Trial Outcomes & Findings for Study of Local Administration of DepoTXA for Reduced Postsurgical Bleeding in Subjects Undergoing TKA (NCT NCT02922582)
NCT ID: NCT02922582
Last Updated: 2020-12-11
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
16 participants
Primary outcome timeframe
Baseline; 5, 15, and 30 min; at 1, 2, 4, 6, 8, 12, 16, and 24 hours after study drug administration for all treatment groups. Additional blood samples were collected at 36, 48, 60, 72, and 96 hours for DepoTXA-treated subjects.
Results posted on
2020-12-11
Participant Flow
Participants were recruited between October 28, 2016 and October 12, 2017 at 4 US sites. The study was terminated on 27-Nov-2017 due to low enrollment.
One patient was screened but was not randomized due to not meeting inclusion criteria.
Participant milestones
| Measure |
DepoTXA 400mg
Single injection of DepoTXA 400 mg into the joint space via catheter prior to capsular closure
|
DepoTXA 800mg
Single injection of DepoTXA 800 mg into the joint space via catheter prior to capsular closure
|
DepoTXA 1200mg
Single injection of DepoTXA 1200 mg into the joint space via catheter prior to capsular closure
|
IV Tranexamic Acid (TXA)
1 g of IV TXA at the end of surgery
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
4
|
4
|
4
|
4
|
|
Overall Study
COMPLETED
|
4
|
3
|
4
|
4
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of Local Administration of DepoTXA for Reduced Postsurgical Bleeding in Subjects Undergoing TKA
Baseline characteristics by cohort
| Measure |
DepoTXA 400mg
n=4 Participants
Single injection of DepoTXA 400 mg into the joint space via catheter prior to capsular closure
|
DepoTXA 800mg
n=3 Participants
Single injection of DepoTXA 800 mg into the joint space via catheter prior to capsular closure
|
DepoTXA 1200mg
n=4 Participants
Single injection of DepoTXA 1200 mg into the joint space via catheter prior to capsular closure
|
IV Tranexamic Acid (TXA)
n=4 Participants
1 g of IV TXA at the end of surgery
|
Total
n=15 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
65 years
STANDARD_DEVIATION 7.12 • n=5 Participants
|
66 years
STANDARD_DEVIATION 1.73 • n=7 Participants
|
59.3 years
STANDARD_DEVIATION 5.38 • n=5 Participants
|
58.0 years
STANDARD_DEVIATION 6.16 • n=4 Participants
|
61.8 years
STANDARD_DEVIATION 6.19 • n=21 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
15 Participants
n=21 Participants
|
|
Ethnicity (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
|
0 Participants
n=21 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
|
0 Participants
n=21 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
|
0 Participants
n=21 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
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
12 Participants
n=21 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
|
0 Participants
n=21 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
|
0 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline; 5, 15, and 30 min; at 1, 2, 4, 6, 8, 12, 16, and 24 hours after study drug administration for all treatment groups. Additional blood samples were collected at 36, 48, 60, 72, and 96 hours for DepoTXA-treated subjects.Population: Pharmacokinetic (PK) analysis set: All subjects who received study drug, provided sufficient samples to allow for calculation of PK parameters required for analysis, and who did not have significant protocol deviations
Outcome measures
| Measure |
DepoTXA 400mg
n=4 Participants
Single injection of DepoTXA 400 mg into the joint space via catheter prior to capsular closure
|
DepoTXA 800mg
n=2 Participants
Single injection of DepoTXA 800 mg into the joint space via catheter prior to capsular closure
|
DepoTXA 1200mg
n=4 Participants
Single injection of DepoTXA 1200 mg into the joint space via catheter prior to capsular closure
|
IV Tranexamic Acid (TXA)
n=4 Participants
1 g of IV TXA at the end of surgery
|
|---|---|---|---|---|
|
Area Under the Plasma Concentration-versus-time Curve From Time 0 Extrapolated to Infinity After Drug Administration
|
46462.15 hr*ng/mL
Standard Deviation 6935.828
|
106422.7 hr*ng/mL
Standard Deviation 42128.84
|
148806.2 hr*ng/mL
Standard Deviation 14137.74
|
134602.2 hr*ng/mL
Standard Deviation 29975.88
