Trial Outcomes & Findings for Phase I/II Dose-escalation Study to Evaluate Safety, PK and Efficacy of TLC590 for Postsurgical Pain Management (NCT NCT03591146)
NCT ID: NCT03591146
Last Updated: 2021-07-14
Results Overview
Event of serious adverse event (SAE) and treatment-related severe adverse event (TRAE)
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
65 participants
Primary outcome timeframe
Screening till 30 days post investigational product (IP) administration, up to 58 days
Results posted on
2021-07-14
Participant Flow
Participant milestones
| Measure |
TLC590 190mg
TLC590 (Ropivacaine Liposome Injectable Suspension) is a sustained-release liposome formulation of ropivacaine, white aqueous suspension with ropivacaine concentration at approximately 19 mg/mL.
TLC590: TLC590 lyophilized cake will be reconstituted with the TLC590 reconstitution solution to form the TLC590 ropivacaine liposome injectable suspension
|
TLC590 380mg
TLC590 (Ropivacaine Liposome Injectable Suspension) is a sustained-release liposome formulation of ropivacaine, white aqueous suspension with ropivacaine concentration at approximately 19 mg/mL.
TLC590: TLC590 lyophilized cake will be reconstituted with the TLC590 reconstitution solution to form the TLC590 ropivacaine liposome injectable suspension
|
TLC590 570mg
TLC590 (Ropivacaine Liposome Injectable Suspension) is a sustained-release liposome formulation of ropivacaine, white aqueous suspension with ropivacaine concentration at approximately 19 mg/mL.
TLC590: TLC590 lyophilized cake will be reconstituted with the TLC590 reconstitution solution to form the TLC590 ropivacaine liposome injectable suspension
|
TLC590 475mg
TLC590 (Ropivacaine Liposome Injectable Suspension) is a sustained-release liposome formulation of ropivacaine, white aqueous suspension with ropivacaine concentration at approximately 19 mg/mL.
TLC590: TLC590 lyophilized cake will be reconstituted with the TLC590 reconstitution solution to form the TLC590 ropivacaine liposome injectable suspension
|
Naropin 150mg
Naropin injection contains ropivacaine HCl. Strength: 150mg/ 30mL (5 mg/mL) Size: 30mL fill, in a 30mL single dose vial
Naropin: Local infiltration of Naropin to produce anesthesia for surgery and analgesia in postoperative pain management. Naropin 150mg \[0.5%, 5mg/mL\] x 30mL
|
|---|---|---|---|---|---|
|
TLC590 190mg and Naropin 150mg
STARTED
|
12
|
0
|
0
|
0
|
4
|
|
TLC590 190mg and Naropin 150mg
COMPLETED
|
12
|
0
|
0
|
0
|
3
|
|
TLC590 190mg and Naropin 150mg
NOT COMPLETED
|
0
|
0
|
0
|
0
|
1
|
|
TLC590 380mg and Naropin 150mg
STARTED
|
0
|
12
|
0
|
0
|
5
|
|
TLC590 380mg and Naropin 150mg
COMPLETED
|
0
|
11
|
0
|
0
|
4
|
|
TLC590 380mg and Naropin 150mg
NOT COMPLETED
|
0
|
1
|
0
|
0
|
1
|
|
TLC590 570mg and Naropin 150mg
STARTED
|
0
|
0
|
12
|
0
|
4
|
|
TLC590 570mg and Naropin 150mg
COMPLETED
|
0
|
0
|
11
|
0
|
3
|
|
TLC590 570mg and Naropin 150mg
NOT COMPLETED
|
0
|
0
|
1
|
0
|
1
|
|
TLC590 475mg and Naropin 150mg
STARTED
|
0
|
0
|
0
|
12
|
4
|
|
TLC590 475mg and Naropin 150mg
COMPLETED
|
0
|
0
|
0
|
12
|
4
|
|
TLC590 475mg and Naropin 150mg
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
TLC590 190mg
TLC590 (Ropivacaine Liposome Injectable Suspension) is a sustained-release liposome formulation of ropivacaine, white aqueous suspension with ropivacaine concentration at approximately 19 mg/mL.
TLC590: TLC590 lyophilized cake will be reconstituted with the TLC590 reconstitution solution to form the TLC590 ropivacaine liposome injectable suspension
|
TLC590 380mg
TLC590 (Ropivacaine Liposome Injectable Suspension) is a sustained-release liposome formulation of ropivacaine, white aqueous suspension with ropivacaine concentration at approximately 19 mg/mL.
TLC590: TLC590 lyophilized cake will be reconstituted with the TLC590 reconstitution solution to form the TLC590 ropivacaine liposome injectable suspension
|
TLC590 570mg
TLC590 (Ropivacaine Liposome Injectable Suspension) is a sustained-release liposome formulation of ropivacaine, white aqueous suspension with ropivacaine concentration at approximately 19 mg/mL.
TLC590: TLC590 lyophilized cake will be reconstituted with the TLC590 reconstitution solution to form the TLC590 ropivacaine liposome injectable suspension
|
TLC590 475mg
TLC590 (Ropivacaine Liposome Injectable Suspension) is a sustained-release liposome formulation of ropivacaine, white aqueous suspension with ropivacaine concentration at approximately 19 mg/mL.
