Recruitment

Recruitment Status
Completed
Estimated Enrollment
118

Inclusion Criteria

patient with global pain intensity during the last 24hours > or egal 40 mm (EVA) at the day of selection
symptomatic gonarthrose defined by a recurrent pain to the walk on 30 days during the last 2 months before the inclusion with radiological findings (grade II to IV on Kellgren-Lawrence)
diagnosis of medial femoro-tibial knee osteoarthrosis
...
patient with global pain intensity during the last 24hours > or egal 40 mm (EVA) at the day of selection
symptomatic gonarthrose defined by a recurrent pain to the walk on 30 days during the last 2 months before the inclusion with radiological findings (grade II to IV on Kellgren-Lawrence)
diagnosis of medial femoro-tibial knee osteoarthrosis
Male or female over 18 years
BMI < or egal to 35kg/m2

Exclusion Criteria

hepatic or renal insufficiency
pregnant women of with no contraception
paracetamol intolerance
...
hepatic or renal insufficiency
pregnant women of with no contraception
paracetamol intolerance
hyaluronic acid or corticosteroid intra-articular injection in the last month prior to inclusion
on going knee viscosupplementation at inclusion
other knee diseases
sensitivity disorders in the lower limbs (diabetes mellitus..)
metabolic arthropathies
femoro-patellar predominant arthrosis
psychiatrics disorders
chronical rheumatismal diseases
slow acting OA drugs (if started in the last 2 months prior to inclusion)
septic arthritis
opioids, corticosteroids, or NSAIDs intake in the last 48 hours prior to inclusion
controlateral gonathrosis with corticoids injections
skin lesions or dermal pathologies
any other serious disease which may interfere with the results
symptomatic coxarthrosis
venous or arterial disorders

Summary

Conditions
  • Osteoarthritis (Knee)
  • Osteoarthritis, Knee
Type
Interventional
Phase
Phase 3
Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: None (Open Label)
  • Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

Description

The main criteria is the evaluation of global knee pain during the last 24 hours at D 49 after the inclusion. The response to the treatment will be evaluated during the inclusion visit (V1/D0) and after 6 weeks of treatment, during the following visit (V3/D49). The level of the global pain of the pa...

The main criteria is the evaluation of global knee pain during the last 24 hours at D 49 after the inclusion. The response to the treatment will be evaluated during the inclusion visit (V1/D0) and after 6 weeks of treatment, during the following visit (V3/D49). The level of the global pain of the patient during the last 24 hours will be collected by investigators with a VAS (0 mm = no pain ; 100mm = maximun pain) at each visit.

Inclusion Criteria

patient with global pain intensity during the last 24hours > or egal 40 mm (EVA) at the day of selection
symptomatic gonarthrose defined by a recurrent pain to the walk on 30 days during the last 2 months before the inclusion with radiological findings (grade II to IV on Kellgren-Lawrence)
diagnosis of medial femoro-tibial knee osteoarthrosis
...
patient with global pain intensity during the last 24hours > or egal 40 mm (EVA) at the day of selection
symptomatic gonarthrose defined by a recurrent pain to the walk on 30 days during the last 2 months before the inclusion with radiological findings (grade II to IV on Kellgren-Lawrence)
diagnosis of medial femoro-tibial knee osteoarthrosis
Male or female over 18 years
BMI < or egal to 35kg/m2

Exclusion Criteria

hepatic or renal insufficiency
pregnant women of with no contraception
paracetamol intolerance
...
hepatic or renal insufficiency
pregnant women of with no contraception
paracetamol intolerance
hyaluronic acid or corticosteroid intra-articular injection in the last month prior to inclusion
on going knee viscosupplementation at inclusion
other knee diseases
sensitivity disorders in the lower limbs (diabetes mellitus..)
metabolic arthropathies
femoro-patellar predominant arthrosis
psychiatrics disorders
chronical rheumatismal diseases
slow acting OA drugs (if started in the last 2 months prior to inclusion)
septic arthritis
opioids, corticosteroids, or NSAIDs intake in the last 48 hours prior to inclusion
controlateral gonathrosis with corticoids injections
skin lesions or dermal pathologies
any other serious disease which may interfere with the results
symptomatic coxarthrosis
venous or arterial disorders

Tracking Information

NCT #
NCT02021136
Collaborators
Not Provided
Investigators
  • Principal Investigator: Philippe THOUMIE, MD Coordinator
  • Philippe THOUMIE, MD Coordinator