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A Pilot Study of Norfloxacin for Hepatopulmonary Syndrome

NCT00362752 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2016-12-07

No results posted yet for this study

Summary

The hepatopulmonary syndrome (HPS)and pre-HPS is a disease seen in patients with chronic liver disease, whereby patients develop dilations in the blood vessels of the lungs, resulting in low oxygen levels and shortness of breath.

In this study, each HPS and pre-HPS subject will be treated with a commonly used antibiotic called "norfloxacin" (approved for use in the treatment of gonorrhea, prostatitis and urinary tract infections) for a 4-week period. In order to ensure that any observed improvement was indeed due to norfloxacin, each subject will also be treated with a separate 4-week course of an identical placebo. There will also be a 4 week wash-out period (no study medication/placebo) between the 2 courses of treatment.

The primary aim of the study will be to measure improvements in oxygen levels while on norfloxacin, although a number of secondary parameters will also be followed.

Conditions

  • Hepatopulmonary Syndrome

Interventions

DRUG

Norfloxacin

400 mg po bid

DRUG

Placebo

Placebo 400 mg po bid

Sponsors & Collaborators

  • University of Toronto

    collaborator OTHER

  • Unity Health Toronto

    lead OTHER

Principal Investigators

  • Marie Faughnan, MD MSc FRCPC · St. Michael's Hospital, Toronto Canada; University of Toronto

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-10-31
Primary Completion
2009-01-31
Completion
2009-12-31

Countries

  • Canada

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00362752 on ClinicalTrials.gov