Safety and Pharmacokinetics Study of Redosing EXPAREL in Healthy Volunteers
Study Details
Study Description
Brief Summary
The purpose of this study is to evaluate the safety and pharmacokinetics of redosing EXPAREL via local subcutaneous infiltration in healthy volunteers.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
Phase 1 |
Detailed Description
During Dosing Period 1, blood samples for pharmacokinetic (PK) analysis will be obtained predose (15 minutes prior to administration of EXPAREL) through 12 hours postdose (i.e., at 15 and 30 minutes, 1, 2, 4, 8, and 12 hours) for Cohort 4; through 36 hours postdose (i.e., at 15 and 30 minutes, 1, 2, 4, 8, 12, 24, and 36 hours) for Cohort 3; through 60 hours postdose (i.e., at 15 and 30 minutes, 1, 2, 4, 8, 12, 24, 36, 48, and 60 hours) for Cohort 2; and through 72 hours postdose (i.e., at 15 and 30 minutes, 1, 2, 4, 8, 12, 24, 36, 48, 60, and 72 hours) for Cohorts 1 and 5.
During Dosing Period 2 (Cohorts 2, 3, and 4 only), blood samples for PK analysis will be obtained predose (15 minutes prior to administration of EXPAREL) through 72 hours postdose (i.e., at 15 and 30 minutes, 1, 2, 4, 8, 12, 24, 36, 48, 60, and 72 hours).
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Active Comparator: Cohort 1 Cohort 1 will receive a single dose of EXPAREL 266 mg on Day 1. No additional dose will be given. |
Drug: EXPAREL
Other Names:
|
Active Comparator: Cohort 2 Cohort 2 will receive a dose of EXPAREL 266 mg on Day 1 and a second dose of EXPAREL 266 mg on Day 4 at 72 hours. |
Drug: EXPAREL
Other Names:
|
Active Comparator: Cohort 3 Cohort 3 will receive a dose of EXPAREL 266 mg on Day 1 and a second dose of EXPAREL 266 mg on Day 3 at 48 hours. |
Drug: EXPAREL
Other Names:
|
Active Comparator: Cohort 4 Cohort 4 will receive a dose of EXPAREL 266 mg on Day 1 and a second dose of EXPAREL 266 mg on Day 2 at 24 hours. |
Drug: EXPAREL
Other Names:
|
Active Comparator: Cohort 5 Cohort 5 will receive a single dose of EXPAREL 266 mg on Day 1 followed immediately by a second dose of EXPAREL 266 mg (total of 532 mg/40 mL). |
Drug: EXPAREL
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Maximum Plasma Concentration (Cmax) [Period(P)1 all cohorts (C) 15 m in pre, 15,30m, 1,2,34,8,12h postdose. C3: +24, 36 h postdose. C2: C3+48,60h postdose; C1 and C5: C2+72h postdose; P2: C2,3,4 only: 15m pre, 1,2,4,8,12,24,36,48,60,72h postdose. Final at D14- all subjects]
- Time to Maximum Concentration (Tmax) [Period(P)1 all cohorts 15 m in pre, 15,30m, 1,2,34,8,12h postdose. C3: +24, 36 h postdose. C2: C3+48,60h postdose; C1 and C5: C2+72h postdose; P2: C2,3,4 only: 15m pre, 1,2,4,8,12,24,36,48,60,72h postdose. Final at D14- all subjects]
- Area Under the Plasma Concentration Time Curve From Time 0 to the Time of the Last Quantifiable Concentration [AUC(0-last)] [Period(P)1 all cohorts (C) 15 m in pre, 15,30m, 1,2,34,8,12h postdose. C3: +24, 36 h postdose. C2: C3+48,60h postdose; C1 and C5: C2+72h postdose; P2: C2,3,4 only: 15m pre, 1,2,4,8,12,24,36,48,60,72h postdose. Final at D14- all subjects]
- Apparent Terminal Elimination Half-life [Period(P)1 all cohorts 15 m in pre, 15,30m, 1,2,34,8,12h postdose. C3: +24, 36 h postdose. C2: C3+48,60h postdose; C1 and C5: C2+72h postdose; P2: C2,3,4 only: 15m pre, 1,2,4,8,12,24,36,48,60,72h postdose. Final at D14- all subjects]
- The Apparent Terminal Elimination Rate Constant (λz) [Period(P)1 all cohorts 15 m in pre, 15,30m, 1,2,34,8,12h postdose. C3: +24, 36 h postdose. C2: C3+48,60h postdose; C1 and C5: C2+72h postdose; P2: C2,3,4 only: 15m pre, 1,2,4,8,12,24,36,48,60,72h postdose. Final at D14- all subjects]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Males or females ≥18 years of age.
