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

This study has been completed.
Information provided by:
Solvay Pharmaceuticals Identifier:
First received: December 9, 2005
Last updated: February 15, 2008
Last verified: February 2008

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 Intervention Phase
Knee Osteoarthritis
Drug: Lamaline® , 3 different doses, Dafalgan codeine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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.

Resource links provided by NLM:

Further study details as provided by Solvay Pharmaceuticals:

Study Start Date: December 2005

Ages Eligible for Study:   40 Years to 85 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00264225

  Show 171 Study Locations
Sponsors and Collaborators
Solvay Pharmaceuticals
Study Director: Global Clinical Director Solvay Solvay Pharmaceuticals
  More Information

No publications provided Identifier: NCT00264225     History of Changes
Other Study ID Numbers: S118.3.005, 2005-003757-27
Study First Received: December 9, 2005
Last Updated: February 15, 2008
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Solvay Pharmaceuticals:
osteoarthritis, pain processed this record on March 03, 2015