University School of Medicine

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

Layout table for study information
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
Actual Primary Completion Date : September 2012
Actual Study Completion Date : October 2012

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



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


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
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

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
Layout table for location information
China, Shanghai
Renji Hospital
Shanghai, Shanghai, China, 200127
Sponsors and Collaborators
Shanghai Jiao Tong University School of Medicine

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
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:
Layout table for MeSH terms
Tetracycline
Peptic Ulcer
Dyspepsia
Signs and Symptoms, Digestive
Signs and Symptoms
Duodenal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases
Amoxicillin
Metronidazole
Furazolidone
Potassium Citrate
Bismuth
Proton Pump Inhibitors
Anti-Bacterial Agents
Anti-Infective Agents
Antiprotozoal Agents
Antiparasitic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Agents
Antacids
Protein Synthesis Inhibitors
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Expectorants
Respiratory System Agents