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Corticosteroid

Triamcinolone acetonide extended release suspension injection for CMC Arthritis

Phase 2

Recruiting

Research Sponsored by Marie Badalamente

Eligibility Criteria Checklist

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

Must have

X ray diagnosis of CMC osteoarthritis Eaton stages I, II or III

VAS pain score in affected thumb of 5 or greater

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 1 of injection to six months post injection

Awards & highlights

Study Summary

This trial aims to find out if a special type of steroid injection can help reduce pain and improve thumb function in people with thumb osteoarthritis. Participants will receive the injection and attend follow-up visits

Who is the study for?

Adults over 18 with X-ray confirmed thumb osteoarthritis (Eaton stages I-III) and significant pain can join this study. They must not take opioids or OTC pain meds during the trial, avoid pregnancy, and have no history of severe reactions to the drug being tested or similar drugs.Check my eligibility

What is being tested?

The trial is testing if a timed-release steroid injection reduces thumb pain and improves function in patients with thumb osteoarthritis. Participants will receive an injection in their thumb joint and attend follow-ups to assess changes in pain and movement.See study design

What are the potential side effects?

Potential side effects may include allergic reactions to the medication, increased risk of infection at the injection site, temporary increase in pain, changes in skin color around the injected area, and possible weakening of bones.

Eligibility Criteria

Inclusion Criteria

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

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My X-ray shows I have early to moderate thumb arthritis.

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My thumb pain is rated 5 or higher on a pain scale.

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I am willing to not use any opioid or over-the-counter pain medications during the study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 1 of injection to six months post injection

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 1 of injection to six months post injection

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 of injection to six months post injection for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Visual Analog Pain Score

Secondary outcome measures

Grip Strength

Key Strength

Pinch Strength

+1 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Triamcinolone acetonide extended release suspension injectionExperimental Treatment1 Intervention

Active drug treatment

Group II: Saline Placebo InjectionPlacebo Group1 Intervention

Placebo comparator

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Marie BadalamenteLead Sponsor

Frequently Asked Questions

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

Has the extended release suspension injection of Triamcinolone acetonide been granted approval by the FDA?

"Triamcinolone acetonide extended release suspension injection is currently being evaluated in a Phase 2 trial. The safety assessment by our team at Power rates it as a 2, indicating that there is some data supporting its safety but none supporting efficacy yet."

Answered by AI

What is the collective count of participants involved in this clinical investigation?

"Indeed, the information available on clinicaltrials.gov indicates that this study is actively seeking eligible candidates. The trial was initially posted on November 21st, 2023 and last updated on January 24th, 2024. A total of 30 participants are being sought from a single location."

Answered by AI

Is the process of enrolling participants still ongoing for this medical study?

"Indeed, the details listed on clinicaltrials.gov indicate that this specific clinical trial is currently in the process of actively enrolling participants. The initial posting date for this study was November 21, 2023, and it received its most recent update on January 24, 2024. To complete the trial successfully, a total of 30 patients will be recruited from one designated location."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Randomized Placebo Controlled Study of Triamcinolone Acetonide Extended Release Injection for Thumb (CMC) Osteoarthritis

Marie Badalamente 2023. "Randomized Placebo Controlled Study of Triamcinolone Acetonide Extended Release Injection for Thumb (CMC) Osteoarthritis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06237153.