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

NCT04640961 | Completed Results

• 1 other identifier: Cingal 20-02
• Study Type: interventional
• Target: 25
• Locations: 2 countries
• Sites: 4

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.

Conditions

Osteoarthritis, Shoulder

Keywords

Sodium Hyaluronate; Triamcinolone Hexacetonide

Outcome Measures

Primary Outcomes (1)

• Numerical Rating Scale (NRS) Pain

  Reduction of Index Shoulder Numerical Rating Scale (NRS) Pain from baseline to 6 months 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 Outcomes (4)

• Disabilities of the Arm, Shoulder and Hand (DASH) Score

  6 Months

• Patient Global Assessment (PGA) Score

  6 Months

• The Outcomes Measures for Rheumatic Arthritis Clinical Trials-Osteoarthritis Research Society International (OMERACT-OARSI) Responder Index. A Calculated Percentage (%) of Participants Responding to Treatment

  6 Months

• Usage of Rescue Medication (Acetaminophen/Paracetamol). Number of Participants NOT Using Rescue Medication.

  6 Months

Study Arms (1)

Cingal

EXPERIMENTAL

Single injection of Cingal into the shoulder joint of subjects diagnosed with osteoarthritis of the shoulder.

Device: Cingal

Interventions

Cingal DEVICE

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).

Cingal

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 years or older
• Body Mass Index (BMI) ≤ 35 kg/m2
• 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.
• Failed conservative treatment for joint osteoarthritis.
• NRS pain ≥4 and ≤9 in the index shoulder.
• Subject must be willing to abstain from other treatments of the index shoulder for the duration of the study.
• 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.
• 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.
• 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).
• Able and willing to provide signed informed consent.
• \. NRS pain ≥4 and ≤9 in index shoulder

You may not qualify if:

• History of hypersensitivity to any of the ingredients in the hyaluronan or corticosteroids
• Infection or skin disease in the area of the injection site or index shoulder
• NRS pain \> 3 in the contralateral shoulder
• 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.
• 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.
• 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.
• 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.
• Significant trauma to the index shoulder within 26 weeks of screening.
• Chronic use of narcotics or cannabis.
• Subject has a decrease of ≥ 2 in the NRS pain from Screening to Baseline in the index shoulder.
• Subject has a contraindication to continue with the study treatment injection based on the visual appearance of the synovial fluid aspirate.

Sponsors & Collaborators

• Anika Therapeutics, Inc.: lead

Study Sites (4)

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

Ústí nad Labem, 401 13, Czechia

Location

NZOZ MEDI-SPATZ M.Spatz

Gliwice, 44-100, Poland

Location

SPORTO sp. z o.o

Lodz, 90-038, Poland

Location

Przychodnia Rodzinna na Sadowej

Torun, 87-100, Poland

Location

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Limitations and Caveats

There were no limitations or caveats associated with the conduct of this trial.

Results Point of Contact

• Title: Kara Mezger, Executive Director Clinical Affairs
• Organization: Anika Therapeutics

kmezger@anika.com

781.457.9000

Study Officials

• Kara Mezger

  Anika Therapeutics

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2020
• First Posted: November 23, 2020
• Study Start: January 16, 2021
• Primary Completion: September 10, 2021
• Study Completion: September 10, 2021
• Last Updated: December 16, 2024
• Results First Posted: March 7, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1); PL (3)