Trial Outcomes & Findings for Repeat Injection of Cingal® for Osteoarthritis of the Knee (NCT NCT02381652)
NCT ID: NCT02381652
Last Updated: 2022-03-22
Results Overview
The primary outcome measure will compare safety results (all adverse events, whether related to the study injection or not) for Cingal 13-01 and Cingal 13-02.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
242 participants
Primary outcome timeframe
Baseline through 6 weeks post-injection
Results posted on
2022-03-22
Participant Flow
Subjects were recruited into Cingal 13-02 in February 2015. Sites that enrolled 5 or more subjects in the Cingal 13-01 study were eligible to participate in the Cingal 13-02 study. All subjects at these sites who met enrollment criteria had the option to participate in the follow-on study.
All enrolled subjects were treated with Cingal in the study. There were no exclusions.
Participant milestones
| Measure |
Cingal/Cingal
Subjects who had received an injection of Cingal in the 13-01 study will receive a single 4 milliliter (mL) intra-articular injection of Cingal (88 milligrams Hyaluronic Acid plus 18 milligramsTriamcinolone Hexacetonide) in the index knee in the 13-02 study.
Cingal: Injection into the knee
|
Cingal/Monovisc
Subjects who had received an injection of Monovisc in the 13-01 study will receive a single 4 milliliter (mL) intra-articular injection of Cingal (88 milligrams Hyaluronic Acid plus 18 milligramsTriamcinolone Hexacetonide) in the index knee in the 13-02 study.
Cingal: Injection into the knee
|
Cingal/Saline
Subjects who had received an injection of Saline in the 13-01 study will receive a single 4 milliliter (mL) intra-articular injection of Cingal (88 milligrams Hyaluronic Acid plus 18 milligramsTriamcinolone Hexacetonide) in the index knee in the 13-02 study.
Cingal: Injection into the knee
|
|---|---|---|---|
|
Overall Study
STARTED
|
94
|
98
|
50
|
|
Overall Study
COMPLETED
|
94
|
98
|
49
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
1
|
Reasons for withdrawal
| Measure |
Cingal/Cingal
Subjects who had received an injection of Cingal in the 13-01 study will receive a single 4 milliliter (mL) intra-articular injection of Cingal (88 milligrams Hyaluronic Acid plus 18 milligramsTriamcinolone Hexacetonide) in the index knee in the 13-02 study.
Cingal: Injection into the knee
|
Cingal/Monovisc
Subjects who had received an injection of Monovisc in the 13-01 study will receive a single 4 milliliter (mL) intra-articular injection of Cingal (88 milligrams Hyaluronic Acid plus 18 milligramsTriamcinolone Hexacetonide) in the index knee in the 13-02 study.
Cingal: Injection into the knee
|
Cingal/Saline
Subjects who had received an injection of Saline in the 13-01 study will receive a single 4 milliliter (mL) intra-articular injection of Cingal (88 milligrams Hyaluronic Acid plus 18 milligramsTriamcinolone Hexacetonide) in the index knee in the 13-02 study.
Cingal: Injection into the knee
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
1
|
Baseline Characteristics
Repeat Injection of Cingal® for Osteoarthritis of the Knee
Baseline characteristics by cohort
| Measure |
Cingal/Cingal
n=94 Participants
Subjects who had received an injection of Cingal in the 13-01 study will receive a single 4 milliliter (mL) intra-articular injection of Cingal (88 milligrams Hyaluronic Acid plus 18 milligramsTriamcinolone Hexacetonide) in the index knee in the 13-02 study.
Cingal: Injection into the knee
|
Cingal/Monovisc
n=98 Participants
Subjects who had received an injection of Monovisc in the 13-01 study will receive a single 4 milliliter (mL) intra-articular injection of Cingal (88 milligrams Hyaluronic Acid plus 18 milligramsTriamcinolone Hexacetonide) in the index knee in the 13-02 study.
Cingal: Injection into the knee
|
Cingal/Saline
n=50 Participants
Subjects who had received an injection of Saline in the 13-01 study will receive a single 4 milliliter (mL) intra-articular injection of Cingal (88 milligrams Hyaluronic Acid plus 18 milligramsTriamcinolone Hexacetonide) in the index knee in the 13-02 study.
Cingal: Injection into the knee
|
Total
n=242 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
58.6 Years
STANDARD_DEVIATION 8.2 • n=5 Participants
|
60.2 Years
STANDARD_DEVIATION 8.4 • n=7 Participants
|
60.5 Years
STANDARD_DEVIATION 8.8 • n=5 Participants
|
59.7 Years
STANDARD_DEVIATION 8.4 • n=4 Participants
|
|
Sex: Female, Male
Female
|
55 Participants
n=5 Participants
|
68 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
161 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
39 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
81 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
|
94 Participants
n=5 Participants
|
98 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
242 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
|
PRIMARY outcome
Timeframe: Baseline through 6 weeks post-injectionPopulation: NOTE: All subjects enrolled in Cingal 13-02 were initially also enrolled in Cingal 13-01 \[NCT01891396\]. Detail on adverse events that occurred in Cingal 13-01 \[NCT01891396\] may be found in the summary for that study on clinicaltrials.gov.
The primary outcome measure will compare safety results (all adverse events, whether related to the study injection or not) for Cingal 13-01 and Cingal 13-02.
