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

Osteoarthritis, Shoulder Clinical Trial

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 Shoulder Joint

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04640961
• Other study ID #: Cingal 20-02
• Status: Completed
• Phase: N/A
• Start date: January 16, 2021
• Est. completion date: September 10, 2021

Study information

• Verified date: August 2023
• Source: Anika Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 shoulder joint.

Description:

Single injection into the shoulder joint of a 4 ml unit dose of Cingal containing 88 mg (22 mg/ml) of cross-linked sodium hyaluronate and 18 mg (4.5 mg/ml) of triamcinolone hexacetonide (TH). Participants to be followed to 6 Months post-injection.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: September 10, 2021
• Est. primary completion date: September 10, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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 shoulder (Kellgren-Lawrence grade I to III or Guyette grade I to III) to be treated with CINGAL injection.

4. Failed conservative treatment for joint osteoarthritis.

5. NRS pain =4 and =9 in the index shoulder.

6. Subject must be willing to abstain from other treatments of the index shoulder 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 assessment, 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 =4 and =9 in index shoulder

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 index shoulder

3. NRS pain > 3 in the contralateral shoulder

4. Subject received an injection of Hyaluronic Acid (HA) and/or steroid in either joint 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 joint during the course of this study.

5. 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 shoulder or affect the ability of the subject to accurately complete the study questionnaires and comply with the study requirements.

6. 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.

7. Subjects who had an oral, intramuscular, intravenous, rectal suppository or topical (excluded in index shoulder only) corticosteroid within 30 days of signing the ICF are excluded. Topical corticosteroid use at any site other than the index joint is allowed.

8. Significant trauma to the index shoulder within 26 weeks of screening.

9. Chronic use of narcotics or cannabis. Baseline Exclusion Criteria

1. Subject has a decrease of = 2 in the NRS pain from Screening to Baseline in the index shoulder.

2. Subject has a contraindication to continue with the study treatment injection based on the visual appearance of the synovial fluid aspirate.

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Shoulder

Intervention

Device:
• Cingal
Single injection into the shoulder joint of a 4 ml unit dose of Cingal containing 88 mg (22 mg/ml) of cross-linked sodium hyaluronate and 18 mg (4.5 mg/ml) of triamcinolone hexacetonide (TH).

Locations

Country	Name	City	State
Czechia	Krajská zdravotní, a.s. - Masarykova nemocnice Ústí nad Labem, o.z.	Ústí Nad Labem
Poland	NZOZ MEDI-SPATZ M.Spatz	Gliwice
Poland	SPORTO sp. z o.o	Lódz
Poland	Przychodnia Rodzinna na Sadowej	Torun

Sponsors (1)

Lead Sponsor	Collaborator
Anika Therapeutics, Inc.

Countries where clinical trial is conducted

Czechia,  Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Numerical Rating Scale (NRS) Pain	Reduction of Index Shoulder Numerical Rating Scale (NRS) Pain from baseline post injection was obtained from participant responses. The NRS Pain Score is an 11-point Likert scale ranged from 0 = No Pain to 10 = Worst Pain level. A negative value for the change in NRS Pain Score indicates less pain post-treatment. A larger negative value indicates a higher level of improvement, and a better outcome.	6 months
Secondary	Disabilities of the Arm, Shoulder and Hand (DASH) Score	Improvement in pain and function in the index shoulder as measured by the Disabilities of the Arm, Shoulder and Hand (DASH) score. The DASH is a 30-item self-reported questionnaire in which the response options are presented as 5-point Likert scales. Scores for each question range from 0 (no pain or disability) to 100 (most severe pain or disability) and are averaged to calculate the final DASH score from 0 to 100. A negative value for the change in DASH score indicates improvement. A larger negative value indicates a higher level of improvement, and a better outcome.	6 Months
Secondary	Patient Global Assessment (PGA) Score	The change from baseline in index shoulder pain post-treatment as measured by the Patient Global Assessment (PGA) Score. PGA Score records participant responses to their assessment of how much their STUDY (treated) shoulder is bothering them today . The PGA Score is a validated 11-point Likert scale from 0 = No Pain to 10 = Worst Pain.; A negative value for the change from baseline indicates improvement in PGA Score. A larger negative value indicates less pain, and a better clinical outcome.	6 Months
Secondary	The Outcomes Measures for Rheumatic Arthritis Clinical Trials-Osteoarthritis Research Society International (OMERACT-OARSI) Responder Index	The post-treatment responder rate is determined through a calculation defined by the Outcomes Measures for Rheumatic Arthritis Clinical Trials-Osteoarthritis Research Society International (OMERACT-OARSI) Responder Index. The OMERACT-OARSI Responder Index reports the percentage of participants that met the criteria to be a good responder to treatment. The criteria for response are (1) improvement in pain or physical function >50% and an absolute change >20 mm; or (2) improvement of >20% with an absolute change >10 mm in at least of the following three categories: pain, physical function, and patient's global assessment.; A higher percentage of subjects responding indicates a better outcome	6 Months
Secondary	Usage of Rescue Medication (Acetaminophen/Paracetamol)	The usage of Rescue Medication (RM) as based on the number of participants at 6 Months post treatmentthat were NOT using acetominophen/paracetamol RM for pain or discomfort.; A larger percentage of participants that were NOT using RM may correlate to a better clinical outcome in terms of pain.	6 Months