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Gentamicin in Cystic Fibrosis Patients With Stop Mutations
NCT00376428Phase 2
Key facts
- Status
- Terminated
- Start
- Jan 2003
- Countries
- 1
- Sponsor
- Assistance publique - Hôpitaux de Paris
- Modality
- Nanoparticles, Implantable Devices, Transdermal Patches
- Drugs
- gentamicin
- Conditions
- cystic fibrosis (CF)
01
Overview
Phase 2, open-label trial of gentamicin in cystic fibrosis (CF) (2 arms), sponsored by Assistance publique - Hôpitaux de Paris. Primary endpoint: CFTR-dependent chloride secretion at 15 days. Started Jan 2003; status: terminated.
02
Design
2 arms- Study design
- Non-randomizedOpen-label
CFTR stop mutations
Patients with CFTR stop mutations receiving gentamicin
No CFTR stop mutations
Control group of patients without CFTR stop mutations receiving gentamicin
03
Who it enrols
Cystic fibrosis patients with CFTR codon stop mutations, excluding those with rhinitis, nasal polyposis, smoking history, or recent aminoglycoside use.
04
Endpoints
Primary
CFTR-dependent chloride secretion
Secondary
CFTR expression in nasal cells
Clinical beneficial effects
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