Outcome measures
| Measure |
Cingal 13-02 Adverse Events
n=242 Participants
All adverse events that occurred in Cingal 13-02 for 6 weeks post-injection, regardless if considered related to the study injection or not.
|
|---|---|
|
Number of Treatment-Emergent Adverse Events: Cingal 13-02 vs. Cingal 13-01
|
73 Adverse events
|
Adverse Events
Cingal/Cingal
Serious events: 0 serious events
Other events: 17 other events
Deaths: 0 deaths
Cingal/Monovisc
Serious events: 1 serious events
Other events: 20 other events
Deaths: 0 deaths
Cingal/Saline
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cingal/Cingal
n=94 participants at risk
Subjects who had received an injection of Cingal in the 13-01 study will receive a single 4 milliliter (mL) intra-articular injection of Cingal (88 milligrams Hyaluronic Acid plus 18 milligramsTriamcinolone Hexacetonide) in the index knee in the 13-02 study.
Cingal: Injection into the knee
|
Cingal/Monovisc
n=98 participants at risk
Subjects who had received an injection of Monovisc in the 13-01 study will receive a single 4 milliliter (mL) intra-articular injection of Cingal (88 milligrams Hyaluronic Acid plus 18 milligramsTriamcinolone Hexacetonide) in the index knee in the 13-02 study.
Cingal: Injection into the knee
|
Cingal/Saline
n=50 participants at risk
Subjects who had received an injection of Saline in the 13-01 study will receive a single 4 milliliter (mL) intra-articular injection of Cingal (88 milligrams Hyaluronic Acid plus 18 milligramsTriamcinolone Hexacetonide) in the index knee in the 13-02 study.
Cingal: Injection into the knee
|
|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Meniscus injury
|
0.00%
0/94 • Adverse events were collected in Cingal 13-02 within the first six weeks after injection.
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).
|
1.0%
1/98 • Number of events 1 • Adverse events were collected in Cingal 13-02 within the first six weeks after injection.
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).
|
0.00%
0/50 • Adverse events were collected in Cingal 13-02 within the first six weeks after injection.
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/Cingal
n=94 participants at risk
Subjects who had received an injection of Cingal in the 13-01 study will receive a single 4 milliliter (mL) intra-articular injection of Cingal (88 milligrams Hyaluronic Acid plus 18 milligramsTriamcinolone Hexacetonide) in the index knee in the 13-02 study.
Cingal: Injection into the knee
|
Cingal/Monovisc
n=98 participants at risk
Subjects who had received an injection of Monovisc in the 13-01 study will receive a single 4 milliliter (mL) intra-articular injection of Cingal (88 milligrams Hyaluronic Acid plus 18 milligramsTriamcinolone Hexacetonide) in the index knee in the 13-02 study.
Cingal: Injection into the knee
|
Cingal/Saline
n=50 participants at risk
Subjects who had received an injection of Saline in the 13-01 study will receive a single 4 milliliter (mL) intra-articular injection of Cingal (88 milligrams Hyaluronic Acid plus 18 milligramsTriamcinolone Hexacetonide) in the index knee in the 13-02 study.
Cingal: Injection into the knee
|
|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
7.4%
7/94 • Adverse events were collected in Cingal 13-02 within the first six weeks after injection.
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).
|
6.1%
6/98 • Adverse events were collected in Cingal 13-02 within the first six weeks after injection.
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).
|
10.0%
5/50 • Adverse events were collected in Cingal 13-02 within the first six weeks after injection.
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).
|
|
Infections and infestations
Nasopharyngitis
|
4.3%
4/94 • Adverse events were collected in Cingal 13-02 within the first six weeks after injection.
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).
|
4.1%
4/98 • Adverse events were collected in Cingal 13-02 within the first six weeks after injection.
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).
|
2.0%
1/50 • Adverse events were collected in Cingal 13-02 within the first six weeks after injection.
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
Joint swelling
|
2.1%
2/94 • Adverse events were collected in Cingal 13-02 within the first six weeks after injection.
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).
|
3.1%
3/98 • Adverse events were collected in Cingal 13-02 within the first six weeks after injection.
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).
|
4.0%
2/50 • Adverse events were collected in Cingal 13-02 within the first six weeks after injection.
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).
|
|
Nervous system disorders
Headache
|
1.1%
1/94 • Adverse events were collected in Cingal 13-02 within the first six weeks after injection.
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).
|
3.1%
3/98 • Adverse events were collected in Cingal 13-02 within the first six weeks after injection.
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).
|
4.0%
2/50 • Adverse events were collected in Cingal 13-02 within the first six weeks after injection.
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
Joint range of motion decreased
|
3.2%
3/94 • Adverse events were collected in Cingal 13-02 within the first six weeks after injection.
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).
|
1.0%
1/98 • Adverse events were collected in Cingal 13-02 within the first six weeks after injection.
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).
|
0.00%
0/50 • Adverse events were collected in Cingal 13-02 within the first six weeks after injection.
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
Back Pain
|
0.00%
0/94 • Adverse events were collected in Cingal 13-02 within the first six weeks after injection.
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).
|
1.0%
1/98 • Adverse events were collected in Cingal 13-02 within the first six weeks after injection.
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).
|
4.0%
2/50 • Adverse events were collected in Cingal 13-02 within the first six weeks after injection.
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).
|
|
General disorders
Injection site pain
|
0.00%
0/94 • Adverse events were collected in Cingal 13-02 within the first six weeks after injection.
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).
|
2.0%
2/98 • Adverse events were collected in Cingal 13-02 within the first six weeks after injection.
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).
|
2.0%
1/50 • Adverse events were collected in Cingal 13-02 within the first six weeks after injection.
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place