Trial Outcomes & Findings for A Study of MDT-10013 in the Treatment of Acute Postoperative Pain Following Bunionectomy (NCT NCT02077140)
NCT ID: NCT02077140
Last Updated: 2017-10-13
Results Overview
Summed pain intensity is a time-weighted average pain score in numeric rating scale (NRS) over 1 to 48hrs (SPI-48). Summed pain intensity is calculated as area under the curve, using the trapezoidal rule to bridge adjacent time points. Specifically, NRS scores for two adjacent time points are averaged and then multiplied by the time span between points (in hours). The theoretical range for SPI-48 is 0 to 470, with lower scores indicative of less pain over this time period (i.e., lower scores are consistent with better analgesia). Time 0 was defined as the time the capsule was closed.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
192 participants
Primary outcome timeframe
over 1 to 48hrs
Results posted on
2017-10-13
Participant Flow
The study was planned to enroll 3 sequential cohorts, the 4th cohort was added after data review from Cohort 1-3. In each cohort, 48 subjects were randomized in a 3:1 ratio (investigational vs. control). The investigational subjects were implanted MDT-10013 strips in surgical wound while control subjects received standard of care for pain control.
Participant milestones
| Measure |
1 MDT-10013 Strip (In Cohort 1)
For the investigational subjects of Cohort 1, one MDT-10013 strip was sutured to the exterior of the capsule wall.
|
2 MDT-10013 Strips (In Cohort 2)
For the investigational subjects of Cohort 2, one MDT-10013 strip was sutured to the exterior of the capsule and 1 strip was sutured to the interior capsule wall.
|
3 MDT-10013 Strips (In Cohort 3)
For the investigational subjects of Cohort 3, one MDT-10013 strip was sutured to the exterior of the capsule and 2 strips were sutured to the interior capsule wall.
|
2 MDT-10013 Strips (In Cohort 4)
For the investigational subjects of Cohort 4, two strips were sutured to the interior capsule wall.
|
Control (In Cohort 1-4)
Control subjects in Cohort 1 to 4 received standard of care (no strip) for pain control.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
36
|
36
|
36
|
36
|
48
|
|
Overall Study
COMPLETED
|
32
|
34
|
34
|
32
|
43
|
|
Overall Study
NOT COMPLETED
|
4
|
2
|
2
|
4
|
5
|
Reasons for withdrawal
| Measure |
1 MDT-10013 Strip (In Cohort 1)
For the investigational subjects of Cohort 1, one MDT-10013 strip was sutured to the exterior of the capsule wall.
|
2 MDT-10013 Strips (In Cohort 2)
For the investigational subjects of Cohort 2, one MDT-10013 strip was sutured to the exterior of the capsule and 1 strip was sutured to the interior capsule wall.
|
3 MDT-10013 Strips (In Cohort 3)
For the investigational subjects of Cohort 3, one MDT-10013 strip was sutured to the exterior of the capsule and 2 strips were sutured to the interior capsule wall.
|
2 MDT-10013 Strips (In Cohort 4)
For the investigational subjects of Cohort 4, two strips were sutured to the interior capsule wall.
|
Control (In Cohort 1-4)
Control subjects in Cohort 1 to 4 received standard of care (no strip) for pain control.
|
|---|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
4
|
1
|
2
|
2
|
3
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
0
|
2
|
2
|
Baseline Characteristics
A Study of MDT-10013 in the Treatment of Acute Postoperative Pain Following Bunionectomy
Baseline characteristics by cohort
| Measure |
1 MDT-10013 Strip (In Cohort 1)
n=36 Participants
For the investigational subjects of Cohort 1, one MDT-10013 strip was sutured to the exterior of the capsule wall.
|
2 MDT-10013 Strips (In Cohort 2)
n=36 Participants
For the investigational subjects of Cohort 2, one MDT-10013 strip was sutured to the exterior of the capsule and 1 strip was sutured to the interior capsule wall.
|
3 MDT-10013 Strips (In Cohort 3)
n=36 Participants
For the investigational subjects of Cohort 3, one MDT-10013 strip was sutured to the exterior of the capsule and 2 strips were sutured to the interior capsule wall.
|
2 MDT-10013 Strips (In Cohort 4)
n=36 Participants
For the investigational subjects of Cohort 4, two MDT-10013 strips were sutured to the interior capsule wall.
|
Control (In Cohort 1 to 4)
n=48 Participants
Control subjects in Cohort 1 to 4 received standard of care for pain control.
|
Total
n=192 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
47.6 years
STANDARD_DEVIATION 13.22 • n=5 Participants
|
39.7 years
STANDARD_DEVIATION 11.90 • n=7 Participants
|
40.4 years
STANDARD_DEVIATION 12.37 • n=5 Participants
|
41.1 years
STANDARD_DEVIATION 13.49 • n=4 Participants
|
40.7 years
STANDARD_DEVIATION 11.78 • n=21 Participants
|
41.8 years
STANDARD_DEVIATION 12.71 • n=10 Participants
|
|
Sex: Female, Male
Female
|
32 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
31 Participants
n=4 Participants
|
43 Participants
n=21 Participants
|
168 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
24 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
American-Indian or Alaska Native
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
4 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Black or African-American
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
24 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
White
|
31 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
30 Participants
n=4 Participants
|
44 Participants
n=21 Participants
|
159 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Other
|
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
|
0 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Data missing
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
|
Weight
|
72.71 lbs
STANDARD_DEVIATION 15.41 • n=5 Participants
|
71.97 lbs
STANDARD_DEVIATION 12.79 • n=7 Participants
|
73.94 lbs
STANDARD_DEVIATION 14.51 • n=5 Participants
|
72.99 lbs
STANDARD_DEVIATION 13.30 • n=4 Participants
|
76.12 lbs
STANDARD_DEVIATION 14.24 • n=21 Participants
|
73.71 lbs
STANDARD_DEVIATION 14.02 • n=10 Participants
|
|
Height
|
162.8 cm
STANDARD_DEVIATION 8.12 • n=5 Participants
|
162.5 cm
STANDARD_DEVIATION 7.38 • n=7 Participants
|
163.8 cm
STANDARD_DEVIATION 8.92 • n=5 Participants
|
162.8 cm
STANDARD_DEVIATION 9.86 • n=4 Participants
|
165.2 cm
STANDARD_DEVIATION 8.67 • n=21 Participants
|
163.5 cm
STANDARD_DEVIATION 8.61 • n=10 Participants
|
|
BMI
|
27.3 kg/m^2
STANDARD_DEVIATION 4.82 • n=5 Participants
|
27.3 kg/m^2
STANDARD_DEVIATION 4.51 • n=7 Participants
|
27.4 kg/m^2
STANDARD_DEVIATION 4.07 • n=5 Participants
|
27.6 kg/m^2
STANDARD_DEVIATION 4.44 • n=4 Participants
|
28.0 kg/m^2
STANDARD_DEVIATION 4.55 • n=21 Participants
|
27.6 kg/m^2
STANDARD_DEVIATION 4.45 • n=10 Participants
|
PRIMARY outcome
Timeframe: over 1 to 48hrsPopulation: The primary efficacy analysis was based on the Full Analysis dataset of Cohort 1 to 3. Full Analysis dataset included Safety population (i.e., all subjects who received at least 1 MDT-10013 strip or completed surgery in a standard-of-care group based on the actual treatment a subject received) having at least 1 postoperative pain assessment.
Summed pain intensity is a time-weighted average pain score in numeric rating scale (NRS) over 1 to 48hrs (SPI-48). Summed pain intensity is calculated as area under the curve, using the trapezoidal rule to bridge adjacent time points. Specifically, NRS scores for two adjacent time points are averaged and then multiplied by the time span between points (in hours). The theoretical range for SPI-48 is 0 to 470, with lower scores indicative of less pain over this time period (i.e., lower scores are consistent with better analgesia). Time 0 was defined as the time the capsule was closed.
Outcome measures
| Measure |
1 MDT-10013 Strip (In Cohort 1)
n=36 Participants
For the investigational subjects of Cohort 1, one MDT-10013 strip was sutured to the exterior of the capsule wall.
|
2 MDT-10013 Strips (In Cohort 2)
n=36 Participants
For the investigational subjects of Cohort 2, one MDT-10013 strip was sutured to the exterior of the capsule and 1 strip was sutured to the interior capsule wall.
|
3 MDT-10013 Strips (In Cohort 3)
n=36 Participants
For the investigational subjects of Cohort 3, one MDT-10013 strip was sutured to the exterior of the capsule and 2 strips were sutured to the interior capsule wall.
|
Control (In Cohort 1-3)
n=36 Participants
Control subjects in Cohort 1 to 3 received standard of care for pain control.
|
Control (In Cohort 1 to 4)
Control subjects of Cohort 1 to 4 received standard of care for pain control.
|
|---|---|---|---|---|---|
|
Summed Pain Intensity Over 1- 48hrs (SPI-48) From Cohort 1 to 3
|
252.29 units on a scale
Standard Deviation 74.423
|
213.28 units on a scale
Standard Deviation 73.330
|
191.97 units on a scale
Standard Deviation 84.940
|
215.35 units on a scale
Standard Deviation 66.133
|
—
|
PRIMARY outcome
Timeframe: over 1 to 48hrsPopulation: The primary efficacy analysis was based on the Full Analysis dataset of Cohort 1 to 3. Full Analysis dataset included Safety population (i.e., all subjects who received at least 1 MDT-10013 strip or completed surgery in a standard-of-care group based on the actual treatment a subject received) having at least 1 postoperative pain assessment.
Similar to SPI-48, the theoretical range for this LOCF adjustment for rescue medication is 0-470, with lower scores indicative of less pain over this time period (i.e., lower scores are consistent with better analgesia). The calculation is identical to SPI-48 in terms of area-under the curve using the trapezoidal rule. However, the NRS score at the final assessment prior to rescue is carried forward through 48 hours, replacing the raw NRS scores post-rescue for each patient as applicable.
Outcome measures
| Measure |
1 MDT-10013 Strip (In Cohort 1)
n=36 Participants
For the investigational subjects of Cohort 1, one MDT-10013 strip was sutured to the exterior of the capsule wall.
|
2 MDT-10013 Strips (In Cohort 2)
n=36 Participants
For the investigational subjects of Cohort 2, one MDT-10013 strip was sutured to the exterior of the capsule and 1 strip was sutured to the interior capsule wall.
|
3 MDT-10013 Strips (In Cohort 3)
n=36 Participants
For the investigational subjects of Cohort 3, one MDT-10013 strip was sutured to the exterior of the capsule and 2 strips were sutured to the interior capsule wall.
|
Control (In Cohort 1-3)
n=36 Participants
Control subjects in Cohort 1 to 3 received standard of care for pain control.
|
Control (In Cohort 1 to 4)
Control subjects of Cohort 1 to 4 received standard of care for pain control.
|
|---|---|---|---|---|---|
|
Summed Pain Intensity Over 1- 48hrs (SPI-48)--Sensitivity Analysis Using Last Observation Carried Forward (LOCF)
|
324.82 units on a scale
Standard Deviation 65.141
|
284.60 units on a scale
Standard Deviation 80.080
|
281.03 units on a scale
Standard Deviation 82.593
|
281.83 units on a scale
Standard Deviation 91.415
|
—
|
PRIMARY outcome
Timeframe: over 1 to 48hrsPopulation: The primary efficacy analysis was based on the Full Analysis dataset of Cohort 1 to 3. Full Analysis dataset included Safety population (i.e., all subjects who received at least 1 MDT-10013 strip or completed surgery in a standard-of-care group based on the actual treatment a subject received) having at least 1 postoperative pain assessment.
This sensitivity analysis is an integrated assessment of summed pain intensity over 1 to 48hrs (SPI-48) and total opioid intake (ME0-48) in first 48hrs. Briefly, subjects were ranked according to SPI-48 regardless of the treatment received (including Standard of Care, SOC). The mean of all the ranks for this variable was calculated. Then, the percent difference for each individual rank from the pooled mean rank was computed. This process was repeated for total opioid intake in the first 48hrs (ME0-48). The integrated endpoint for each subject was the sum of the rank order percent differences for SPI-48 and ME0-48. The theoretical minimum and maximum on the integrated endpoint are -197% and +197% in this study. Lower scores are better, indicative of less pain and/or less opioid intake.
Outcome measures
| Measure |
1 MDT-10013 Strip (In Cohort 1)
n=36 Participants
For the investigational subjects of Cohort 1, one MDT-10013 strip was sutured to the exterior of the capsule wall.
|
2 MDT-10013 Strips (In Cohort 2)
n=36 Participants
For the investigational subjects of Cohort 2, one MDT-10013 strip was sutured to the exterior of the capsule and 1 strip was sutured to the interior capsule wall.
|
3 MDT-10013 Strips (In Cohort 3)
n=36 Participants
For the investigational subjects of Cohort 3, one MDT-10013 strip was sutured to the exterior of the capsule and 2 strips were sutured to the interior capsule wall.
|
Control (In Cohort 1-3)
n=36 Participants
Control subjects in Cohort 1 to 3 received standard of care for pain control.
|
Control (In Cohort 1 to 4)
Control subjects of Cohort 1 to 4 received standard of care for pain control.
|
|---|---|---|---|---|---|
|
Integrated Summed Pain Intensity Over 1- 48hrs (SPI-48) and Total Opioid Intake in First 48hrs --Sensitivity Analysis Using Silverman Method
|
23.66 percent difference
Standard Deviation 54.274
|
-4.79 percent difference
Standard Deviation 55.043
|
-17.36 percent difference
Standard Deviation 62.466
|
-1.51 percent difference
Standard Deviation 52.306
|
—
|
PRIMARY outcome
Timeframe: over 1 to 48hrsPopulation: The primary efficacy analysis was based on the Full Analysis dataset of Cohort 1 to 3. Full Analysis dataset included Safety population (i.e., all subjects who received at least 1 MDT-10013 strip or completed surgery in a standard-of-care group based on the actual treatment a subject received) having at least 1 postoperative pain assessment.
Similar to SPI-48, the theoretical range for this WOCF adjustment for rescue medication is 0-470, with lower scores indicative of less pain over this time period (i.e., lower scores are consistent with better analgesia). The calculation is identical in terms of area-under the curve using the trapezoidal rule. However, the NRS score at the final assessment prior to each instance of rescue medication is carried forward through for a window based on the approximate half-life of the drug, replacing the raw NRS scores post-rescue for each patient until the end of the pharmacological activity window, at which point calculations revert to raw NRS as applicable. Note that WOCF SPI-48 may include multiple adjustment windows for each patient, depending on the number or rescue events and the active life of the medication selected.
Outcome measures
| Measure |
1 MDT-10013 Strip (In Cohort 1)
n=36 Participants
For the investigational subjects of Cohort 1, one MDT-10013 strip was sutured to the exterior of the capsule wall.
|
2 MDT-10013 Strips (In Cohort 2)
n=36 Participants
For the investigational subjects of Cohort 2, one MDT-10013 strip was sutured to the exterior of the capsule and 1 strip was sutured to the interior capsule wall.
|
3 MDT-10013 Strips (In Cohort 3)
n=36 Participants
For the investigational subjects of Cohort 3, one MDT-10013 strip was sutured to the exterior of the capsule and 2 strips were sutured to the interior capsule wall.
|
Control (In Cohort 1-3)
n=36 Participants
Control subjects in Cohort 1 to 3 received standard of care for pain control.
|
Control (In Cohort 1 to 4)
Control subjects of Cohort 1 to 4 received standard of care for pain control.
|
|---|---|---|---|---|---|
|
Summed Pain Intensity Over 1- 48hrs (SPI-48)--Sensitivity Analysis Using Windowed Worst Observation Carried Forward (WOCF)
|
322.08 units on a scale
Standard Deviation 93.298
|
278.44 units on a scale
Standard Deviation 83.515
|
257.57 units on a scale
Standard Deviation 100.430
|
302.54 units on a scale
Standard Deviation 82.105
|
—
|
SECONDARY outcome
Timeframe: over 1 to 24hrs, 1 to 72hrs, and 1 to 96hrsPopulation: The primary efficacy analysis was based on the Full Analysis dataset of Cohort 1 to 3. Full Analysis dataset included Safety population (i.e., all subjects who received at least 1 MDT-10013 strip or completed surgery in a standard-of-care group based on the actual treatment a subject received) having at least 1 postoperative pain assessment.
The theoretical range for SPI-24, SPI-72, and SPI-96 is 0 to 230, 0-710, and 0-960, respectively, with lower scores indicative of less pain over this time period (i.e., lower scores are consistent with better analgesia). Summed pain intensity is calculated as area under the curve, using the trapezoidal rule to bridge adjacent time points. Specifically, NRS scores for two adjacent time points are averaged and then multiplied by the time span between points (in hours).
Outcome measures
| Measure |
1 MDT-10013 Strip (In Cohort 1)
n=36 Participants
For the investigational subjects of Cohort 1, one MDT-10013 strip was sutured to the exterior of the capsule wall.
|
2 MDT-10013 Strips (In Cohort 2)
n=36 Participants
For the investigational subjects of Cohort 2, one MDT-10013 strip was sutured to the exterior of the capsule and 1 strip was sutured to the interior capsule wall.
|
3 MDT-10013 Strips (In Cohort 3)
n=36 Participants
For the investigational subjects of Cohort 3, one MDT-10013 strip was sutured to the exterior of the capsule and 2 strips were sutured to the interior capsule wall.
|
Control (In Cohort 1-3)
n=36 Participants
Control subjects in Cohort 1 to 3 received standard of care for pain control.
|
Control (In Cohort 1 to 4)
Control subjects of Cohort 1 to 4 received standard of care for pain control.
|
|---|---|---|---|---|---|
|
Summed Pain Intensity Scores Over 1- 24hrs (SPI-24), 1- 72hrs (SPI-72) and 1- 96hrs (SPI-96)
SPI-24
|
132.18 units on a scale
Standard Deviation 35.321
|
110.83 units on a scale
Standard Deviation 35.831
|
102.42 units on a scale
Standard Deviation 38.324
|
118.13 units on a scale
Standard Deviation 33.591
|
—
|
|
Summed Pain Intensity Scores Over 1- 24hrs (SPI-24), 1- 72hrs (SPI-72) and 1- 96hrs (SPI-96)
SPI-96
|
393.29 units on a scale
Standard Deviation 155.314
|
345.50 units on a scale
Standard Deviation 144.692
|
322.97 units on a scale
Standard Deviation 168.672
|
344.90 units on a scale
Standard Deviation 147.835
|
—
|
|
Summed Pain Intensity Scores Over 1- 24hrs (SPI-24), 1- 72hrs (SPI-72) and 1- 96hrs (SPI-96)
SPI-72
|
325.96 units on a scale
Standard Deviation 113.416
|
285.50 units on a scale
Standard Deviation 109.126
|
259.42 units on a scale
Standard Deviation 126.691
|
282.90 units on a scale
Standard Deviation 105.476
|
—
|
SECONDARY outcome
Timeframe: over 0 to 24hrs, 0 to 48hrs, 0 to 72hrs, and 0 to 96hrsPopulation: The primary efficacy analysis was based on the Full Analysis dataset of Cohort 1 to 3. Full Analysis dataset included Safety population (i.e., all subjects who received at least 1 MDT-10013 strip or completed surgery in a standard-of-care group based on the actual treatment a subject received) having at least 1 postoperative pain assessment.
Total use of opioid analgesia over 0 to 24hrs, 0 to 48hrs, 0 to 72hrs, and 0 to 96hrs. The analgesia administered was converted to a morphine equivalent by using a standard conversion table.
