Analgesic Effectiveness of Three Different Doses of a New Formulation of Lamaline in a Model of Painful Knee (Gonarthrosis)

Solvay

Status and phase: Completed; Phase 3

Conditions: Knee Osteoarthritis

Treatments: Drug: Lamaline® , 3 different doses, Dafalgan codeine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00264225

S118.3.005

2005-003757-27

Details and patient eligibility

About

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

Sex: All

Ages: 40 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind