Cingal™ for Patellofemoral Pain Syndrome

Overseen By Julie-Anne Fritz, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Banff Sport Medicine Foundation

Disqualifiers: Knee osteoarthritis, Previous knee surgery, Diabetes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

Duration: 12 weeks

24 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial investigates Cingal™, a treatment for patients with Anterior Knee Pain (AKP). Cingal™ combines a lubricant for the knee joint and an anti-inflammatory to reduce pain and swelling, aiming to improve knee function. A recent trial demonstrated that patients treated with Cingal experienced greater pain reductions compared to other treatments.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, it mentions that participants should have failed to improve with treatments like NSAIDs (non-steroidal anti-inflammatory drugs), so you might need to discuss your current medications with the trial team.

Is Cingal™ (Triamcinolone) generally safe for humans?

Triamcinolone, used in various forms for conditions like osteoarthritis and asthma, is generally well tolerated but can cause side effects such as weight gain, menstrual changes, high blood pressure, and swelling. Extended-release forms may reduce some side effects by limiting how much of the drug enters the bloodstream. ^{1 2 3 4 5}

How is the drug Cingal different from other treatments for patellofemoral pain syndrome?

Cingal combines triamcinolone hexacetonide, a corticosteroid that reduces inflammation, with a hyaluronic acid component, which may provide lubrication and cushioning in the joint. This combination aims to offer both immediate and longer-lasting pain relief compared to standard treatments that typically use only one of these components. ^{1 3 6 7 8}

What data supports the effectiveness of the drug Cingal for treating patellofemoral pain syndrome?

Research shows that triamcinolone hexacetonide, a component of Cingal, effectively reduces pain and improves function in conditions like osteoarthritis and tendinitis. It has been shown to provide longer-lasting pain relief compared to other similar treatments. ^{1 3 6 7 8}

Who Is on the Research Team?

Laurie Hiemstra, MD PhD FRCSC

Principal Investigator

Banff Sport Medicine Foundation

Are You a Good Fit for This Trial?

This trial is for people aged 18-35 with Anterior Knee Pain (AKP) lasting over 2 months, who haven't improved after at least 6 weeks of non-surgical treatments. They must have pain during activities like squatting or stair climbing and can't be overweight, pregnant, or have had previous knee surgery among other exclusions.

Inclusion Criteria

I have had specific knee x-rays taken while standing.

I have had knee pain around my kneecap for at least 2 months.

My AKP hasn't improved after 6 weeks of non-surgical treatments.

Exclusion Criteria

I am allergic to Cingal™ or its ingredients.

I have no health issues that prevent knee injections.

Pregnant or breastfeeding

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Cingal™ injection administered by fellowship-trained physicians through ultrasound-guided injection into the knee joint

12 weeks

3 visits (in-person) at baseline, 6 weeks, and 12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

14 weeks

3 visits (in-person) at 4 days, 2 weeks, and 4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Cingal
• Triamcinolone Hexacetonide

Trial Overview The trial tests Cingal™, which combines hyaluronic acid for joint lubrication and a steroid called triamcinolone hexacetonide to relieve pain. It aims to see if this treatment improves knee function and reduces pain in those with AKP.

How Is the Trial Designed?

Group I: Cingal Injection Experimental Treatment 1 Intervention

Cingal will be administered by fellowship-trained physicians through ultrasound-guided injection using a 20-gauge needle into the joint space of the knee under sterile conditions. The needle track will be anesthetized with local anesthetic.

Who Is Running the Clinical Trial?

Banff Sport Medicine Foundation

Lead Sponsor

Trials

4

Recruited

160+

Published Research Related to This Trial

FX006, a new extended-release formulation of triamcinolone acetonide, did not meet the primary endpoint of significantly reducing knee pain compared to saline placebo at week 12, but showed greater pain relief at earlier weeks (1-11) and a longer duration of effect with higher doses.

Both doses of FX006 (32 mg and 16 mg) were well tolerated, indicating a safety profile similar to that of saline placebo, suggesting that FX006 could be a viable treatment option for managing osteoarthritis pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Brief Report: A Phase IIb Trial of a Novel Extended-Release Microsphere Formulation of Triamcinolone Acetonide for Intraarticular Injection in Knee Osteoarthritis. Conaghan, PG., Cohen, SB., Berenbaum, F., et al.[2019]

In a Phase-3 study involving 484 adults with knee osteoarthritis, FX006 (32 mg) significantly reduced average daily pain intensity compared to saline placebo, achieving about a 50% improvement by week 12.