Outcome measures
| Measure |
1 MDT-10013 Strip (In Cohort 1)
n=36 Participants
For the investigational subjects of Cohort 1, one MDT-10013 strip was sutured to the exterior of the capsule wall.
|
2 MDT-10013 Strips (In Cohort 2)
n=36 Participants
For the investigational subjects of Cohort 2, one MDT-10013 strip was sutured to the exterior of the capsule and 1 strip was sutured to the interior capsule wall.
|
3 MDT-10013 Strips (In Cohort 3)
n=36 Participants
For the investigational subjects of Cohort 3, one MDT-10013 strip was sutured to the exterior of the capsule and 2 strips were sutured to the interior capsule wall.
|
Control (In Cohort 1-3)
n=36 Participants
Control subjects in Cohort 1 to 3 received standard of care for pain control.
|
Control (In Cohort 1 to 4)
Control subjects of Cohort 1 to 4 received standard of care for pain control.
|
|---|---|---|---|---|---|
|
Total Use of Opioid Analgesia Over 0 to 24hrs, 0 to 48hrs, 0 to 72hrs, and 0 to 96hrs.
Total opioid analgesia use over 0 to 72 hrs
|
95.35 morphine mg equivalent
Standard Deviation 50.886
|
73.68 morphine mg equivalent
Standard Deviation 45.773
|
69.58 morphine mg equivalent
Standard Deviation 46.876
|
95.63 morphine mg equivalent
Standard Deviation 45.862
|
—
|
|
Total Use of Opioid Analgesia Over 0 to 24hrs, 0 to 48hrs, 0 to 72hrs, and 0 to 96hrs.
Total opioid analgesia use over 0 to 96 hrs
|
106.04 morphine mg equivalent
Standard Deviation 57.744
|
81.98 morphine mg equivalent
Standard Deviation 54.366
|
77.92 morphine mg equivalent
Standard Deviation 54.803
|
102.92 morphine mg equivalent
Standard Deviation 51.805
|
—
|
|
Total Use of Opioid Analgesia Over 0 to 24hrs, 0 to 48hrs, 0 to 72hrs, and 0 to 96hrs.
Total opioid analgesia use over 0 to 24 hrs
|
51.04 morphine mg equivalent
Standard Deviation 21.798
|
37.64 morphine mg equivalent
Standard Deviation 21.654
|
34.17 morphine mg equivalent
Standard Deviation 18.927
|
55.42 morphine mg equivalent
Standard Deviation 19.987
|
—
|
|
Total Use of Opioid Analgesia Over 0 to 24hrs, 0 to 48hrs, 0 to 72hrs, and 0 to 96hrs.
Total opioid analgesia use over 0 to 48 hrs
|
81.67 morphine mg equivalent
Standard Deviation 38.526
|
59.10 morphine mg equivalent
Standard Deviation 32.278
|
56.04 morphine mg equivalent
Standard Deviation 34.040
|
82.08 morphine mg equivalent
Standard Deviation 34.203
|
—
|
SECONDARY outcome
Timeframe: up to 96hrsPopulation: The primary efficacy analysis was based on the Full Analysis dataset of Cohort 1 to 3. Full Analysis dataset included Safety population (i.e., all subjects who received at least 1 MDT-10013 strip or completed surgery in a standard-of-care group based on the actual treatment a subject received) having at least 1 postoperative pain assessment.
Outcome measures
| Measure |
1 MDT-10013 Strip (In Cohort 1)
n=36 Participants
For the investigational subjects of Cohort 1, one MDT-10013 strip was sutured to the exterior of the capsule wall.
|
2 MDT-10013 Strips (In Cohort 2)
n=36 Participants
For the investigational subjects of Cohort 2, one MDT-10013 strip was sutured to the exterior of the capsule and 1 strip was sutured to the interior capsule wall.
|
3 MDT-10013 Strips (In Cohort 3)
n=36 Participants
For the investigational subjects of Cohort 3, one MDT-10013 strip was sutured to the exterior of the capsule and 2 strips were sutured to the interior capsule wall.
|
Control (In Cohort 1-3)
n=36 Participants
Control subjects in Cohort 1 to 3 received standard of care for pain control.
|
Control (In Cohort 1 to 4)
Control subjects of Cohort 1 to 4 received standard of care for pain control.
|
|---|---|---|---|---|---|
|
Time to First Use of Opioid Analgesia
|
4.4 hours
Interval 3.3 to 5.1
|
5.3 hours
Interval 4.5 to 6.3
|
5.1 hours
Interval 4.3 to 5.9
|
3.7 hours
Interval 3.2 to 4.3
|
—
|
SECONDARY outcome
Timeframe: up to 72hrsPopulation: The primary efficacy analysis was based on the Full Analysis dataset of Cohort 1 to 3. Full Analysis dataset included Safety population (i.e., all subjects who received at least 1 MDT-10013 strip or completed surgery in a standard-of-care group based on the actual treatment a subject received) having at least 1 postoperative pain assessment.
Subject's satisfaction with study treatment as measured by a 5-point categorical scale where 0 = poor, 1 = fair, 2 = good, 3 = very good, and 4 = excellent
Outcome measures
| Measure |
1 MDT-10013 Strip (In Cohort 1)
n=36 Participants
For the investigational subjects of Cohort 1, one MDT-10013 strip was sutured to the exterior of the capsule wall.
|
2 MDT-10013 Strips (In Cohort 2)
n=36 Participants
For the investigational subjects of Cohort 2, one MDT-10013 strip was sutured to the exterior of the capsule and 1 strip was sutured to the interior capsule wall.
|
3 MDT-10013 Strips (In Cohort 3)
n=36 Participants
For the investigational subjects of Cohort 3, one MDT-10013 strip was sutured to the exterior of the capsule and 2 strips were sutured to the interior capsule wall.
|
Control (In Cohort 1-3)
n=36 Participants
Control subjects in Cohort 1 to 3 received standard of care for pain control.
|
Control (In Cohort 1 to 4)
Control subjects of Cohort 1 to 4 received standard of care for pain control.
|
|---|---|---|---|---|---|
|
Subject's Satisfaction With Study Treatment
Excellent
|
4 Participants
|
8 Participants
|
5 Participants
|
3 Participants
|
—
|
|
Subject's Satisfaction With Study Treatment
Poor
|
11 Participants
|
3 Participants
|
3 Participants
|
9 Participants
|
—
|
|
Subject's Satisfaction With Study Treatment
Fair
|
3 Participants
|
5 Participants
|
4 Participants
|
6 Participants
|
—
|
|
Subject's Satisfaction With Study Treatment
Good
|
10 Participants
|
9 Participants
|
11 Participants
|
10 Participants
|
—
|
|
Subject's Satisfaction With Study Treatment
Very good
|
8 Participants
|
11 Participants
|
13 Participants
|
8 Participants
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: up to 10 daysPopulation: PK analysis population consisted of all subjects who had PK samples analyzed.
Blood samples were taken for pharmacokinetic parameters of MDT-10013 determinations before surgery on Day 0; at 1, 2, 4, 6, 8, 12, 24, 48, 72, and 96 hours after Time 0 (96-hour sample for Cohort 4 only); and on Days 7 to 10 after Time 0. Time 0 was defined as the time the capsule was closed. Actual sampling times after T0 (to 1/1000th of an hour) were used to calculate PK parameters.
Outcome measures
| Measure |
1 MDT-10013 Strip (In Cohort 1)
n=36 Participants
For the investigational subjects of Cohort 1, one MDT-10013 strip was sutured to the exterior of the capsule wall.
|
2 MDT-10013 Strips (In Cohort 2)
n=36 Participants
For the investigational subjects of Cohort 2, one MDT-10013 strip was sutured to the exterior of the capsule and 1 strip was sutured to the interior capsule wall.
|
3 MDT-10013 Strips (In Cohort 3)
n=36 Participants
For the investigational subjects of Cohort 3, one MDT-10013 strip was sutured to the exterior of the capsule and 2 strips were sutured to the interior capsule wall.
|
Control (In Cohort 1-3)
n=36 Participants
Control subjects in Cohort 1 to 3 received standard of care for pain control.
|
Control (In Cohort 1 to 4)
Control subjects of Cohort 1 to 4 received standard of care for pain control.
|
|---|---|---|---|---|---|
|
Pharmacokinetic (PK) Parameters of MDT-10013: Area Under the Concentration-time Curve From Time 0 to Time of Last Quantifiable Concentration (AUC0-t)
|
73885.02 h*pg/mL
Standard Deviation 16743.59
|
127987.04 h*pg/mL
Standard Deviation 36290.88
|
174207.74 h*pg/mL
Standard Deviation 45114.71
|
144138.55 h*pg/mL
Standard Deviation 40723.92
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: up to 10 daysPopulation: PK analysis population consisted of all subjects who had PK samples analyzed.
Blood samples were taken for pharmacokinetic parameters of MDT-10013 determinations before surgery on Day 0; at 1, 2, 4, 6, 8, 12, 24, 48, 72, and 96 hours after Time 0 (96-hour sample for Cohort 4 only); and on Days 7 to 10 after Time 0. Time 0 was defined as the time the capsule was closed. Actual sampling times after T0 (to 1/1000th of an hour) were used to calculate PK parameters.
Outcome measures
| Measure |
1 MDT-10013 Strip (In Cohort 1)
n=30 Participants
For the investigational subjects of Cohort 1, one MDT-10013 strip was sutured to the exterior of the capsule wall.
|
2 MDT-10013 Strips (In Cohort 2)
n=21 Participants
For the investigational subjects of Cohort 2, one MDT-10013 strip was sutured to the exterior of the capsule and 1 strip was sutured to the interior capsule wall.
|
3 MDT-10013 Strips (In Cohort 3)
n=18 Participants
For the investigational subjects of Cohort 3, one MDT-10013 strip was sutured to the exterior of the capsule and 2 strips were sutured to the interior capsule wall.
|
Control (In Cohort 1-3)
n=35 Participants
Control subjects in Cohort 1 to 3 received standard of care for pain control.
|
Control (In Cohort 1 to 4)
Control subjects of Cohort 1 to 4 received standard of care for pain control.
|
|---|---|---|---|---|---|
|
Pharmacokinetic (PK) Parameters of MDT-10013: Area Under the Concentration-time Curve From Time Zero to Infinity (AUC0-∞)
|
79553.78 h*pg/mL
Standard Deviation 18857.19
|
130511.64 h*pg/mL
Standard Deviation 27496.95
|
216167.36 h*pg/mL
Standard Deviation 72319.99
|
166887.29 h*pg/mL
Standard Deviation 47337.97
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: up to 10 daysPopulation: PK analysis population consisted of all subjects who had PK samples analyzed.
