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

NCT ID: NCT01511549

Last Updated: 2012-10-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2012-09-30

Brief Summary

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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

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

Conditions

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Knee Osteoarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Dose 1

SAR113945 low dose

Group Type EXPERIMENTAL

SAR113945

Intervention Type DRUG

Pharmaceutical form:injection

Route of administration: intra-articular

Dose 2

SAR113945 medium dose

Group Type EXPERIMENTAL

SAR113945

Intervention Type DRUG

Pharmaceutical form:injection

Route of administration: intra-articular

Dose 3

SAR113945 high dose

Group Type EXPERIMENTAL

SAR113945

Intervention Type DRUG

Pharmaceutical form:injection

Route of administration: intra-articular

Placebo

Placebo

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

Pharmaceutical form:injection

Route of administration: intra-articular

Interventions

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placebo

Pharmaceutical form:injection

Route of administration: intra-articular

Intervention Type DRUG

SAR113945

Pharmaceutical form:injection

Route of administration: intra-articular

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sanofi

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Sciences & Operations

Role: STUDY_DIRECTOR

Sanofi

Locations

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Investigational Site Number 392001

Osaka, , Japan

Site Status

Countries

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Japan

Other Identifiers

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U1111-1121-4499

Identifier Type: OTHER

Identifier Source: secondary_id

TDU11333

Identifier Type: -

Identifier Source: org_study_id