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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06269705
Other study ID # 006-C-301
Secondary ID
Status Recruiting
Phase Phase 3
First received
Last updated
Start date February 5, 2024
Est. completion date August 2025

Study information

Verified date May 2024
Source Pacira Pharmaceuticals, Inc
Contact Jennifer Gordon
Phone 973-451-4055
Email jennifer.gordon@pacira.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Primary Objective: To assess the efficacy of ZILRETTA on pain following an intra-articular (IA) injection in subjects with glenohumeral osteoarthritis (OA) relative to normal saline placebo Secondary Objective: - To assess the efficacy of ZILRETTA on pain following an IA injection in subjects with glenohumeral OA relative to triamcinolone acetonide injectable suspension, immediate release (TCA-IR) and normal saline placebo - To assess the safety of ZILRETTA in subjects with glenohumeral OA relative to normal saline placebo and TCA-IR


Description:

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Study Design


Related Conditions & MeSH terms


Intervention

Drug:
ZILRETTA
IA injection of 32 mg ZILRETTA
TCA-IR
IA injection of 40 mg TCA-IR
Other:
Placebo
IA injection of placebo (normal saline)

Locations

Country Name City State
United States University Orthopedics Center Altoona Pennsylvania
United States Spectrum Medical Danville Virginia
United States Physicians Research Options Draper Utah
United States Sundance Clinical Research Saint Louis Missouri
United States Clinical Research of West Florida Tampa Florida
United States Alabama Orthopaedic Center- Research Vestavia Hills Alabama
United States International Spine, Pain & Performance Center Washington District of Columbia

Sponsors (1)

Lead Sponsor Collaborator
Pacira Pharmaceuticals, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change from Baseline on the Worst Daily Pain (24-hr) mean score (0-10 Numeric Rating Scale (NRS); 0 = no pain, 10 = worst possible pain) at Week 12 for ZILRETTA relative to placebo Week 12
Secondary Change from Baseline on the Worst Daily Pain (24-hr) mean score (0-10 Numeric Rating Scale (NRS); 0 = no pain, 10 = worst possible pain) at Week 12 for ZILRETTA relative to TCA-IR Week 12
Secondary Change from Baseline on the Worst Daily Pain (24-hr) mean score (0-10 Numeric Rating Scale (NRS); 0 = no pain, 10 = worst possible pain) at Week 18 for ZILRETTA relative to TCA-IR Week 18
Secondary Change from Baseline on the Worst Daily Pain (24-hr) mean score (0-10 Numeric Rating Scale (NRS); 0 = no pain, 10 = worst possible pain) at Week 2 for ZILRETTA relative to placebo Week 2
Secondary Change from Baseline on the Worst Daily Pain (24-hr) mean score (0-10 Numeric Rating Scale (NRS); 0 = no pain, 10 = worst possible pain) at Week 4 for ZILRETTA relative to placebo Week 4
Secondary Change from Baseline on the Worst Daily Pain (24-hr) mean score (0-10 Numeric Rating Scale (NRS); 0 = no pain, 10 = worst possible pain) at Week 8 for ZILRETTA relative to placebo Week 8
Secondary Change from Baseline at Week 12 on the Shoulder Pain and Disability Index (SPADI) total score and subscales (0-10 Numeric Rating Scale (NRS); 0 = no pain, 10 = worst possible pain) for ZILRETTA relative to placebo Week 12
Secondary Change from Baseline at Week 12 on the SPADI total score and subscales (0-10 Numeric Rating Scale (NRS); 0 = no pain, 10 = worst possible pain) for ZILRETTA relative to TCA-IR Week 12
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