Blood samples were taken for pharmacokinetic parameters of MDT-10013 determinations before surgery on Day 0; at 1, 2, 4, 6, 8, 12, 24, 48, 72, and 96 hours after Time 0 (96-hour sample for Cohort 4 only); and on Days 7 to 10 after Time 0. Time 0 was defined as the time the capsule was closed. Actual sampling times after T0 (to 1/1000th of an hour) were used to calculate PK parameters.
Outcome measures
| Measure |
1 MDT-10013 Strip (In Cohort 1)
n=36 Participants
For the investigational subjects of Cohort 1, one MDT-10013 strip was sutured to the exterior of the capsule wall.
|
2 MDT-10013 Strips (In Cohort 2)
n=36 Participants
For the investigational subjects of Cohort 2, one MDT-10013 strip was sutured to the exterior of the capsule and 1 strip was sutured to the interior capsule wall.
|
3 MDT-10013 Strips (In Cohort 3)
n=36 Participants
For the investigational subjects of Cohort 3, one MDT-10013 strip was sutured to the exterior of the capsule and 2 strips were sutured to the interior capsule wall.
|
Control (In Cohort 1-3)
n=36 Participants
Control subjects in Cohort 1 to 3 received standard of care for pain control.
|
Control (In Cohort 1 to 4)
Control subjects of Cohort 1 to 4 received standard of care for pain control.
|
|---|---|---|---|---|---|
|
Pharmacokinetic (PK) Parameters of MDT-10013: Maximum Observed Plasma Concentration (Cmax)
|
620.98 pg/mL
Standard Deviation 135.36
|
1057.91 pg/mL
Standard Deviation 269.09
|
1492.96 pg/mL
Standard Deviation 470.27
|
1304.46 pg/mL
Standard Deviation 360.07
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: up to 10 daysPopulation: PK analysis population consisted of all subjects who had PK samples analyzed.
Blood samples were taken for pharmacokinetic parameters of MDT-10013 determinations before surgery on Day 0; at 1, 2, 4, 6, 8, 12, 24, 48, 72, and 96 hours after Time 0 (96-hour sample for Cohort 4 only); and on Days 7 to 10 after Time 0. Time 0 was defined as the time the capsule was closed. Actual sampling times after T0 (to 1/1000th of an hour) were used to calculate PK parameters.
Outcome measures
| Measure |
1 MDT-10013 Strip (In Cohort 1)
n=36 Participants
For the investigational subjects of Cohort 1, one MDT-10013 strip was sutured to the exterior of the capsule wall.
|
2 MDT-10013 Strips (In Cohort 2)
n=36 Participants
For the investigational subjects of Cohort 2, one MDT-10013 strip was sutured to the exterior of the capsule and 1 strip was sutured to the interior capsule wall.
|
3 MDT-10013 Strips (In Cohort 3)
n=36 Participants
For the investigational subjects of Cohort 3, one MDT-10013 strip was sutured to the exterior of the capsule and 2 strips were sutured to the interior capsule wall.
|
Control (In Cohort 1-3)
n=36 Participants
Control subjects in Cohort 1 to 3 received standard of care for pain control.
|
Control (In Cohort 1 to 4)
Control subjects of Cohort 1 to 4 received standard of care for pain control.
|
|---|---|---|---|---|---|
|
Pharmacokinetic (PK) Parameters of MDT-10013: Time to Maximum Plasma Concentration Observed (Tmax)
|
48.1 hrs
Interval 12.1 to 72.2
|
48.1 hrs
Interval 12.1 to 72.2
|
60.2 hrs
Interval 12.2 to 72.5
|
48.2 hrs
Interval 24.1 to 72.5
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: up to 10 daysPopulation: PK analysis population consisted of all subjects who had PK samples analyzed.
Blood samples were taken for pharmacokinetic parameters of MDT-10013 determinations before surgery on Day 0; at 1, 2, 4, 6, 8, 12, 24, 48, 72, and 96 hours after Time 0 (96-hour sample for Cohort 4 only); and on Days 7 to 10 after Time 0. Time 0 was defined as the time the capsule was closed. Actual sampling times after T0 (to 1/1000th of an hour) were used to calculate PK parameters.
Outcome measures
| Measure |
1 MDT-10013 Strip (In Cohort 1)
n=36 Participants
For the investigational subjects of Cohort 1, one MDT-10013 strip was sutured to the exterior of the capsule wall.
|
2 MDT-10013 Strips (In Cohort 2)
n=36 Participants
For the investigational subjects of Cohort 2, one MDT-10013 strip was sutured to the exterior of the capsule and 1 strip was sutured to the interior capsule wall.
|
3 MDT-10013 Strips (In Cohort 3)
n=36 Participants
For the investigational subjects of Cohort 3, one MDT-10013 strip was sutured to the exterior of the capsule and 2 strips were sutured to the interior capsule wall.
|
Control (In Cohort 1-3)
n=36 Participants
Control subjects in Cohort 1 to 3 received standard of care for pain control.
|
Control (In Cohort 1 to 4)
Control subjects of Cohort 1 to 4 received standard of care for pain control.
|
|---|---|---|---|---|---|
|
Pharmacokinetic (PK) Parameters of MDT-10013: Lag Time Before First Measurable Drug Concentration (Tlag)
|
1.07 hrs
Interval 0.0 to 2.08
|
0.00 hrs
Interval 0.0 to 1.15
|
0.00 hrs
Interval 0.0 to 2.08
|
1.05 hrs
Interval 0.0 to 2.08
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: up to 10 daysPopulation: PK analysis population consisted of all subjects who had PK samples analyzed.
Blood samples were taken for pharmacokinetic parameters of MDT-10013 determinations before surgery on Day 0; at 1, 2, 4, 6, 8, 12, 24, 48, 72, and 96 hours after Time 0 (96-hour sample for Cohort 4 only); and on Days 7 to 10 after Time 0. Time 0 was defined as the time the capsule was closed.
Outcome measures
| Measure |
1 MDT-10013 Strip (In Cohort 1)
n=30 Participants
For the investigational subjects of Cohort 1, one MDT-10013 strip was sutured to the exterior of the capsule wall.
|
2 MDT-10013 Strips (In Cohort 2)
n=21 Participants
For the investigational subjects of Cohort 2, one MDT-10013 strip was sutured to the exterior of the capsule and 1 strip was sutured to the interior capsule wall.
|
3 MDT-10013 Strips (In Cohort 3)
n=18 Participants
For the investigational subjects of Cohort 3, one MDT-10013 strip was sutured to the exterior of the capsule and 2 strips were sutured to the interior capsule wall.
|
Control (In Cohort 1-3)
n=35 Participants
Control subjects in Cohort 1 to 3 received standard of care for pain control.
|
Control (In Cohort 1 to 4)
Control subjects of Cohort 1 to 4 received standard of care for pain control.
|
|---|---|---|---|---|---|
|
Pharmacokinetic (PK) Parameters of MDT-10013: Terminal Plasma Half-life (t½)
|
49.03 hrs
Standard Deviation 7.32
|
52.28 hrs
Standard Deviation 7.10
|
61.67 hrs
Standard Deviation 16.79
|
50.55 hrs
Standard Deviation 6.34
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: up to 10 daysPopulation: PK analysis population consisted of all subjects who had PK samples analyzed.
Blood samples were taken for pharmacokinetic parameters of MDT-10013 determinations before surgery on Day 0; at 1, 2, 4, 6, 8, 12, 24, 48, 72, and 96 hours after Time 0 (96-hour sample for Cohort 4 only); and on Days 7 to 10 after Time 0. Time 0 was defined as the time the capsule was closed.
Outcome measures
| Measure |
1 MDT-10013 Strip (In Cohort 1)
n=30 Participants
For the investigational subjects of Cohort 1, one MDT-10013 strip was sutured to the exterior of the capsule wall.
|
2 MDT-10013 Strips (In Cohort 2)
n=21 Participants
For the investigational subjects of Cohort 2, one MDT-10013 strip was sutured to the exterior of the capsule and 1 strip was sutured to the interior capsule wall.
|
3 MDT-10013 Strips (In Cohort 3)
n=18 Participants
For the investigational subjects of Cohort 3, one MDT-10013 strip was sutured to the exterior of the capsule and 2 strips were sutured to the interior capsule wall.
|
Control (In Cohort 1-3)
n=35 Participants
Control subjects in Cohort 1 to 3 received standard of care for pain control.
|
Control (In Cohort 1 to 4)
Control subjects of Cohort 1 to 4 received standard of care for pain control.
|
|---|---|---|---|---|---|
|
Pharmacokinetic (PK) Parameters of MDT-10013: Terminal Phase Rate Constant (λz)
|
0.0144 /hr
Standard Deviation 0.0021
|
0.0135 /hr
Standard Deviation 0.0019
|
0.0118 /hr
Standard Deviation 0.0025
|
0.0139 /hr
Standard Deviation 0.0017
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: over 1 to 24hr, 1 to 48 hrs, 1 to 72hrs, and 1 to 96hrsPopulation: The efficacy analyses of Cohort 1 to 4 were considered for exploratory analyses.
The theoretical range for SPI-24, SPI-48, SPI-72, and SPI-96 is 0 to 230, 0-470, 0-710, and 0-960, respectively, with lower scores indicative of less pain over this time period (i.e., lower scores are consistent with better analgesia). Summed pain intensity is calculated as area under the curve, using the trapezoidal rule to bridge adjacent time points. Specifically, NRS scores for two adjacent time points are averaged and then multiplied by the time span between points (in hours).
Outcome measures
| Measure |
1 MDT-10013 Strip (In Cohort 1)
n=36 Participants
For the investigational subjects of Cohort 1, one MDT-10013 strip was sutured to the exterior of the capsule wall.
|
2 MDT-10013 Strips (In Cohort 2)
n=36 Participants
For the investigational subjects of Cohort 2, one MDT-10013 strip was sutured to the exterior of the capsule and 1 strip was sutured to the interior capsule wall.
|
3 MDT-10013 Strips (In Cohort 3)
n=36 Participants
For the investigational subjects of Cohort 3, one MDT-10013 strip was sutured to the exterior of the capsule and 2 strips were sutured to the interior capsule wall.
|
Control (In Cohort 1-3)
n=36 Participants
Control subjects in Cohort 1 to 3 received standard of care for pain control.
|
Control (In Cohort 1 to 4)
n=48 Participants
Control subjects of Cohort 1 to 4 received standard of care for pain control.
|
|---|---|---|---|---|---|
|
Summed Pain Intensity Scores (Exploratory Analysis)
SPI-24
|
132.18 units on a scale
Standard Deviation 35.321
|
110.83 units on a scale
Standard Deviation 35.831
|
102.42 units on a scale
Standard Deviation 38.324
|
98.39 units on a scale
Standard Deviation 33.481
|
116.94 units on a scale
Standard Deviation 37.117
|
|
Summed Pain Intensity Scores (Exploratory Analysis)
SPI-48
|
252.29 units on a scale
Standard Deviation 74.423
|
213.28 units on a scale
Standard Deviation 73.330
|
191.97 units on a scale
Standard Deviation 84.940
|
205.83 units on a scale
Standard Deviation 72.126
|
218.35 units on a scale
Standard Deviation 74.235
|
|
Summed Pain Intensity Scores (Exploratory Analysis)
SPI-96
|
393.29 units on a scale
Standard Deviation 155.314
|
345.50 units on a scale
Standard Deviation 144.692
|
322.97 units on a scale
Standard Deviation 168.672
|
369.17 units on a scale
Standard Deviation 157.870
|
354.60 units on a scale
Standard Deviation 161.791
|
|
Summed Pain Intensity Scores (Exploratory Analysis)
SPI-72
|
325.96 units on a scale
Standard Deviation 113.416
|
285.50 units on a scale
Standard Deviation 109.126
|
259.42 units on a scale
Standard Deviation 126.691
|
291.17 units on a scale
Standard Deviation 113.586
|
290.44 units on a scale
Standard Deviation 116.649
|
OTHER_PRE_SPECIFIED outcome
Timeframe: over 0 to 24hrs, 0 to 48hrs, 0 to 72hrs, and 0 to 96hrsPopulation: The efficacy analyses of Cohort 1 to 4 were considered for exploratory analyses.
Outcome measures
| Measure |
1 MDT-10013 Strip (In Cohort 1)
n=36 Participants
For the investigational subjects of Cohort 1, one MDT-10013 strip was sutured to the exterior of the capsule wall.
|
2 MDT-10013 Strips (In Cohort 2)
n=36 Participants
For the investigational subjects of Cohort 2, one MDT-10013 strip was sutured to the exterior of the capsule and 1 strip was sutured to the interior capsule wall.
|
3 MDT-10013 Strips (In Cohort 3)
n=36 Participants
For the investigational subjects of Cohort 3, one MDT-10013 strip was sutured to the exterior of the capsule and 2 strips were sutured to the interior capsule wall.
|
Control (In Cohort 1-3)
n=36 Participants
Control subjects in Cohort 1 to 3 received standard of care for pain control.
|
Control (In Cohort 1 to 4)
n=48 Participants
Control subjects of Cohort 1 to 4 received standard of care for pain control.
|
|---|---|---|---|---|---|
|
Total Use of Opioid Analgesia (Exploratory Analysis).
Total opioid analgesia use over 0 to 24 hrs
|
51.04 morphine mg equivalent
Standard Deviation 21.798
|
37.64 morphine mg equivalent
Standard Deviation 21.654
|
34.17 morphine mg equivalent
Standard Deviation 18.927
|
40.00 morphine mg equivalent
Standard Deviation 19.558
|
52.66 morphine mg equivalent
Standard Deviation 20.082
|
|
Total Use of Opioid Analgesia (Exploratory Analysis).
Total opioid analgesia use over 0 to 48 hrs
|
81.67 morphine mg equivalent
Standard Deviation 38.526
|
59.10 morphine mg equivalent
Standard Deviation 32.278
|
56.04 morphine mg equivalent
Standard Deviation 34.040
|
65.63 morphine mg equivalent
Standard Deviation 33.845
|
76.41 morphine mg equivalent
Standard Deviation 33.314
|
|
Total Use of Opioid Analgesia (Exploratory Analysis).
Total opioid analgesia use over 0 to 72 hrs
|
95.35 morphine mg equivalent
Standard Deviation 50.886
|
73.68 morphine mg equivalent
Standard Deviation 45.773
|
69.58 morphine mg equivalent
Standard Deviation 46.876
|
85.56 morphine mg equivalent
Standard Deviation 50.611
|
90.16 morphine mg equivalent
Standard Deviation 44.586
|
|
Total Use of Opioid Analgesia (Exploratory Analysis).
Total opioid analgesia use over 0 to 96 hrs
|
106.04 morphine mg equivalent
Standard Deviation 57.744
|
81.98 morphine mg equivalent
Standard Deviation 54.366
|
77.92 morphine mg equivalent
Standard Deviation 54.803
|
103.47 morphine mg equivalent
Standard Deviation 67.189
|
97.34 morphine mg equivalent
Standard Deviation 50.863
|
OTHER_PRE_SPECIFIED outcome
Timeframe: up to 96hrsPopulation: The efficacy analyses of Cohort 1 to 4 were considered for exploratory analyses.
Outcome measures
| Measure |
1 MDT-10013 Strip (In Cohort 1)
n=36 Participants
For the investigational subjects of Cohort 1, one MDT-10013 strip was sutured to the exterior of the capsule wall.
|
2 MDT-10013 Strips (In Cohort 2)
n=36 Participants
For the investigational subjects of Cohort 2, one MDT-10013 strip was sutured to the exterior of the capsule and 1 strip was sutured to the interior capsule wall.
|
3 MDT-10013 Strips (In Cohort 3)
n=36 Participants
For the investigational subjects of Cohort 3, one MDT-10013 strip was sutured to the exterior of the capsule and 2 strips were sutured to the interior capsule wall.
|
Control (In Cohort 1-3)
n=36 Participants
Control subjects in Cohort 1 to 3 received standard of care for pain control.
|
Control (In Cohort 1 to 4)
n=48 Participants
Control subjects of Cohort 1 to 4 received standard of care for pain control.
|
|---|---|---|---|---|---|
|
Time to First Use of Opioid Analgesia (Exploratory Analysis)
|
4.4 hours
Interval 3.3 to 5.1
|
5.3 hours
Interval 4.5 to 6.3
|
5.1 hours
Interval 4.3 to 5.9
|
5.1 hours
Interval 3.7 to 5.9
|
4.2 hours
Interval 3.2 to 4.4
|
OTHER_PRE_SPECIFIED outcome
Timeframe: up to 72hrsPopulation: The efficacy analyses of Cohort 1 to 4 were considered for exploratory analyses.
Subject's satisfaction with study treatment as measured by a 5-point categorical scale where 0 = poor, 1 = fair, 2 = good, 3 = very good, and 4 = excellent
Outcome measures
| Measure |
1 MDT-10013 Strip (In Cohort 1)
n=36 Participants
For the investigational subjects of Cohort 1, one MDT-10013 strip was sutured to the exterior of the capsule wall.
|
2 MDT-10013 Strips (In Cohort 2)
n=36 Participants
For the investigational subjects of Cohort 2, one MDT-10013 strip was sutured to the exterior of the capsule and 1 strip was sutured to the interior capsule wall.
|
3 MDT-10013 Strips (In Cohort 3)
n=36 Participants
For the investigational subjects of Cohort 3, one MDT-10013 strip was sutured to the exterior of the capsule and 2 strips were sutured to the interior capsule wall.
|
Control (In Cohort 1-3)
n=36 Participants
Control subjects in Cohort 1 to 3 received standard of care for pain control.
|
Control (In Cohort 1 to 4)
n=48 Participants
Control subjects of Cohort 1 to 4 received standard of care for pain control.
|
|---|---|---|---|---|---|
|
Subject's Satisfaction With Study Treatment (Exploratory Analysis)
Fair
|
3 Participants
|
5 Participants
|
4 Participants
|
4 Participants
|
7 Participants
|
|
Subject's Satisfaction With Study Treatment (Exploratory Analysis)
Good
|
10 Participants
|
9 Participants
|
11 Participants
|
8 Participants
|
17 Participants
|
|
Subject's Satisfaction With Study Treatment (Exploratory Analysis)
Very good
|
8 Participants
|
11 Participants
|
13 Participants
|
10 Participants
|
10 Participants
|
|
Subject's Satisfaction With Study Treatment (Exploratory Analysis)
Excellent
|
4 Participants
|
8 Participants
|
5 Participants
|
6 Participants
|
4 Participants
|
|
Subject's Satisfaction With Study Treatment (Exploratory Analysis)
Poor
|
11 Participants
|
3 Participants
|
3 Participants
|
8 Participants
|
10 Participants
|
Adverse Events
1 MDT-10013 Strip (In Cohort 1)
Serious events: 0 serious events
Other events: 28 other events
Deaths: 0 deaths
2 MDT-10013 Strips (In Cohort 2)
Serious events: 0 serious events
Other events: 34 other events
Deaths: 0 deaths
3 MDT-10013 Strips (In Cohort 3)
Serious events: 0 serious events
Other events: 30 other events
Deaths: 0 deaths
2 MDT-10013 Strips (In Cohort 4)
Serious events: 0 serious events
Other events: 24 other events
Deaths: 0 deaths
Control (In Cohort 1 to 4)
Serious events: 0 serious events
Other events: 38 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
1 MDT-10013 Strip (In Cohort 1)
n=36 participants at risk
For the investigational subjects of Cohort 1, one MDT-10013 strip was sutured to the exterior of the capsule wall.