-
American Society of Anesthesiologists (ASA) physical status 1 or 2.
-
Female subjects must be surgically sterile, at least 2 years postmenopausal, or using a medically acceptable method of birth control. If of childbearing potential, must have a documented negative pregnancy test within 24 hours before the first study drug administration.
-
Able to provide informed consent, adhere to the study visit schedule, and complete all study assessments.
Exclusion Criteria:
-
History of hypersensitivity or idiosyncratic reactions to amide-type local anesthetics.
-
History of abnormal bleeding tendencies/clotting disorders.
-
Regular use of anticoagulants (except for low dose aspirin for cardioprotection).
-
Received any investigational drug within 30 days prior to study drug administration, and/or has planned administration of another investigational product or procedure during his/her participation in this study.
-
Currently pregnant, nursing, or planning to become pregnant during the study or within 1 month after study drug administration.
-
Subjects with significant medical conditions or laboratory results that, in the opinion of the Investigator, would constitute a contraindication to participation in the study, or cause inability to comply with the study requirements.
-
Received bupivacaine or other local anesthetic within 7 days of first study drug administration.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Medpace Clinical Pharmacology Unit | Cincinnati | Ohio | United States | 45227 |
Sponsors and Collaborators
- Pacira Pharmaceuticals, Inc
Investigators
- Principal Investigator: Lukasz Biernat, MD, Medpace Clinical Pharmacology Unit
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 402-C-113
Study Results
Participant Flow
Recruitment Details | |
---|---|
Pre-assignment Detail |
Arm/Group Title | Cohort 1 | Cohort 2 | Cohort 3 | Cohort 4 | Cohort 5 |
---|---|---|---|---|---|
Arm/Group Description | Cohort 1 received a single dose of EXPAREL 266 mg on Day 1. No additional dose was given. EXPAREL | Cohort 2 received a dose of EXPAREL 266 mg on Day 1 and a second dose of EXPAREL 266 mg on Day 4 at 72 hours. EXPAREL | Cohort 3 received a dose of EXPAREL 266 mg on Day 1 and a second dose of EXPAREL 266 mg on Day 3 at 48 hours. EXPAREL | Cohort 4 received a dose of EXPAREL 266 mg on Day 1 and a second dose of EXPAREL 266 mg on Day 2 at 24 hours. EXPAREL | Cohort 5 received a single dose of EXPAREL 266 mg on Day 1 followed immediately by a second dose of EXPAREL 266 mg (total of 532 mg/40 mL). EXPAREL |
Period Title: Overall Study | |||||
STARTED | 12 | 12 | 12 | 12 | 12 |
COMPLETED | 12 | 12 | 12 | 12 | 12 |
NOT COMPLETED | 0 | 0 | 0 | 0 | 0 |
Baseline Characteristics
Arm/Group Title | Cohort 1 | Cohort 2 | Cohort 3 | Cohort 4 | Cohort 5 | Total |
---|---|---|---|---|---|---|