|
PRIMARY outcome
Timeframe: Baseline; 5, 15, and 30 min; at 1, 2, 4, 6, 8, 12, 16, and 24 hours after study drug administration for all treatment groups. Additional blood samples were collected at 36, 48, 60, 72, and 96 hours for DepoTXA-treated subjects.Population: Pharmacokinetic (PK) analysis set: All subjects who received study drug, provided sufficient samples to allow for calculation of PK parameters required for analysis, and who did not have significant protocol deviations
Outcome measures
| Measure |
DepoTXA 400mg
n=4 Participants
Single injection of DepoTXA 400 mg into the joint space via catheter prior to capsular closure
|
DepoTXA 800mg
n=2 Participants
Single injection of DepoTXA 800 mg into the joint space via catheter prior to capsular closure
|
DepoTXA 1200mg
n=4 Participants
Single injection of DepoTXA 1200 mg into the joint space via catheter prior to capsular closure
|
IV Tranexamic Acid (TXA)
n=4 Participants
1 g of IV TXA at the end of surgery
|
|---|---|---|---|---|
|
Area Under the Plasma Concentration-versus-time Curve From Time 0 to the Last Collection Time After Drug Administration
|
43784.71 hr*ng/mL
Standard Deviation 6463.220
|
104546.5 hr*ng/mL
Standard Deviation 42813.20
|
143562.9 hr*ng/mL
Standard Deviation 13931.94
|
131153.0 hr*ng/mL
Standard Deviation 27286.97
|
PRIMARY outcome
Timeframe: Baseline; 5, 15, and 30 min; at 1, 2, 4, 6, 8, 12, 16, and 24 hours after study drug administration for all treatment groups. Additional blood samples were collected at 36, 48, 60, 72, and 96 hours for DepoTXA-treated subjects.Population: Pharmacokinetic (PK) analysis set: All subjects who received study drug, provided sufficient samples to allow for calculation of PK parameters required for analysis, and who did not have significant protocol deviations
Outcome measures
| Measure |
DepoTXA 400mg
n=4 Participants
Single injection of DepoTXA 400 mg into the joint space via catheter prior to capsular closure
|
DepoTXA 800mg
n=2 Participants
Single injection of DepoTXA 800 mg into the joint space via catheter prior to capsular closure
|
DepoTXA 1200mg
n=4 Participants
Single injection of DepoTXA 1200 mg into the joint space via catheter prior to capsular closure
|
IV Tranexamic Acid (TXA)
n=4 Participants
1 g of IV TXA at the end of surgery
|
|---|---|---|---|---|
|
Maximum Plasma Concentration (Cmax)
|
2775.0 ng/mL
Standard Deviation 741.96
|
7722.0 ng/mL
Standard Deviation 2015.25
|
9827.0 ng/mL
Standard Deviation 1545.83
|
125390.0 ng/mL
Standard Deviation 154587.6
|
PRIMARY outcome
Timeframe: Baseline; 5, 15, and 30 min; at 1, 2, 4, 6, 8, 12, 16, and 24 hours after study drug administration for all treatment groups. Additional blood samples were collected at 36, 48, 60, 72, and 96 hours for DepoTXA-treated subjects.Population: Pharmacokinetic (PK) analysis set: All subjects who received study drug, provided sufficient samples to allow for calculation of PK parameters required for analysis, and who did not have significant protocol deviations
Outcome measures
| Measure |
DepoTXA 400mg
n=4 Participants
Single injection of DepoTXA 400 mg into the joint space via catheter prior to capsular closure
|
DepoTXA 800mg
n=2 Participants
Single injection of DepoTXA 800 mg into the joint space via catheter prior to capsular closure
|
DepoTXA 1200mg
n=4 Participants
Single injection of DepoTXA 1200 mg into the joint space via catheter prior to capsular closure
|
IV Tranexamic Acid (TXA)
n=4 Participants
1 g of IV TXA at the end of surgery
|
|---|---|---|---|---|
|
Time to Maximum Plasma Concentration (Tmax)
|
1.6 hr
Standard Deviation 0.55
|
1.5 hr
Standard Deviation 0.57
|
2.5 hr
Standard Deviation 0.96
|
0.1 hr
Standard Deviation 0
|
PRIMARY outcome
Timeframe: Baseline; 5, 15, and 30 min; at 1, 2, 4, 6, 8, 12, 16, and 24 hours after study drug administration for all treatment groups. Additional blood samples were collected at 36, 48, 60, 72, and 96 hours for DepoTXA-treated subjects.Population: Pharmacokinetic (PK) analysis set: All subjects who received study drug, provided sufficient samples to allow for calculation of PK parameters required for analysis, and who did not have significant protocol deviations
Outcome measures
| Measure |
DepoTXA 400mg
n=4 Participants
