Status:

WITHDRAWN

Efficacy and Safety Study in Patients Suffering From Knee Osteoarthritis

Lead Sponsor:

Pierre Fabre Medicament

Conditions:

Knee Osteoarthritis

Eligibility:

All Genders

40-80 years

Phase:

NA

Brief Summary

The primary objective of this study is to compare a combination of hyaluronic acid and chondroitin sulfate (V0220) to Hyalgan® on pain relief in patients with symptomatic knee osteoarthritis (OA) over...

Eligibility Criteria

Inclusion

  • presenting with uni or bilateral medial and/or lateral femorotibial osteoarthritis of the knee evolving for more than 6 months
  • patients taking analgesic medications for at least 3 months prior to randomisation and dissatisfied with their current therapy

Exclusion

  • isolated symptomatic femoropatellar osteoarthritis
  • target knee prothesis
  • having undergone an articular lavage, or an arthroscopy or any surgery on the target knee in the 6 months preceding randomisation,
  • target knee osteoarthritis with clinical joint effusion at selection and at randomization
  • body mass index (BMI) greater than or equal to 30,
  • patient having received any corticosteroid treatment by any administration route (other than inhalers, ocular, auricular route) in the month preceding randomisation,
  • patient having received intra-articular steroid injection in the target knee within the month preceding randomisation or patient having received intra-articular hyaluronic acid in the target knee in the 6 months preceding randomisation

Key Trial Info

Start Date :

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

Estimated Enrollment :

Patients enrolled

Trial Details

Trial ID

NCT01469507

Last Update

February 21 2013

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