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Effect of ZILRETTA Versus CELESTONE on Quality of Life, Pain, Neuromuscular Function, and Physical Performance

NCT05058209 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2021-09-27

No results posted yet for this study

Summary

The purpose of this study is to examine the pre, post, and follow up effects of a single ZILRETTA knee injection vs a single CELESTONE SOLUSPAN knee injection on physiological measure of self-reported quality of life, pain, physical function, and physical performance in individuals with osteoarthritis (OA) knee pain. The Primary Investigator (PI) will recruit 20 symptomatic knee OA patients for this study. Patients will be randomized into one of two treatment arms, Arm 1 (ZILRETTA injection) or Arm 2 (CELESTONE SOLUSPAN injection). Patients in Arm 1 will receive a single 5 mL IV injection of 32 mg ZILRETTA into the affected knee joint. Patients in Arm 2 will receive a 5ml IV injection of 6mg/ml CELESTONE SOLUSPAN into the affected knee joint. Each study arm will include 10 patients. All data will be collected prior to injection (baseline), as well as at 6-week (post 1) and 12-week follow-ups (post 2). Patients will blinded to treatment arm until after they complete their 12-week follow up.

Conditions

  • Osteoarthritis, Knee

Interventions

DRUG

Triamcinolone acetonide extended-release injectable suspension

Zilretta (Triamcinolone acetonide extended-release injectable suspension) is indicated as an intra-articular injection for the management of pain due to knee OA. The most commonly reported adverse reactions (incidence ≥1%) in clinical studies included sinusitis (2%), cough (2%), contusions (2%) and joint swelling (3%). For additional details, please see Package Insert (http://www.zilrettalabel.com/PI.pdf). The website for Zilretta additionally lists: joint pain, headache, back pain, sore throat and runny nose, and bruising as common side effects of receiving a Zilretta injection.

DRUG

Betamethasone sodium phosphate and betamethasone acetate Injectable Suspension

Celestone (betamethasone sodium phosphate and betamethasone acetate Injectable Suspension, USP 6 mg per mL) is indicated as an intra-articular injection for the management of chronic or long-term inflammation associated with multiple conditions including severe allergies, dermatological diseases, endocrine disorders, gastrointestinal diseases, hematologic disorders, neoplastic diseases, nervous system disorders, ophthalmologic diseases, renal diseases, respiratory diseases and rheumatic disorders, and others that may not be listed. Celestone Soluspan is available in generic form. The most commonly reported adverse reactions include acne, increased hunger, and weight gain.

Sponsors & Collaborators

  • ROC Foundation

    lead OTHER

Principal Investigators

  • Sara C DePaoli · ROC Foundation

  • Timothy J Bray, MD · ROC Foundation

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-30
Primary Completion
2021-04-28
Completion
2021-04-28
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05058209 on ClinicalTrials.gov