Trial Outcomes & Findings for Pharmacokinetics, Relative Bioavailability and Safety of Xaracoll Implant (NCT NCT02232178)
NCT ID: NCT02232178
Last Updated: 2020-10-20
Results Overview
Maximum drug plasma concentration
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
64 participants
Primary outcome timeframe
0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36, 48, 72, and 96 hours after surgery.
Results posted on
2020-10-20
Participant Flow
Participant milestones
| Measure |
2 100mg Xaracoll Implants
Bupivacaine HCl implant
2 100mg Xaracoll implants
|
3 100mg Xaracoll Implants
Bupivacaine HCl implant
3 100mg Xaracoll implants
|
150mg Bupivacaine HCl Injection
Bupivacaine HCl
150mg Bupivacaine HCl injection
|
|---|---|---|---|
|
Overall Study
STARTED
|
26
|
25
|
13
|
|
Overall Study
Per Protocol PK Population
|
26
|
24
|
11
|
|
Overall Study
Safety Population
|
26
|
24
|
12
|
|
Overall Study
COMPLETED
|
25
|
24
|
12
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
1
|
Reasons for withdrawal
| Measure |
2 100mg Xaracoll Implants
Bupivacaine HCl implant
2 100mg Xaracoll implants
|
3 100mg Xaracoll Implants
Bupivacaine HCl implant
3 100mg Xaracoll implants
|
150mg Bupivacaine HCl Injection
Bupivacaine HCl
150mg Bupivacaine HCl injection
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
0
|
|
Overall Study
ineligibility
|
0
|
0
|
1
|
|
Overall Study
surgical complication
|
1
|
0
|
0
|
Baseline Characteristics
Pharmacokinetics, Relative Bioavailability and Safety of Xaracoll Implant
Baseline characteristics by cohort
| Measure |
2 100mg Xaracoll Implants
n=26 Participants
Bupivacaine HCl implant
2 100mg Xaracoll implants
|
3 100mg Xaracoll Implants
n=25 Participants
Bupivacaine HCl implant
3 100mg Xaracoll implants
|
150mg Bupivacaine HCl Injection
n=13 Participants
Bupivacaine HCl
150mg Bupivacaine HCl injection
|
Total
n=64 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
42.7 years
STANDARD_DEVIATION 11.93 • n=5 Participants
|
46.1 years
STANDARD_DEVIATION 11.40 • n=7 Participants
|
48.2 years
STANDARD_DEVIATION 12.76 • n=5 Participants
|
45.2 years
STANDARD_DEVIATION 11.90 • n=4 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
61 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
26 participants
n=5 Participants
|
25 participants
n=7 Participants
|
13 participants
n=5 Participants
|
64 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36, 48, 72, and 96 hours after surgery.Maximum drug plasma concentration
Outcome measures
| Measure |
2 100mg Xaracoll Implants
n=26 Participants
Bupivacaine HCl implant
2 100mg Xaracoll implants
|
3 100mg Xaracoll Implants
n=24 Participants
Bupivacaine HCl implant
3 100mg Xaracoll implants
|
150mg Bupivacaine HCl Injection
n=11 Participants
Bupivacaine HCl
150mg Bupivacaine HCl injection
|
|---|---|---|---|
|
Cmax
|
340.4 ng/mL
Standard Deviation 111.05
|
524.8 ng/mL
Standard Deviation 146.45
|
348.4 ng/mL
Standard Deviation 184.02
|
PRIMARY outcome
Timeframe: 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36, 48, 72, and 96 hours after surgery.Area under the plasma concentration-time curve from Time 0 to time of last quantifiable plasma concentration.
Outcome measures
| Measure |
2 100mg Xaracoll Implants
n=26 Participants
Bupivacaine HCl implant
2 100mg Xaracoll implants
|
3 100mg Xaracoll Implants
n=24 Participants
Bupivacaine HCl implant
3 100mg Xaracoll implants
|
150mg Bupivacaine HCl Injection
n=11 Participants
Bupivacaine HCl
150mg Bupivacaine HCl injection
|
|---|---|---|---|
|
AUC0-last
|
10793.449 ng/mL∙hr
Standard Deviation 5523.4326
|
18589.907 ng/mL∙hr
Standard Deviation 7841.1973
|
8323.188 ng/mL∙hr
Standard Deviation 4312.1940
|
PRIMARY outcome
Timeframe: 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36, 48, 72, and 96 hours after surgery.Time to maximum plasma concentration.
