Overview

Safety, Tolerability and Pharmacokinetics of SAR113945 Following Intra-articular Administration in Patients With Knee Osteoarthritis

Status:
Completed
Trial end date:
2011-02-01
Target enrollment:
0
Participant gender:
All
Summary
Primary Objective: - Assess the safety and tolerability of single intra-articular doses of SAR113945 in patients with knee osteoarthritis. Secondary Objective: - Assess systemic exposure of SAR113945 following intra-articular delivery.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Sanofi
Criteria
Inclusion criteria:

- Male patients or female patients of non child-bearing potential, aged at least 40
years with primary knee osteoarthritis having:

- X-ray or Magnetic Resonance Imaging (MRI) evidence for Kellgren Lawrence Grades
II./III joint space narrowing and osteophyte formation,

- Western Ontario MacMaster (WOMAC) score ≦ 72,

- American College of Rheumatology (ACR) Clinical and Radiographic criteria for
osteoarthritis.

Exclusion criteria:

- Any uncontrolled, chronic condition or laboratory finding which, in the opinion of the
Principal Investigator, could potentially put the patient at increased risk.

- Secondary osteoarthritis.

- Moderate/severe renal impairment.

- Underlying hepatobiliary disease and/or elevated Alanine Aminotransferase (ALT) > 3
Upper Limit of Normal range.

- Intra-articular injection within 3 months.

- Presence of local skin abnormality at the affected knee joint.

- Unable to be maintained for at least 2 weeks prior to entry into study on paracetamol
or metamizole as analgesic.

- Any Investigational Product within 3 months.

- Any patient unlikely to comply with the requirements of the study.

The above information is not intended to contain all considerations relevant to a patient's
potential participation in a clinical trial.