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Triamcinolone Acetonide Injectable

Phase 1

Osteoarthritis, Knee | Small molecule | Musculoskeletal |Pacira BioSciences, Inc.|Last Updated: May 20, 2022

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment35

FDA Designations

No designations recorded

Clinical trial landscape

Triamcinolone Acetonide Injectable · 1 trial · 1 indication

Phase 1 1
NCT04261049Effect of Zilretta InjectionOsteoarthritis, Knee
COMPLETED35 Analytics
PHASE1COMPLETED
Effect of Zilretta Injection
Osteoarthritis, KneeUnlock trial analytics

Study Endpoints

Primary Endpoints

Percentage Change in Mean Maximal Quadriceps Strength as Measured by the Maximal Isometric Voluntary Contractions Normalized to Body Weight from Baseline to the 8-week follow-up.
Baseline and 8-week follow-up

Quadriceps strength was measured in Newton Meters normalized to body weight of the individuals. Strength was assessed in 90 degrees of knee flexion.

Percentage Change in Mean Voluntary Quadriceps Activation as Measured by the Central Activation Ratio Expressed as a Percent of Full Activation from Baseline to the 8-week follow-up.
Baseline and 8-week follow-up

The investigators assessed voluntary quadriceps central activation ratio as a representative variable of lower extremity neuromuscular activation using the supra imposition technique. Quadriceps central activation ratio has been demonstrated to be significantly decreased in knee osteoarthritis (OA) compared to healthy, matched controls, and the investigators have reported acceptable measurement reliability (ICC2,k = 0.85)

Percentage Change in Mean Knee Flexion Angle During Walking Gait Measured in Degrees of Knee Flexion from Baseline to the 8-week follow-up.
Baseline and 8-week follow-up

The peak Knee Flexion Angle was calculated using using inverse dynamics calculations in the first 50% of the stance phase of gait and during self selected gait speed.

Percentage Change in Mean Internal Knee Extension Moment During Walking Gait Measured in Nm/ Body Weight*m from Baseline to the 8-week follow-up.
Baseline and 8-week follow-up

The peak internal knee extension moment was calculated using using inverse dynamics calculations in the first 50% of the stance phase of gait and normalized to the Body Weight\* height (m) of the individual during self selected gait speed.

Percentage Change in Mean of Self-reported Disability Score as Measured by the Western Ontario and McMasters Universities Index from Baseline to the 8-week follow-up.
Baseline and 8-week follow-up

The Western Ontario and McMasters Universities Index is reliable and valid measure of self reported disability. The physical function consists of 17 items and asks about the magnitude of difficulty when ascending and descending stairs, rising from sitting, standing, bending, walking, getting in / out of a car, shopping, putting on and taking off socks, rising from bed, lying in bed, getting in and out of the bath, sitting, getting on and off the toilet, completing heavy household duties, and completing light household duties. Each item is presented in a 5 point Likert-type format and uses the following descriptors for possible answer choices none, mild moderate, severe, and extreme. Each descriptor corresponds to an ordinal scale of 0-4. The scores are summed for the items in each subscale, with total possible ranges as 0-68. Higher scores on the WOMAC indicate greater amounts of functional limitations.

Percentage Change in mean of self-reported Disability Score as Measured by the Knee Injury and Osteoarthritis Outcome Score from Baseline to the 8-week follow-up.
Baseline and 8-week follow-up

The Knee Injury and Osteoarthritis Outcomes Score (KOOS) consists of five subscales: Pain (9 items), Symptoms (7 items), Function in Activities of Daily Living (17 items), Function in Sport and Recreation (5 items) and Knee Related Quality of Life (4 items). Each item is presented in a 5 point Likert-type format that ranges from 0 (no problems) to 4 (extreme problems). Totals from each subscale are transformed to a 0-100 score. Lower scores on the KOOS indicate greater amounts of functional limitations.

Percentage Change in Physical Activity Scale for the Elderly from baseline to the 8-week follow-up.
Baseline and 8-week follow-up

Physical Activity Scale for the Elderly (PASE) scores are calculated from weights and frequency values for each of 12 types of activity. Responses to the first question about sitting activities are not scored. The scale is continuous with higher scores indicating greater physical activity.

Percentage Change in 30-s chair-stand test from Baseline to the 8-week follow-up.
Baseline and 8-week follow-up

The number of times that an individual can sit and stand in 30 seconds.

Percentage Change in 20 meter fast-paced walk test from Baseline to the 8-week follow-up.
Baseline and 8-week follow-up

The investigators will time the amount of seconds it takes to walk 20 meters.

Percentage Change in Stair-climb test from Baseline to the 8-week follow-up.
Baseline and 8-week follow-up

The investigators will time the amount of seconds it takes to walk up and down a flight of stairs.

The percentage change in steps per day from Baseline to the 8-week follow-up.
Baseline and 8-week follow-up

Physical activity will be measured in the form of steps per day using an ActiGraph accelerometer. Participants will wear the ActiGraph for 7 days following each testing session.

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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
ZILRETTA InjectionEXPERIMENTALAll patients upon enrolling in the study will receive a single 5 mL injection of 32 mg ZILRETTA into the affected knee joint.

Interventions

NameTypeDescription
Triamcinolone Acetonide Extended-Release Injectable SuspensionDRUGA single ZILRETTA® (triamcinolone acetonide extended-release injectable suspension) intra-articular knee injection.
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Eligibility Criteria

Age Range40 Years to 75 Years
SexALL
Healthy VolunteersNo
Study Sites1

Full Inclusion Criteria: * Male or female between the ages of 40 and 75 years old who: * Exhibit symptomatic knee OA, defined as a normalized WOMAC function subscale score \>31(out of 100 points, indicating highest degree of dysfunction) * Have radiographic evidence of tibiofemoral OA (2-4 on the K...

Countries:United States
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