Outcome measures
| Measure |
2 100mg Xaracoll Implants
n=26 Participants
Bupivacaine HCl implant
2 100mg Xaracoll implants
|
3 100mg Xaracoll Implants
n=24 Participants
Bupivacaine HCl implant
3 100mg Xaracoll implants
|
150mg Bupivacaine HCl Injection
n=11 Participants
Bupivacaine HCl
150mg Bupivacaine HCl injection
|
|---|---|---|---|
|
Tmax
|
7.271 hours
Standard Deviation 10.8603
|
8.567 hours
Standard Deviation 10.2484
|
8.783 hours
Standard Deviation 01.8761
|
PRIMARY outcome
Timeframe: 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36, 48, 72, and 96 hours after surgery.Population: Per protocol PK population.
Terminal half-life.
Outcome measures
| Measure |
2 100mg Xaracoll Implants
n=26 Participants
Bupivacaine HCl implant
2 100mg Xaracoll implants
|
3 100mg Xaracoll Implants
n=24 Participants
Bupivacaine HCl implant
3 100mg Xaracoll implants
|
150mg Bupivacaine HCl Injection
n=11 Participants
Bupivacaine HCl
150mg Bupivacaine HCl injection
|
|---|---|---|---|
|
t1/2 (Hour)
|
16.922 hours
Standard Deviation 7.6260
|
18.058 hours
Standard Deviation 7.6699
|
8.819 hours
Standard Deviation 4.5292
|
Adverse Events
2 100mg Xaracoll Implants
Serious events: 0 serious events
Other events: 21 other events
Deaths: 0 deaths
3 100mg Xaracoll Implants
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
150mg Bupivacaine HCl Injection
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
2 100mg Xaracoll Implants
n=26 participants at risk
Bupivacaine HCl implant
2 100mg Xaracoll implants
|
3 100mg Xaracoll Implants
n=24 participants at risk
Bupivacaine HCl implant
3 100mg Xaracoll implants
|
150mg Bupivacaine HCl Injection
n=12 participants at risk
Bupivacaine HCl
150mg Bupivacaine HCl injection
|
|---|---|---|---|
|
Injury, poisoning and procedural complications
incision site haematoma
|
3.8%
1/26 • Number of events 1 • 30 days
|
0.00%
0/24 • 30 days
|
0.00%
0/12 • 30 days
|
|
Injury, poisoning and procedural complications
incision site erythema
|
0.00%
0/26 • 30 days
|
4.2%
1/24 • Number of events 1 • 30 days
|
0.00%
0/12 • 30 days
|
|
Gastrointestinal disorders
constipation
|
23.1%
6/26 • Number of events 6 • 30 days
|
12.5%
3/24 • Number of events 3 • 30 days
|
16.7%
2/12 • Number of events 2 • 30 days
|
|
Gastrointestinal disorders
nausea
|
15.4%
4/26 • Number of events 4 • 30 days
|
0.00%
0/24 • 30 days
|
0.00%
0/12 • 30 days
|
|
Injury, poisoning and procedural complications
incision site haemorrhage
|
0.00%
0/26 • 30 days
|
8.3%
2/24 • Number of events 2 • 30 days
|
0.00%
0/12 • 30 days
|
|
Injury, poisoning and procedural complications
post procedural oedema
|
15.4%
4/26 • Number of events 4 • 30 days
|
8.3%
2/24 • Number of events 2 • 30 days
|
8.3%
1/12 • Number of events 1 • 30 days
|
|
Injury, poisoning and procedural complications
procedural hypotension
|
3.8%
1/26 • Number of events 1 • 30 days
|
8.3%
2/24 • Number of events 2 • 30 days
|
8.3%
1/12 • Number of events 1 • 30 days
|
|
Nervous system disorders
somnolence
|
15.4%
4/26 • Number of events 4 • 30 days
|
8.3%
2/24 • Number of events 2 • 30 days
|
8.3%
1/12 • Number of events 1 • 30 days
|
|
Reproductive system and breast disorders
penile haemorrhage
|
11.5%
3/26 • Number of events 3 • 30 days
|
0.00%
0/24 • 30 days
|
0.00%
0/12 • 30 days
|
|
Reproductive system and breast disorders
testicular pain
|
7.7%
2/26 • Number of events 2 • 30 days
|
4.2%
1/24 • Number of events 1 • 30 days
|
0.00%
0/12 • 30 days
|
