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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests Cingal™, a treatment for individuals with patellofemoral pain syndrome, a type of knee pain. Cingal™ combines hyaluronic acid, which lubricates the joint, and a corticosteroid (Triamcinolone Hexacetonide) to reduce inflammation and relieve pain. The trial aims to determine if Cingal™ can improve knee function and provide short-term pain relief. Individuals with persistent knee pain for at least two months, which worsens with activities like squatting or climbing stairs, and who have not found relief from other treatments, might be suitable candidates for this trial.

As an unphased trial, this study provides an opportunity to explore new treatment options for knee pain relief.

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 there any evidence suggesting that Cingal™ is likely to be safe for humans?

Research shows that Cingal™, a treatment combining hyaluronic acid and the steroid triamcinolone hexacetonide, is generally safe. Previous studies found that Cingal™ improves knee joint function and reduces pain. Importantly, these trials reported no deaths linked to its use. However, some rare side effects, such as infections or tendon problems, have occurred.

Triamcinolone hexacetonide, a component of Cingal™, is also used in other treatments, with both 10 mg and 40 mg doses effectively relieving knee pain without major safety concerns. Still, all treatments can have risks, and individual experiences may vary. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for patellofemoral pain syndrome, like physical therapy and oral pain relievers, Cingal is administered directly into the knee joint via an ultrasound-guided injection. This precise delivery method ensures that the active ingredients reach the site of pain more effectively. Additionally, Cingal combines a hyaluronic acid with a corticosteroid, triamcinolone hexacetonide, which not only lubricates the joint but also reduces inflammation. Researchers are excited about Cingal because this dual-action approach could provide faster and longer-lasting relief compared to existing options.

What evidence suggests that Cingal™ might be an effective treatment for patellofemoral pain syndrome?

Research shows that Cingal™, a treatment combining hyaluronic acid (a joint lubricant) and a corticosteroid, can improve knee movement and reduce pain. In this trial, participants will receive Cingal, which studies have found to result in less pain compared to treatments like Monovisc. Triamcinolone acetonide, one of Cingal's ingredients, significantly lessened knee pain for up to 24 weeks in people with knee problems. Both 10 mg and 40 mg doses of this ingredient effectively reduced knee pain. Overall, these findings suggest that Cingal could ease patellofemoral pain syndrome by reducing pain and improving knee function. ^{3 4 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 knee pain around my kneecap for at least 2 months.

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

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

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]

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]

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 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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9896831/

The efficacy of intra-articular triamcinolone acetonide 10 ... The 10 mg of TA is non-inferior to 40 mg TA in improving pain in patients with symptomatic knee OA. Both 10 mg and 40 mg of TA significantly improved pain and ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5560514/

Comparison of the 3 Different Injection Techniques Used in ... The results of this trial showed that patients treated with Cingal experienced significantly greater pain reductions than both the Monovisc and ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT01891396

NCT01891396 | Cingal Study for Knee Osteoarthritis The purpose of this study is to see if a single injection of Cingal into the knee provides safe relief of pain caused by osteoarthritis. Detailed Description.

4. withpower.com withpower.com/trial/phase-patellofemoral-pain-syndrome-3-2023-1e62d

Cingal™ for Patellofemoral Pain Syndrome Triamcinolone acetonide extended-release (ER) 32 mg significantly reduces knee osteoarthritis pain over 24 weeks compared to placebo, while also improving ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT03390036

Study of Cingal for the Relief of Knee Osteoarthritis ... A higher percentage of subjects responding indicates a better outcome. The change from baseline in knee pain as measured by the Western Ontario and McMaster ...

6. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/18/NCT04231318/Prot_000.pdf

Cingal 19-01 The data supports the safety of Cingal®. There were no deaths in any ... To determine the contribution of Triamcinolone Hexacetonide (TH) to pain ...

7. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2014/016466s046lbl.pdf

Aristospan® (Triamcinolone Hexacetonide Injectable ... The safety and effectiveness of epidural administration of corticosteroids have not been established, and corticosteroids are not approved for this use. General.

8. pendopharm.com pendopharm.com/wp-content/uploads/2022/05/CINGAL-Package-Insert-EN.pdf?x87476

Difference in WOMAC Pain from BL - ITT Cingal® ... Rare side effects include infection, tendinopathy, or Nicolau's syndrome (dermatitis). A complete listing of the frequency and rate of adverse events identified ...