Comparative Study of NXL103 versus comparator in adults with community acquired pneumonia
Study identifier:NXL103/2001
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
A double blind, multicenter, multinational, randomized, double-dummy, three-arm parallel-group comparative study of the efficacy, safety and tolerance of oral NXL103 (500 mg twice daily) versus oral NXL103 (600 mg twice daily) versus oral Amoxicillin (1000 mg three times daily) in the treatment of community-acquired pneumonia in adults
Medical condition
Community Acquired Pneumonia
Phase
Phase 2
Healthy volunteers
No
Study drug
NXL103 500 mg, NXL103 600 mg, Comparator
Sex
All
Actual Enrollment
302
Study type
Interventional
Age
18 Years - 70 Years
Date
Study Start Date: 01 Oct 2007
Primary Completion Date: 01 Jul 2009
Study Completion Date: 01 Jul 2009
Study design
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment
Verification:
Verified 01 Jul 2011 by AstraZeneca Pharmaceuticals
Sponsors
AstraZeneca Pharmaceuticals
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: NXL103 500 mg | Drug: NXL103 500 mg 500 mg orally twice daily |
| Experimental: NXL103 600 mg | Drug: NXL103 600 mg 600 mg orally twice daily |
| Active Comparator: Amoxicillin 1000 mg | Drug: Comparator Comparator three times daily |
