Clinical trial NCT04640961: Study of Cingal® for Symptomatic Relief of Osteoarthritis of Shoulder Joint
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis, Shoulder
Keywords: Sodium Hyaluronate
Triamcinolone Hexacetonide
Lead sponsor: Anika Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2020-11-23
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 shoulder joint.

Detailed 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.

Eligibility 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 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.

Primary outcomes:
measure: Numerical Rating Scale (NRS) Pain
timeFrame: 6 months
Secondary outcomes:
measure: Disabilities of the Arm, Shoulder and Hand (DASH) Score
timeFrame: 6 Months
measure: Patient Global Assessment (PGA) Score
timeFrame: 6 Months
measure: The Outcomes Measures for Rheumatic Arthritis Clinical Trials-Osteoarthritis Research Society International (OMERACT-OARSI) Responder Index. A Calculated Percentage (%) of Participants Responding to Treatment
timeFrame: 6 Months
measure: Usage of Rescue Medication (Acetaminophen/Paracetamol). Number of Participants NOT Using Rescue Medication.
timeFrame: 6 Months
Other outcomes:
Locations:
city: Ústí Nad Labem
country: Czechia
facility: Krajská zdravotní, a.s. - Masarykova nemocnice Ústí nad Labem, o.z.
city: Gliwice
country: Poland
facility: NZOZ MEDI-SPATZ M.Spatz
city: Toruń
country: Poland
facility: Przychodnia Rodzinna na Sadowej
city: Łódź
country: Poland
facility: SPORTO sp. z o.o
Study officials:
affiliation: Anika Therapeutics
name: Kara Mezger
role: STUDY_DIRECTOR
References: