Trial Outcomes & Findings for Study of Cingal for the Relief of Knee Osteoarthritis Compared to Triamcinolone Hexacetonide at 39 Weeks Follow up (NCT NCT03390036)
NCT ID: NCT03390036
Last Updated: 2023-05-31
Results Overview
The post treatment Responder Rate at 39 weeks 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. 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 two of the following three categories: pain, physical function, and patient's global assessment. A higher percentage of subjects responding indicates a better outcome.
COMPLETED
PHASE3
526 participants
39 weeks
2023-05-31
Participant Flow
Subjects enrolled in Cingal 16-02 were given the option to enroll in Cingal 17-02 for a 39-week follow-up. 233 subjects in the Cingal arm (95%), 230 subjects in the Monovisc arm (93%), and 63 subjects in the Triamcinolone Hexacetonide arm (90%) elected to enroll in the extension study.
No enrolled participants were excluded.
Participant milestones
| Measure |
Cingal
Cingal is a combination product consisting of 88 milligrams of crosslinked HA (hyaluronic acid) with 18 milligrams of TH (triamcinolone hexacetonide) in a 4 milliliter (mL) intra-articular injection.
Cingal: Hyaluronic Acid with Triamcinolone Hexacetonide
|
Monovisc
Monovisc is a device that consists of 88 milligrams of cross-linked HA (hyaluronic acid) in a 4 milliliter (mL) intra-articular injection.
Monovisc: Hyaluronic Acid
|
Triamcinolone Hexacetonide (TH)
Triamcinolone hexacetonide (TH) is a corticosteroid supplied in a 20 milligram per 1 milliliter (20 mg/mL) intra-articular injection.
Triamcinolone Hexacetonide: Triamcinolone Hexacetonide
|
|---|---|---|---|
|
Overall Study
STARTED
|
233
|
230
|
63
|
|
Overall Study
COMPLETED
|
231
|
230
|
63
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
0
|
Reasons for withdrawal
| Measure |
Cingal
Cingal is a combination product consisting of 88 milligrams of crosslinked HA (hyaluronic acid) with 18 milligrams of TH (triamcinolone hexacetonide) in a 4 milliliter (mL) intra-articular injection.
Cingal: Hyaluronic Acid with Triamcinolone Hexacetonide
|
Monovisc
Monovisc is a device that consists of 88 milligrams of cross-linked HA (hyaluronic acid) in a 4 milliliter (mL) intra-articular injection.
Monovisc: Hyaluronic Acid
|
Triamcinolone Hexacetonide (TH)
Triamcinolone hexacetonide (TH) is a corticosteroid supplied in a 20 milligram per 1 milliliter (20 mg/mL) intra-articular injection.
Triamcinolone Hexacetonide: Triamcinolone Hexacetonide
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
0
|
|
Overall Study
Lack of Efficacy
|
1
|
0
|
0
|
Baseline Characteristics
Study of Cingal for the Relief of Knee Osteoarthritis Compared to Triamcinolone Hexacetonide at 39 Weeks Follow up
Baseline characteristics by cohort
| Measure |
Cingal
n=233 Participants
Cingal is a combination product consisting of 88 milligrams of crosslinked HA (hyaluronic acid) with 18 milligrams of TH (triamcinolone hexacetonide) in a 4 milliliter (mL) intra-articular injection.
Cingal: Hyaluronic Acid with Triamcinolone Hexacetonide
|
Monovisc
n=230 Participants
Monovisc is a device that consists of 88 milligrams of cross-linked HA (hyaluronic acid) in a 4 milliliter (mL) intra-articular injection.
Monovisc: Hyaluronic Acid
|
Triamcinolone Hexacetonide (TH)
n=63 Participants
Triamcinolone hexacetonide (TH) is a corticosteroid supplied in a 20 milligram per 1 milliliter (20 mg/mL) intra-articular injection.