|
2 MDT-10013 Strips (In Cohort 2)
n=36 participants at risk
For the investigational subjects of Cohort 2, one MDT-10013 strip was sutured to the exterior of the capsule and 1 strip was sutured to the interior capsule wall.
|
3 MDT-10013 Strips (In Cohort 3)
n=36 participants at risk
For the investigational subjects of Cohort 3, one MDT-10013 strip was sutured to the exterior of the capsule and 2 strips were sutured to the interior capsule wall.
|
2 MDT-10013 Strips (In Cohort 4)
n=36 participants at risk
For the investigational subjects of Cohort 4, two strips were sutured to the interior capsule wall.
|
Control (In Cohort 1 to 4)
n=48 participants at risk
Control subjects in Cohort 1 to 4 received standard of care (no strip) for pain control.
|
|---|---|---|---|---|---|
|
Cardiac disorders
Bradycardia
|
0.00%
0/36 • up to 3 months
|
2.8%
1/36 • up to 3 months
|
0.00%
0/36 • up to 3 months
|
0.00%
0/36 • up to 3 months
|
0.00%
0/48 • up to 3 months
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/36 • up to 3 months
|
0.00%
0/36 • up to 3 months
|
0.00%
0/36 • up to 3 months
|
0.00%
0/36 • up to 3 months
|
2.1%
1/48 • up to 3 months
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/36 • up to 3 months
|
0.00%
0/36 • up to 3 months
|
2.8%
1/36 • up to 3 months
|
0.00%
0/36 • up to 3 months
|
0.00%
0/48 • up to 3 months
|
|
Eye disorders
Ocular hyperaemia
|
2.8%
1/36 • up to 3 months
|
0.00%
0/36 • up to 3 months
|
0.00%
0/36 • up to 3 months
|
0.00%
0/36 • up to 3 months
|
0.00%
0/48 • up to 3 months
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/36 • up to 3 months
|
0.00%
0/36 • up to 3 months
|
0.00%
0/36 • up to 3 months
|
2.8%
1/36 • up to 3 months
|
0.00%
0/48 • up to 3 months
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/36 • up to 3 months
|
0.00%
0/36 • up to 3 months
|
0.00%
0/36 • up to 3 months
|
0.00%
0/36 • up to 3 months
|
2.1%
1/48 • up to 3 months
|
|
Gastrointestinal disorders
Aphthous stomatitis
|
0.00%
0/36 • up to 3 months
|
0.00%
0/36 • up to 3 months
|
0.00%
0/36 • up to 3 months
|
0.00%
0/36 • up to 3 months
|
2.1%
1/48 • up to 3 months
|
|
Gastrointestinal disorders
Constipation
|
5.6%
2/36 • up to 3 months
|
13.9%
5/36 • up to 3 months
|
5.6%
2/36 • up to 3 months
|
11.1%
4/36 • up to 3 months
|
10.4%
5/48 • up to 3 months
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/36 • up to 3 months
|
0.00%
0/36 • up to 3 months
|
11.1%
4/36 • up to 3 months
|
2.8%
1/36 • up to 3 months
|
0.00%
0/48 • up to 3 months
|
|
Gastrointestinal disorders
Dry mouth
|
2.8%
1/36 • up to 3 months
|
11.1%
4/36 • up to 3 months
|
30.6%
11/36 • up to 3 months
|
8.3%
3/36 • up to 3 months
|
4.2%
2/48 • up to 3 months
|
|
Gastrointestinal disorders
Dyspepsia
|
2.8%
1/36 • up to 3 months
|
2.8%
1/36 • up to 3 months
|
5.6%
2/36 • up to 3 months
|
0.00%
0/36 • up to 3 months
|
4.2%
2/48 • up to 3 months
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/36 • up to 3 months
|
0.00%
0/36 • up to 3 months
|
0.00%
0/36 • up to 3 months
|
2.8%
1/36 • up to 3 months
|
0.00%
0/48 • up to 3 months
|
|
Gastrointestinal disorders
Nausea
|
50.0%
18/36 • up to 3 months
|
58.3%
21/36 • up to 3 months
|
47.2%
17/36 • up to 3 months
|
22.2%
8/36 • up to 3 months
|
64.6%
31/48 • up to 3 months
|
|
Gastrointestinal disorders
Paraesthesia oral
|
0.00%
0/36 • up to 3 months
|
5.6%
2/36 • up to 3 months
|
0.00%
0/36 • up to 3 months
|
0.00%
0/36 • up to 3 months
|
0.00%
0/48 • up to 3 months
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/36 • up to 3 months
|
0.00%
0/36 • up to 3 months
|
0.00%
0/36 • up to 3 months
|
2.8%
1/36 • up to 3 months
|
0.00%
0/48 • up to 3 months
|
|
Gastrointestinal disorders
Vomiting
|
16.7%
6/36 • up to 3 months
|
30.6%
11/36 • up to 3 months
|
19.4%
7/36 • up to 3 months
|
19.4%
7/36 • up to 3 months
|
16.7%
8/48 • up to 3 months
|
|
General disorders
Chills
|
0.00%
0/36 • up to 3 months
|
2.8%
1/36 • up to 3 months
|
2.8%
1/36 • up to 3 months
|
0.00%
0/36 • up to 3 months
|
4.2%
2/48 • up to 3 months
|
|
General disorders
Fatigue
|
0.00%
0/36 • up to 3 months
|
0.00%
0/36 • up to 3 months
|
0.00%
0/36 • up to 3 months
|
0.00%
0/36 • up to 3 months
|
2.1%
1/48 • up to 3 months
|
|
General disorders
Feeling hot
|
0.00%
0/36 • up to 3 months
|
0.00%
0/36 • up to 3 months
|
2.8%
1/36 • up to 3 months
|
0.00%
0/36 • up to 3 months
|
2.1%
1/48 • up to 3 months
|
|
General disorders
Granuloma
|
0.00%
0/36 • up to 3 months
|
2.8%
1/36 • up to 3 months
|
0.00%
0/36 • up to 3 months
|
0.00%
0/36 • up to 3 months
|
0.00%
0/48 • up to 3 months
|
|
General disorders
Hypothermia
|
0.00%
0/36 • up to 3 months
|
0.00%
0/36 • up to 3 months
|
0.00%
0/36 • up to 3 months
|
0.00%
0/36 • up to 3 months
|
2.1%
1/48 • up to 3 months
|
|
General disorders
Impaired healing
|
0.00%
0/36 • up to 3 months
|
0.00%
0/36 • up to 3 months
|
2.8%
1/36 • up to 3 months
|
0.00%
0/36 • up to 3 months
|
0.00%
0/48 • up to 3 months
|
|
General disorders
Infusion site bruising
|
0.00%
0/36 • up to 3 months
|
2.8%
1/36 • up to 3 months
|
0.00%
0/36 • up to 3 months
|
0.00%
0/36 • up to 3 months
|
0.00%
0/48 • up to 3 months
|
|
General disorders
Infusion site haematoma
|
0.00%
0/36 • up to 3 months
|
2.8%
1/36 • up to 3 months
|
0.00%
0/36 • up to 3 months
|
0.00%
0/36 • up to 3 months
|
0.00%
0/48 • up to 3 months
|
|
General disorders
Infusion site pain
|
0.00%
0/36 • up to 3 months
|
2.8%
1/36 • up to 3 months
|
0.00%
0/36 • up to 3 months
|
0.00%
0/36 • up to 3 months
|
0.00%
0/48 • up to 3 months
|
|
General disorders
Infusion site phlebitis
|
0.00%
0/36 • up to 3 months
|
2.8%
1/36 • up to 3 months
|
0.00%
0/36 • up to 3 months
|
0.00%
0/36 • up to 3 months
|
0.00%
0/48 • up to 3 months
|
|
General disorders
Infusion site pruritus
|
0.00%
0/36 • up to 3 months
|
0.00%
0/36 • up to 3 months
|
0.00%
0/36 • up to 3 months
|
0.00%
0/36 • up to 3 months
|
2.1%
1/48 • up to 3 months
|
|
General disorders
Mucosal dryness
|
0.00%
0/36 • up to 3 months
|
2.8%
1/36 • up to 3 months
|
0.00%
0/36 • up to 3 months
|
0.00%
0/36 • up to 3 months
|
0.00%
0/48 • up to 3 months
|
|
General disorders
Oedema peripheral
|
0.00%
0/36 • up to 3 months
|
0.00%
0/36 • up to 3 months
|
0.00%
0/36 • up to 3 months
|
2.8%
1/36 • up to 3 months
|
0.00%
0/48 • up to 3 months
|
|
General disorders
Pain
|
2.8%
1/36 • up to 3 months
|
2.8%
1/36 • up to 3 months
|
0.00%
0/36 • up to 3 months
|
0.00%
0/36 • up to 3 months
|
0.00%
0/48 • up to 3 months
|
|
General disorders
Pyrexia
|
0.00%
0/36 • up to 3 months
|
5.6%
2/36 • up to 3 months
|
0.00%
0/36 • up to 3 months
|
0.00%
0/36 • up to 3 months
|
0.00%
0/48 • up to 3 months
|
|
Immune system disorders
Allergy to animal
|
0.00%
0/36 • up to 3 months
|
0.00%
0/36 • up to 3 months
|
2.8%
1/36 • up to 3 months
|
0.00%
0/36 • up to 3 months
|
0.00%
0/48 • up to 3 months
|
|
Immune system disorders
Drug hypersensitivity
|
5.6%
2/36 • up to 3 months
|
0.00%
0/36 • up to 3 months
|
0.00%
0/36 • up to 3 months
|
0.00%
0/36 • up to 3 months
|
0.00%
0/48 • up to 3 months
|
|
Immune system disorders
Seasonal allergy
|
2.8%
1/36 • up to 3 months
|
0.00%
0/36 • up to 3 months
|
0.00%
0/36 • up to 3 months
|
0.00%
0/36 • up to 3 months
|
0.00%
0/48 • up to 3 months
|
|
Infections and infestations
Cellulitis
|
0.00%
0/36 • up to 3 months
|
2.8%
1/36 • up to 3 months
|
2.8%
1/36 • up to 3 months
|
0.00%
0/36 • up to 3 months
|
0.00%
0/48 • up to 3 months
|
|
Infections and infestations
Clostridium difficile colitis
|
2.8%
1/36 • up to 3 months
|
0.00%
0/36 • up to 3 months
|
0.00%
0/36 • up to 3 months
|
0.00%
0/36 • up to 3 months
|
0.00%
0/48 • up to 3 months
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/36 • up to 3 months
|
2.8%
1/36 • up to 3 months
|
0.00%
0/36 • up to 3 months
|
0.00%
0/36 • up to 3 months
|
0.00%
0/48 • up to 3 months
|
|
Infections and infestations
Influenza
|
2.8%
1/36 • up to 3 months
|
0.00%
0/36 • up to 3 months
|
0.00%
0/36 • up to 3 months
|
0.00%
0/36 • up to 3 months
|
0.00%
0/48 • up to 3 months
|
|
Infections and infestations
Nasopharyngitis
|
2.8%
1/36 • up to 3 months
|
2.8%
1/36 • up to 3 months
|
0.00%
0/36 • up to 3 months
|
0.00%
0/36 • up to 3 months
|
0.00%
0/48 • up to 3 months
|
|
Infections and infestations
Post procedural cellulitis
|
5.6%
2/36 • up to 3 months
|
0.00%
0/36 • up to 3 months
|
5.6%
2/36 • up to 3 months
|
0.00%
0/36 • up to 3 months
|
2.1%
1/48 • up to 3 months
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/36 • up to 3 months
|
0.00%
0/36 • up to 3 months
|
0.00%
0/36 • up to 3 months
|
2.8%
1/36 • up to 3 months
|
0.00%
0/48 • up to 3 months
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/36 • up to 3 months
|
0.00%
0/36 • up to 3 months
|
0.00%
0/36 • up to 3 months
|
2.8%
1/36 • up to 3 months
|
4.2%
2/48 • up to 3 months
|
|
Infections and infestations
Viral infection
|
2.8%
1/36 • up to 3 months
|
0.00%
0/36 • up to 3 months
|
0.00%
0/36 • up to 3 months
|
0.00%
0/36 • up to 3 months
|
0.00%
0/48 • up to 3 months
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/36 • up to 3 months
|
0.00%
0/36 • up to 3 months
|
0.00%
0/36 • up to 3 months
|
0.00%
0/36 • up to 3 months
|
2.1%
1/48 • up to 3 months
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
0.00%
0/36 • up to 3 months
|
0.00%
0/36 • up to 3 months
|
0.00%
0/36 • up to 3 months
|
0.00%
0/36 • up to 3 months
|
2.1%
1/48 • up to 3 months
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/36 • up to 3 months
|
2.8%
1/36 • up to 3 months
|
0.00%
0/36 • up to 3 months
|
0.00%
0/36 • up to 3 months
|
0.00%
0/48 • up to 3 months
|
|
Injury, poisoning and procedural complications
Eschar
|
0.00%
0/36 • up to 3 months
|
0.00%
0/36 • up to 3 months
|
2.8%
1/36 • up to 3 months
|
0.00%
0/36 • up to 3 months
|
0.00%
0/48 • up to 3 months
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/36 • up to 3 months
|
2.8%
1/36 • up to 3 months
|
0.00%
0/36 • up to 3 months
|
0.00%
0/36 • up to 3 months
|
0.00%
0/48 • up to 3 months
|
|
Injury, poisoning and procedural complications
Incision site haemorrhage
|
0.00%
0/36 • up to 3 months
|
0.00%
0/36 • up to 3 months
|
2.8%
1/36 • up to 3 months
|
0.00%
0/36 • up to 3 months
|
0.00%
0/48 • up to 3 months
|
|
Injury, poisoning and procedural complications
Incision site pain
|
0.00%
0/36 • up to 3 months
|
0.00%
0/36 • up to 3 months
|
0.00%
0/36 • up to 3 months
|
0.00%
0/36 • up to 3 months
|
2.1%
1/48 • up to 3 months
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/36 • up to 3 months
|
0.00%
0/36 • up to 3 months
|
0.00%
0/36 • up to 3 months
|
0.00%
0/36 • up to 3 months
|
2.1%
1/48 • up to 3 months
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/36 • up to 3 months
|
0.00%
0/36 • up to 3 months
|
2.8%
1/36 • up to 3 months
|
0.00%
0/36 • up to 3 months
|
0.00%
0/48 • up to 3 months
|
|
Injury, poisoning and procedural complications
Post procedural complication
|
0.00%
0/36 • up to 3 months
|
0.00%
0/36 • up to 3 months
|
2.8%
1/36 • up to 3 months
|
0.00%
0/36 • up to 3 months
|
4.2%
2/48 • up to 3 months
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.00%
0/36 • up to 3 months
|
0.00%
0/36 • up to 3 months
|
2.8%
1/36 • up to 3 months
|
0.00%
0/36 • up to 3 months
|
0.00%
0/48 • up to 3 months
|
|
Injury, poisoning and procedural complications
Post procedural oedema
|
2.8%
1/36 • up to 3 months
|
0.00%
0/36 • up to 3 months
|
0.00%
0/36 • up to 3 months
|
0.00%
0/36 • up to 3 months
|
0.00%
0/48 • up to 3 months
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/36 • up to 3 months
|
2.8%
1/36 • up to 3 months
|
0.00%
0/36 • up to 3 months
|
0.00%
0/36 • up to 3 months
|
0.00%
0/48 • up to 3 months
|
|
Injury, poisoning and procedural complications
Stress fracture
|
2.8%
1/36 • up to 3 months
|
0.00%
0/36 • up to 3 months
|
0.00%
0/36 • up to 3 months
|
0.00%
0/36 • up to 3 months
|
0.00%
0/48 • up to 3 months
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/36 • up to 3 months
|
0.00%
0/36 • up to 3 months
|
0.00%
0/36 • up to 3 months
|
0.00%
0/36 • up to 3 months
|
2.1%
1/48 • up to 3 months
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
2.8%
1/36 • up to 3 months
|
0.00%
0/36 • up to 3 months
|
0.00%
0/36 • up to 3 months
|
0.00%
0/36 • up to 3 months
|
0.00%
0/48 • up to 3 months
|
|
Investigations
Alanine aminotransferase increased
|
2.8%
1/36 • up to 3 months
|
0.00%
0/36 • up to 3 months
|
0.00%
0/36 • up to 3 months
|
0.00%
0/36 • up to 3 months
|
0.00%
0/48 • up to 3 months
|
|
Investigations
Body temperature increased
|
0.00%
0/36 • up to 3 months
|
0.00%
0/36 • up to 3 months
|
2.8%
1/36 • up to 3 months
|
0.00%
0/36 • up to 3 months
|
0.00%
0/48 • up to 3 months
|
|
Investigations
Liver function test abnormal
|
0.00%
0/36 • up to 3 months
|
2.8%
1/36 • up to 3 months
|
0.00%
0/36 • up to 3 months
|
0.00%
0/36 • up to 3 months
|
0.00%
0/48 • up to 3 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.8%
1/36 • up to 3 months
|
0.00%
0/36 • up to 3 months
|
2.8%
1/36 • up to 3 months
|
0.00%
0/36 • up to 3 months
|
0.00%
0/48 • up to 3 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.8%
1/36 • up to 3 months
|
2.8%
1/36 • up to 3 months
|
2.8%
1/36 • up to 3 months
|
0.00%
0/36 • up to 3 months
|
0.00%
0/48 • up to 3 months
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
2.8%
1/36 • up to 3 months
|
0.00%
0/36 • up to 3 months
|
0.00%
0/36 • up to 3 months
|
0.00%
0/36 • up to 3 months
|
0.00%
0/48 • up to 3 months
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
8.3%
3/36 • up to 3 months
|
2.8%
1/36 • up to 3 months
|
0.00%
0/36 • up to 3 months
|
0.00%
0/36 • up to 3 months
|
0.00%
0/48 • up to 3 months
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/36 • up to 3 months
|
2.8%
1/36 • up to 3 months
|
0.00%
0/36 • up to 3 months
|
0.00%
0/36 • up to 3 months
|
4.2%
2/48 • up to 3 months
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
2.8%
1/36 • up to 3 months
|
0.00%
0/36 • up to 3 months
|
0.00%
0/36 • up to 3 months
|
0.00%
0/36 • up to 3 months
|
0.00%
0/48 • up to 3 months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/36 • up to 3 months
|
2.8%
1/36 • up to 3 months
|
2.8%
1/36 • up to 3 months
|
0.00%
0/36 • up to 3 months
|
0.00%
0/48 • up to 3 months
|
|
Nervous system disorders
Dizziness
|
25.0%
9/36 • up to 3 months
|
33.3%
12/36 • up to 3 months
|
41.7%
15/36 • up to 3 months
|
16.7%
6/36 • up to 3 months
|
29.2%
14/48 • up to 3 months
|
|
Nervous system disorders
Dizziness postural
|
0.00%
0/36 • up to 3 months
|
0.00%
0/36 • up to 3 months
|
2.8%
1/36 • up to 3 months
|
0.00%
0/36 • up to 3 months
|
0.00%
0/48 • up to 3 months
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/36 • up to 3 months
|
2.8%
1/36 • up to 3 months
|
2.8%
1/36 • up to 3 months
|
0.00%
0/36 • up to 3 months
|
2.1%
1/48 • up to 3 months
|
|
Nervous system disorders
Headache
|
13.9%
5/36 • up to 3 months
|
25.0%
9/36 • up to 3 months
|
11.1%
4/36 • up to 3 months
|
5.6%
