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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Knee Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Neurologic Manifestations Osteoarthritis Osteoarthritis, Knee Pain Pathological Conditions, Signs and Symptoms Rheumatic Diseases Signs and Symptoms

Age range

40 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Site 2, Albi, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lamaline® , 3 different doses, Dafalgan codeine

Drug

Sponsors and collaborators

Lead sponsor

Solvay Pharmaceuticals

Industry

Registry information

Official study 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.

Important dates

Study start: 2005
First posted: Dec 12, 2005
Registry last updated: Feb 20, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed