Quadruple Therapy Versus Dual Therapy as Rescue Regimens for Helicobacter Pylori Infection

Rescue Therapy for Helicobacter Pylori Clinical Trial

Official title:

Quadruple Therapy With Furazolidone Versus Dual Therapy With High Doses of Amoxicillin as Rescue Regimens for Helicobacter Pylori Infection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01805934
• Other study ID #: rjyyxhk2013-01
• Status: Completed
• Phase: Phase 2
• First received: February 28, 2013
• Last updated: March 5, 2013
• Start date: May 2012
• Est. completion date: February 2013

Study information

• Verified date: March 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 eradication rates of first-line treatment for Helicobacter pylori(Hp) infection are not satisfactory. The study aims to compare the efficacy and safety between quadruple therapy with furazolidone and dual therapy with high doses of amoxicillin as rescue regimens for Hp.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 114
• Est. completion date: February 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Patients aged from 18 to 80 years, who presented with upper gastrointestinal symptoms and endoscopically proven H. pylori-positive non-ulcer dyspepsia, were recruited into the study.

Exclusion Criteria:

• patients with peptic ulcer,

• previous H. pylori eradication treatment,

• previous gastric surgery,

• pregnancy,

• lactation,

• major systemic diseases,

• receipt of anti-secretory therapy,

• antibiotics or bismuth in the preceding four weeks, or - allergy to any one of the medications in the regimen.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Helicobacter Infections
• Rescue Therapy for Helicobacter Pylori

Intervention

Drug:
• RBLF
The patients in Group RBLF will receive a 14-day quadruple therapy,including rabeprazole(10mg bid),bismuth citrate(220mg bid),levofloxacin(200mg qm) and furazolidone(100mg bid).
• RA
The patients in Group RA will be sent to a penicillin skin test before treatment except they were given penicillin before. They will receive a 14-day dual therapy with high doses of rabeprazole(20mg bid) and amoxicillin(1000mg tid).

Locations

Country	Name	City	State
China	Shanghai 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
Other	13C-urea breath test		baseline	Yes
Primary	13C-urea breath test	When the outcome of 13C-urea breath test is more than 4%, the helicobacter pylori infection is still exist(positive).	4 weeks after treatment	Yes
Secondary	scale analysis of drug safety		4 weeks after treatment	Yes