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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.
Sponsor:
Information provided by:
Solvay Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00264225
First received: December 9, 2005
Last updated: February 15, 2008
Last verified: February 2008
History of Changes
  Purpose

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:

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

Further study details as provided by Solvay Pharmaceuticals:

Study Start Date: December 2005
  Eligibility

Ages Eligible for Study:   40 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00264225

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

No publications provided

ClinicalTrials.gov 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

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Analgesics
Codeine
Sensory System Agents
Peripheral Nervous System Agents
 Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Analgesics, Opioid
Central Nervous System Depressants
Antitussive Agents
Respiratory System Agents
Narcotics

ClinicalTrials.gov processed this record on May 16, 2013