Trial Outcomes & Findings for Study of Cingal® for Symptomatic Relief of Osteoarthritis of Shoulder Joint (NCT NCT04640961)

NCT ID: NCT04640961

Last Updated: 2024-12-16

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 25 participants
• Primary outcome timeframe: 6 months
• Results posted on: 2024-12-16

Participant Flow

Participant milestones

Measure	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).
Overall Study STARTED	25
Overall Study COMPLETED	25
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Cingal n=25 Participants Single injection into the hip 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).
Age, Continuous	60.12 years STANDARD_DEVIATION 9.52 • n=5 Participants
Sex: Female, Male Female	14 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	25 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Index Shoulder Right	17 Participants n=5 Participants
Index Shoulder Left	8 Participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months

Population: Intent To Treat (ITT)

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.

Outcome measures

Measure	Cingal n=25 Participants 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).
Numerical Rating Scale (NRS) Pain	-3.72 score on a scale Standard Deviation 2.19

SECONDARY outcome

Timeframe: 6 Months

Population: Intent To Treat (ITT)

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.

Outcome measures

Measure	Cingal n=25 Participants 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).
Disabilities of the Arm, Shoulder and Hand (DASH) Score	-38.40 score on a scale Standard Deviation 14.89

SECONDARY outcome

Timeframe: 6 Months

Population: Intent To Treat (ITT)

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.

Outcome measures

Measure	Cingal n=25 Participants 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).
Patient Global Assessment (PGA) Score	-3.88 score on a scale Standard Deviation 2.35

SECONDARY outcome

Timeframe: 6 Months

Population: Intent To Treat (ITT)

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

Outcome measures

Measure	Cingal n=25 Participants 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).
The Outcomes Measures for Rheumatic Arthritis Clinical Trials-Osteoarthritis Research Society International (OMERACT-OARSI) Responder Index. A Calculated Percentage (%) of Participants Responding to Treatment	24 Participants

SECONDARY outcome

Timeframe: 6 Months

Population: Intent To Treat (ITT)

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.

Outcome measures

Measure	Cingal n=25 Participants 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).
Usage of Rescue Medication (Acetaminophen/Paracetamol). Number of Participants NOT Using Rescue Medication.	21 Participants

Adverse Events

Cingal

Serious events: 1 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Measure

Cingal n=25 participants at risk 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).

Cardiac disorders Myocardial Infarction

4.0% 1/25 • Number of events 1 • Adverse Events were collected from the time of the Baseline Study Visit until Study Completion at 26 Weeks. The definitions of adverse events and serious adverse events is the same as used in the clinicaltrials.gov definitions. The incidence, timing, severity, and relationship to treatment of all Adverse Events (AE) were collected and coded using Medical Dictionary for Regulatory Activities (MedDRA).

Other adverse events

Measure	Cingal n=25 participants at risk 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).
Nervous system disorders Headache	12.0% 3/25 • Number of events 3 • Adverse Events were collected from the time of the Baseline Study Visit until Study Completion at 26 Weeks. The definitions of adverse events and serious adverse events is the same as used in the clinicaltrials.gov definitions. The incidence, timing, severity, and relationship to treatment of all Adverse Events (AE) were collected and coded using Medical Dictionary for Regulatory Activities (MedDRA).
Musculoskeletal and connective tissue disorders Polymyalgia rheumatica	4.0% 1/25 • Number of events 1 • Adverse Events were collected from the time of the Baseline Study Visit until Study Completion at 26 Weeks. The definitions of adverse events and serious adverse events is the same as used in the clinicaltrials.gov definitions. The incidence, timing, severity, and relationship to treatment of all Adverse Events (AE) were collected and coded using Medical Dictionary for Regulatory Activities (MedDRA).
Reproductive system and breast disorders Ovulation Pain	4.0% 1/25 • Number of events 1 • Adverse Events were collected from the time of the Baseline Study Visit until Study Completion at 26 Weeks. The definitions of adverse events and serious adverse events is the same as used in the clinicaltrials.gov definitions. The incidence, timing, severity, and relationship to treatment of all Adverse Events (AE) were collected and coded using Medical Dictionary for Regulatory Activities (MedDRA).

Additional Information

Kara Mezger, Executive Director Clinical Affairs

Anika Therapeutics

Phone: 781.457.9000

Email: kmezger@anika.com

Results disclosure agreements

• Principal investigator is a sponsor employee INVESTIGATOR may publish the Data/Results with the consent of the SPONSOR if: 1. Publication is done after primary publication covering data from all participating sites, and provided the Data/Results do not contain any Confidential Information. 2. Eighteen (18) months has elapsed after entire completion of the Clinical Trial at all participating sites.
• Publication restrictions are in place

Restriction type: OTHER