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Safety of Single Doses of SAR113945 and Efficacy and Safety of a New Formulation Given Into the Knee in Osteoarthritis Patients / Part I

NCT ID: NCT01463488

Last Updated: 2012-08-23

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

2011-11-30

Study Completion Date

2012-08-31

Brief Summary

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Study objectives:

* Part 1 TDU11685 To assess in patients with knee Osteoarthritis (OA), the safety, tolerability and pharmacokinetics (PK) of single intra-articular doses of SAR113945.
* Part 2 ACT12505 To assess in patients with knee OA, the efficacy, safety and tolerability of a single intra-articular dose of SAR113945.

Detailed Description

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\- Screening will be performed within 28 days of dosing. 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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SAR113945 - Dose 1

Group Type EXPERIMENTAL

SAR113945

Intervention Type DRUG

Pharmaceutical form:Injection

Route of administration: Intra-articular

SAR113945 - Dose 2

Group Type EXPERIMENTAL

SAR113945

Intervention Type DRUG

Pharmaceutical form:Injection

Route of administration: Intra-articular

SAR113945 - Dose 3

Group Type EXPERIMENTAL

SAR113945

Intervention Type DRUG

Pharmaceutical form:Injection

Route of administration: Intra-articular

Placebo

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

Pharmaceutical form:Injection

Route of administration: Intra-articular

Interventions

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SAR113945

Pharmaceutical form:Injection

Route of administration: Intra-articular

Intervention Type DRUG

placebo

Pharmaceutical form:Injection

Route of administration: Intra-articular

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

\- Diagnosis of primary knee osteoarthritis, based upon the following:

* X-ray or Magnetic Resonance Imaging (MRI) evidence within the last 6 months for joint space narrowing and osteophyte formation
* Patients will be Kellgren and Lawrence classification II/III, and total Western Ontario McMaster (WOMAC) score 24 -72.
* Patients fulfilling the American College of Rheumatology Clinical and Radiographic criteria for Osteoarthritis.

Exclusion Criteria

* Patients younger than 40 years
* Women of child bearing potential.
* Women either sterilized for more than 3 months, or post-menopausal for more than 12 months. Menopause is defined as over age of 60 years or being amenorrheic for at least 2 years with plasma FSH level \>30 IU/L.
* 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, haemophilia, haemochromatosis, calcium pyrophosphate deposition disease, or neuropathic arthropathy.
* Presence of local skin abnormality at the affected knee joint.
* Intra-articular injection within 3 months.

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 276001

Berlin, , Germany

Site Status

Countries

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Germany

Other Identifiers

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2011-003232-31

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

U1111-1121-3831

Identifier Type: OTHER

Identifier Source: secondary_id

TDU11685/ACT12505

Identifier Type: OTHER

Identifier Source: secondary_id

TDU11685

Identifier Type: -

Identifier Source: org_study_id