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

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.

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00264225

Enrollment

Unknown

Registered

2005-12-12

Start date

2005-12-31

Completion date

Unknown

Last updated

2008-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Knee Osteoarthritis

Keywords

osteoarthritis, pain

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

Interventions

DRUGLamaline® , 3 different doses, Dafalgan codeine

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

40 Years to 85 Years

Healthy volunteers

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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026