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

Primary Purpose

Knee Osteoarthritis

Status
Completed
Phase
Phase 1
Locations
Japan
Study Type
Interventional
Intervention
placebo
SAR113945
Sponsored by
Sanofi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Osteoarthritis

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Investigational Site Number 392001

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

Dose 1

Dose 2

Dose 3

Placebo

Arm Description

SAR113945 low dose

SAR113945 medium dose

SAR113945 high dose

Placebo

Outcomes

Primary Outcome Measures

Number of patients with safety assessments (adverse events, vital signs, 12 lead ECGs and laboratory tests)
Examination of skin/soft tissue of injected knee, and knee joint
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

Pharmacokinetic parameter (AUC)
Pharmacokinetic parameter (Cmax)
Pharmacokinetic parameter (tmax)
Pharmacokinetic parameter (t1/2)
Pharmacodynamic parameter (WOMAC index)
Pharmacodynamic parameter (biomarkers relating to osteoarthritis)

Full Information

First Posted
January 6, 2012
Last Updated
September 28, 2012
Sponsor
Sanofi
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1. Study Identification

Unique Protocol Identification Number
NCT01511549
Brief Title
Safety, Tolerability and Pharmacokinetics of SAR113945 in Japanese Patients With Knee Osteoarthritis
Official Title
A Randomized, Double-blind, Placebo-controlled Ascending Single Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of SAR113945 (IKK Inhibitor) Following Intra-articular Administration in Japanese Patients With Knee Osteoarthritis
Study Type
Interventional

2. Study Status

Record Verification Date
September 2012
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
September 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanofi

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dose 1
Arm Type
Experimental
Arm Description
SAR113945 low dose
Arm Title
Dose 2
Arm Type
Experimental
Arm Description
SAR113945 medium dose
Arm Title
Dose 3
Arm Type
Experimental
Arm Description
SAR113945 high dose
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
Pharmaceutical form:injection Route of administration: intra-articular
Intervention Type
Drug
Intervention Name(s)
SAR113945
Intervention Description
Pharmaceutical form:injection Route of administration: intra-articular
Primary Outcome Measure Information:
Title
Number of patients with safety assessments (adverse events, vital signs, 12 lead ECGs and laboratory tests)
Time Frame
up to 24 weeks
Title
Examination of skin/soft tissue of injected knee, and knee joint
Description
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.
Time Frame
up to 24 weeks
Secondary Outcome Measure Information:
Title
Pharmacokinetic parameter (AUC)
Time Frame
21 time points up to 24 weeks
Title
Pharmacokinetic parameter (Cmax)
Time Frame
21 time points up to 24 weeks
Title
Pharmacokinetic parameter (tmax)
Time Frame
21 time points up to 24 weeks
Title
Pharmacokinetic parameter (t1/2)
Time Frame
21 time points up to 24 weeks
Title
Pharmacodynamic parameter (WOMAC index)
Time Frame
up to 24 weeks
Title
Pharmacodynamic parameter (biomarkers relating to osteoarthritis)
Time Frame
up to 24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Sciences & Operations
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Investigational Site Number 392001
City
Osaka-Shi
ZIP/Postal Code
532-0003
Country
Japan

12. IPD Sharing Statement

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

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