Arm/Group Description | Cohort 1 received a single dose of EXPAREL 266 mg on Day 1. No additional dose was given. EXPAREL | Cohort 2 received a dose of EXPAREL 266 mg on Day 1 and a second dose of EXPAREL 266 mg on Day 4 at 72 hours. EXPAREL | Cohort 3 received a dose of EXPAREL 266 mg on Day 1 and a second dose of EXPAREL 266 mg on Day 3 at 48 hours. EXPAREL | Cohort 4 received a dose of EXPAREL 266 mg on Day 1 and a second dose of EXPAREL 266 mg on Day 2 at 24 hours. EXPAREL | Cohort 5 received a single dose of EXPAREL 266 mg on Day 1 followed immediately by a second dose of EXPAREL 266 mg (total of 532 mg/40 mL). EXPAREL | Total of all reporting groups |
Overall Participants | 12 | 12 | 12 | 12 | 12 | 60 |
Age (years) [Mean (Standard Deviation) ] | ||||||
Mean (Standard Deviation) [years] |
45.6
(11.90)
|
37.8
(11.66)
|
36.9
(10.83)
|
41.6
(12.38)
|
44.1
(14.56)
|
41.2
(12.39)
|
Sex: Female, Male (Count of Participants) | ||||||
Female |
7
58.3%
|
0
0%
|
2
16.7%
|
8
66.7%
|
6
50%
|
23
38.3%
|
Male |
5
41.7%
|
12
100%
|
10
83.3%
|
4
33.3%
|
6
50%
|
37
61.7%
|
Ethnicity (NIH/OMB) (Count of Participants) | ||||||
Hispanic or Latino |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
Not Hispanic or Latino |
12
100%
|
12
100%
|
12
100%
|
12
100%
|
12
100%
|
60
100%
|
Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
Race (NIH/OMB) (Count of Participants) | ||||||
American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
Asian |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
Black or African American |
6
50%
|
10
83.3%
|
9
75%
|
9
75%
|
8
66.7%
|
42
70%
|
White |
6
50%
|
2
16.7%
|
3
25%
|
3
25%
|
4
33.3%
|
18
30%
|
More than one race |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
Region of Enrollment (participants) [Number] | ||||||
United States |
12
100%
|
12
100%
|
12
100%
|
12
100%
|
12
100%
|
60
100%
|
Outcome Measures
Title | Maximum Plasma Concentration (Cmax) |
---|---|
Description | |
Time Frame | Period(P)1 all cohorts (C) 15 m in pre, 15,30m, 1,2,34,8,12h postdose. C3: +24, 36 h postdose. C2: C3+48,60h postdose; C1 and C5: C2+72h postdose; P2: C2,3,4 only: 15m pre, 1,2,4,8,12,24,36,48,60,72h postdose. Final at D14- all subjects |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Cohort 1 | Cohort 2 | Cohort 3 | Cohort 4 | Cohort 5 |
---|---|---|---|---|---|
Arm/Group Description | Cohort 1 will receive a single dose of EXPAREL 266 mg on Day 1. No additional dose will be given. EXPAREL | Cohort 2 will receive a dose of EXPAREL 266 mg on Day 1 and a second dose of EXPAREL 266 mg on Day 4 at 72 hours. EXPAREL | Cohort 3 will receive a dose of EXPAREL 266 mg on Day 1 and a second dose of EXPAREL 266 mg on Day 3 at 48 hours. EXPAREL | Cohort 4 will receive a dose of EXPAREL 266 mg on Day 1 and a second dose of EXPAREL 266 mg on Day 2 at 24 hours. EXPAREL | Cohort 5 will receive a single dose of EXPAREL 266 mg on Day 1 followed immediately by a second dose of EXPAREL 266 mg (total of 532 mg/40 mL). EXPAREL |
