Safety of Single Doses of SAR113945 and Efficacy and Safety of a New Formulation Given Into the Knee in Osteoarthritis Patients / Part I
This study has been completed.
Sponsor:
Sanofi
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01463488
First received: October 29, 2011
Last updated: August 22, 2012
Last verified: August 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Knee Osteoarthritis |
Drug: SAR113945 Drug: placebo |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | A Two Part Protocol to Assess, Using Double Blind Placebo Control, the Safety, Tolerability, and Pharmacokinetics of Ascending Single Doses of a New Intra-articular Administration Formulation of SAR113945 (IKK Inhibitor) Followed by Assessment of Efficacy, Safety, Tolerability and Pharmacokinetics of a Single Dose in Patients With Knee Osteoarthritis |
Resource links provided by NLM:
Further study details as provided by Sanofi:
Primary Outcome Measures:
- Pain, Stiffness and Physical Function sub-scales from the WOMAC Index [ Time Frame: during 24 weeks ] [ Designated as safety issue: No ]
- Number of patients reporting Adverse Events of special interest: tolerability at the site of injection and in the knee + other events reported by the patient [ Time Frame: during 24 weeks ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Pharmacokinetics (Cmax) [ Time Frame: during 24 weeks ] [ Designated as safety issue: No ]
- Pharmacokinetics (AUC) [ Time Frame: during 24 weeks ] [ Designated as safety issue: No ]
- Pharmacokinetics (t1/2) [ Time Frame: during 24 weeks ] [ Designated as safety issue: No ]
- synovial fluid levels [ Time Frame: during 24 weeks ] [ Designated as safety issue: No ]
| Enrollment: | 24 |
| Study Start Date: | November 2011 |
| Study Completion Date: | August 2012 |
| Primary Completion Date: | August 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: SAR113945 - Dose 1 |
Drug: SAR113945
Pharmaceutical form:Injection Route of administration: Intra-articular |
| Experimental: SAR113945 - Dose 2 |
Drug: SAR113945
Pharmaceutical form:Injection Route of administration: Intra-articular |
| Experimental: SAR113945 - Dose 3 |
Drug: SAR113945
Pharmaceutical form:Injection Route of administration: Intra-articular |
| Placebo Comparator: Placebo |
Drug: placebo
Pharmaceutical form:Injection Route of administration: Intra-articular |
Detailed Description:
- 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.
Eligibility| Ages Eligible for Study: | 40 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Contacts and Locations More Information
No publications provided
| Responsible Party: | Sanofi |
| ClinicalTrials.gov Identifier: | NCT01463488 History of Changes |
| Other Study ID Numbers: | TDU11685, 2011-003232-31, U1111-1121-3831, TDU11685/ACT12505 |
| Study First Received: | October 29, 2011 |
| Last Updated: | August 22, 2012 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Additional relevant MeSH terms:
|
Osteoarthritis Osteoarthritis, Knee Arthritis |
Joint Diseases Musculoskeletal Diseases Rheumatic Diseases |
ClinicalTrials.gov processed this record on June 18, 2013