Trial Outcomes & Findings for A Phase 3 Study to Evaluate the Safety and Efficacy of SKY0402 in Subjects Undergoing Total Knee Arthroplasty (NCT NCT00745290)
NCT ID: NCT00745290
Last Updated: 2013-08-06
Results Overview
The subject's pain intensity was assessed with activity (NRS-A), while actively flexing the involved knee from the maximum extension point to the maximum flexion point possible. The subject responded to the following question, "On a scale of 0 to 10, where 0 = no pain and 10 = worst possible pain, how much pain did you have while bending your knee?"
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
245 participants
Primary outcome timeframe
through 72 hours post surgery
Results posted on
2013-08-06
Participant Flow
Participant milestones
| Measure |
Bupivacaine HCl
randomized in a 1:1 ratio to receive 200 mg bupivacaine HCl and stratified by site and by modality.
|
SKY0402
randomized in a 1:1 ratio to receive 600 mg SKY0402 (study drug) and stratified by site and by modality.
|
|---|---|---|
|
Overall Study
STARTED
|
123
|
122
|
|
Overall Study
COMPLETED
|
123
|
122
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Phase 3 Study to Evaluate the Safety and Efficacy of SKY0402 in Subjects Undergoing Total Knee Arthroplasty
Baseline characteristics by cohort
| Measure |
Bupivacaine HCl
n=123 Participants
randomized in a 1:1 ratio to receive 200 mg bupivacaine HCl and stratified by site and by modality.
|
SKY0402
n=122 Participants
randomized in a 1:1 ratio to receive 600 mg SKY0402 (study drug) and stratified by site and by modality.
|
Total
n=245 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
67 Participants
n=5 Participants
|
52 Participants
n=7 Participants
|
119 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
56 Participants
n=5 Participants
|
70 Participants
n=7 Participants
|
126 Participants
n=5 Participants
|
|
Age Continuous
|
64.8 years
STANDARD_DEVIATION 10.4 • n=5 Participants
|
66.8 years
STANDARD_DEVIATION 10.6 • n=7 Participants
|
65.8 years
STANDARD_DEVIATION 10.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
73 Participants
n=5 Participants
|
83 Participants
n=7 Participants
|
156 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
50 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
89 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
123 participants
n=5 Participants
|
122 participants
n=7 Participants
|
245 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: through 72 hours post surgeryPopulation: Note: 245 subjects were randomized and received study drug and were included in the analyses.
The subject's pain intensity was assessed with activity (NRS-A), while actively flexing the involved knee from the maximum extension point to the maximum flexion point possible. The subject responded to the following question, "On a scale of 0 to 10, where 0 = no pain and 10 = worst possible pain, how much pain did you have while bending your knee?"
Outcome measures
| Measure |
Bupivacaine HCl
n=123 Participants
randomized in a 1:1 ratio to receive 200 mg bupivacaine HCl and stratified by site and by modality.
|
SKY0402
n=122 Participants
randomized in a 1:1 ratio to receive 600 mg SKY0402 (study drug) and stratified by site and by modality.
|
|---|---|---|
|
Area Under the Curve (AUC) of the Numeric Rating Scale (NRS) With Activity (NRS-A) Pain Intensity Scores
|
335 Units on a scale*hours
Standard Deviation 113
|
359 Units on a scale*hours
Standard Deviation 124
|
SECONDARY outcome
Timeframe: through 30 daysOutcome measures
Outcome data not reported
Adverse Events
Bupivacaine HCl
Serious events: 18 serious events
Other events: 107 other events
Deaths: 0 deaths
SKY0402
Serious events: 12 serious events
Other events: 108 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Bupivacaine HCl
n=123 participants at risk
randomized in a 1:1 ratio to receive 200 mg bupivacaine HCl and stratified by site and by modality.
|
SKY0402
n=122 participants at risk
randomized in a 1:1 ratio to receive 600 mg SKY0402 (study drug) and stratified by site and by modality.
