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

NCT01511549 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2012-10-01

No results posted yet for this study

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

Conditions

Interventions

DRUG

placebo

Pharmaceutical form:injection Route of administration: intra-articular

DRUG

SAR113945

Pharmaceutical form:injection Route of administration: intra-articular

Sponsors & Collaborators

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-01-31
Primary Completion
2012-09-30
Completion
2012-09-30

Countries

  • Japan

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01511549 on ClinicalTrials.gov