Status:
COMPLETED
Safety, Tolerability and Efficacy of MP-376 Given for 28 Days to Cystic Fibrosis (CF) Patients
Lead Sponsor:
Amgen
Conditions:
Cystic Fibrosis (CF)
Eligibility:
All Genders
16+ years
Phase:
PHASE2
Brief Summary
Patients with cystic fibrosis (CF) suffer from chronic infections of the lower respiratory tract that can be caused by one or multiple bacteria, including Pseudomonas aeruginosa, which has been partic...
Detailed Description
This trial will be a double-blind, placebo-controlled study to evaluate the safety, tolerability and efficacy of levofloxacin administered as MP-376 of three dosage regimens given for 28 days by the a...
Eligibility Criteria
Inclusion
- Inclusion Criteria (selected):
- \> 16 years of age
- Confirmed Diagnosis of Cystic Fibrosis
- Positive sputum culture for P. aeruginosa within the past 18 months
- Patients are able to elicit a forced expiratory volume in 1 second (FEV1) \>/= 25% but \</= 85% of predicted value at screening
- Have received at least 3 courses of inhaled antimicrobials over the preceding 12 months
- Clinically stable with no changes in health status within the last 30 days
- Able to reproducibly produce sputum and perform spirometry
- Exclusion Criteria (selected):
- Use of any nebulized or systemic antibiotics within 30 days prior to baseline
- History of hypersensitivity to fluoroquinolones or intolerance with aerosol medication
- Evidence of acute upper within 10 days or lower respiratory infections within 30 days prior to dosing
- Creatine clearance \< 50mg/ml, aspartate transaminase (AST), alanine transaminase (ALT) or total bilirubin \>/= 3 x upper limit of normal (ULN) at Screening
Exclusion
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2009
Estimated Enrollment :
151 Patients enrolled
Trial Details
Trial ID
NCT00677365
Start Date
June 1 2008
End Date
June 1 2009
Last Update
December 27 2024
Active Locations (50)
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Mobile, Alabama, United States, 36608
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Phoenix, Arizona, United States, 85016
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Tucson, Arizona, United States, 85724
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Little Rock, Arkansas, United States, 72202