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Corticosteroid

ZILRETTA for Shoulder Osteoarthritis

Phase 3

Recruiting

Research Sponsored by Pacira Pharmaceuticals, Inc

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Shoulder pain due to OA for >15 days over the last month as reported by the subject

Grade 2 or 3 OA in the index glenohumeral joint based on the Samilson-Prieto classification system as confirmed by X-ray taken at, or within 6 months of, the Screening Visit and read by the central reader

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 18

Awards & highlights

Study Summary

This trial is testing the effectiveness of ZILRETTA in reducing pain in people with glenohumeral osteoarthritis when compared to a placebo. The secondary objectives include comparing the pain

Who is the study for?

This trial is for individuals with shoulder osteoarthritis, specifically in the glenohumeral joint. Participants should have a history of pain due to their condition and be suitable candidates for intra-articular injection treatments.Check my eligibility

What is being tested?

The study aims to compare the effectiveness and safety of ZILRETTA (an extended-release corticosteroid) against a placebo (normal saline) and an immediate-release steroid (TCA-IR), all administered through single-dose injections directly into the shoulder joint.See study design

What are the potential side effects?

Potential side effects may include reactions at the injection site, increased risk of infection, changes in blood sugar levels, temporary increase in pain, allergic reactions, or other steroid-related effects such as mood swings.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have had shoulder pain for more than 15 days in the last month.

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My shoulder joint shows moderate to severe arthritis on an X-ray.

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My shoulder pain scores between 4 and 9 on average over the last week.

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My shoulder pain score is between 5 and 9.

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I am between 50 and 80 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 18

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 18

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 18 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change from Baseline on the Worst Daily Pain (24-hr) mean score at Week 12 for ZILRETTA relative to placebo

Secondary outcome measures

Change from Baseline at Week 12 on the SPADI total score and subscales for ZILRETTA relative to TCA-IR

Change from Baseline at Week 12 on the SPADI total score and subscales for ZILRETTA relative to placebo

Change from Baseline on the Worst Daily Pain (24-hr) mean score at Week 12 for ZILRETTA relative to TCA-IR

+4 more

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Placebo Group

Group I: ZILRETTAExperimental Treatment1 Intervention

100 subjects will receive 32 mg ZILRETTA

Group II: TCA-IRActive Control1 Intervention

100 subjects will receive 40 mg TCA-IR

Group III: PlaceboPlacebo Group1 Intervention

50 subjects will receive normal saline placebo

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Pacira Pharmaceuticals, IncLead Sponsor

136 Previous Clinical Trials

13,783 Total Patients Enrolled

Nino Joy, MDStudy DirectorPacira Pharmaceuticals, Inc

1 Previous Clinical Trials

24 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What characteristics or criteria make an individual suitable for enrollment in this clinical study?

"Individuals aged between 50 and 80 with a confirmed diagnosis of shoulder osteoarthritis are eligible for participation in this clinical trial, which aims to enroll approximately 250 participants."

Answered by AI

What is the level of risk associated with ZILRETTA for individuals?

"Our team at Power ranks ZILRETTA's safety as 3 on the scale due to it being a Phase III trial, signifying existing evidence of efficacy and robust safety data."

Answered by AI

Are patients currently being enrolled in this research study?

"Affirmative. The details on clinicaltrials.gov affirm that this research study is presently seeking volunteers. This trial was initially disclosed on February 5th, 2024 and the latest update occurred on February 13th, 2024. It aims to enroll a total of 250 participants from one designated site."

Answered by AI

What is the total number of individuals participating in this clinical study?

"Affirmative. Records from clinicaltrials.gov show that this investigation is presently seeking participants. The trial was first uploaded on February 5th, 2024, and underwent its latest revision on February 13th, 2024. A total of 250 patients are sought at a single designated site."

Answered by AI

Does this medical study include individuals aged 70 and older?

"Patients aged between 50 and 80 are eligible for participation in this clinical investigation. There are a total of 25 trials catering to individuals below the age of legal adulthood, while there are 560 trials designed for patients surpassing the age of 65 years."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

ZILRETTA in Subjects With Glenohumeral Osteoarthritis

2024. "ZILRETTA in Subjects With Glenohumeral Osteoarthritis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06269705.