Trial Outcomes & Findings for Study of Cingal® for Symptomatic Relief of Osteoarthritis of Hip Joint (NCT NCT04640298)

NCT ID: NCT04640298

Last Updated: 2024-12-16

Results Overview

Reduction of Index Hip Numerical Rating Scale (NRS) Pain on Walking 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

Participant milestones
Measure	Cingal 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).
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 Hip Joint

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cingal n=25 Participants Single injection of Cingal into the hip joint of subjects diagnosed with osteoarthritis of the hip.
Age, Continuous	58.8 years STANDARD_DEVIATION 12.7 • n=5 Participants
Sex: Female, Male Female	20 Participants n=5 Participants
Sex: Female, Male Male	5 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 Hip Right	17 Participants n=5 Participants
Index Hip Left	8 Participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months

Population: Intent To Treat (ITT)

Reduction of Index Hip Numerical Rating Scale (NRS) Pain on Walking 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

Outcome measures
Measure	Cingal n=25 Participants Single injection 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 on Walking	-2.48 score on a scale Standard Deviation 1.61

SECONDARY outcome

Timeframe: 6 Months

Population: Intent To Treat (ITT)

Improvement from baseline to 6 months in The Lequesne Hip Index. The Lequesne Hip Index is a three-section patient questionnaire that evaluates (1) pain or discomfort, (2) maximum distance walked, and (3) activities of daily living with 0 = best results / normal scores, to scores \>14 = extremely severe, to a maximum index score of 24 points. A negative value for the change in Lequesne Hip Index indicates improvement. A larger negative value indicates a higher level of improvement, and a better outcome.

Outcome measures

Outcome measures
Measure	Cingal n=25 Participants Single injection 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)
Lequesne Hip Index	-2.76 score on a scale Standard Deviation 2.57

SECONDARY outcome

Timeframe: 6 Months

Population: Intent To Treat (ITT)

The change from baseline to 6 months in hip 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) hip is bothering them today . The PGA Score is a validated 11-point Likert scale ranged 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

Outcome measures
Measure	Cingal n=25 Participants Single injection 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	-2.56 score on a scale Standard Deviation 1.73

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 subjects 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

Outcome measures
Measure	Cingal n=25 Participants Single injection 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	18 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 treatment that 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

Outcome measures
Measure	Cingal n=25 Participants Single injection 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.	20 Participants

Adverse Events

Cingal

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Cingal n=25 participants at risk Single injection 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 recorded from the time of the baseline study visit until study completion at 6 Months. The definitions of adverse event (AE) and serious adverse event (SAE) are 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).
Gastrointestinal disorders Abdominal Pain	4.0% 1/25 • Number of events 1 • Adverse Events were recorded from the time of the baseline study visit until study completion at 6 Months. The definitions of adverse event (AE) and serious adverse event (SAE) are 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: [email protected]

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