Status:
COMPLETED
Safety, Tolerability and Pharmacokinetics of SAR113945 in Japanese Patients With Knee Osteoarthritis
Lead Sponsor:
Sanofi
Conditions:
Knee Osteoarthritis
Eligibility:
All Genders
40+ years
Phase:
PHASE1
Brief Summary
Primary Objective: To assess the safety and tolerability of SAR113945 in Japanese patients with knee osteoarthritis after ascending single intra-articular doses Secondary Objective: To assess the p...
Detailed Description
Following the single dose of study medication, the study period for each patient will be 168 days.
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Japanese male or female patients, aged 40 years or older, with knee osteoarthritis
- Diagnosis of primary knee osteoarthritis, based upon the following:
- X-ray or magnetic response imaging (MRI) evidence within the last 6 months for joint space narrowing and osteophyte formation
- Patients will be Kellegen and Lawrence classification II or III, and total Western Ontario McMaster (WOMAC) score below or equal to 72
- Patients fulfilling the American College of Rheumatology Clinical and Radiographic criteria for Osteoarthritis
- Exclusion criteria:
- Women of child bearing potential
- 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, hemophilia, hemochromatosis, calcium pyrophosphate disposition disease, or neuropathic arthropathy
- Presence of local skin abnormality at the affected knee joint
- Any patient who received intra-articular injection within 3 months prior to administration
- 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 :
January 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2012
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT01511549
Start Date
January 1 2012
End Date
September 1 2012
Last Update
October 1 2012
Active Locations (1)
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1
Investigational Site Number 392001
Osaka, Japan, 532-0003