Triamcinolone Hexacetonide: Triamcinolone Hexacetonide
|
Total
n=526 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
57.8 years
STANDARD_DEVIATION 8.8 • n=5 Participants
|
57.7 years
STANDARD_DEVIATION 8.9 • n=7 Participants
|
59.2 years
STANDARD_DEVIATION 8.4 • n=5 Participants
|
57.9 years
STANDARD_DEVIATION 8.8 • n=4 Participants
|
|
Sex: Female, Male
Female
|
165 Participants
n=5 Participants
|
152 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
361 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
68 Participants
n=5 Participants
|
78 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
165 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
233 Participants
n=5 Participants
|
230 Participants
n=7 Participants
|
63 Participants
n=5 Participants
|
526 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Baseline WOMAC Pain in Index Knee
|
63.5 millimeters (mm)
STANDARD_DEVIATION 11.1 • n=5 Participants
|
63.7 millimeters (mm)
STANDARD_DEVIATION 11.4 • n=7 Participants
|
64.6 millimeters (mm)
STANDARD_DEVIATION 10.9 • n=5 Participants
|
63.7 millimeters (mm)
STANDARD_DEVIATION 11.2 • n=4 Participants
|
PRIMARY outcome
Timeframe: 39 weeksPopulation: Intent to Treat population
The post treatment Responder Rate at 39 weeks 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. 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 two 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=233 Participants
Cingal is a combination product consisting of 88 milligrams of crosslinked HA (hyaluronic acid) with 18 milligrams of TH (triamcinolone hexacetonide) in a 4 milliliter (mL) intra-articular injection.
Cingal: Hyaluronic Acid with Triamcinolone Hexacetonide
|
Monovisc
n=230 Participants
Monovisc is a device that consists of 88 milligrams of cross-linked HA (hyaluronic acid) in a 4 milliliter (mL) intra-articular injection.
Monovisc: Hyaluronic Acid
|
Triamcinolone Hexacetonide (TH)
n=63 Participants
Triamcinolone hexacetonide (TH) is a corticosteroid supplied in a 20 milligram per 1 milliliter (20 mg/mL) intra-articular injection.
Triamcinolone Hexacetonide: Triamcinolone Hexacetonide
|
|---|---|---|---|
|
OMERACT-OARSI Responder Rate at 39 Weeks
|
91.2 Percentage of subjects
|
92.4 Percentage of subjects
|
93.2 Percentage of subjects
|
SECONDARY outcome
Timeframe: 39 WeeksPopulation: Intent to Treat Population
The change from baseline in knee pain as measured by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score at 39 weeks post treatment comparing the Cingal group to the Triamcinolone Hexacetonide group. The WOMAC Pain Score is a validated visual analog scale from 0 to 100 mm, where a higher score is equal to a higher pain level. A negative number for the difference from baseline indicates improvement in pain. A greater negative difference from baseline indicates a better outcome.
Outcome measures
| Measure |
Cingal
n=233 Participants
Cingal is a combination product consisting of 88 milligrams of crosslinked HA (hyaluronic acid) with 18 milligrams of TH (triamcinolone hexacetonide) in a 4 milliliter (mL) intra-articular injection.
Cingal: Hyaluronic Acid with Triamcinolone Hexacetonide
|
Monovisc
n=230 Participants
Monovisc is a device that consists of 88 milligrams of cross-linked HA (hyaluronic acid) in a 4 milliliter (mL) intra-articular injection.
Monovisc: Hyaluronic Acid
|
Triamcinolone Hexacetonide (TH)
n=63 Participants
Triamcinolone hexacetonide (TH) is a corticosteroid supplied in a 20 milligram per 1 milliliter (20 mg/mL) intra-articular injection.
Triamcinolone Hexacetonide: Triamcinolone Hexacetonide
|
|---|---|---|---|
|
Change From Baseline in WOMAC Pain Score at 39 Weeks
39 Week WOMAC Pain in mm
|
17.0 Millimeters (mm)
Standard Deviation 19.3
|
16.0 Millimeters (mm)
Standard Deviation 18.6
|
20.1 Millimeters (mm)
Standard Deviation 21.1
|
|
Change From Baseline in WOMAC Pain Score at 39 Weeks
Change from Baseline in WOMAC Pain 39 Weeks
|
-46.3 Millimeters (mm)
Standard Deviation 20.2
|
-47.2 Millimeters (mm)
Standard Deviation 18.6
|
-43.6 Millimeters (mm)
Standard Deviation 21.4
|
|
Change From Baseline in WOMAC Pain Score at 39 Weeks
Baseline WOMAC Pain in mm
|
63.3 Millimeters (mm)
Standard Deviation 11.0
|
63.3 Millimeters (mm)
Standard Deviation 11.3
|
63.8 Millimeters (mm)
Standard Deviation 11.3
|
SECONDARY outcome
Timeframe: 39 WeeksPopulation: Intent to Treat Population
This endpoint compares the change of the WOMAC Physical Function Score from baseline to Week 39 between the Cingal and Triamcinolone Hexacetonide arms. The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Score is a validated visual analog scale from 0 to 100 mm, where a higher score is equal to a higher degree of functional limitation. A negative number for the change from baseline indicates improvement in physical function.
