Empirical Rescue Therapies of Helicobacter Pylori Infection

Functional Dyspepsia Clinical Trial

Official title:

Helicobacter Pylori Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01668927
• Other study ID #: rjkls_2012009
• Status: Completed
• Phase: Phase 4
• First received: August 16, 2012
• Last updated: June 1, 2013
• Start date: July 2012
• Est. completion date: October 2012

Study information

• Verified date: June 2013
• Source: Shanghai Jiao Tong University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 424
• Est. completion date: October 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Functional Dyspepsia
• Peptic Ulcer
• Scarred Peptic Ulcer

Intervention

Drug:
• Proton Pump Inhibitor

• Bismuth

• Metronidazole

• Tetracycline

• Furazolidone

• Amoxicillin

Locations

Country	Name	City	State
China	Renji Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	eradication rate of H. pylori		2 months	Yes