Use of Extended Release Triamcinolone in the Treatment of Rotator Cuff Disease

NCT04094298 | Active Not Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: 19-0258
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of this study is to assess the overall safety and general tolerability of extended release triamcinolone acetate (TA-ER/FX006) in patient with rotator cuff disease. The study will enroll 65 patients, aged 40-75 years old, in a longitudinal case series level IV study using extended release triamcinolone to treat shoulder pain from rotator cuff disease. Inclusion criteria will be shoulder pain without a history of trauma and physical exam consistent with rotator cuff tendinitis, impingement syndrome or rotator cuff tear.

Conditions

Rotator Cuff Tears; Rotator Cuff Tendinitis; Rotator Cuff Impingement; Injections; Glucocorticoids

Outcome Measures

Primary Outcomes (1)

• Incidence of adverse events

  Assess the overall safety extended release triamcinolone in acetate (TA-ER/FX006) in patient with rotator cuff disease. Safety is evaluated on the basis of incidence of adverse events (AE). These would be reported by the patient or discovered by the investigator from the following measure below: VAS (Visual Analogue Scale) is a scale to measure patient's pain. SANE (Single Assessment Numeric Evaluation) a scale of 0 to 100 that patients rate their joint function, with 100 being normal function. VR12 (Veterans RAND 12 Item Health Survey) is a patient-reported measure of a patient's overall health. ASES (American Shoulder and Elbow Surgeons Standardized Shoulder Assessment) is a survey which measures function and pain in the shoulder. Surveys could indicate an AE if there was increasing pain or worsening function which would not be expected. This would direct the investigator into further physical exam and inquiry on possible injuries or any other AE. Outcomes will not be aggregated.

  24 weeks

Secondary Outcomes (4)

• Change in shoulder pain as assessed by VAS

  24 weeks

• Change in shoulder function as assessed by SANE

  24 weeks

• Change in shoulder function as assessed by VR-12

  24 weeks

• Change in shoulder function and pain as assessed by ASES

  24 weeks

Study Arms (1)

Treatment Group

EXPERIMENTAL

Patients receiving the 32-unit injection of FX006.

Drug: FX006 Injection

Interventions

FX006 Injection DRUG

One injection of extended release triamcinolone. 32 milligram injection of the extended release triamcinolone in a 75:25 ratio of polylactic-co-glycolic acid (PLGA) microspheres to drug load of 25%. The drug product is reconstituted with diluent containing an isotonic, sterile aqueous solution of sodium chloride, carboxymethylcellulose sodium and polysorbate-80 to form a suspension prior to injection.

Also known as: No other interventions

Treatment Group

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female between the ages of 40-75 years old.
• Able and willing to give written informed consent in accordance with the IRB.
• Read and Speak English.
• History indicative of rotator cuff disease.
• Physical exam consistent with rotator cuff disease.
• All patients will have AP and Outlet X ray views.
• X rays will be normal or indicative of chronic RTC tearing
• Musculoskeletal Ultrasound indicating intact RTC, full thickness tears, or large and massive cuff tears in older, sedentary individuals.
• Willing to abstain from use of NSAIDs

You may not qualify if:

• Females who are pregnant or nursing or plan to become pregnant during the study; men who plan to conceive during the study; or unwilling to practice birth control during participation in the study.
• Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.
• Known or suspected hypersensitivity to FX006 (or component of FX006), triamcinolone acetonide.

Sponsors & Collaborators

• Northwell Health: lead

Study Sites (1)

Northwell Health Orthopedic Institute at Great Neck

Great Neck, New York, 11021, United States

Location

Related Publications (5)

• Conaghan PG, Hunter DJ, Cohen SB, Kraus VB, Berenbaum F, Lieberman JR, Jones DG, Spitzer AI, Jevsevar DS, Katz NP, Burgess DJ, Lufkin J, Johnson JR, Bodick N; FX006-2014-008 Participating Investigators. Effects of a Single Intra-Articular Injection of a Microsphere Formulation of Triamcinolone Acetonide on Knee Osteoarthritis Pain: A Double-Blinded, Randomized, Placebo-Controlled, Multinational Study. J Bone Joint Surg Am. 2018 Apr 18;100(8):666-677. doi: 10.2106/JBJS.17.00154.

  PMID: 29664853 BACKGROUND

• Gaujoux-Viala C, Dougados M, Gossec L. Efficacy and safety of steroid injections for shoulder and elbow tendonitis: a meta-analysis of randomised controlled trials. Ann Rheum Dis. 2009 Dec;68(12):1843-9. doi: 10.1136/ard.2008.099572. Epub 2008 Dec 3.

  PMID: 19054817 BACKGROUND

• Tashjian RZ, Deloach J, Green A, Porucznik CA, Powell AP. Minimal clinically important differences in ASES and simple shoulder test scores after nonoperative treatment of rotator cuff disease. J Bone Joint Surg Am. 2010 Feb;92(2):296-303. doi: 10.2106/JBJS.H.01296.

  PMID: 20124055 BACKGROUND

• Tashjian RZ, Deloach J, Porucznik CA, Powell AP. Minimal clinically important differences (MCID) and patient acceptable symptomatic state (PASS) for visual analog scales (VAS) measuring pain in patients treated for rotator cuff disease. J Shoulder Elbow Surg. 2009 Nov-Dec;18(6):927-32. doi: 10.1016/j.jse.2009.03.021. Epub 2009 Jun 16.

  PMID: 19535272 BACKGROUND

• Jain NB. Do These Crystals Really Sparkle?: Commentary on an article by Philip G. Conaghan, MBBS, PhD, FRACP, FRCP, et al.: "Effects of a Single Intra-Articular Injection of a Microsphere Formulation of Triamcinolone Acetonide on Knee Osteoarthritis Pain. A Double-Blinded, Randomized, Placebo-Controlled, Multinational Study". J Bone Joint Surg Am. 2018 Apr 18;100(8):e56. doi: 10.2106/JBJS.17.01520. No abstract available.

  PMID: 29664865 RESULT

MeSH Terms

Conditions

Rotator Cuff Injuries; Shoulder Impingement Syndrome

Interventions

FX006

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries; Joint Diseases; Musculoskeletal Diseases

Study Officials

• Russell Camhi

  Northwell Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2019
• First Posted: September 18, 2019
• Study Start: July 15, 2019
• Primary Completion: October 10, 2024
• Study Completion: January 31, 2025
• Last Updated: December 27, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)