Single injection of DepoTXA 400 mg into the joint space via catheter prior to capsular closure
|
DepoTXA 800mg
n=2 Participants
Single injection of DepoTXA 800 mg into the joint space via catheter prior to capsular closure
|
DepoTXA 1200mg
n=4 Participants
Single injection of DepoTXA 1200 mg into the joint space via catheter prior to capsular closure
|
IV Tranexamic Acid (TXA)
n=4 Participants
1 g of IV TXA at the end of surgery
|
|---|---|---|---|---|
|
The Apparent Terminal Elimination Rate Constant
|
0.048 1/hr
Standard Deviation 0.0084
|
0.035 1/hr
Standard Deviation 0.0120
|
0.035 1/hr
Standard Deviation 0.0095
|
0.136 1/hr
Standard Deviation 0.0261
|
PRIMARY outcome
Timeframe: Baseline; 5, 15, and 30 min; at 1, 2, 4, 6, 8, 12, 16, and 24 hours after study drug administration for all treatment groups. Additional blood samples were collected at 36, 48, 60, 72, and 96 hours for DepoTXA-treated subjects.Population: Pharmacokinetic (PK) analysis set: All subjects who received study drug, provided sufficient samples to allow for calculation of PK parameters required for analysis, and who did not have significant protocol deviations
Outcome measures
| Measure |
DepoTXA 400mg
n=4 Participants
Single injection of DepoTXA 400 mg into the joint space via catheter prior to capsular closure
|
DepoTXA 800mg
n=2 Participants
Single injection of DepoTXA 800 mg into the joint space via catheter prior to capsular closure
|
DepoTXA 1200mg
n=4 Participants
Single injection of DepoTXA 1200 mg into the joint space via catheter prior to capsular closure
|
IV Tranexamic Acid (TXA)
n=4 Participants
1 g of IV TXA at the end of surgery
|
|---|---|---|---|---|
|
The Apparent Terminal Elimination Half-life
|
14.679 hr
Standard Deviation 2.6980
|
21.132 hr
Standard Deviation 7.2508
|
20.956 hr
Standard Deviation 5.7276
|
5.220 hr
Standard Deviation 0.8540
|
SECONDARY outcome
Timeframe: 12, 24, 36, 48, 60, 72, and 96 hours after study drug administrationPopulation: Safety analysis set: All subjects who received study drug treatment
Neurological assessment at 12, 24, 36, 48, 60, 72, and 96 hours after study drug administration
Outcome measures
| Measure |
DepoTXA 400mg
n=4 Participants
Single injection of DepoTXA 400 mg into the joint space via catheter prior to capsular closure
|
DepoTXA 800mg
n=3 Participants
Single injection of DepoTXA 800 mg into the joint space via catheter prior to capsular closure
|
DepoTXA 1200mg
n=4 Participants
Single injection of DepoTXA 1200 mg into the joint space via catheter prior to capsular closure
|
IV Tranexamic Acid (TXA)
n=4 Participants
1 g of IV TXA at the end of surgery
|
|---|---|---|---|---|
|
Summary of Neurological Assessments (Proportion of Subjects Who Were Oriented and Proportion of Subjects Who Had Any of the Neurologic Events) at Each Assessed Timepoint
Number of subjects who had any of the neurologic events at 36 hours
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Summary of Neurological Assessments (Proportion of Subjects Who Were Oriented and Proportion of Subjects Who Had Any of the Neurologic Events) at Each Assessed Timepoint
Number of subjects who had any of the neurologic events at 48 hours
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Summary of Neurological Assessments (Proportion of Subjects Who Were Oriented and Proportion of Subjects Who Had Any of the Neurologic Events) at Each Assessed Timepoint
Number of subjects who had any of the neurologic events at 60 hours
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Summary of Neurological Assessments (Proportion of Subjects Who Were Oriented and Proportion of Subjects Who Had Any of the Neurologic Events) at Each Assessed Timepoint
Number of subjects who had any of the neurologic events at 72 hours
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Summary of Neurological Assessments (Proportion of Subjects Who Were Oriented and Proportion of Subjects Who Had Any of the Neurologic Events) at Each Assessed Timepoint
Number of subjects who had any of the neurologic events at 96 hours
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Summary of Neurological Assessments (Proportion of Subjects Who Were Oriented and Proportion of Subjects Who Had Any of the Neurologic Events) at Each Assessed Timepoint
Number of subjects who had any of the neurologic events at baseline
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Summary of Neurological Assessments (Proportion of Subjects Who Were Oriented and Proportion of Subjects Who Had Any of the Neurologic Events) at Each Assessed Timepoint
Number of subjects who had any of the neurologic events at 12 hours
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Summary of Neurological Assessments (Proportion of Subjects Who Were Oriented and Proportion of Subjects Who Had Any of the Neurologic Events) at Each Assessed Timepoint
Number of subjects who had any of the neurologic events at 24 hours
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Through day 60Population: Safety analysis set: All subjects who received study drug treatment
Number of subjects who underwent reoperation due to hematoma or wound dehiscence
Outcome measures
| Measure |
DepoTXA 400mg
n=4 Participants
Single injection of DepoTXA 400 mg into the joint space via catheter prior to capsular closure
|
DepoTXA 800mg
n=3 Participants
Single injection of DepoTXA 800 mg into the joint space via catheter prior to capsular closure
|
DepoTXA 1200mg
n=4 Participants
Single injection of DepoTXA 1200 mg into the joint space via catheter prior to capsular closure
|
IV Tranexamic Acid (TXA)
n=4 Participants
1 g of IV TXA at the end of surgery
|
|---|---|---|---|---|
|
Incidence of Reoperation Due to Hematoma or Wound Dehiscence
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Day 60Population: Efficacy analysis set: All subjects who received study drug and underwent planned surgery.
Outcome measures
| Measure |
DepoTXA 400mg
n=4 Participants
Single injection of DepoTXA 400 mg into the joint space via catheter prior to capsular closure
|
DepoTXA 800mg
n=3 Participants
Single injection of DepoTXA 800 mg into the joint space via catheter prior to capsular closure
|
DepoTXA 1200mg
n=4 Participants
Single injection of DepoTXA 1200 mg into the joint space via catheter prior to capsular closure
|
IV Tranexamic Acid (TXA)
n=4 Participants
1 g of IV TXA at the end of surgery
|
|---|---|---|---|---|
|
Incidence of Transfusion (Number of Units, Number of Units/Subject, Number of Subjects Transfused)
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 24, 48, and 72 hoursPopulation: Efficacy analysis set: All subjects who received study drug and underwent planned surgery.
Outcome measures
| Measure |
DepoTXA 400mg
n=4 Participants
Single injection of DepoTXA 400 mg into the joint space via catheter prior to capsular closure
|
DepoTXA 800mg
n=3 Participants
Single injection of DepoTXA 800 mg into the joint space via catheter prior to capsular closure
|
DepoTXA 1200mg
n=4 Participants
Single injection of DepoTXA 1200 mg into the joint space via catheter prior to capsular closure
|
IV Tranexamic Acid (TXA)
n=4 Participants
1 g of IV TXA at the end of surgery
|
|---|---|---|---|---|
|
Number of Participants With 90˚ Passive and Active Knee Flexion
Number of subjects who had 90˚ passive knee flexion at 48 hours
|
1 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Number of Participants With 90˚ Passive and Active Knee Flexion
Number of subjects who had 90˚ active knee flexion at 24 hours
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With 90˚ Passive and Active Knee Flexion
Number of subjects who had 90˚ active knee flexion at 48 hours
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Number of Participants With 90˚ Passive and Active Knee Flexion
Number of subjects who had 90˚ active knee flexion at 72 hours
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With 90˚ Passive and Active Knee Flexion
Number of subjects who had 90˚ passive knee flexion at 24 hours
|
0 participants
|
1 participants
|
0 participants
|
1 participants
|
|
Number of Participants With 90˚ Passive and Active Knee Flexion
Number of subjects who had 90˚ passive knee flexion at 72 hours
|
2 participants
|
1 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Day 1; at approximately 8:00 am and 8:00 pm (±2 hours) daily from Day 2 through hospital discharge; and on Day 7Population: Efficacy analysis set: All subjects who received study drug and underwent planned surgery.
Physical therapy assessment (Timed Up-and-Go (TUG) test) was conducted once postsurgically on Day 1; at approximately 8:00 am and 8:00 pm (±2 hours) daily from Day 2 through hospital discharge; and on Day 7
Outcome measures
| Measure |
DepoTXA 400mg
n=4 Participants
Single injection of DepoTXA 400 mg into the joint space via catheter prior to capsular closure
|
DepoTXA 800mg
n=3 Participants
Single injection of DepoTXA 800 mg into the joint space via catheter prior to capsular closure
|
DepoTXA 1200mg
n=4 Participants
Single injection of DepoTXA 1200 mg into the joint space via catheter prior to capsular closure
|
IV Tranexamic Acid (TXA)
n=4 Participants
1 g of IV TXA at the end of surgery
|
|---|---|---|---|---|
|
Time to Complete Timed Up-and-Go (TUG) Test
Baseline
|
16.4 seconds
Standard Deviation 4.25
|
18.1 seconds
Standard Deviation 10.73
|
14.6 seconds
Standard Deviation 8.97
|
15.4 seconds
Standard Deviation 6.92
|
|
Time to Complete Timed Up-and-Go (TUG) Test
Day 1
|
50.0 seconds
Standard Deviation NA
1 participant only
|
80.0 seconds
Standard Deviation NA
1 participant only
|
40.0 seconds
Standard Deviation 7.07
|
80.0 seconds
Standard Deviation NA
1 participant only
|
|
Time to Complete Timed Up-and-Go (TUG) Test
Day 2 - AM
|
47.5 seconds
Standard Deviation 10.61
|
90.0 seconds
Standard Deviation 7.07
|
66.7 seconds
Standard Deviation 23.63
|
85.0 seconds
Standard Deviation 21.88
|
|
Time to Complete Timed Up-and-Go (TUG) Test
Day 2- PM
|
48.0 seconds
Standard Deviation 14.14
|
85.0 seconds
Standard Deviation 7.07
|
69.0 seconds
Standard Deviation 25.94
|
41.0 seconds
Standard Deviation 6.08
|
|
Time to Complete Timed Up-and-Go (TUG) Test
Day 2 -Discharge
|
44.3 seconds
Standard Deviation 6.03
|
51.1 seconds
Standard Deviation 32.85
|
61.3 seconds
Standard Deviation 31.76
|
40.0 seconds
Standard Deviation 0.00
|
|
Time to Complete Timed Up-and-Go (TUG) Test
Day 7
|
28.4 seconds
Standard Deviation 11.64
|
51.2 seconds
Standard Deviation 32.89
|
32.3 seconds
Standard Deviation 15.72
|
13.1 seconds
Standard Deviation NA
1 participant only
|
SECONDARY outcome
Timeframe: 48 hours and Day 7Population: Efficacy analysis set: All subjects who received study drug and underwent planned surgery.
Leg difference in change from baseline is calculated by = (Operated Leg Change from Baseline) - (Non-Operated Leg Change from Baseline)
Outcome measures
| Measure |
DepoTXA 400mg
n=4 Participants
Single injection of DepoTXA 400 mg into the joint space via catheter prior to capsular closure
|
DepoTXA 800mg
n=3 Participants
Single injection of DepoTXA 800 mg into the joint space via catheter prior to capsular closure
|
DepoTXA 1200mg
n=4 Participants
Single injection of DepoTXA 1200 mg into the joint space via catheter prior to capsular closure
|
IV Tranexamic Acid (TXA)
n=4 Participants
1 g of IV TXA at the end of surgery
|
|---|---|---|---|---|
|
Change in Knee and Thigh Measurements
Leg Difference in Change from Baseline in Knee Circumference at Day 7
|
2.6 cm
Standard Deviation 3.20
|
3.8 cm
Standard Deviation 8.25
|
-1.4 cm
Standard Deviation 4.03
|
4.3 cm
Standard Deviation 0.35
|
|
Change in Knee and Thigh Measurements
Leg Difference in Change from Baseline in Thigh Circumference (cm) at 48 hours
|
5.0 cm
Standard Deviation 4.73
|
6.7 cm
Standard Deviation 6.37
|
3.4 cm
Standard Deviation 4.54
|
6.1 cm
Standard Deviation 1.39
|
|
Change in Knee and Thigh Measurements
Leg Difference in Change from Baseline in Thigh Circumference (cm) at Day 7
|
4.3 cm
Standard Deviation 1.70
|
5.2 cm
Standard Deviation 6.17
|
0.8 cm
Standard Deviation 5.09
|
3.3 cm
Standard Deviation 3.18
|
|
Change in Knee and Thigh Measurements
Leg Difference in Change from Baseline in Knee Circumference at 48 hours
|
4.1 cm
Standard Deviation 3.47
|
5.8 cm
Standard Deviation 5.37
|
2.2 cm
Standard Deviation 4.85
|
1.0 cm
Standard Deviation 5.25
|
SECONDARY outcome
Timeframe: Preoperative; arrival in Post-Anesthesia Care Unit (PACU); 2, 4, 6, 8, 12, 16, 24, 36, 48 hours, Day 7Population: Efficacy analysis set: All subjects who received study drug and underwent planned surgery.
Numerical rating scale (NRS) at rest pain score (0 \[no pain\] to 10 \[worst possible pain\]) upon arrival at the PACU; at each in-hospital vital sign assessment beginning with the 2-hour assessment and ending with the 48-hour assessment; and the Day-7 follow-up visit. Summary is provided as area under the curve (AUC) of NRS from timepoint 0 to 24 hours, 0 to 48 hours, and 24 to 48 hours.
Outcome measures
| Measure |
DepoTXA 400mg
n=4 Participants
Single injection of DepoTXA 400 mg into the joint space via catheter prior to capsular closure
|
DepoTXA 800mg
n=3 Participants
Single injection of DepoTXA 800 mg into the joint space via catheter prior to capsular closure
|
DepoTXA 1200mg
n=4 Participants
Single injection of DepoTXA 1200 mg into the joint space via catheter prior to capsular closure
|
IV Tranexamic Acid (TXA)
n=4 Participants
1 g of IV TXA at the end of surgery
|
|---|---|---|---|---|
|
Area Under the Curve (AUC) of NRS From 0-24 Hours, 0-48 Hours, and 24-48 Hours
AUC(0-48)
|
11375.1 scores on a scale*hour
Standard Deviation 6159.89
|
12063.0 scores on a scale*hour
Standard Deviation 3331.38
|
10859.5 scores on a scale*hour
Standard Deviation 4761.97
|
13406.8 scores on a scale*hour
Standard Deviation 5495.40
|
|
Area Under the Curve (AUC) of NRS From 0-24 Hours, 0-48 Hours, and 24-48 Hours
AUC(0-24)
|
5230.0 scores on a scale*hour
Standard Deviation 3416.48
|
4723.0 scores on a scale*hour
Standard Deviation 3242.87
|
5119.3 scores on a scale*hour
Standard Deviation 2587.32
|
6876.3 scores on a scale*hour
Standard Deviation 2560.73
|
|
Area Under the Curve (AUC) of NRS From 0-24 Hours, 0-48 Hours, and 24-48 Hours
AUC(24-48)
|
6145.1 scores on a scale*hour
Standard Deviation 2786.30
|
7340.0 scores on a scale*hour
Standard Deviation 1880.10
|
5740.3 scores on a scale*hour
Standard Deviation 2244.90
|
6530.5 scores on a scale*hour
Standard Deviation 2936.93
|
Adverse Events
DepoTXA 400mg
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
DepoTXA 800mg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
DepoTXA 1200mg
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
IV Tranexamic Acid (TXA)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
DepoTXA 400mg
n=4 participants at risk
Single injection of DepoTXA 400 mg into the joint space via catheter prior to capsular closure
|
DepoTXA 800mg
n=3 participants at risk
Single injection of DepoTXA 800 mg into the joint space via catheter prior to capsular closure
|
DepoTXA 1200mg
n=4 participants at risk
Single injection of DepoTXA 1200 mg into the joint space via catheter prior to capsular closure
|
IV Tranexamic Acid (TXA)
n=4 participants at risk
1 g of IV TXA at the end of surgery
|
|---|---|---|---|---|
|
Injury, poisoning and procedural complications
Procedural pain
|
75.0%
3/4 • From screening to postsurgical day 60
An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov.
|
66.7%
2/3 • From screening to postsurgical day 60
An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov.
|
75.0%
3/4 • From screening to postsurgical day 60
An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov.
|
50.0%
2/4 • From screening to postsurgical day 60
An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov.
|
|
Injury, poisoning and procedural complications
Postprocedural hemorrhage
|
0.00%
0/4 • From screening to postsurgical day 60
An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov.
|
0.00%
0/3 • From screening to postsurgical day 60
An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov.
|
0.00%
0/4 • From screening to postsurgical day 60
An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov.
|
25.0%
1/4 • From screening to postsurgical day 60
An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov.