Outcome measures
| Measure |
Cingal
n=233 Participants
Cingal is a combination product consisting of 88 milligrams of crosslinked HA (hyaluronic acid) with 18 milligrams of TH (triamcinolone hexacetonide) in a 4 milliliter (mL) intra-articular injection.
Cingal: Hyaluronic Acid with Triamcinolone Hexacetonide
|
Monovisc
n=230 Participants
Monovisc is a device that consists of 88 milligrams of cross-linked HA (hyaluronic acid) in a 4 milliliter (mL) intra-articular injection.
Monovisc: Hyaluronic Acid
|
Triamcinolone Hexacetonide (TH)
n=63 Participants
Triamcinolone hexacetonide (TH) is a corticosteroid supplied in a 20 milligram per 1 milliliter (20 mg/mL) intra-articular injection.
Triamcinolone Hexacetonide: Triamcinolone Hexacetonide
|
|---|---|---|---|
|
Change From Baseline in WOMAC Physical Function Score at 39 Weeks
Change from Baseline WOMAC Function 39 Weeks
|
-42.5 Millimeters (mm)
Standard Deviation 22.4
|
-43.5 Millimeters (mm)
Standard Deviation 20.7
|
-41.1 Millimeters (mm)
Standard Deviation 22.5
|
|
Change From Baseline in WOMAC Physical Function Score at 39 Weeks
Baseline WOMAC Function
|
60.8 Millimeters (mm)
Standard Deviation 15.2
|
60.8 Millimeters (mm)
Standard Deviation 15.8
|
61.8 Millimeters (mm)
Standard Deviation 15.7
|
|
Change From Baseline in WOMAC Physical Function Score at 39 Weeks
39 Week WOMAC Function
|
18.4 Millimeters (mm)
Standard Deviation 19.8
|
17.3 Millimeters (mm)
Standard Deviation 18.6
|
20.7 Millimeters (mm)
Standard Deviation 21.3
|
SECONDARY outcome
Timeframe: 39 WeeksPopulation: Intent to Treat Population
The change from baseline in knee stiffness as measured by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Score at 39 weeks post treatment comparing the Cingal group to the Triamcinolone Hexacetonide group. The WOMAC Stiffness Score is a validated visual analog scale from 0 to 100 mm, where a higher score is equal to a higher degree of stiffness. A negative number for the change from baseline indicates improvement in knee stiffness.
Outcome measures
| Measure |
Cingal
n=233 Participants
Cingal is a combination product consisting of 88 milligrams of crosslinked HA (hyaluronic acid) with 18 milligrams of TH (triamcinolone hexacetonide) in a 4 milliliter (mL) intra-articular injection.
Cingal: Hyaluronic Acid with Triamcinolone Hexacetonide
|
Monovisc
n=230 Participants
Monovisc is a device that consists of 88 milligrams of cross-linked HA (hyaluronic acid) in a 4 milliliter (mL) intra-articular injection.
Monovisc: Hyaluronic Acid
|
Triamcinolone Hexacetonide (TH)
n=63 Participants
Triamcinolone hexacetonide (TH) is a corticosteroid supplied in a 20 milligram per 1 milliliter (20 mg/mL) intra-articular injection.
Triamcinolone Hexacetonide: Triamcinolone Hexacetonide
|
|---|---|---|---|
|
Change From Baseline in WOMAC Stiffness Score at 39 Weeks
Baseline WOMAC Stiffness in mm
|
57.7 Millimeters (mm)
Standard Deviation 19.3
|
59.2 Millimeters (mm)
Standard Deviation 18.1
|
57.9 Millimeters (mm)
Standard Deviation 17.6
|
|
Change From Baseline in WOMAC Stiffness Score at 39 Weeks
39 Week WOMAC Stiffness in mm
|
17.9 Millimeters (mm)
Standard Deviation 20.0
|
17.2 Millimeters (mm)
Standard Deviation 18.6
|
19.9 Millimeters (mm)
Standard Deviation 21.9
|
|
Change From Baseline in WOMAC Stiffness Score at 39 Weeks
Change from Baseline in WOMAC Stiffness 39 Weeks
|
-39.8 Millimeters (mm)
Standard Deviation 24.4
|
-42.0 Millimeters (mm)
Standard Deviation 22.4
|
-38.0 Millimeters (mm)
Standard Deviation 24.9
|
SECONDARY outcome
Timeframe: 39 WeeksPopulation: Intent to Treat Population
The change from baseline as measured by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Total Score at 39 weeks post treatment comparing the Cingal group to the Triamcinolone Hexacetonide group. The Total WOMAC Score is determined from the SUM of the scores from the WOMAC Pain Score, the WOMAC Stiffness Score, and the WOMAC Physical Function Score, resulting in a final range for Total Score from 0 mm to 240 mm. A higher Total WOMAC Score indicates a higher overall degree of pain, stiffness and functional limitations. A negative number for the change from baseline indicates improvement in the Total WOMAC Score.
Outcome measures
| Measure |
Cingal
n=233 Participants
Cingal is a combination product consisting of 88 milligrams of crosslinked HA (hyaluronic acid) with 18 milligrams of TH (triamcinolone hexacetonide) in a 4 milliliter (mL) intra-articular injection.
Cingal: Hyaluronic Acid with Triamcinolone Hexacetonide
|
Monovisc
n=230 Participants
Monovisc is a device that consists of 88 milligrams of cross-linked HA (hyaluronic acid) in a 4 milliliter (mL) intra-articular injection.
Monovisc: Hyaluronic Acid
|
Triamcinolone Hexacetonide (TH)
n=63 Participants
Triamcinolone hexacetonide (TH) is a corticosteroid supplied in a 20 milligram per 1 milliliter (20 mg/mL) intra-articular injection.
Triamcinolone Hexacetonide: Triamcinolone Hexacetonide
|
|---|---|---|---|
|
Change From Baseline in Total WOMAC Score at 39 Weeks
Change from Baseline in Total WOMAC 39 Weeks
|
-128.4 Millimeters (mm)
Standard Deviation 63.1
|
-132.6 Millimeters (mm)
Standard Deviation 56.6
|
-122.7 Millimeters (mm)
Standard Deviation 62.2
|
|
Change From Baseline in Total WOMAC Score at 39 Weeks
39 Week Total WOMAC in mm
|
53.4 Millimeters (mm)
Standard Deviation 58.1
|
50.8 Millimeters (mm)
Standard Deviation 54.6
|
60.8 Millimeters (mm)
Standard Deviation 62.5
|
|
Change From Baseline in Total WOMAC Score at 39 Weeks
Baseline Total WOMAC in mm
|
181.8 Millimeters (mm)
Standard Deviation 40.6
|
183.4 Millimeters (mm)
Standard Deviation 39.4
|
183.5 Millimeters (mm)
Standard Deviation 38.4
|
SECONDARY outcome
Timeframe: 39 WeeksPopulation: Intent to Treat Population
Comparison of the change of the Patient Global Assessment from baseline to 39 weeks between the Cingal and Triamcinolone Hexacetonide arms (ITT population). The Patient Global Assessment is done by the subject, and answers the question "Considering all the ways the osteoarthritis in your index knee bothers you, what is your assessment of how much your knee is bothering you today?" The Patient Global Assessment is scored on a 0 to 100 mm visual analog scale, where a higher number means the patient is bothered to a higher degree. A negative number for the change from baseline indicates a reduction (improvement) in the assessment.
Outcome measures
| Measure |
Cingal
n=233 Participants
Cingal is a combination product consisting of 88 milligrams of crosslinked HA (hyaluronic acid) with 18 milligrams of TH (triamcinolone hexacetonide) in a 4 milliliter (mL) intra-articular injection.
Cingal: Hyaluronic Acid with Triamcinolone Hexacetonide
|
Monovisc
n=230 Participants
Monovisc is a device that consists of 88 milligrams of cross-linked HA (hyaluronic acid) in a 4 milliliter (mL) intra-articular injection.
Monovisc: Hyaluronic Acid
|
Triamcinolone Hexacetonide (TH)
n=63 Participants
Triamcinolone hexacetonide (TH) is a corticosteroid supplied in a 20 milligram per 1 milliliter (20 mg/mL) intra-articular injection.
Triamcinolone Hexacetonide: Triamcinolone Hexacetonide
|
|---|---|---|---|
|
Change From Baseline in Patient Global Assessment at 39 Weeks
Change from Baseline in Patient Global 39 weeks
|
-38.6 Millimeters (mm)
Standard Deviation 25.4
|
-38.2 Millimeters (mm)
Standard Deviation 22.8
|
-36.7 Millimeters (mm)
Standard Deviation 28.0
|
|
Change From Baseline in Patient Global Assessment at 39 Weeks
Baseline Patient Global in mm
|
57.0 Millimeters (mm)
Standard Deviation 18.9
|
56.0 Millimeters (mm)
Standard Deviation 18.6
|
58.2 Millimeters (mm)
Standard Deviation 20.3
|
|
Change From Baseline in Patient Global Assessment at 39 Weeks
39 Week Patient Global in mm
|
18.4 Millimeters (mm)
Standard Deviation 19.8
|
17.8 Millimeters (mm)
Standard Deviation 19.4
|
21.5 Millimeters (mm)
Standard Deviation 22.1
|
SECONDARY outcome
Timeframe: 39 WeeksPopulation: Intent to Treat Population
Comparison of the change of the Evaluator Global Assessment from baseline to 39 weeks between the Cingal and Triamcinolone Hexacetonide arms (ITT population). The Evaluator Global Assessment is done by the Blinded Outcomes Assessor, and answers the question "Considering all the ways the osteoarthritis in the patient's index knee bothers him/her, what is your assessment of how much the patient's knee is bothering him/her today?" The Evaluator Global Assessment is scored on a 0 to 100 mm visual analog scale, where a higher number means the Evaluator assesses that the patient is bothered to a higher degree. A negative number for the change from baseline indicates a reduction (improvement) in the assessment.
Outcome measures
| Measure |
Cingal
n=233 Participants
Cingal is a combination product consisting of 88 milligrams of crosslinked HA (hyaluronic acid) with 18 milligrams of TH (triamcinolone hexacetonide) in a 4 milliliter (mL) intra-articular injection.
Cingal: Hyaluronic Acid with Triamcinolone Hexacetonide
|
Monovisc
n=230 Participants
Monovisc is a device that consists of 88 milligrams of cross-linked HA (hyaluronic acid) in a 4 milliliter (mL) intra-articular injection.
Monovisc: Hyaluronic Acid
|
Triamcinolone Hexacetonide (TH)
n=63 Participants
Triamcinolone hexacetonide (TH) is a corticosteroid supplied in a 20 milligram per 1 milliliter (20 mg/mL) intra-articular injection.
Triamcinolone Hexacetonide: Triamcinolone Hexacetonide
|
|---|---|---|---|
|
Change From Baseline in Evaluator Global Assessment at 39 Weeks
Change from Baseline in Evaluator Global 39 eeks
|
-37.1 Millimeters (mm)
Standard Deviation 21.3
|
-37.7 Millimeters (mm)
Standard Deviation 19.9
|
-39.1 Millimeters (mm)
Standard Deviation 22.1
|
|
Change From Baseline in Evaluator Global Assessment at 39 Weeks
Baseline Evaluator Global in mm
|
52.9 Millimeters (mm)
Standard Deviation 17.2
|
52.3 Millimeters (mm)
Standard Deviation 17.7
|
56.6 Millimeters (mm)
Standard Deviation 18.1
|
|
Change From Baseline in Evaluator Global Assessment at 39 Weeks
39 Week Evaluator Global in mm
|
15.8 Millimeters (mm)
Standard Deviation 16.5
|
14.6 Millimeters (mm)
Standard Deviation 16.5
|
17.4 Millimeters (mm)
Standard Deviation 15.6
|
SECONDARY outcome
Timeframe: 39 WeeksPopulation: Intent to Treat Population
The usage of rescue medication (number of pills of acetominophen) at Week 39 weeks post treatment in the Cingal group compared to the Triamcinolone Hexacetonide group.
Outcome measures
| Measure |
Cingal
n=233 Participants
Cingal is a combination product consisting of 88 milligrams of crosslinked HA (hyaluronic acid) with 18 milligrams of TH (triamcinolone hexacetonide) in a 4 milliliter (mL) intra-articular injection.
Cingal: Hyaluronic Acid with Triamcinolone Hexacetonide
|
Monovisc
n=230 Participants
Monovisc is a device that consists of 88 milligrams of cross-linked HA (hyaluronic acid) in a 4 milliliter (mL) intra-articular injection.
Monovisc: Hyaluronic Acid
|
Triamcinolone Hexacetonide (TH)
n=63 Participants
Triamcinolone hexacetonide (TH) is a corticosteroid supplied in a 20 milligram per 1 milliliter (20 mg/mL) intra-articular injection.
Triamcinolone Hexacetonide: Triamcinolone Hexacetonide
|
|---|---|---|---|
|
The Usage of Rescue Medication (Acetaminophen) at Week 39
|
7.9 Number of pills
Standard Deviation 39.5
|
6.0 Number of pills
Standard Deviation 18.7
|
6.9 Number of pills
Standard Deviation 22.8
|
Adverse Events
Cingal
Monovisc
Triamcinolone Hexacetonide (TH)
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Cingal
n=233 participants at risk
Cingal is a combination product consisting of 88 milligrams of crosslinked HA (hyaluronic acid) with 18 milligrams of TH (triamcinolone hexacetonide) in a 4 milliliter (mL) intra-articular injection.
Cingal: Hyaluronic Acid with Triamcinolone Hexacetonide
|
Monovisc
n=230 participants at risk
Monovisc is a device that consists of 88 milligrams of cross-linked HA (hyaluronic acid) in a 4 milliliter (mL) intra-articular injection.
Monovisc: Hyaluronic Acid
|
Triamcinolone Hexacetonide (TH)
n=63 participants at risk
Triamcinolone hexacetonide (TH) is a corticosteroid supplied in a 20 milligram per 1 milliliter (20 mg/mL) intra-articular injection.
Triamcinolone Hexacetonide: Triamcinolone Hexacetonide
|
|---|---|---|---|
|
Nervous system disorders
Headache
|
3.0%
7/233 • Number of events 7 • Adverse events were collected from the 26 Week visit (the last one in the Cingal 16-02 study) through the 39 Week visit in the Cingal 17-02 extension study.
The adverse event descriptions used are consistent with the clinicaltrials.gov definitions.
|
2.6%
6/230 • Number of events 6 • Adverse events were collected from the 26 Week visit (the last one in the Cingal 16-02 study) through the 39 Week visit in the Cingal 17-02 extension study.
The adverse event descriptions used are consistent with the clinicaltrials.gov definitions.
|
0.00%
0/63 • Adverse events were collected from the 26 Week visit (the last one in the Cingal 16-02 study) through the 39 Week visit in the Cingal 17-02 extension study.
The adverse event descriptions used are consistent with the clinicaltrials.gov definitions.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.4%
8/233 • Number of events 8 • Adverse events were collected from the 26 Week visit (the last one in the Cingal 16-02 study) through the 39 Week visit in the Cingal 17-02 extension study.
The adverse event descriptions used are consistent with the clinicaltrials.gov definitions.
|
1.7%
4/230 • Number of events 4 • Adverse events were collected from the 26 Week visit (the last one in the Cingal 16-02 study) through the 39 Week visit in the Cingal 17-02 extension study.
The adverse event descriptions used are consistent with the clinicaltrials.gov definitions.
|
0.00%
0/63 • Adverse events were collected from the 26 Week visit (the last one in the Cingal 16-02 study) through the 39 Week visit in the Cingal 17-02 extension study.