2/36 • up to 3 months
|
10.4%
5/48 • up to 3 months
|
|
Nervous system disorders
Hyperaesthesia
|
0.00%
0/36 • up to 3 months
|
0.00%
0/36 • up to 3 months
|
0.00%
0/36 • up to 3 months
|
2.8%
1/36 • up to 3 months
|
0.00%
0/48 • up to 3 months
|
|
Nervous system disorders
Lethargy
|
0.00%
0/36 • up to 3 months
|
2.8%
1/36 • up to 3 months
|
0.00%
0/36 • up to 3 months
|
0.00%
0/36 • up to 3 months
|
0.00%
0/48 • up to 3 months
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/36 • up to 3 months
|
8.3%
3/36 • up to 3 months
|
0.00%
0/36 • up to 3 months
|
0.00%
0/36 • up to 3 months
|
4.2%
2/48 • up to 3 months
|
|
Nervous system disorders
Presyncope
|
0.00%
0/36 • up to 3 months
|
0.00%
0/36 • up to 3 months
|
2.8%
1/36 • up to 3 months
|
0.00%
0/36 • up to 3 months
|
2.1%
1/48 • up to 3 months
|
|
Nervous system disorders
Sinus headache
|
0.00%
0/36 • up to 3 months
|
0.00%
0/36 • up to 3 months
|
0.00%
0/36 • up to 3 months
|
0.00%
0/36 • up to 3 months
|
2.1%
1/48 • up to 3 months
|
|
Nervous system disorders
Somnolence
|
2.8%
1/36 • up to 3 months
|
2.8%
1/36 • up to 3 months
|
11.1%
4/36 • up to 3 months
|
2.8%
1/36 • up to 3 months
|
4.2%
2/48 • up to 3 months
|
|
Nervous system disorders
Syncope
|
0.00%
0/36 • up to 3 months
|
0.00%
0/36 • up to 3 months
|
2.8%
1/36 • up to 3 months
|
0.00%
0/36 • up to 3 months
|
4.2%
2/48 • up to 3 months
|
|
Nervous system disorders
Tremor
|
0.00%
0/36 • up to 3 months
|
0.00%
0/36 • up to 3 months
|
0.00%
0/36 • up to 3 months
|
0.00%
0/36 • up to 3 months
|
2.1%
1/48 • up to 3 months
|
|
Psychiatric disorders
Anxiety
|
2.8%
1/36 • up to 3 months
|
2.8%
1/36 • up to 3 months
|
0.00%
0/36 • up to 3 months
|
0.00%
0/36 • up to 3 months
|
0.00%
0/48 • up to 3 months
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/36 • up to 3 months
|
0.00%
0/36 • up to 3 months
|
0.00%
0/36 • up to 3 months
|
0.00%
0/36 • up to 3 months
|
2.1%
1/48 • up to 3 months
|
|
Renal and urinary disorders
Glycosuria
|
0.00%
0/36 • up to 3 months
|
0.00%
0/36 • up to 3 months
|
0.00%
0/36 • up to 3 months
|
0.00%
0/36 • up to 3 months
|
2.1%
1/48 • up to 3 months
|
|
Renal and urinary disorders
Haematuria
|
2.8%
1/36 • up to 3 months
|
0.00%
0/36 • up to 3 months
|
0.00%
0/36 • up to 3 months
|
0.00%
0/36 • up to 3 months
|
0.00%
0/48 • up to 3 months
|
|
Renal and urinary disorders
Pollakiuria
|
2.8%
1/36 • up to 3 months
|
0.00%
0/36 • up to 3 months
|
0.00%
0/36 • up to 3 months
|
0.00%
0/36 • up to 3 months
|
0.00%
0/48 • up to 3 months
|
|
Renal and urinary disorders
Urinary tract disorder
|
0.00%
0/36 • up to 3 months
|
0.00%
0/36 • up to 3 months
|
2.8%
1/36 • up to 3 months
|
0.00%
0/36 • up to 3 months
|
0.00%
0/48 • up to 3 months
|
|
Reproductive system and breast disorders
Breast cyst
|
0.00%
0/36 • up to 3 months
|
2.8%
1/36 • up to 3 months
|
0.00%
0/36 • up to 3 months
|
0.00%
0/36 • up to 3 months
|
0.00%
0/48 • up to 3 months
|
|
Reproductive system and breast disorders
Breast pain
|
2.8%
1/36 • up to 3 months
|
0.00%
0/36 • up to 3 months
|
0.00%
0/36 • up to 3 months
|
0.00%
0/36 • up to 3 months
|
0.00%
0/48 • up to 3 months
|
|
Reproductive system and breast disorders
Menopausal symptoms
|
0.00%
0/36 • up to 3 months
|
2.8%
1/36 • up to 3 months
|
0.00%
0/36 • up to 3 months
|
0.00%
0/36 • up to 3 months
|
0.00%
0/48 • up to 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
2.8%
1/36 • up to 3 months
|
0.00%
0/36 • up to 3 months
|
0.00%
0/36 • up to 3 months
|
0.00%
0/36 • up to 3 months
|
0.00%
0/48 • up to 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.8%
1/36 • up to 3 months
|
5.6%
2/36 • up to 3 months
|
0.00%
0/36 • up to 3 months
|
0.00%
0/36 • up to 3 months
|
0.00%
0/48 • up to 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Dry throat
|
0.00%
0/36 • up to 3 months
|
0.00%
0/36 • up to 3 months
|
0.00%
0/36 • up to 3 months
|
0.00%
0/36 • up to 3 months
|
2.1%
1/48 • up to 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.8%
1/36 • up to 3 months
|
0.00%
0/36 • up to 3 months
|
2.8%
1/36 • up to 3 months
|
0.00%
0/36 • up to 3 months
|
0.00%
0/48 • up to 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/36 • up to 3 months
|
2.8%
1/36 • up to 3 months
|
0.00%
0/36 • up to 3 months
|
0.00%
0/36 • up to 3 months
|
0.00%
0/48 • up to 3 months
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/36 • up to 3 months
|
8.3%
3/36 • up to 3 months
|
2.8%
1/36 • up to 3 months
|
2.8%
1/36 • up to 3 months
|
0.00%
0/48 • up to 3 months
|
|
Skin and subcutaneous tissue disorders
Erythema
|
2.8%
1/36 • up to 3 months
|
2.8%
1/36 • up to 3 months
|
2.8%
1/36 • up to 3 months
|
5.6%
2/36 • up to 3 months
|
2.1%
1/48 • up to 3 months
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
2.8%
1/36 • up to 3 months
|
8.3%
3/36 • up to 3 months
|
2.8%
1/36 • up to 3 months
|
2.8%
1/36 • up to 3 months
|
10.4%
5/48 • up to 3 months
|
|
Skin and subcutaneous tissue disorders
Ingrowing nail
|
0.00%
0/36 • up to 3 months
|
2.8%
1/36 • up to 3 months
|
0.00%
0/36 • up to 3 months
|
0.00%
0/36 • up to 3 months
|
0.00%
0/48 • up to 3 months
|
|
Skin and subcutaneous tissue disorders
Papule
|
0.00%
0/36 • up to 3 months
|
0.00%
0/36 • up to 3 months
|
0.00%
0/36 • up to 3 months
|
0.00%
0/36 • up to 3 months
|
2.1%
1/48 • up to 3 months
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
0.00%
0/36 • up to 3 months
|
0.00%
0/36 • up to 3 months
|
2.8%
1/36 • up to 3 months
|
0.00%
0/36 • up to 3 months
|
0.00%
0/48 • up to 3 months
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
2.8%
1/36 • up to 3 months
|
2.8%
1/36 • up to 3 months
|
5.6%
2/36 • up to 3 months
|
2.8%
1/36 • up to 3 months
|
16.7%
8/48 • up to 3 months
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
5.6%
2/36 • up to 3 months
|
0.00%
0/36 • up to 3 months
|
0.00%
0/36 • up to 3 months
|
2.8%
1/36 • up to 3 months
|
8.3%
4/48 • up to 3 months
|
|
Skin and subcutaneous tissue disorders
Rash
|
5.6%
2/36 • up to 3 months
|
0.00%
0/36 • up to 3 months
|
5.6%
2/36 • up to 3 months
|
0.00%
0/36 • up to 3 months
|
0.00%
0/48 • up to 3 months
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
0.00%
0/36 • up to 3 months
|
0.00%
0/36 • up to 3 months
|
5.6%
2/36 • up to 3 months
|
0.00%
0/36 • up to 3 months
|
0.00%
0/48 • up to 3 months
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
0.00%
0/36 • up to 3 months
|
2.8%
1/36 • up to 3 months
|
0.00%
0/36 • up to 3 months
|
0.00%
0/36 • up to 3 months
|
0.00%
0/48 • up to 3 months
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/36 • up to 3 months
|
0.00%
0/36 • up to 3 months
|
0.00%
0/36 • up to 3 months
|
2.8%
1/36 • up to 3 months
|
0.00%
0/48 • up to 3 months
|
|
Vascular disorders
Hot flush
|
0.00%
0/36 • up to 3 months
|
0.00%
0/36 • up to 3 months
|
0.00%
0/36 • up to 3 months
|
2.8%
1/36 • up to 3 months
|
8.3%
4/48 • up to 3 months
|
|
Vascular disorders
Hypotension
|
0.00%
0/36 • up to 3 months
|
30.6%
11/36 • up to 3 months
|
19.4%
7/36 • up to 3 months
|
13.9%
5/36 • up to 3 months
|
2.1%
1/48 • up to 3 months
|
|
Vascular disorders
Orthostatic hypotension
|
2.8%
1/36 • up to 3 months
|
0.00%
0/36 • up to 3 months
|
0.00%
0/36 • up to 3 months
|
0.00%
0/36 • up to 3 months
|
0.00%
0/48 • up to 3 months
|
|
Vascular disorders
Phlebitis
|
0.00%
0/36 • up to 3 months
|
2.8%
1/36 • up to 3 months
|
0.00%
0/36 • up to 3 months
|
8.3%
3/36 • up to 3 months
|
2.1%
1/48 • up to 3 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60