Safety, Tolerability and Pharmacokinetics of SAR113945 in Japanese Patients With Knee Osteoarthritis

Phase 1

Completed

• Conditions: Knee Osteoarthritis
• Interventions: Drug: SAR113945; Drug: placebo

• Registration Number: NCT01511549
• Lead Sponsor: Sanofi

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 pharmacokinetics of SAR113945 in Japanese patients with knee osteoarthritis after ascending single intra-articular doses

Detailed Description

Following the single dose of study medication, the study period for each patient will be 168 days.

Study Timeline

• Study Start: 2012-01
• Study First Submitted: 2012-01-06
• Study First Submitted QC: 2012-01-12
• Study First Posted: 2012-01-18
• Status Verified: 2012-09
• Primary Completion: 2012-09
• Study Completion: 2012-09
• Last Update Submitted: 2012-09-28
• Last Update Posted: 2012-10-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dose 2	SAR113945	SAR113945 medium dose
Placebo	placebo	Placebo
Dose 1	SAR113945	SAR113945 low dose
Dose 3	SAR113945	SAR113945 high dose

Primary Outcome Measures

Name	Time	Method
Number of patients with safety assessments (adverse events, vital signs, 12 lead ECGs and laboratory tests)	up to 24 weeks
Examination of skin/soft tissue of injected knee, and knee joint	up to 24 weeks	Examination of skin/soft tissue of injected knee: Any reaction is classified as erythema, edema, pain, hematoma and graded none, mild, moderate or severe.; Examination of knee joint of injected knee: Any reaction is classified as effusion/worsening of effusion, warmth and pain.

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetic parameter (AUC)	21 time points up to 24 weeks
Pharmacokinetic parameter (Cmax)	21 time points up to 24 weeks
Pharmacokinetic parameter (tmax)	21 time points up to 24 weeks
Pharmacokinetic parameter (t1/2)	21 time points up to 24 weeks
Pharmacodynamic parameter (WOMAC index)	up to 24 weeks
Pharmacodynamic parameter (biomarkers relating to osteoarthritis)	up to 24 weeks

Trial Locations

Locations (1)

Investigational Site Number 392001; 🇯🇵 Osaka-Shi, Japan