The adverse event descriptions used are consistent with the clinicaltrials.gov definitions.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.86%
2/233 • Number of events 2 • Adverse events were collected from the 26 Week visit (the last one in the Cingal 16-02 study) through the 39 Week visit in the Cingal 17-02 extension study.
The adverse event descriptions used are consistent with the clinicaltrials.gov definitions.
|
0.87%
2/230 • Number of events 2 • Adverse events were collected from the 26 Week visit (the last one in the Cingal 16-02 study) through the 39 Week visit in the Cingal 17-02 extension study.
The adverse event descriptions used are consistent with the clinicaltrials.gov definitions.
|
3.2%
2/63 • Number of events 2 • Adverse events were collected from the 26 Week visit (the last one in the Cingal 16-02 study) through the 39 Week visit in the Cingal 17-02 extension study.
The adverse event descriptions used are consistent with the clinicaltrials.gov definitions.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.43%
1/233 • Number of events 1 • Adverse events were collected from the 26 Week visit (the last one in the Cingal 16-02 study) through the 39 Week visit in the Cingal 17-02 extension study.
The adverse event descriptions used are consistent with the clinicaltrials.gov definitions.
|
1.7%
4/230 • Number of events 4 • Adverse events were collected from the 26 Week visit (the last one in the Cingal 16-02 study) through the 39 Week visit in the Cingal 17-02 extension study.
The adverse event descriptions used are consistent with the clinicaltrials.gov definitions.
|
0.00%
0/63 • Adverse events were collected from the 26 Week visit (the last one in the Cingal 16-02 study) through the 39 Week visit in the Cingal 17-02 extension study.
The adverse event descriptions used are consistent with the clinicaltrials.gov definitions.
|
|
Musculoskeletal and connective tissue disorders
Spinal pain
|
0.43%
1/233 • Number of events 1 • Adverse events were collected from the 26 Week visit (the last one in the Cingal 16-02 study) through the 39 Week visit in the Cingal 17-02 extension study.
The adverse event descriptions used are consistent with the clinicaltrials.gov definitions.
|
1.3%
3/230 • Number of events 3 • Adverse events were collected from the 26 Week visit (the last one in the Cingal 16-02 study) through the 39 Week visit in the Cingal 17-02 extension study.
The adverse event descriptions used are consistent with the clinicaltrials.gov definitions.
|
1.6%
1/63 • Number of events 1 • Adverse events were collected from the 26 Week visit (the last one in the Cingal 16-02 study) through the 39 Week visit in the Cingal 17-02 extension study.
The adverse event descriptions used are consistent with the clinicaltrials.gov definitions.
|
|
Cardiac disorders
Arrythmia
|
0.43%
1/233 • Number of events 1 • Adverse events were collected from the 26 Week visit (the last one in the Cingal 16-02 study) through the 39 Week visit in the Cingal 17-02 extension study.
The adverse event descriptions used are consistent with the clinicaltrials.gov definitions.
|
0.00%
0/230 • Adverse events were collected from the 26 Week visit (the last one in the Cingal 16-02 study) through the 39 Week visit in the Cingal 17-02 extension study.
The adverse event descriptions used are consistent with the clinicaltrials.gov definitions.
|
1.6%
1/63 • Number of events 1 • Adverse events were collected from the 26 Week visit (the last one in the Cingal 16-02 study) through the 39 Week visit in the Cingal 17-02 extension study.
The adverse event descriptions used are consistent with the clinicaltrials.gov definitions.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/233 • Adverse events were collected from the 26 Week visit (the last one in the Cingal 16-02 study) through the 39 Week visit in the Cingal 17-02 extension study.
The adverse event descriptions used are consistent with the clinicaltrials.gov definitions.
|
0.00%
0/230 • Adverse events were collected from the 26 Week visit (the last one in the Cingal 16-02 study) through the 39 Week visit in the Cingal 17-02 extension study.
The adverse event descriptions used are consistent with the clinicaltrials.gov definitions.
|
3.2%
2/63 • Number of events 2 • Adverse events were collected from the 26 Week visit (the last one in the Cingal 16-02 study) through the 39 Week visit in the Cingal 17-02 extension study.
The adverse event descriptions used are consistent with the clinicaltrials.gov definitions.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place