FX006 also showed favorable results in secondary and exploratory measures of osteoarthritis symptoms compared to placebo, while its efficacy was similar to that of standard triamcinolone acetonide (TAcs) in terms of pain reduction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of a Single Intra-Articular Injection of a Microsphere Formulation of Triamcinolone Acetonide on Knee Osteoarthritis Pain: A Double-Blinded, Randomized, Placebo-Controlled, Multinational Study. Conaghan, PG., Hunter, DJ., Cohen, SB., et al.[2019]

Triamcinolone acetonide extended-release (ER) 32 mg significantly reduces knee osteoarthritis pain over 24 weeks compared to placebo, while also improving stiffness and physical function, demonstrating its efficacy as a treatment option.

The formulation of triamcinolone acetonide ER in PLGA microspheres allows for prolonged release in the joint, minimizing systemic exposure and related side effects, making it a safer alternative to traditional corticosteroid injections.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Triamcinolone Acetonide Extended-Release: A Review in Osteoarthritis Pain of the Knee. Paik, J., Duggan, ST., Keam, SJ.[2023]

In a 26-week study involving 215 patients with osteoarthritis, hylan G-F 20 (HG-F 20) provided significantly better pain relief and functional improvement compared to triamcinolone hexacetonide (TH) at both 12 and 26 weeks.

HG-F 20 demonstrated a longer duration of effect and was better tolerated, with no patients discontinuing treatment due to lack of efficacy, while 15 patients treated with TH did discontinue for this reason.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized, single-blind comparison of the efficacy and tolerability of hylan G-F 20 and triamcinolone hexacetonide in patients with osteoarthritis of the knee. Caborn, D., Rush, J., Lanzer, W., et al.[2015]

In a study of 145 patients with severe bronchial asthma, repeated intramuscular injections of triamcinolone acetonide (Kenalog) resulted in excellent or good outcomes in 88.3% of cases, indicating its high efficacy for patients who did not respond to other treatments.

While Kenalog was effective, 13.8% of patients experienced side effects such as weight gain and increased blood pressure, highlighting the need for careful monitoring during prolonged steroid use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The use of triamcinolone acetonide in the treatment of severe intrinsic bronchial asthma. Romański, B., Pawlik, K., Wilewska-Klubo, T.[2013]

In a phase 3b study involving 208 patients with knee osteoarthritis, repeat injections of triamcinolone acetonide extended-release (TA-ER) were found to be safe and well tolerated, with no unexpected adverse events or significant changes in knee radiographs after 52 weeks.

Both the first and second injections of TA-ER provided similar and substantial pain relief, with most patients experiencing at least a 50% reduction in pain, indicating effective symptom management across varying severities of osteoarthritis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and Efficacy of Repeat Administration of Triamcinolone Acetonide Extended-release in Osteoarthritis of the Knee: A Phase 3b, Open-label Study. Spitzer, AI., Richmond, JC., Kraus, VB., et al.[2020]

In a study involving 30 children with non-infectious uveitis, subtenon triamcinolone acetonide (STA) injections showed significant efficacy, with 85.4% of eyes experiencing inflammation improvement and 77.8% resolution of macular edema at the 3-month follow-up.

The procedure was safe, with no immediate complications reported, and only a 12.5% incidence of ocular hypertension at 6 months, indicating that STA injections are a well-tolerated treatment option for pediatric patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Subtenon Triamcinolone Acetonide Injection with Topical Anesthesia in Pediatric Non-Infectious Uveitis. Jung, JL., Harasawa, M., Patnaik, JL., et al.[2023]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Brief Report: A Phase IIb Trial of a Novel Extended-Release Microsphere Formulation of Triamcinolone Acetonide for Intraarticular Injection in Knee Osteoarthritis. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Effects of a Single Intra-Articular Injection of a Microsphere Formulation of Triamcinolone Acetonide on Knee Osteoarthritis Pain: A Double-Blinded, Randomized, Placebo-Controlled, Multinational Study. [2019]

3. New Zealand pubmed.ncbi.nlm.nih.gov

Triamcinolone Acetonide Extended-Release: A Review in Osteoarthritis Pain of the Knee. [2023]

4. Canada pubmed.ncbi.nlm.nih.gov

A randomized, single-blind comparison of the efficacy and tolerability of hylan G-F 20 and triamcinolone hexacetonide in patients with osteoarthritis of the knee. [2015]

5. Norway pubmed.ncbi.nlm.nih.gov

Subacromial triamcinolone mexacetonide and methylprednisolone injections in treatment of supra spinam tendinitis. A comparative trial. [2019]

6. Singapore pubmed.ncbi.nlm.nih.gov

The use of triamcinolone acetonide in the treatment of severe intrinsic bronchial asthma. [2013]

7. England pubmed.ncbi.nlm.nih.gov

Safety and Efficacy of Repeat Administration of Triamcinolone Acetonide Extended-release in Osteoarthritis of the Knee: A Phase 3b, Open-label Study. [2020]

8. England pubmed.ncbi.nlm.nih.gov

Subtenon Triamcinolone Acetonide Injection with Topical Anesthesia in Pediatric Non-Infectious Uveitis. [2023]