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

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ClinicalTrials.gov Identifier: NCT00264225
Recruitment Status : Completed
First Posted : December 12, 2005
Last Update Posted : February 20, 2008
Information provided by:
Solvay Pharmaceuticals

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

Condition or disease Intervention/treatment Phase
Knee Osteoarthritis Drug: Lamaline® , 3 different doses, Dafalgan codeine Phase 3

Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
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 Start Date : December 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis
Drug Information available for: Codeine
U.S. FDA Resources

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00264225

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Sponsors and Collaborators
Solvay Pharmaceuticals
Study Director: Global Clinical Director Solvay Solvay Pharmaceuticals

ClinicalTrials.gov Identifier: NCT00264225     History of Changes
Other Study ID Numbers: S118.3.005
First Posted: December 12, 2005    Key Record Dates
Last Update Posted: February 20, 2008
Last Verified: February 2008

Keywords provided by Solvay Pharmaceuticals:
osteoarthritis, pain

Additional relevant MeSH terms:
Osteoarthritis, Knee
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Analgesics, Opioid
Central Nervous System Depressants
Antitussive Agents
Respiratory System Agents