Analgesic Effectiveness of Three Different Doses of a New Formulation of Lamaline in a Model of Painful Knee (Gonarthrosis)
Information source: Solvay Pharmaceuticals
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Knee Osteoarthritis
Intervention: LamalineĀ® , 3 different doses, Dafalgan codeine (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Solvay Pharmaceuticals Official(s) and/or principal investigator(s): Global Clinical Director Solvay, Study Director, Affiliation: Solvay Pharmaceuticals
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
Clinical Details
Official title: 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.
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Eligibility
Minimum age: 40 Years.
Maximum age: 85 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- History of knee (unilateral or bilateral) osteoarthritis for at least 6 months
- Pain intensity assessed by Visual Analogue Scale ā„ 40 mm
- Partial functional disability assessed by Lequesne index ā„4 and < than 12
Exclusion Criteria:
- Patient unable to interrupt his/her NSAIDs to participate in the clinical study
Locations and Contacts
Site 2, Albi, France
Site 3, Andernos Les Bains, France
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Additional Information
Starting date: December 2005
Last updated: February 15, 2008
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