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New treatment option for Carpometacarpal (CMC) Osteoarthritis
Official title Randomized Placebo Controlled Study of Triamcinolone Acetonide Extended Release Injection for Thumb (CMC) Osteoarthritis
ClinicalTrials.gov ID: NCT06237153
What this study is testing
What is Triamcinolone Acetonide extended release suspension?
Triamcinolone Acetonide extended release suspension is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for carpometacarpal (cmc) osteoarthritis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The goal of this study is to investigate if a timed release steroid injection may be beneficial in treating carpometacarpal (CMC) joint (thumb) osteoarthritis. The main questions to be answered are: 1.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Male or female \> 18 years of age.
- X ray diagnosis of CMC osteoarthritis Eaton stages I, II or III.
- VAS pain score in affected thumb of 5 or greater.
- Written informed consent obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study.
- Willing to abstain from use of the following protocol-restricted medications during the study to be kept in a log if non compliant.
You likely can't join if
- Females who are pregnant or nursing or plan to become pregnant during the study; women who plan to conceive during the study; or unwilling to...
- 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 TA-ER (or component of TA-ER), triamcinolone acetonide.
- Stage IV CMC osteoarthritis is excluded. Rationale for exclusion of stage IV is that these patients are most likely surgical candidates due to severe...
See the full eligibility criteria
- Male or female \> 18 years of age.
- X ray diagnosis of CMC osteoarthritis Eaton stages I, II or III.
- VAS pain score in affected thumb of 5 or greater.
- Written informed consent obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study.
- Willing to abstain from use of the following protocol-restricted medications during the study to be kept in a log if non compliant.
- Opioid or over the counter medications for pain for the study duration
- Females who are pregnant or nursing or plan to become pregnant during the study; women 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 TA-ER (or component of TA-ER), triamcinolone acetonide.
- Stage IV CMC osteoarthritis is excluded. Rationale for exclusion of stage IV is that these patients are most likely surgical candidates due to severe joint damage. Other exclusion criteria include rheumatoid arthritis...
The study team makes the final eligibility decision.
Where it's taking place
- Stony Brook, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Stony Brook, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.