|
|---|---|---|
|
Infections and infestations
Cellulitis
|
0.00%
0/123
|
2.5%
3/122
|
|
Infections and infestations
Postoperative wound infection
|
0.81%
1/123 • Number of events 1
|
0.82%
1/122 • Number of events 1
|
|
Infections and infestations
Urinary tract infection
|
0.81%
1/123 • Number of events 1
|
0.00%
0/122
|
|
Cardiac disorders
Atrial fibrillation
|
1.6%
2/123
|
0.00%
0/122
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/123
|
1.6%
2/122
|
|
Cardiac disorders
Myocardial Infarction
|
0.00%
0/123
|
0.82%
1/122 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Arthrofibrosis
|
2.4%
3/123
|
0.00%
0/122
|
|
Musculoskeletal and connective tissue disorders
Haemarthrosis
|
0.81%
1/123 • Number of events 1
|
0.00%
0/122
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.81%
1/123 • Number of events 1
|
0.00%
0/122
|
|
Nervous system disorders
Embolic stroke
|
0.00%
0/123
|
0.82%
1/122 • Number of events 1
|
|
Nervous system disorders
Peroneal nerve palsy
|
0.81%
1/123
|
0.00%
0/122
|
|
Nervous system disorders
Sedation
|
0.00%
0/123
|
0.82%
1/122 • Number of events 1
|
|
Nervous system disorders
Syncope
|
0.81%
1/123
|
0.00%
0/122
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
1.6%
2/123
|
0.00%
0/122
|
|
Metabolism and nutrition disorders
Dehydration
|
0.81%
1/123
|
0.00%
0/122
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.81%
1/123
|
0.00%
0/122
|
|
General disorders
Adverse drug reaction
|
0.81%
1/123 • Number of events 1
|
0.00%
0/122
|
|
General disorders
Chest pain
|
0.00%
0/123
|
0.82%
1/122 • Number of events 1
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.81%
1/123 • Number of events 1
|
0.00%
0/122
|
|
Injury, poisoning and procedural complications
Postprocedural hematoma
|
0.81%
1/123 • Number of events 1
|
0.00%
0/122
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/123
|
0.82%
1/122 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/123
|
0.82%
1/122 • Number of events 1
|
|
Vascular disorders
Deep vein thrombosis
|
1.6%
2/123
|
0.00%
0/122
|
|
Gastrointestinal disorders
Gastrointestinal hemorrhage
|
0.81%
1/123
|
0.00%
0/122
|
|
Skin and subcutaneous tissue disorders
Blood blister
|
0.00%
0/123
|
0.82%
1/122 • Number of events 1
|
|
Surgical and medical procedures
Knee arthroplasty
|
0.81%
1/123 • Number of events 1
|
0.00%
0/122
|
Other adverse events
| Measure |
Bupivacaine HCl
n=123 participants at risk
randomized in a 1:1 ratio to receive 200 mg bupivacaine HCl and stratified by site and by modality.
|
SKY0402
n=122 participants at risk
randomized in a 1:1 ratio to receive 600 mg SKY0402 (study drug) and stratified by site and by modality.
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
57.7%
71/123
|
62.3%
76/122
|
|
Gastrointestinal disorders
Constipation
|
38.2%
47/123
|
45.9%
56/122
|
|
Gastrointestinal disorders
Vomiting
|
34.1%
42/123
|
31.1%
38/122
|
|
Blood and lymphatic system disorders
Haemorrhagic anemia
|
6.5%
8/123
|
3.3%
4/122
|
|
Injury, poisoning and procedural complications
Anemia postoperative
|
8.1%
10/123
|
9.8%
12/122
|
|
Injury, poisoning and procedural complications
Procedural pain
|
7.3%
9/123
|
8.2%
10/122
|
|
General disorders
Pyrexia
|
13.0%
16/123
|
11.5%
14/122
|
|
General disorders
Oedema peripheral
|
4.1%
5/123
|
7.4%
9/122
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
13.0%
16/123
|
9.0%
11/122
|
|
Psychiatric disorders
Insomnia
|
7.3%
9/123
|
7.4%
9/122
|
|
Nervous system disorders
Dizziness
|
2.4%
3/123
|
6.6%
8/122
|
|
Vascular disorders
Hypotension
|
3.3%
4/123
|
7.4%
9/122
|
|
Cardiac disorders
Tachycardia
|
2.4%
3/123
|
5.7%
7/122
|
|
Blood and lymphatic system disorders
Anemia
|
22.8%
28/123
|
23.0%
28/122
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place