NCT00264225
Completed
Phase 3
A Randomized, Double-Blind, Comparative Parallel Group Study of Analgesic Effectiveness and Safety of Three Different Doses of Lamaline® New Formulation vs Dafalgan® Codeine, After 10 Days Administration in Subjects With Painful Gonarthrosis.
Overview
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Solvay Pharmaceuticals
- Locations
- 171
Overview
Brief Summary
This study aims to assess the analgesic effectiveness and safety of three different doses of a new formulation of Lamaline® versus Dafalgan® Codeine after 10 days administration in subjects with painful gonarthrosis
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double
Eligibility Criteria
- Ages
- 40 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •History of knee (unilateral or bilateral) osteoarthritis for at least 6 months
- •Pain intensity assessed by Visual Analogue Scale ≥ 40 mm
- •Partial functional disability assessed by Lequesne index ≥4 and \< than 12
Exclusion Criteria
- •Patient unable to interrupt his/her NSAIDs to participate in the clinical study
Investigators
Study Sites (171)
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