Measure Participants | 12 | 12 | 12 | 12 | 12 |
Mean (Standard Deviation) [ng/mL] |
129
(47)
|
207
(57)
|
202
(74)
|
290
(119)
|
246
(78)
|
Title | Time to Maximum Concentration (Tmax) |
---|---|
Description | |
Time Frame | Period(P)1 all cohorts 15 m in pre, 15,30m, 1,2,34,8,12h postdose. C3: +24, 36 h postdose. C2: C3+48,60h postdose; C1 and C5: C2+72h postdose; P2: C2,3,4 only: 15m pre, 1,2,4,8,12,24,36,48,60,72h postdose. Final at D14- all subjects |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Cohort 1 | Cohort 2 | Cohort 3 | Cohort 4 | Cohort 5 |
---|---|---|---|---|---|
Arm/Group Description | Cohort 1 received a single dose of EXPAREL 266 mg on Day 1. No additional dose was given. EXPAREL | Cohort 2 received a dose of EXPAREL 266 mg on Day 1 and a second dose of EXPAREL 266 mg on Day 4 at 72 hours. EXPAREL | Cohort 3 received a dose of EXPAREL 266 mg on Day 1 and a second dose of EXPAREL 266 mg on Day 3 at 48 hours. EXPAREL | Cohort 4 received a dose of EXPAREL 266 mg on Day 1 and a second dose of EXPAREL 266 mg on Day 2 at 24 hours. EXPAREL | Cohort 5 received a single dose of EXPAREL 266 mg on Day 1 followed immediately by a second dose of EXPAREL 266 mg (total of 532 mg/40 mL). EXPAREL |
Measure Participants | 12 | 12 | 12 | 12 | 12 |
Median (Full Range) [hours] |
24
|
48
|
48
|
36
|
24
|
Title | Area Under the Plasma Concentration Time Curve From Time 0 to the Time of the Last Quantifiable Concentration [AUC(0-last)] |
---|---|
Description | |
Time Frame | Period(P)1 all cohorts (C) 15 m in pre, 15,30m, 1,2,34,8,12h postdose. C3: +24, 36 h postdose. C2: C3+48,60h postdose; C1 and C5: C2+72h postdose; P2: C2,3,4 only: 15m pre, 1,2,4,8,12,24,36,48,60,72h postdose. Final at D14- all subjects |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Cohort 1 | Cohort 2 | Cohort 3 | Cohort 4 | Cohort 5 |
---|---|---|---|---|---|
Arm/Group Description | Cohort 1 received a single dose of EXPAREL 266 mg on Day 1. No additional dose was given. EXPAREL | Cohort 2 received a dose of EXPAREL 266 mg on Day 1 and a second dose of EXPAREL 266 mg on Day 4 at 72 hours. EXPAREL | Cohort 3 received a dose of EXPAREL 266 mg on Day 1 and a second dose of EXPAREL 266 mg on Day 3 at 48 hours. EXPAREL | Cohort 4 received a dose of EXPAREL 266 mg on Day 1 and a second dose of EXPAREL 266 mg on Day 2 at 24 hours. EXPAREL | Cohort 5 received a single dose of EXPAREL 266 mg on Day 1 followed immediately by a second dose of EXPAREL 266 mg (total of 532 mg/40 mL). EXPAREL |
Measure Participants | 12 | 12 | 12 | 12 | 12 |
Mean (Standard Deviation) [H*ng/mL] |
5917
(1738)
|
10976
(2879)
|
10201
(3721)
|
15227
(7463)
|
11567
(3737)
|
Title | Apparent Terminal Elimination Half-life |
---|---|
Description | |
