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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01511549
Recruitment Status : Completed
First Posted : January 18, 2012
Last Update Posted : October 1, 2012
Sponsor:
Information provided by (Responsible Party):

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


Condition or disease Intervention/treatment Phase
Knee Osteoarthritis Drug: placebo Drug: SAR113945 Phase 1

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

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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 Start Date : January 2012
Primary Completion Date : September 2012
Study Completion Date : September 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Dose 1
SAR113945 low dose
Drug: SAR113945

Pharmaceutical form:injection

Route of administration: intra-articular

Experimental: Dose 2
SAR113945 medium dose
Drug: SAR113945

Pharmaceutical form:injection

Route of administration: intra-articular

Experimental: Dose 3
SAR113945 high dose
Drug: SAR113945

Pharmaceutical form:injection

Route of administration: intra-articular

Placebo Comparator: Placebo
Placebo
Drug: placebo

Pharmaceutical form:injection

Route of administration: intra-articular



Outcome Measures

Primary Outcome Measures :
  1. Number of patients with safety assessments (adverse events, vital signs, 12 lead ECGs and laboratory tests) [ Time Frame: up to 24 weeks ]
  2. Examination of skin/soft tissue of injected knee, and knee joint [ Time Frame: 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 :
  1. Pharmacokinetic parameter (AUC) [ Time Frame: 21 time points up to 24 weeks ]
  2. Pharmacokinetic parameter (Cmax) [ Time Frame: 21 time points up to 24 weeks ]
  3. Pharmacokinetic parameter (tmax) [ Time Frame: 21 time points up to 24 weeks ]
  4. Pharmacokinetic parameter (t1/2) [ Time Frame: 21 time points up to 24 weeks ]
  5. Pharmacodynamic parameter (WOMAC index) [ Time Frame: up to 24 weeks ]
  6. Pharmacodynamic parameter (biomarkers relating to osteoarthritis) [ Time Frame: up to 24 weeks ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01511549


Locations
Japan
Investigational Site Number 392001
Osaka-Shi, Japan, 532-0003
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Clinical Sciences & Operations Sanofi
More Information

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT01511549     History of Changes
Other Study ID Numbers: TDU11333
U1111-1121-4499 ( Other Identifier: UTN )
First Posted: January 18, 2012    Key Record Dates
Last Update Posted: October 1, 2012
Last Verified: September 2012

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases