Osteoarthritis, ShoulderNCT04640961
Study of Cingal® for Symptomatic Relief of Osteoarthritis of Shoulder Joint
A study testing Cingal in people with Osteoarthritis, Shoulder, run by Anika Therapeutics, Inc. at 4 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Osteoarthritis, Shoulder
- What is being tested?
- Cingal
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 16 Jan 2021to 10 Sep 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Screening Inclusion Criteria
- 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.
Baseline Inclusion Criteria
- NRS pain ≥4 and ≤9 in index shoulder
Screening Exclusion Criteria:
- 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.
Baseline Exclusion Criteria
- 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.
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
Poland3 sites
NZOZ MEDI-SPATZ M.Spatz
Gliwice, 44-100
SPORTO sp. z o.o
Lodz, 90-038
Przychodnia Rodzinna na Sadowej
Torun, 87-100
Czechia1 site
Krajská zdravotní, a.s. - Masarykova nemocnice Ústí nad Labem, o.z.
Ústí nad Labem, 401 13
About this study
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
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.
Read the 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.
- Conditions
- Osteoarthritis, Shoulder
- Being tested
- Cingal
- Keywords
- Sodium Hyaluronate, Triamcinolone Hexacetonide
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CingalDevice
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).
| Study group | Role | What they receive |
|---|---|---|
| Cingal | Experimental | Single injection of Cingal into the shoulder joint of subjects diagnosed with osteoarthritis of the shoulder. Receives: Device: Cingal |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (4)
Disabilities of the Arm, Shoulder and Hand (DASH) Score
Improvement in pain and function in the index shoulder from baseline to 6 months 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.
Measured: 6 Months
Patient Global Assessment (PGA) Score
The change from baseline to 6 months 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.
Measured: 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
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
Measured: 6 Months
Usage of Rescue Medication (Acetaminophen/Paracetamol). Number of Participants NOT Using Rescue Medication.
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.
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2020
- Study start16 Jan 2021
- Primary completion10 Sep 2021
- Study completion10 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Osteoarthritis, ShoulderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Anika Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kara Mezger, Study director, Anika Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04640961
- Sponsor's protocol ID
- Cingal 20-02
- Status last verified
- Dec 2024
- First submitted
- 19 Nov 2020
- Last updated
- 16 Dec 2024
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04640961
- Acronym / sponsor ID
- Cingal 20-02
- Conditions
- Osteoarthritis, Shoulder
- Keywords
- Sodium Hyaluronate, Triamcinolone Hexacetonide
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Anika Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 16 Jan 2021 (actual)
- Primary completion
- 10 Sep 2021 (actual)
- Study completion
- 10 Sep 2021 (actual)
- First posted
- 23 Nov 2020 (actual)
- Results
- Posted 7 Mar 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cingal | Experimental | Device: CingalSingle injection of Cingal into the shoulder joint of subjects diagnosed with osteoarthritis of the shoulder. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CingalSingle 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). | Device | Cingal |
Primary outcome
Numerical Rating Scale (NRS) Pain
Time frame: 6 months
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.
4 secondary outcomes
Disabilities of the Arm, Shoulder and Hand (DASH) Score
Time frame: 6 Months
Patient Global Assessment (PGA) Score
Time frame: 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
Time frame: 6 Months
Usage of Rescue Medication (Acetaminophen/Paracetamol). Number of Participants NOT Using Rescue Medication.
Time frame: 6 Months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kara Mezger study director
Anika Therapeutics
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cingal in people with Osteoarthritis, Shoulder, run by Anika Therapeutics, Inc. at 4 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Poland, Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Mar 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numerical Rating Scale (NRS) Pain (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2024.