Time Frame | Period(P)1 all cohorts 15 m in pre, 15,30m, 1,2,34,8,12h postdose. C3: +24, 36 h postdose. C2: C3+48,60h postdose; C1 and C5: C2+72h postdose; P2: C2,3,4 only: 15m pre, 1,2,4,8,12,24,36,48,60,72h postdose. Final at D14- all subjects |
Outcome Measure Data
Analysis Population Description |
---|
Where n per group <12, values were either not calculated or not reported. |
Arm/Group Title | Cohort 1 | Cohort 2 | Cohort 3 | Cohort 4 | Cohort 5 |
---|---|---|---|---|---|
Arm/Group Description | Cohort 1 will receive a single dose of EXPAREL 266 mg on Day 1. No additional dose will be given. EXPAREL | Cohort 2 will receive a dose of EXPAREL 266 mg on Day 1 and a second dose of EXPAREL 266 mg on Day 4 at 72 hours. EXPAREL | Cohort 3 will receive a dose of EXPAREL 266 mg on Day 1 and a second dose of EXPAREL 266 mg on Day 3 at 48 hours. EXPAREL | Cohort 4 will receive a dose of EXPAREL 266 mg on Day 1 and a second dose of EXPAREL 266 mg on Day 2 at 24 hours. EXPAREL | Cohort 5 will receive a single dose of EXPAREL 266 mg on Day 1 followed immediately by a second dose of EXPAREL 266 mg (total of 532 mg/40 mL). EXPAREL |
Measure Participants | 2 | 6 | 6 | 2 | 7 |
Mean (Standard Deviation) [hours] |
80.24
(22.64)
|
44.88
(25.64)
|
51.70
(26.99)
|
33.22
(3.80)
|
59.13
(25.03)
|
Title | The Apparent Terminal Elimination Rate Constant (λz) |
---|---|
Description | |
Time Frame | Period(P)1 all cohorts 15 m in pre, 15,30m, 1,2,34,8,12h postdose. C3: +24, 36 h postdose. C2: C3+48,60h postdose; C1 and C5: C2+72h postdose; P2: C2,3,4 only: 15m pre, 1,2,4,8,12,24,36,48,60,72h postdose. Final at D14- all subjects |
Outcome Measure Data
Analysis Population Description |
---|
Where n per group <12, values were either not calculated or not reported. |
Arm/Group Title | Cohort 1 | Cohort 2 | Cohort 3 | Cohort 4 | Cohort 5 |
---|---|---|---|---|---|
Arm/Group Description | Cohort 1 will receive a single dose of EXPAREL 266 mg on Day 1. No additional dose will be given. EXPAREL | Cohort 2 will receive a dose of EXPAREL 266 mg on Day 1 and a second dose of EXPAREL 266 mg on Day 4 at 72 hours. EXPAREL | Cohort 3 will receive a dose of EXPAREL 266 mg on Day 1 and a second dose of EXPAREL 266 mg on Day 3 at 48 hours. EXPAREL | Cohort 4 will receive a dose of EXPAREL 266 mg on Day 1 and a second dose of EXPAREL 266 mg on Day 2 at 24 hours. EXPAREL | Cohort 5 will receive a single dose of EXPAREL 266 mg on Day 1 followed immediately by a second dose of EXPAREL 266 mg (total of 532 mg/40 mL). EXPAREL |
Measure Participants | 2 | 6 | 6 | 2 | 7 |
Mean (Standard Deviation) [1/hours] |
0.009
(0.003)
|
0.019
(0.007)
|
0.016
(0.007)
|
0.021
(0.002)
|
0.014
(0.006)
|
Adverse Events
Time Frame | ||||||||||
---|---|---|---|---|---|---|---|---|---|---|
Adverse Event Reporting Description | ||||||||||
Arm/Group Title | Cohort 1 | Cohort 2 | Cohort 3 | Cohort 4 | Cohort 5 | |||||
