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Clinical Trials/NCT01598415
NCT01598415
Completed
Phase 2

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.

Sanofi2 sites in 1 country130 target enrollmentStarted: April 2012Last updated:
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ConditionsKnee Osteoarthritis
InterventionsSAR113945placebo
DrugsSAR113945placebo

Overview

Phase
Phase 2
Status
Completed
Sponsor
Sanofi
Enrollment
130
Locations
2
Primary Endpoint
Womac Pain Score (5 items)
OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Overview

Brief Summary

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

  • 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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Eligibility Criteria

Ages
40 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Arms & Interventions

SAR113945

Experimental

TDU11685 selected dose

Intervention: SAR113945 (Drug)

Placebo

Placebo Comparator

Intervention: placebo (Drug)

Outcomes

Primary Outcomes

Womac Pain Score (5 items)

Time Frame: at 8 weeks

Secondary Outcomes

  • Womac Pain Score (5 items)(during 24 weeks)
  • Womac Total Score (24 items)(during 24 weeks)
  • Womac Stiffness (2 items)(during 24 weeks)
  • Womac Physical Function (17 items)(during 24 weeks)
  • synovial fluid levels(during 24 weeks)
  • 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(during 24 weeks)

Investigators

Sponsor
Sanofi
Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (2)

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