Status:
COMPLETED
Safety of Single Doses of SAR113945 and Efficacy and Safety of a New Formulation Given Into the Knee in Osteoarthritis Patients / Part I
Lead Sponsor:
Sanofi
Conditions:
Knee Osteoarthritis
Eligibility:
All Genders
40+ years
Phase:
PHASE1
Brief Summary
Study objectives: * Part 1 TDU11685 To assess in patients with knee Osteoarthritis (OA), the safety, tolerability and pharmacokinetics (PK) of single intra-articular doses of SAR113945. * Part 2 ACT1...
Detailed Description
\- Screening will be performed within 28 days of dosing. Following the single dose of study medication, the study period for each patient will be 168 days.
Eligibility Criteria
Inclusion
- Inclusion criteria:
- \- Diagnosis of primary knee osteoarthritis, based upon the following:
- X-ray or Magnetic Resonance Imaging (MRI) evidence within the last 6 months for joint space narrowing and osteophyte formation
- Patients will be Kellgren and Lawrence classification II/III, and total Western Ontario McMaster (WOMAC) score 24 -72.
- Patients fulfilling the American College of Rheumatology Clinical and Radiographic criteria for Osteoarthritis.
- Exclusion criteria:
- Patients younger than 40 years
- Women of child bearing potential.
- Women either sterilized for more than 3 months, or post-menopausal for more than 12 months. Menopause is defined as over age of 60 years or being amenorrheic for at least 2 years with plasma FSH level \>30 IU/L.
- Secondary osteoarthritis: e.g., autoimmune disease, joint dysplasia, aseptic osteonecrosis, acromegaly, Paget's disease, Ehlers-Danlos Syndrome, Gaucher's disease, Stickler's syndrome, joint infection, haemophilia, haemochromatosis, calcium pyrophosphate deposition disease, or neuropathic arthropathy.
- Presence of local skin abnormality at the affected knee joint.
- Intra-articular injection within 3 months.
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Exclusion
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2012
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT01463488
Start Date
November 1 2011
End Date
August 1 2012
Last Update
August 23 2012
Active Locations (1)
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1
Investigational Site Number 276001
Berlin, Germany, 14050