|
|
Gastrointestinal disorders
Nausea
|
25.0%
1/4 • From screening to postsurgical day 60
An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov.
|
33.3%
1/3 • From screening to postsurgical day 60
An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov.
|
25.0%
1/4 • From screening to postsurgical day 60
An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov.
|
25.0%
1/4 • From screening to postsurgical day 60
An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov.
|
|
Gastrointestinal disorders
Constipation
|
25.0%
1/4 • From screening to postsurgical day 60
An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov.
|
0.00%
0/3 • From screening to postsurgical day 60
An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov.
|
25.0%
1/4 • From screening to postsurgical day 60
An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov.
|
0.00%
0/4 • From screening to postsurgical day 60
An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/4 • From screening to postsurgical day 60
An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov.
|
33.3%
1/3 • From screening to postsurgical day 60
An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov.
|
25.0%
1/4 • From screening to postsurgical day 60
An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov.
|
0.00%
0/4 • From screening to postsurgical day 60
An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov.
|
|
Gastrointestinal disorders
Flatulence
|
25.0%
1/4 • From screening to postsurgical day 60
An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov.
|
0.00%
0/3 • From screening to postsurgical day 60
An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov.
|
0.00%
0/4 • From screening to postsurgical day 60
An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov.
|
0.00%
0/4 • From screening to postsurgical day 60
An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov.
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/4 • From screening to postsurgical day 60
An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov.
|
0.00%
0/3 • From screening to postsurgical day 60
An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov.
|
25.0%
1/4 • From screening to postsurgical day 60
An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov.
|
0.00%
0/4 • From screening to postsurgical day 60
An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/4 • From screening to postsurgical day 60
An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov.
|
0.00%
0/3 • From screening to postsurgical day 60
An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov.
|
0.00%
0/4 • From screening to postsurgical day 60
An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov.
|
25.0%
1/4 • From screening to postsurgical day 60
An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/4 • From screening to postsurgical day 60
An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov.
|
0.00%
0/3 • From screening to postsurgical day 60
An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov.
|
50.0%
2/4 • From screening to postsurgical day 60
An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov.
|
0.00%
0/4 • From screening to postsurgical day 60
An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
50.0%
2/4 • From screening to postsurgical day 60
An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov.
|
0.00%
0/3 • From screening to postsurgical day 60
An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov.
|
0.00%
0/4 • From screening to postsurgical day 60
An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov.
|
0.00%
0/4 • From screening to postsurgical day 60
An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov.
|
|
Vascular disorders
Hypertension
|
25.0%
1/4 • From screening to postsurgical day 60
An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov.
|
0.00%
0/3 • From screening to postsurgical day 60
An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov.
|
0.00%
0/4 • From screening to postsurgical day 60
An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov.
|
25.0%
1/4 • From screening to postsurgical day 60
An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/4 • From screening to postsurgical day 60
An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov.
|
0.00%
0/3 • From screening to postsurgical day 60
An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov.
|
25.0%
1/4 • From screening to postsurgical day 60
An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov.
|
0.00%
0/4 • From screening to postsurgical day 60
An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov.
|
|
Nervous system disorders
Hypoesthesia
|
0.00%
0/4 • From screening to postsurgical day 60
An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov.
|
0.00%
0/3 • From screening to postsurgical day 60
An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov.
|
0.00%
0/4 • From screening to postsurgical day 60
An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov.
|
25.0%
1/4 • From screening to postsurgical day 60
An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov.
|
|
Cardiac disorders
Sinus arrhythmia
|
25.0%
1/4 • From screening to postsurgical day 60
An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov.
|
0.00%
0/3 • From screening to postsurgical day 60
An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov.
|
0.00%
0/4 • From screening to postsurgical day 60
An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov.
|
0.00%
0/4 • From screening to postsurgical day 60
An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov.
|
Additional Information
Pacira Medical Information
Pacira Pharmaceuticals, Inc.
Phone: 1-855-793-9727
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Institution and investigator shall reasonably cooperate with Pacira to prepare abstract and manuscript reporting primary results within 90 and 120 days, respectively, of single and/or pooled analysis final CSR and shall publish no other trial results within 12 months after completion of final CSR. Institution shall submit all proposed written materials related to the trial ≥60 days before submission for presentation/publication. Pacira may embargo publication for an additional 90 days.
- Publication restrictions are in place
Restriction type: OTHER