TLC590: TLC590 lyophilized cake will be reconstituted with the TLC590 reconstitution solution to form the TLC590 ropivacaine liposome injectable suspension
|
Naropin 150mg
Naropin injection contains ropivacaine HCl. Strength: 150mg/ 30mL (5 mg/mL) Size: 30mL fill, in a 30mL single dose vial
Naropin: Local infiltration of Naropin to produce anesthesia for surgery and analgesia in postoperative pain management. Naropin 150mg \[0.5%, 5mg/mL\] x 30mL
|
|---|---|---|---|---|---|
|
TLC590 190mg and Naropin 150mg
Lost to Follow-up
|
0
|
0
|
0
|
0
|
1
|
|
TLC590 380mg and Naropin 150mg
Lost to Follow-up
|
0
|
1
|
0
|
0
|
0
|
|
TLC590 380mg and Naropin 150mg
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
1
|
|
TLC590 570mg and Naropin 150mg
Lost to Follow-up
|
0
|
0
|
1
|
0
|
1
|
Baseline Characteristics
Phase I/II Dose-escalation Study to Evaluate Safety, PK and Efficacy of TLC590 for Postsurgical Pain Management
Baseline characteristics by cohort
| Measure |
TLC590 190mg
n=12 Participants
TLC590 (Ropivacaine Liposome Injectable Suspension) is a sustained-release liposome formulation of ropivacaine, white aqueous suspension with ropivacaine concentration at approximately 19 mg/mL.
TLC590: TLC590 lyophilized cake will be reconstituted with the TLC590 reconstitution solution to form the TLC590 ropivacaine liposome injectable suspension
|
TLC590 380mg
n=12 Participants
TLC590 (Ropivacaine Liposome Injectable Suspension) is a sustained-release liposome formulation of ropivacaine, white aqueous suspension with ropivacaine concentration at approximately 19 mg/mL.
TLC590: TLC590 lyophilized cake will be reconstituted with the TLC590 reconstitution solution to form the TLC590 ropivacaine liposome injectable suspension
|
TLC590 570mg
n=12 Participants
TLC590 (Ropivacaine Liposome Injectable Suspension) is a sustained-release liposome formulation of ropivacaine, white aqueous suspension with ropivacaine concentration at approximately 19 mg/mL.
TLC590: TLC590 lyophilized cake will be reconstituted with the TLC590 reconstitution solution to form the TLC590 ropivacaine liposome injectable suspension
|
TLC590 475mg
n=12 Participants
TLC590 (Ropivacaine Liposome Injectable Suspension) is a sustained-release liposome formulation of ropivacaine, white aqueous suspension with ropivacaine concentration at approximately 19 mg/mL.
TLC590: TLC590 lyophilized cake will be reconstituted with the TLC590 reconstitution solution to form the TLC590 ropivacaine liposome injectable suspension
|
Naropin 150mg
n=16 Participants
Naropin injection contains ropivacaine HCl. Strength: 150mg/ 30mL (5 mg/mL) Size: 30mL fill, in a 30mL single dose vial
Naropin: Local infiltration of Naropin to produce anesthesia for surgery and analgesia in postoperative pain management. Naropin 150mg \[0.5%, 5mg/mL\] x 30mL
|
Total
n=64 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
12 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
16 Participants
n=21 Participants
|
64 Participants
n=10 Participants
|
|
Age, Categorical
>=65 years
|
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
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
4 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
15 Participants
n=21 Participants
|
60 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
11 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
16 Participants
n=21 Participants
|
63 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
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
|
|
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
|
0 Participants
n=10 Participants
|
|
Region of Enrollment
United States
|
12 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
16 Participants
n=21 Participants
|
64 Participants
n=10 Participants
|
|
Body Mass Index (BMI)
BMI <=35 kg/m2
|
12 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
16 Participants
n=21 Participants
|
64 Participants
n=10 Participants
|
|
Body Mass Index (BMI)
BMI > 35 kg/m2
|
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
|
PRIMARY outcome
Timeframe: Screening till 30 days post investigational product (IP) administration, up to 58 daysEvent of serious adverse event (SAE) and treatment-related severe adverse event (TRAE)
Outcome measures
| Measure |
TLC590 190mg
n=12 Participants
TLC590 (Ropivacaine Liposome Injectable Suspension) is a sustained-release liposome formulation of ropivacaine, white aqueous suspension with ropivacaine concentration at approximately 19 mg/mL.
TLC590: TLC590 lyophilized cake will be reconstituted with the TLC590 reconstitution solution to form the TLC590 ropivacaine liposome injectable suspension
|
TLC590 380mg
n=12 Participants
TLC590 (Ropivacaine Liposome Injectable Suspension) is a sustained-release liposome formulation of ropivacaine, white aqueous suspension with ropivacaine concentration at approximately 19 mg/mL.
TLC590: TLC590 lyophilized cake will be reconstituted with the TLC590 reconstitution solution to form the TLC590 ropivacaine liposome injectable suspension
|
TLC570mg
n=12 Participants
TLC590 (Ropivacaine Liposome Injectable Suspension) is a sustained-release liposome formulation of ropivacaine, white aqueous suspension with ropivacaine concentration at approximately 19 mg/mL.
TLC590: TLC590 lyophilized cake will be reconstituted with the TLC590 reconstitution solution to form the TLC590 ropivacaine liposome injectable suspension
|
TLC590 475mg
n=12 Participants
TLC590 (Ropivacaine Liposome Injectable Suspension) is a sustained-release liposome formulation of ropivacaine, white aqueous suspension with ropivacaine concentration at approximately 19 mg/mL.
TLC590: TLC590 lyophilized cake will be reconstituted with the TLC590 reconstitution solution to form the TLC590 ropivacaine liposome injectable suspension
|
Naropin
n=16 Participants
Naropin injection contains ropivacaine HCl. Strength: 150mg/ 30mL (5 mg/mL) Size: 30mL fill, in a 30mL single dose vial
Naropin: Local infiltration of Naropin to produce anesthesia for surgery and analgesia in postoperative pain management. Naropin 150mg \[0.5%, 5mg/mL\] x 30mL
|
|---|---|---|---|---|---|
|
Safety and Tolerability: Event of SAE and Treatment-related Severe AE
|
2 Event
|
1 Event
|
2 Event
|
2 Event
|
2 Event
|
Adverse Events
TLC590 190mg
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
TLC590 380mg
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
TL590 570mg
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
TLC590 475mg
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Naropin 150mg
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
TLC590 190mg
n=12 participants at risk
TLC590 (Ropivacaine Liposome Injectable Suspension) is a sustained-release liposome formulation of ropivacaine, white aqueous suspension with ropivacaine concentration at approximately 19 mg/mL.
TLC590: TLC590 lyophilized cake will be reconstituted with the TLC590 reconstitution solution to form the TLC590 ropivacaine liposome injectable suspension
|
TLC590 380mg
n=12 participants at risk
TLC590 (Ropivacaine Liposome Injectable Suspension) is a sustained-release liposome formulation of ropivacaine, white aqueous suspension with ropivacaine concentration at approximately 19 mg/mL.
TLC590: TLC590 lyophilized cake will be reconstituted with the TLC590 reconstitution solution to form the TLC590 ropivacaine liposome injectable suspension
|
TL590 570mg
n=12 participants at risk
TLC590 (Ropivacaine Liposome Injectable Suspension) is a sustained-release liposome formulation of ropivacaine, white aqueous suspension with ropivacaine concentration at approximately 19 mg/mL.
TLC590: TLC590 lyophilized cake will be reconstituted with the TLC590 reconstitution solution to form the TLC590 ropivacaine liposome injectable suspension
|
TLC590 475mg
n=12 participants at risk
TLC590 (Ropivacaine Liposome Injectable Suspension) is a sustained-release liposome formulation of ropivacaine, white aqueous suspension with ropivacaine concentration at approximately 19 mg/mL.
TLC590: TLC590 lyophilized cake will be reconstituted with the TLC590 reconstitution solution to form the TLC590 ropivacaine liposome injectable suspension
|
Naropin 150mg
n=16 participants at risk
Naropin injection contains ropivacaine HCl. Strength: 150mg/ 30mL (5 mg/mL) Size: 30mL fill, in a 30mL single dose vial
Naropin: Local infiltration of Naropin to produce anesthesia for surgery and analgesia in postoperative pain management. Naropin 150mg \[0.5%, 5mg/mL\] x 30mL
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
33.3%
4/12 • Number of events 5 • 58 days
Total 64 subjects were enrolled in the study, 12 subjects in each TLC590 group and 16 subjects in Naropin group.
|
16.7%
2/12 • Number of events 3 • 58 days
Total 64 subjects were enrolled in the study, 12 subjects in each TLC590 group and 16 subjects in Naropin group.
|
16.7%
2/12 • Number of events 3 • 58 days
Total 64 subjects were enrolled in the study, 12 subjects in each TLC590 group and 16 subjects in Naropin group.
|
41.7%
5/12 • Number of events 5 • 58 days
Total 64 subjects were enrolled in the study, 12 subjects in each TLC590 group and 16 subjects in Naropin group.
|
43.8%
7/16 • Number of events 7 • 58 days
Total 64 subjects were enrolled in the study, 12 subjects in each TLC590 group and 16 subjects in Naropin group.
|
|
Gastrointestinal disorders
Constipation
|
16.7%
2/12 • Number of events 2 • 58 days
Total 64 subjects were enrolled in the study, 12 subjects in each TLC590 group and 16 subjects in Naropin group.
|
8.3%
1/12 • Number of events 1 • 58 days
Total 64 subjects were enrolled in the study, 12 subjects in each TLC590 group and 16 subjects in Naropin group.
|
25.0%
3/12 • Number of events 3 • 58 days
Total 64 subjects were enrolled in the study, 12 subjects in each TLC590 group and 16 subjects in Naropin group.
|
8.3%
1/12 • Number of events 1 • 58 days
Total 64 subjects were enrolled in the study, 12 subjects in each TLC590 group and 16 subjects in Naropin group.
|
50.0%
8/16 • Number of events 8 • 58 days
Total 64 subjects were enrolled in the study, 12 subjects in each TLC590 group and 16 subjects in Naropin group.
|
|
Gastrointestinal disorders
Vomiting
|
16.7%
2/12 • Number of events 2 • 58 days
Total 64 subjects were enrolled in the study, 12 subjects in each TLC590 group and 16 subjects in Naropin group.
|
16.7%
2/12 • Number of events 3 • 58 days
Total 64 subjects were enrolled in the study, 12 subjects in each TLC590 group and 16 subjects in Naropin group.
|
0.00%
0/12 • 58 days
Total 64 subjects were enrolled in the study, 12 subjects in each TLC590 group and 16 subjects in Naropin group.
|
16.7%
2/12 • Number of events 2 • 58 days
Total 64 subjects were enrolled in the study, 12 subjects in each TLC590 group and 16 subjects in Naropin group.
|
31.2%
5/16 • Number of events 5 • 58 days
Total 64 subjects were enrolled in the study, 12 subjects in each TLC590 group and 16 subjects in Naropin group.
|
|
Nervous system disorders
Headache
|
16.7%
2/12 • Number of events 2 • 58 days
Total 64 subjects were enrolled in the study, 12 subjects in each TLC590 group and 16 subjects in Naropin group.
|
0.00%
0/12 • 58 days
Total 64 subjects were enrolled in the study, 12 subjects in each TLC590 group and 16 subjects in Naropin group.
|
8.3%
1/12 • Number of events 1 • 58 days
Total 64 subjects were enrolled in the study, 12 subjects in each TLC590 group and 16 subjects in Naropin group.
|
33.3%
4/12 • Number of events 4 • 58 days
Total 64 subjects were enrolled in the study, 12 subjects in each TLC590 group and 16 subjects in Naropin group.
|
18.8%
3/16 • Number of events 3 • 58 days
Total 64 subjects were enrolled in the study, 12 subjects in each TLC590 group and 16 subjects in Naropin group.
|
|
Nervous system disorders
Dizziness
|
16.7%
2/12 • Number of events 4 • 58 days
Total 64 subjects were enrolled in the study, 12 subjects in each TLC590 group and 16 subjects in Naropin group.
|
16.7%
2/12 • Number of events 2 • 58 days
Total 64 subjects were enrolled in the study, 12 subjects in each TLC590 group and 16 subjects in Naropin group.
|
0.00%
0/12 • 58 days
Total 64 subjects were enrolled in the study, 12 subjects in each TLC590 group and 16 subjects in Naropin group.
|
16.7%
2/12 • Number of events 2 • 58 days
Total 64 subjects were enrolled in the study, 12 subjects in each TLC590 group and 16 subjects in Naropin group.
|
6.2%
1/16 • Number of events 1 • 58 days
Total 64 subjects were enrolled in the study, 12 subjects in each TLC590 group and 16 subjects in Naropin group.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/12 • 58 days
Total 64 subjects were enrolled in the study, 12 subjects in each TLC590 group and 16 subjects in Naropin group.
|
0.00%
0/12 • 58 days
Total 64 subjects were enrolled in the study, 12 subjects in each TLC590 group and 16 subjects in Naropin group.
|
25.0%
3/12 • Number of events 3 • 58 days
Total 64 subjects were enrolled in the study, 12 subjects in each TLC590 group and 16 subjects in Naropin group.
|
0.00%
0/12 • 58 days
Total 64 subjects were enrolled in the study, 12 subjects in each TLC590 group and 16 subjects in Naropin group.
|
0.00%
0/16 • 58 days
Total 64 subjects were enrolled in the study, 12 subjects in each TLC590 group and 16 subjects in Naropin group.
|
|
General disorders
Pyrexia
|
33.3%
4/12 • Number of events 4 • 58 days
Total 64 subjects were enrolled in the study, 12 subjects in each TLC590 group and 16 subjects in Naropin group.
|
16.7%
2/12 • Number of events 2 • 58 days
Total 64 subjects were enrolled in the study, 12 subjects in each TLC590 group and 16 subjects in Naropin group.
|
0.00%
0/12 • 58 days
Total 64 subjects were enrolled in the study, 12 subjects in each TLC590 group and 16 subjects in Naropin group.
|
16.7%
2/12 • Number of events 2 • 58 days
Total 64 subjects were enrolled in the study, 12 subjects in each TLC590 group and 16 subjects in Naropin group.
|
0.00%
0/16 • 58 days
Total 64 subjects were enrolled in the study, 12 subjects in each TLC590 group and 16 subjects in Naropin group.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
16.7%
2/12 • Number of events 2 • 58 days
Total 64 subjects were enrolled in the study, 12 subjects in each TLC590 group and 16 subjects in Naropin group.
|
0.00%
0/12 • 58 days
Total 64 subjects were enrolled in the study, 12 subjects in each TLC590 group and 16 subjects in Naropin group.
|
0.00%
0/12 • 58 days
Total 64 subjects were enrolled in the study, 12 subjects in each TLC590 group and 16 subjects in Naropin group.
|
0.00%
0/12 • 58 days
Total 64 subjects were enrolled in the study, 12 subjects in each TLC590 group and 16 subjects in Naropin group.
|
0.00%
0/16 • 58 days
Total 64 subjects were enrolled in the study, 12 subjects in each TLC590 group and 16 subjects in Naropin group.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/12 • 58 days
Total 64 subjects were enrolled in the study, 12 subjects in each TLC590 group and 16 subjects in Naropin group.
|
0.00%
0/12 • 58 days
Total 64 subjects were enrolled in the study, 12 subjects in each TLC590 group and 16 subjects in Naropin group.
|
16.7%
2/12 • Number of events 2 • 58 days
Total 64 subjects were enrolled in the study, 12 subjects in each TLC590 group and 16 subjects in Naropin group.
|
0.00%
0/12 • 58 days
Total 64 subjects were enrolled in the study, 12 subjects in each TLC590 group and 16 subjects in Naropin group.
|
0.00%
0/16 • 58 days
Total 64 subjects were enrolled in the study, 12 subjects in each TLC590 group and 16 subjects in Naropin group.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/12 • 58 days
Total 64 subjects were enrolled in the study, 12 subjects in each TLC590 group and 16 subjects in Naropin group.
|
8.3%
1/12 • Number of events 1 • 58 days
Total 64 subjects were enrolled in the study, 12 subjects in each TLC590 group and 16 subjects in Naropin group.
|
0.00%
0/12 • 58 days
Total 64 subjects were enrolled in the study, 12 subjects in each TLC590 group and 16 subjects in Naropin group.
|
16.7%
2/12 • Number of events 2 • 58 days
Total 64 subjects were enrolled in the study, 12 subjects in each TLC590 group and 16 subjects in Naropin group.
|
0.00%
0/16 • 58 days
Total 64 subjects were enrolled in the study, 12 subjects in each TLC590 group and 16 subjects in Naropin group.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/12 • 58 days
Total 64 subjects were enrolled in the study, 12 subjects in each TLC590 group and 16 subjects in Naropin group.
|
0.00%
0/12 • 58 days
Total 64 subjects were enrolled in the study, 12 subjects in each TLC590 group and 16 subjects in Naropin group.
|
0.00%
0/12 • 58 days
Total 64 subjects were enrolled in the study, 12 subjects in each TLC590 group and 16 subjects in Naropin group.
|
8.3%
1/12 • Number of events 1 • 58 days
Total 64 subjects were enrolled in the study, 12 subjects in each TLC590 group and 16 subjects in Naropin group.
|
0.00%
0/16 • 58 days
Total 64 subjects were enrolled in the study, 12 subjects in each TLC590 group and 16 subjects in Naropin group.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/12 • 58 days
Total 64 subjects were enrolled in the study, 12 subjects in each TLC590 group and 16 subjects in Naropin group.
|
0.00%
0/12 • 58 days
Total 64 subjects were enrolled in the study, 12 subjects in each TLC590 group and 16 subjects in Naropin group.
|
8.3%
1/12 • Number of events 1 • 58 days
Total 64 subjects were enrolled in the study, 12 subjects in each TLC590 group and 16 subjects in Naropin group.
|
0.00%
0/12 • 58 days
Total 64 subjects were enrolled in the study, 12 subjects in each TLC590 group and 16 subjects in Naropin group.
|
0.00%
0/16 • 58 days
Total 64 subjects were enrolled in the study, 12 subjects in each TLC590 group and 16 subjects in Naropin group.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
8.3%
1/12 • Number of events 1 • 58 days
Total 64 subjects were enrolled in the study, 12 subjects in each TLC590 group and 16 subjects in Naropin group.
|
0.00%
0/12 • 58 days
Total 64 subjects were enrolled in the study, 12 subjects in each TLC590 group and 16 subjects in Naropin group.
|
0.00%
0/12 • 58 days
Total 64 subjects were enrolled in the study, 12 subjects in each TLC590 group and 16 subjects in Naropin group.
|
0.00%
0/12 • 58 days
Total 64 subjects were enrolled in the study, 12 subjects in each TLC590 group and 16 subjects in Naropin group.
|
0.00%
0/16 • 58 days
Total 64 subjects were enrolled in the study, 12 subjects in each TLC590 group and 16 subjects in Naropin group.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/12 • 58 days
Total 64 subjects were enrolled in the study, 12 subjects in each TLC590 group and 16 subjects in Naropin group.
|
0.00%
0/12 • 58 days
Total 64 subjects were enrolled in the study, 12 subjects in each TLC590 group and 16 subjects in Naropin group.
|
0.00%
0/12 • 58 days
Total 64 subjects were enrolled in the study, 12 subjects in each TLC590 group and 16 subjects in Naropin group.
|
8.3%
1/12 • Number of events 1 • 58 days
Total 64 subjects were enrolled in the study, 12 subjects in each TLC590 group and 16 subjects in Naropin group.
|
0.00%
0/16 • 58 days
Total 64 subjects were enrolled in the study, 12 subjects in each TLC590 group and 16 subjects in Naropin group.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/12 • 58 days
Total 64 subjects were enrolled in the study, 12 subjects in each TLC590 group and 16 subjects in Naropin group.
|
0.00%
0/12 • 58 days
Total 64 subjects were enrolled in the study, 12 subjects in each TLC590 group and 16 subjects in Naropin group.
|
0.00%
0/12 • 58 days
Total 64 subjects were enrolled in the study, 12 subjects in each TLC590 group and 16 subjects in Naropin group.
|
8.3%
1/12 • Number of events 1 • 58 days
Total 64 subjects were enrolled in the study, 12 subjects in each TLC590 group and 16 subjects in Naropin group.
|
0.00%
0/16 • 58 days
Total 64 subjects were enrolled in the study, 12 subjects in each TLC590 group and 16 subjects in Naropin group.
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnoea
|
0.00%
0/12 • 58 days
Total 64 subjects were enrolled in the study, 12 subjects in each TLC590 group and 16 subjects in Naropin group.
|
0.00%
0/12 • 58 days
Total 64 subjects were enrolled in the study, 12 subjects in each TLC590 group and 16 subjects in Naropin group.
|
0.00%
0/12 • 58 days
Total 64 subjects were enrolled in the study, 12 subjects in each TLC590 group and 16 subjects in Naropin group.
|
8.3%
1/12 • Number of events 1 • 58 days
Total 64 subjects were enrolled in the study, 12 subjects in each TLC590 group and 16 subjects in Naropin group.
|
0.00%
0/16 • 58 days
Total 64 subjects were enrolled in the study, 12 subjects in each TLC590 group and 16 subjects in Naropin group.
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
0.00%
0/12 • 58 days
Total 64 subjects were enrolled in the study, 12 subjects in each TLC590 group and 16 subjects in Naropin group.
|
0.00%
0/12 • 58 days
Total 64 subjects were enrolled in the study, 12 subjects in each TLC590 group and 16 subjects in Naropin group.
|
0.00%
0/12 • 58 days
Total 64 subjects were enrolled in the study, 12 subjects in each TLC590 group and 16 subjects in Naropin group.
|
8.3%
1/12 • Number of events 1 • 58 days
Total 64 subjects were enrolled in the study, 12 subjects in each TLC590 group and 16 subjects in Naropin group.
|
0.00%
0/16 • 58 days
Total 64 subjects were enrolled in the study, 12 subjects in each TLC590 group and 16 subjects in Naropin group.
|
|
Injury, poisoning and procedural complications
Incision site hypoaesthesia
|
8.3%
1/12 • Number of events 1 • 58 days
Total 64 subjects were enrolled in the study, 12 subjects in each TLC590 group and 16 subjects in Naropin group.
|
0.00%
0/12 • 58 days
Total 64 subjects were enrolled in the study, 12 subjects in each TLC590 group and 16 subjects in Naropin group.
|
0.00%
0/12 • 58 days
Total 64 subjects were enrolled in the study, 12 subjects in each TLC590 group and 16 subjects in Naropin group.
|
0.00%
0/12 • 58 days
Total 64 subjects were enrolled in the study, 12 subjects in each TLC590 group and 16 subjects in Naropin group.
|
0.00%
0/16 • 58 days
Total 64 subjects were enrolled in the study, 12 subjects in each TLC590 group and 16 subjects in Naropin group.
|
|
Injury, poisoning and procedural complications
Procedural hypotension
|
0.00%
0/12 • 58 days
Total 64 subjects were enrolled in the study, 12 subjects in each TLC590 group and 16 subjects in Naropin group.
|
8.3%
1/12 • Number of events 1 • 58 days
Total 64 subjects were enrolled in the study, 12 subjects in each TLC590 group and 16 subjects in Naropin group.
|
0.00%
0/12 • 58 days
Total 64 subjects were enrolled in the study, 12 subjects in each TLC590 group and 16 subjects in Naropin group.
|
0.00%
0/12 • 58 days
Total 64 subjects were enrolled in the study, 12 subjects in each TLC590 group and 16 subjects in Naropin group.
|
0.00%
0/16 • 58 days
Total 64 subjects were enrolled in the study, 12 subjects in each TLC590 group and 16 subjects in Naropin group.
|
|
Injury, poisoning and procedural complications
Procedural dizziness
|
0.00%
0/12 • 58 days
Total 64 subjects were enrolled in the study, 12 subjects in each TLC590 group and 16 subjects in Naropin group.
|
0.00%
0/12 • 58 days
Total 64 subjects were enrolled in the study, 12 subjects in each TLC590 group and 16 subjects in Naropin group.
|
0.00%
0/12 • 58 days
Total 64 subjects were enrolled in the study, 12 subjects in each TLC590 group and 16 subjects in Naropin group.
|
0.00%
0/12 • 58 days
Total 64 subjects were enrolled in the study, 12 subjects in each TLC590 group and 16 subjects in Naropin group.
|
6.2%
1/16 • Number of events 1 • 58 days
Total 64 subjects were enrolled in the study, 12 subjects in each TLC590 group and 16 subjects in Naropin group.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/12 • 58 days
Total 64 subjects were enrolled in the study, 12 subjects in each TLC590 group and 16 subjects in Naropin group.
|
8.3%
1/12 • Number of events 1 • 58 days
Total 64 subjects were enrolled in the study, 12 subjects in each TLC590 group and 16 subjects in Naropin group.
|
0.00%
0/12 • 58 days
Total 64 subjects were enrolled in the study, 12 subjects in each TLC590 group and 16 subjects in Naropin group.
|
0.00%
0/12 • 58 days
Total 64 subjects were enrolled in the study, 12 subjects in each TLC590 group and 16 subjects in Naropin group.
|
0.00%
0/16 • 58 days
Total 64 subjects were enrolled in the study, 12 subjects in each TLC590 group and 16 subjects in Naropin group.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/12 • 58 days
Total 64 subjects were enrolled in the study, 12 subjects in each TLC590 group and 16 subjects in Naropin group.
|
0.00%
0/12 • 58 days
Total 64 subjects were enrolled in the study, 12 subjects in each TLC590 group and 16 subjects in Naropin group.
|
0.00%
0/12 • 58 days
Total 64 subjects were enrolled in the study, 12 subjects in each TLC590 group and 16 subjects in Naropin group.
|
0.00%
0/12 • 58 days
Total 64 subjects were enrolled in the study, 12 subjects in each TLC590 group and 16 subjects in Naropin group.
|
6.2%
1/16 • Number of events 1 • 58 days
Total 64 subjects were enrolled in the study, 12 subjects in each TLC590 group and 16 subjects in Naropin group.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/12 • 58 days
Total 64 subjects were enrolled in the study, 12 subjects in each TLC590 group and 16 subjects in Naropin group.
|
0.00%
0/12 • 58 days
Total 64 subjects were enrolled in the study, 12 subjects in each TLC590 group and 16 subjects in Naropin group.
|
0.00%
0/12 • 58 days
Total 64 subjects were enrolled in the study, 12 subjects in each TLC590 group and 16 subjects in Naropin group.
|
0.00%
0/12 • 58 days
Total 64 subjects were enrolled in the study, 12 subjects in each TLC590 group and 16 subjects in Naropin group.
|
6.2%
1/16 • Number of events 1 • 58 days
Total 64 subjects were enrolled in the study, 12 subjects in each TLC590 group and 16 subjects in Naropin group.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/12 • 58 days
Total 64 subjects were enrolled in the study, 12 subjects in each TLC590 group and 16 subjects in Naropin group.
|
0.00%
0/12 • 58 days
Total 64 subjects were enrolled in the study, 12 subjects in each TLC590 group and 16 subjects in Naropin group.
|
8.3%
1/12 • Number of events 1 • 58 days
Total 64 subjects were enrolled in the study, 12 subjects in each TLC590 group and 16 subjects in Naropin group.
|
8.3%
1/12 • Number of events 1 • 58 days
Total 64 subjects were enrolled in the study, 12 subjects in each TLC590 group and 16 subjects in Naropin group.
|
0.00%
0/16 • 58 days
Total 64 subjects were enrolled in the study, 12 subjects in each TLC590 group and 16 subjects in Naropin group.
|
|
Renal and urinary disorders
Urinary retention
|
8.3%
1/12 • Number of events 1 • 58 days
Total 64 subjects were enrolled in the study, 12 subjects in each TLC590 group and 16 subjects in Naropin group.
