Study of Cingal® for Symptomatic Relief of Osteoarthritis of Ankle Joint

• ClinicalTrials.gov Identifier: NCT04640974
• Recruitment Status: Completed
• First Posted: November 23, 2020
• Last Update Posted: February 11, 2022
• Sponsor: Anika Therapeutics, Inc.
• Information provided by (Responsible Party): Anika Therapeutics, Inc.

Study Description

Brief Summary:

This Trial will obtain clinical data to support an expanded indication for a single injection of Cingal® used for the symptomatic relief of osteoarthritis in the ankle joint.

Condition or disease	Intervention/treatment	Phase
Osteoarthritis, Ankle	Device: Cingal	Phase 3

Detailed Description:

CINGAL® is a chemically cross-linked sodium hyaluronate combined with Triamcinolone Hexacetonide supplied as a 4-mL unit dose in a 5-mL glass syringe. Cingal will be injected into the intraarticular (IA) space of the index hip using an 18-21-gauge needle. It is used for the symptomatic relief of osteoarthritis in the ankle joint.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 25 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Prospective Study of a Single Injection Cross-linked Sodium Hyaluronate Combined With Triamcinolone Hexacetonide (CINGAL®) to Provide Symptomatic Relief of Osteoarthritis of Ankle Joint
• Actual Study Start Date: January 14, 2021
• Actual Primary Completion Date: September 24, 2021
• Actual Study Completion Date: September 24, 2021

Arms and Interventions

Arm	Intervention/treatment
Experimental: Cingal	Device: Cingal; CINGAL® is a chemically cross-linked sodium hyaluronate combined with Triamcinolone Hexacetonide supplied as a 4-mL unit dose in a 5-mL glass syringe.

Outcome Measures

Primary Outcome Measures :

1. Reduction of index ankle Numerical Rating Scale (NRS) pain [ Time Frame: 6 months ]
   (0 to 10 with 0 No Pain and 10 Worst Pain) on walking from baseline to 6 Months post injection.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 75 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Screening Inclusion Criteria:

1. Age 18 years or older
2. Body Mass Index (BMI) ≤ 35 kg/m2
3. Diagnosis of symptomatic osteoarthritic joint in the index ankle (Kellgren-Lawrence grade I to III) to be treated with Cingal injection.
4. Failed conservative treatment for joint osteoarthritis.
5. NRS pain on walking ≥4 and ≤9 in the index ankle.
6. Subject must be willing to abstain from other treatments of the index ankle for the duration of the study.
7. Subject is willing to discontinue all analgesics including NSAIDs, except acetaminophen/paracetamol, at least seven days before the treatment injection and through the completion of the study.
8. Subject is willing to use only acetaminophen/paracetamol (up to a maximum of 4.0 grams per day per the package insert) for the treatment of joint pain for the duration of the study. At least forty-eight hours prior to the Baseline Visit and each follow-up visit, the subject is willing to discontinue use of acetaminophen/paracetamol.
9. Subject is willing to maintain a stable dose of oral glucosamine and/or chondroitin sulfate products throughout the study, if taken prior to signing the informed consent form (ICF).
10. Able and willing to provide signed informed consent

Baseline Inclusion Criteria

1. NRS pain on walking ≥4 and ≤ 9 in index ankle

Screening Exclusion Criteria:

1. History of hypersensitivity to any of the ingredients in the hyaluronan or corticosteroids
2. Infection or skin disease in the area of the injection site or ankle joint
3. NRS pain on walking > 3 in the contralateral ankle
4. NRS pain on walking > 3 in the ipsilateral knee or hip
5. Subject received an injection of Hyaluronic Acid (HA) and/or steroid in either ankle within 6 months of signing the informed consent form (ICF). A subject will be excluded if they are planning to receive an HA or steroid injection (other than the study injection) in either ankle during the course of this study.
6. Known inflammatory or autoimmune disorders (including rheumatoid arthritis, gout), or other pre-existing medical conditions that, in the opinion of the investigator, could impact treatment of the index ankle or affect the ability of the subject to accurately complete the study questionnaires and comply with the study requirements.
7. Subject is taking medications at the time of signing the ICF which could interfere with the treatment procedure, healing and/or assessments. This includes but is not limited to oral or injectable anticoagulant treatments, anti-aggregant platelet treatment, chronic opioid analgesics. Low dose aspirin used for cardiovascular protection is allowed if a stable regimen is maintained for the duration of the study.
8. Subjects who had an oral, intramuscular, intravenous, rectal suppository or topical (excluded in index ankle only) corticosteroid prior 30 days of signing the ICF are excluded. Topical corticosteroid use at any site other than the index ankle is allowed.
9. Significant trauma to the index ankle within 26 weeks of screening
10. Chronic use of narcotics or cannabis.
11. Ligament instability or tear in index ankle.
12. Chronic impingement in the index ankle requiring surgical treatment
13. Diagnosis of fibromyalgia
14. Diagnosis of osteonecrosis in index ankle
15. Subject has significant varus or valgus deformity greater than 10 degrees in either knee.
16. Subject requires consistent use of an assistive device (e.g. wheelchair, walker, etc.) Occasional use of a cane is acceptable.
17. Uncontrolled diabetes with HbA1c of >7%.
18. Subject is a woman who is pregnant or breastfeeding at the Screening Visit or a woman of child bearing potential who refuses to use effective contraception during the course of the study.
19. Subject is receiving or in litigation for worker's compensation.
20. Otherwise determined by the investigator to be medically unsuitable for participation in this study.

Baseline Exclusion Criteria

1. Subject has a decrease of ≥ 2 in the NRS pain on walking from Screening to Baseline in the index ankle.
2. Subject has a contraindication to continue with the study treatment injection based on the visual appearance of the synovial fluid aspirate.

Contacts and Locations

Locations

Czechia

Krajská zdravotní, a.s. - Masarykova nemocnice Ústí nad Labem, o.z.

Ústí Nad Labem, Czechia, 401 13

Poland

NZOZ MEDI-SPATZ M.Spatz

Gliwice, Poland, 44-100

Przychodnia Rodzinna na Sadowej

Toruń, Poland, 87-100

SPORTO sp. z o.o

Łódź, Poland, 90-038

Sponsors and Collaborators

Anika Therapeutics, Inc.

More Information

• Responsible Party: Anika Therapeutics, Inc.
• ClinicalTrials.gov Identifier: NCT04640974
• Other Study ID Numbers: Cingal 20-03
• First Posted: November 23, 2020
• Last Update Posted: February 11, 2022
• Last Verified: February 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Anika Therapeutics, Inc.:

Sodium Hyaluronate; Triamcinolone Hexacetonide

Additional relevant MeSH terms:

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases