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Corticosteroid
Triamcinolone Injections for Knee Osteoarthritis
Phase 4
Recruiting
Led By Dien Hung Luong, MD
Research Sponsored by Centre hospitalier de l'Université de Montréal (CHUM)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1, 2, 3 and 6 months post-injection
Awards & highlights
No Placebo-Only Group
Pivotal Trial
Drug Has Already Been Approved
Summary
This trial will study the effects of different doses of an anti-inflammatory drug (TA) injected into the knee to reduce osteoarthritis pain, with potential side effects.
Who is the study for?
This trial is for individuals with knee pain due to osteoarthritis, rated between 4 and 8 on the pain scale, lasting over 6 months. Participants should have a specific grade of joint damage but not the most severe form or bilateral issues. They shouldn't have had recent cortisone injections or treatments like hyaluronic acid or platelet-rich plasma in their knees.
What is being tested?
The study tests three different doses of Triamcinolone Acetonide (5mg, 10mg, and 40mg) injected into the knee to determine which dose best reduces pain and improves function without causing significant side effects.
What are the potential side effects?
Possible side effects include increased blood sugar levels, higher blood pressure, reduced stress hormone secretion temporarily. Long-term risks may involve thinning of cartilage in the knee and decreased bone density.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1, 2, 3 and 6 months post-injection
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1, 2, 3 and 6 months post-injection
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
WOMAC Function
Secondary study objectives
LIKERT
VAS
WOMAC Total
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Trial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: Group A TA 40 mgExperimental Treatment1 Intervention
intra-articular injection of 40 mg of triamcinolone acetonide, which is the standard dose used
Group II: Group B TA 10 mgActive Control1 Intervention
intra-articular injection of 10 mg of triamcinolone acetonide
Group III: Group C TA 5 mgActive Control1 Intervention
intra-articular injection of 5 mg of triamcinolone acetonide
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Triamcinolone Acetonide
2018
Completed Phase 4
~3730
Find a Location
Who is running the clinical trial?
Centre hospitalier de l'Université de Montréal (CHUM)Lead Sponsor
377 Previous Clinical Trials
131,193 Total Patients Enrolled
4 Trials studying Osteoarthritis
231 Patients Enrolled for Osteoarthritis
Dien Hung Luong, MDPrincipal InvestigatorCentre hospitalier de l'Université de Montréal (CHUM)
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have any serious health issues that prevent me from joining the study.I have pain in both knees due to arthritis.My study joint is not affected by conditions like inflammation, infection, or bone death.I might have cancer that has spread or is only in one area.I have had a platelet-rich plasma injection in a joint within the last year.I have had a joint injection with hyaluronic acid in the last year.I haven't had a knee steroid injection in the last 3 months and don't take steroids by mouth regularly.I have arthritis in my kneecap area only.I might have an active infection.I have had knee arthritis symptoms for more than 6 months.My knee arthritis is mild to severe but not the most severe.My knee pain during activity is moderate but not severe.I have severe knee arthritis.I have had a severe knee injury in the last 3 months.
Research Study Groups:
This trial has the following groups:- Group 1: Group A TA 40 mg
- Group 2: Group B TA 10 mg
- Group 3: Group C TA 5 mg
Awards:
This trial has 3 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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