|
0.00%
0/12 • 58 days
Total 64 subjects were enrolled in the study, 12 subjects in each TLC590 group and 16 subjects in Naropin group.
|
0.00%
0/12 • 58 days
Total 64 subjects were enrolled in the study, 12 subjects in each TLC590 group and 16 subjects in Naropin group.
|
0.00%
0/12 • 58 days
Total 64 subjects were enrolled in the study, 12 subjects in each TLC590 group and 16 subjects in Naropin group.
|
6.2%
1/16 • Number of events 1 • 58 days
Total 64 subjects were enrolled in the study, 12 subjects in each TLC590 group and 16 subjects in Naropin group.
|
|
Vascular disorders
Hypertension
|
0.00%
0/12 • 58 days
Total 64 subjects were enrolled in the study, 12 subjects in each TLC590 group and 16 subjects in Naropin group.
|
8.3%
1/12 • Number of events 1 • 58 days
Total 64 subjects were enrolled in the study, 12 subjects in each TLC590 group and 16 subjects in Naropin group.
|
0.00%
0/12 • 58 days
Total 64 subjects were enrolled in the study, 12 subjects in each TLC590 group and 16 subjects in Naropin group.
|
8.3%
1/12 • Number of events 1 • 58 days
Total 64 subjects were enrolled in the study, 12 subjects in each TLC590 group and 16 subjects in Naropin group.
|
0.00%
0/16 • 58 days
Total 64 subjects were enrolled in the study, 12 subjects in each TLC590 group and 16 subjects in Naropin group.
|
|
Vascular disorders
Pallor
|
8.3%
1/12 • Number of events 1 • 58 days
Total 64 subjects were enrolled in the study, 12 subjects in each TLC590 group and 16 subjects in Naropin group.
|
0.00%
0/12 • 58 days
Total 64 subjects were enrolled in the study, 12 subjects in each TLC590 group and 16 subjects in Naropin group.
|
0.00%
0/12 • 58 days
Total 64 subjects were enrolled in the study, 12 subjects in each TLC590 group and 16 subjects in Naropin group.
|
0.00%
0/12 • 58 days
Total 64 subjects were enrolled in the study, 12 subjects in each TLC590 group and 16 subjects in Naropin group.
|
0.00%
0/16 • 58 days
Total 64 subjects were enrolled in the study, 12 subjects in each TLC590 group and 16 subjects in Naropin group.
|
|
Infections and infestations
Upper respiratory tract infection
|
8.3%
1/12 • Number of events 1 • 58 days
Total 64 subjects were enrolled in the study, 12 subjects in each TLC590 group and 16 subjects in Naropin group.
|
8.3%
1/12 • Number of events 1 • 58 days
Total 64 subjects were enrolled in the study, 12 subjects in each TLC590 group and 16 subjects in Naropin group.
|
0.00%
0/12 • 58 days
Total 64 subjects were enrolled in the study, 12 subjects in each TLC590 group and 16 subjects in Naropin group.
|
0.00%
0/12 • 58 days
Total 64 subjects were enrolled in the study, 12 subjects in each TLC590 group and 16 subjects in Naropin group.
|
0.00%
0/16 • 58 days
Total 64 subjects were enrolled in the study, 12 subjects in each TLC590 group and 16 subjects in Naropin group.
|
|
Infections and infestations
Epididymitis
|
0.00%
0/12 • 58 days
Total 64 subjects were enrolled in the study, 12 subjects in each TLC590 group and 16 subjects in Naropin group.
|
0.00%
0/12 • 58 days
Total 64 subjects were enrolled in the study, 12 subjects in each TLC590 group and 16 subjects in Naropin group.
|
0.00%
0/12 • 58 days
Total 64 subjects were enrolled in the study, 12 subjects in each TLC590 group and 16 subjects in Naropin group.
|
0.00%
0/12 • 58 days
Total 64 subjects were enrolled in the study, 12 subjects in each TLC590 group and 16 subjects in Naropin group.
|
6.2%
1/16 • Number of events 1 • 58 days
Total 64 subjects were enrolled in the study, 12 subjects in each TLC590 group and 16 subjects in Naropin group.
|
|
Investigations
Electrocardiogram QRS complex prolonged
|
0.00%
0/12 • 58 days
Total 64 subjects were enrolled in the study, 12 subjects in each TLC590 group and 16 subjects in Naropin group.
|
0.00%
0/12 • 58 days
Total 64 subjects were enrolled in the study, 12 subjects in each TLC590 group and 16 subjects in Naropin group.
|
0.00%
0/12 • 58 days
Total 64 subjects were enrolled in the study, 12 subjects in each TLC590 group and 16 subjects in Naropin group.
|
8.3%
1/12 • Number of events 1 • 58 days
Total 64 subjects were enrolled in the study, 12 subjects in each TLC590 group and 16 subjects in Naropin group.
|
6.2%
1/16 • Number of events 1 • 58 days
Total 64 subjects were enrolled in the study, 12 subjects in each TLC590 group and 16 subjects in Naropin group.
|
|
Investigations
Electrocardiogram ST-T change
|
0.00%
0/12 • 58 days
Total 64 subjects were enrolled in the study, 12 subjects in each TLC590 group and 16 subjects in Naropin group.
|
8.3%
1/12 • Number of events 1 • 58 days
Total 64 subjects were enrolled in the study, 12 subjects in each TLC590 group and 16 subjects in Naropin group.
|
0.00%
0/12 • 58 days
Total 64 subjects were enrolled in the study, 12 subjects in each TLC590 group and 16 subjects in Naropin group.
|
0.00%
0/12 • 58 days
Total 64 subjects were enrolled in the study, 12 subjects in each TLC590 group and 16 subjects in Naropin group.
|
0.00%
0/16 • 58 days
Total 64 subjects were enrolled in the study, 12 subjects in each TLC590 group and 16 subjects in Naropin group.
|
|
Investigations
Electrocardiogram T wave inversion
|
0.00%
0/12 • 58 days
Total 64 subjects were enrolled in the study, 12 subjects in each TLC590 group and 16 subjects in Naropin group.
|
0.00%
0/12 • 58 days
Total 64 subjects were enrolled in the study, 12 subjects in each TLC590 group and 16 subjects in Naropin group.
|
0.00%
0/12 • 58 days
Total 64 subjects were enrolled in the study, 12 subjects in each TLC590 group and 16 subjects in Naropin group.
|
8.3%
1/12 • Number of events 1 • 58 days
Total 64 subjects were enrolled in the study, 12 subjects in each TLC590 group and 16 subjects in Naropin group.
|
0.00%
0/16 • 58 days
Total 64 subjects were enrolled in the study, 12 subjects in each TLC590 group and 16 subjects in Naropin group.
|
|
Investigations
Oxygen saturation decreased
|
0.00%
0/12 • 58 days
Total 64 subjects were enrolled in the study, 12 subjects in each TLC590 group and 16 subjects in Naropin group.
|
0.00%
0/12 • 58 days
Total 64 subjects were enrolled in the study, 12 subjects in each TLC590 group and 16 subjects in Naropin group.
|
0.00%
0/12 • 58 days
Total 64 subjects were enrolled in the study, 12 subjects in each TLC590 group and 16 subjects in Naropin group.
|
8.3%
1/12 • Number of events 1 • 58 days
Total 64 subjects were enrolled in the study, 12 subjects in each TLC590 group and 16 subjects in Naropin group.
|
0.00%
0/16 • 58 days
Total 64 subjects were enrolled in the study, 12 subjects in each TLC590 group and 16 subjects in Naropin group.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
8.3%
1/12 • Number of events 1 • 58 days
Total 64 subjects were enrolled in the study, 12 subjects in each TLC590 group and 16 subjects in Naropin group.
|
0.00%
0/12 • 58 days
Total 64 subjects were enrolled in the study, 12 subjects in each TLC590 group and 16 subjects in Naropin group.
|
0.00%
0/12 • 58 days
Total 64 subjects were enrolled in the study, 12 subjects in each TLC590 group and 16 subjects in Naropin group.
|
0.00%
0/12 • 58 days
Total 64 subjects were enrolled in the study, 12 subjects in each TLC590 group and 16 subjects in Naropin group.
|
0.00%
0/16 • 58 days
Total 64 subjects were enrolled in the study, 12 subjects in each TLC590 group and 16 subjects in Naropin group.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/12 • 58 days
Total 64 subjects were enrolled in the study, 12 subjects in each TLC590 group and 16 subjects in Naropin group.
|
8.3%
1/12 • Number of events 1 • 58 days
Total 64 subjects were enrolled in the study, 12 subjects in each TLC590 group and 16 subjects in Naropin group.
|
0.00%
0/12 • 58 days
Total 64 subjects were enrolled in the study, 12 subjects in each TLC590 group and 16 subjects in Naropin group.
|
0.00%
0/12 • 58 days
Total 64 subjects were enrolled in the study, 12 subjects in each TLC590 group and 16 subjects in Naropin group.
|
0.00%
0/16 • 58 days
Total 64 subjects were enrolled in the study, 12 subjects in each TLC590 group and 16 subjects in Naropin group.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/12 • 58 days
Total 64 subjects were enrolled in the study, 12 subjects in each TLC590 group and 16 subjects in Naropin group.
|
0.00%
0/12 • 58 days
Total 64 subjects were enrolled in the study, 12 subjects in each TLC590 group and 16 subjects in Naropin group.
|
0.00%
0/12 • 58 days
Total 64 subjects were enrolled in the study, 12 subjects in each TLC590 group and 16 subjects in Naropin group.
|
8.3%
1/12 • Number of events 1 • 58 days
Total 64 subjects were enrolled in the study, 12 subjects in each TLC590 group and 16 subjects in Naropin group.
|
6.2%
1/16 • Number of events 1 • 58 days
Total 64 subjects were enrolled in the study, 12 subjects in each TLC590 group and 16 subjects in Naropin group.
|
|
Reproductive system and breast disorders
Testicular oedema
|
0.00%
0/12 • 58 days
Total 64 subjects were enrolled in the study, 12 subjects in each TLC590 group and 16 subjects in Naropin group.
|
0.00%
0/12 • 58 days
Total 64 subjects were enrolled in the study, 12 subjects in each TLC590 group and 16 subjects in Naropin group.
|
8.3%
1/12 • Number of events 1 • 58 days
Total 64 subjects were enrolled in the study, 12 subjects in each TLC590 group and 16 subjects in Naropin group.
|
0.00%
0/12 • 58 days
Total 64 subjects were enrolled in the study, 12 subjects in each TLC590 group and 16 subjects in Naropin group.
|
0.00%
0/16 • 58 days
Total 64 subjects were enrolled in the study, 12 subjects in each TLC590 group and 16 subjects in Naropin group.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Unless Sponsor provides prior written consent, Institution may not use Confidential Information for any purpose other than that authorized in this Agreement, nor may Institution disclose Confidential Information to any third party except as authorized in this Agreement or as required by law. Required disclosure of Confidential Information to the Institutional Review Board (IRB) or to FDA representatives is specifically authorized.
- Publication restrictions are in place
Restriction type: OTHER