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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:
ClinicalTrials.gov Identifier:
NCT00264225
First Posted: December 12, 2005
Last Update Posted: February 20, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Solvay Pharmaceuticals
  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
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.

Resource links provided by NLM:


Further study details as provided by Solvay Pharmaceuticals:

Study Start Date: December 2005
  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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


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

ClinicalTrials.gov Identifier: NCT00264225     History of Changes
Other Study ID Numbers: S118.3.005
2005-003757-27
First Submitted: December 9, 2005
First Posted: December 12, 2005
Last Update Posted: February 20, 2008
Last Verified: February 2008

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
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Antitussive Agents
Respiratory System Agents