|
Skin and subcutaneous tissue disorders
ecchymosis
|
11.5%
3/26 • Number of events 3 • 30 days
|
0.00%
0/24 • 30 days
|
0.00%
0/12 • 30 days
|
|
Vascular disorders
hypertension
|
11.5%
3/26 • Number of events 3 • 30 days
|
8.3%
2/24 • Number of events 2 • 30 days
|
0.00%
0/12 • 30 days
|
|
Cardiac disorders
bradycardia
|
0.00%
0/26 • 30 days
|
0.00%
0/24 • 30 days
|
8.3%
1/12 • Number of events 1 • 30 days
|
|
Cardiac disorders
ventricular extrasystoles
|
3.8%
1/26 • Number of events 1 • 30 days
|
0.00%
0/24 • 30 days
|
0.00%
0/12 • 30 days
|
|
Gastrointestinal disorders
abdominal distention
|
3.8%
1/26 • Number of events 1 • 30 days
|
0.00%
0/24 • 30 days
|
0.00%
0/12 • 30 days
|
|
Gastrointestinal disorders
diarrhoea
|
3.8%
1/26 • Number of events 1 • 30 days
|
0.00%
0/24 • 30 days
|
0.00%
0/12 • 30 days
|
|
Gastrointestinal disorders
dyspepsia
|
3.8%
1/26 • Number of events 1 • 30 days
|
0.00%
0/24 • 30 days
|
0.00%
0/12 • 30 days
|
|
Gastrointestinal disorders
hypoaesthesia oral
|
0.00%
0/26 • 30 days
|
0.00%
0/24 • 30 days
|
8.3%
1/12 • Number of events 1 • 30 days
|
|
Gastrointestinal disorders
inguinal hernia
|
3.8%
1/26 • Number of events 1 • 30 days
|
0.00%
0/24 • 30 days
|
0.00%
0/12 • 30 days
|
|
Gastrointestinal disorders
paraesthesia oral
|
3.8%
1/26 • Number of events 1 • 30 days
|
0.00%
0/24 • 30 days
|
0.00%
0/12 • 30 days
|
|
Gastrointestinal disorders
toothache
|
3.8%
1/26 • Number of events 1 • 30 days
|
0.00%
0/24 • 30 days
|
0.00%
0/12 • 30 days
|
|
Gastrointestinal disorders
vomiting
|
3.8%
1/26 • Number of events 1 • 30 days
|
0.00%
0/24 • 30 days
|
0.00%
0/12 • 30 days
|
|
General disorders
catheter site erythema
|
3.8%
1/26 • Number of events 1 • 30 days
|
0.00%
0/24 • 30 days
|
0.00%
0/12 • 30 days
|
|
Gastrointestinal disorders
catheter site pain
|
3.8%
1/26 • Number of events 1 • 30 days
|
0.00%
0/24 • 30 days
|
0.00%
0/12 • 30 days
|
|
General disorders
local swelling
|
0.00%
0/26 • 30 days
|
0.00%
0/24 • 30 days
|
8.3%
1/12 • Number of events 1 • 30 days
|
|
General disorders
oedema peripheral
|
3.8%
1/26 • Number of events 1 • 30 days
|
0.00%
0/24 • 30 days
|
0.00%
0/12 • 30 days
|
|
General disorders
pain
|
3.8%
1/26 • Number of events 1 • 30 days
|
0.00%
0/24 • 30 days
|
0.00%
0/12 • 30 days
|
|
Infections and infestations
tooth abscess
|
3.8%
1/26 • Number of events 1 • 30 days
|
0.00%
0/24 • 30 days
|
0.00%
0/12 • 30 days
|
|
General disorders
wound infection
|
0.00%
0/26 • 30 days
|
4.2%
1/24 • Number of events 1 • 30 days
|
0.00%
0/12 • 30 days
|
|
Injury, poisoning and procedural complications
incision site pain
|
3.8%
1/26 • Number of events 1 • 30 days
|
0.00%
0/24 • 30 days
|
0.00%
0/12 • 30 days
|
|
Injury, poisoning and procedural complications
procedural pain
|
3.8%
1/26 • Number of events 1 • 30 days
|
0.00%
0/24 • 30 days
|
0.00%
0/12 • 30 days
|
|
Injury, poisoning and procedural complications
seroma
|
0.00%
0/26 • 30 days
|
0.00%
0/24 • 30 days
|
8.3%
1/12 • Number of events 1 • 30 days
|
|
Injury, poisoning and procedural complications
wound complication
|
0.00%
0/26 • 30 days
|
0.00%
0/24 • 30 days
|
8.3%
1/12 • Number of events 1 • 30 days
|
|
Injury, poisoning and procedural complications
wound dehiscence
|
3.8%
1/26 • Number of events 1 • 30 days
|
4.2%
1/24 • Number of events 1 • 30 days
|
0.00%
0/12 • 30 days
|
|
Injury, poisoning and procedural complications
wound haemorrhage
|
3.8%
1/26 • Number of events 1 • 30 days
|
0.00%
0/24 • 30 days
|
0.00%
0/12 • 30 days
|
|
Injury, poisoning and procedural complications
wound secretion
|
0.00%
0/26 • 30 days
|
4.2%
1/24 • Number of events 1 • 30 days
|
0.00%
0/12 • 30 days
|
|
Investigations
blood pressure increased
|
0.00%
0/26 • 30 days
|
0.00%
0/24 • 30 days
|
8.3%
1/12 • Number of events 1 • 30 days
|
|
Musculoskeletal and connective tissue disorders
musculoskeletal stiffness
|
3.8%
1/26 • Number of events 1 • 30 days
|
0.00%
0/24 • 30 days
|
0.00%
0/12 • 30 days
|
|
Nervous system disorders
dizziness
|
3.8%
1/26 • Number of events 1 • 30 days
|
0.00%
0/24 • 30 days
|
0.00%
0/12 • 30 days
|
|
Nervous system disorders
dysgeusia
|
3.8%
1/26 • Number of events 1 • 30 days
|
0.00%
0/24 • 30 days
|
0.00%
0/12 • 30 days
|
|
Nervous system disorders
headache
|
0.00%
0/26 • 30 days
|
4.2%
1/24 • Number of events 1 • 30 days
|
0.00%
0/12 • 30 days
|
|
Psychiatric disorders
anxiety
|
3.8%
1/26 • Number of events 1 • 30 days
|
4.2%
1/24 • Number of events 1 • 30 days
|
8.3%
1/12 • Number of events 1 • 30 days
|
|
Renal and urinary disorders
dysuria
|
0.00%
0/26 • 30 days
|
0.00%
0/24 • 30 days
|
8.3%
1/12 • Number of events 1 • 30 days
|
|
Reproductive system and breast disorders
benign prostatic hyperplasia
|
3.8%
1/26 • Number of events 1 • 30 days
|
0.00%
0/24 • 30 days
|
0.00%
0/12 • 30 days
|
|
Reproductive system and breast disorders
genital haemorrhage
|
3.8%
1/26 • Number of events 1 • 30 days
|
0.00%
0/24 • 30 days
|
0.00%
0/12 • 30 days
|
|
Reproductive system and breast disorders
scrotal oedema
|
3.8%
1/26 • Number of events 1 • 30 days
|
4.2%
1/24 • Number of events 1 • 30 days
|
8.3%
1/12 • Number of events 1 • 30 days
|
|
Reproductive system and breast disorders
scrotal swelling
|
3.8%
1/26 • Number of events 1 • 30 days
|
4.2%
1/24 • Number of events 1 • 30 days
|
8.3%
1/12 • Number of events 1 • 30 days
|
|
Reproductive system and breast disorders
testicular oedema
|
3.8%
1/26 • Number of events 1 • 30 days
|
0.00%
0/24 • 30 days
|
0.00%
0/12 • 30 days
|
|
Reproductive system and breast disorders
testicular swelling
|
0.00%
0/26 • 30 days
|
4.2%
1/24 • Number of events 1 • 30 days
|
8.3%
1/12 • Number of events 1 • 30 days
|
|
Respiratory, thoracic and mediastinal disorders
respiratory distress
|
0.00%
0/26 • 30 days
|
4.2%
1/24 • Number of events 1 • 30 days
|
0.00%
0/12 • 30 days
|
|
Respiratory, thoracic and mediastinal disorders
sneezing
|
0.00%
0/26 • 30 days
|
0.00%
0/24 • 30 days
|
8.3%
1/12 • Number of events 1 • 30 days
|
|
Skin and subcutaneous tissue disorders
hyperhidrosis
|
3.8%
1/26 • Number of events 1 • 30 days
|
0.00%
0/24 • 30 days
|
0.00%
0/12 • 30 days
|
|
Skin and subcutaneous tissue disorders
rash
|
3.8%
1/26 • Number of events 1 • 30 days
|
0.00%
0/24 • 30 days
|
0.00%
0/12 • 30 days
|
|
Skin and subcutaneous tissue disorders
incisional drainage
|
0.00%
0/26 • 30 days
|
0.00%
0/24 • 30 days
|
8.3%
1/12 • Number of events 1 • 30 days
|
|
Surgical and medical procedures
post procedural drainage
|
0.00%
0/26 • 30 days
|
4.2%
1/24 • Number of events 1 • 30 days
|
0.00%
0/12 • 30 days
|
Additional Information
Charlene A. Tucker, MS Executive Director, Medical Writing and Document Management
Innocoll
Phone: 484-406-5211
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee results of the multicenter study had to be published prior to the publication of any site specific data.
- Publication restrictions are in place
Restriction type: OTHER