Arm/Group Description | Cohort 1 received a single dose of EXPAREL 266 mg on Day 1. No additional dose was given. EXPAREL | Cohort 2 received a dose of EXPAREL 266 mg on Day 1 and a second dose of EXPAREL 266 mg on Day 4 at 72 hours. EXPAREL | Cohort 3 received a dose of EXPAREL 266 mg on Day 1 and a second dose of EXPAREL 266 mg on Day 3 at 48 hours. EXPAREL | Cohort 4 received a dose of EXPAREL 266 mg on Day 1 and a second dose of EXPAREL 266 mg on Day 2 at 24 hours. EXPAREL | Cohort 5 received a single dose of EXPAREL 266 mg on Day 1 followed immediately by a second dose of EXPAREL 266 mg (total of 532 mg/40 mL). EXPAREL | |||||
All Cause Mortality |
||||||||||
Cohort 1 | Cohort 2 | Cohort 3 | Cohort 4 | Cohort 5 | ||||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | |||||
Serious Adverse Events |
||||||||||
Cohort 1 | Cohort 2 | Cohort 3 | Cohort 4 | Cohort 5 | ||||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/12 (0%) | 0/12 (0%) | 0/12 (0%) | 0/12 (0%) | 0/12 (0%) | |||||
Other (Not Including Serious) Adverse Events |
||||||||||
Cohort 1 | Cohort 2 | Cohort 3 | Cohort 4 | Cohort 5 | ||||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 5/12 (41.7%) | 2/12 (16.7%) | 7/12 (58.3%) | 2/12 (16.7%) | 3/12 (25%) | |||||
Cardiac disorders | ||||||||||
Tachycardia | 0/12 (0%) | 0 | 0/12 (0%) | 0 | 0/12 (0%) | 0 | 0/12 (0%) | 0 | 1/12 (8.3%) | 1 |
Gastrointestinal disorders | ||||||||||
Abdominal pain | 0/12 (0%) | 0 | 0/12 (0%) | 0 | 1/12 (8.3%) | 1 | 0/12 (0%) | 0 | 0/12 (0%) | 0 |
Diarrhoea | 0/12 (0%) | 0 | 0/12 (0%) | 0 | 1/12 (8.3%) | 1 | 0/12 (0%) | 0 | 0/12 (0%) | 0 |
Nausea | 1/12 (8.3%) | 1 | 0/12 (0%) | 0 | 0/12 (0%) | 0 | 0/12 (0%) | 0 | 0/12 (0%) | 0 |
Toothache | 0/12 (0%) | 0 | 0/12 (0%) | 0 | 1/12 (8.3%) | 1 | 0/12 (0%) | 0 | 0/12 (0%) | 0 |
Vomiting | 1/12 (8.3%) | 1 | 0/12 (0%) | 0 | 0/12 (0%) | 0 | 0/12 (0%) | 0 | 0/12 (0%) | 0 |
General disorders | ||||||||||
Injection-site reaction | 0/12 (0%) | 0 | 0/12 (0%) | 0 | 2/12 (16.7%) | 2 | 0/12 (0%) | 0 | 1/12 (8.3%) | 1 |
Vessel puncture site haematoma | 2/12 (16.7%) | 2 | 0/12 (0%) | 0 | 0/12 (0%) | 0 | 0/12 (0%) | 0 | 0/12 (0%) | 0 |
Infections and infestations | ||||||||||
Vaginal infection | 0/12 (0%) | 0 | 0/12 (0%) | 0 | 0/12 (0%) | 0 | 1/12 (8.3%) | 1 | 0/12 (0%) | 0 |
Musculoskeletal and connective tissue disorders | ||||||||||
Arthralgia | 0/12 (0%) | 0 | 0/12 (0%) | 0 | 1/12 (8.3%) | 1 | 0/12 (0%) | 0 | 0/12 (0%) | 0 |
Musculoskeletal chest pain | 0/12 (0%) | 0 | 0/12 (0%) | 0 | 1/12 (8.3%) | 1 | 0/12 (0%) | 0 | 0/12 (0%) | 0 |
Neck pain | 0/12 (0%) | 0 | 0/12 (0%) | 0 | 0/12 (0%) | 0 | 1/12 (8.3%) | 1 | 0/12 (0%) | 0 |
Nervous system disorders | ||||||||||
Headache | 3/12 (25%) | 3 | 0/12 (0%) | 0 | 1/12 (8.3%) | 1 | 0/12 (0%) | 0 | 1/12 (8.3%) | 1 |
Dysgeusia | 0/12 (0%) | 0 | 0/12 (0%) | 0 | 1/12 (8.3%) | 1 | 0/12 (0%) | 0 | 0/12 (0%) | 0 |
Presyncope | 0/12 (0%) | 0 | 1/12 (8.3%) | 1 | 0/12 (0%) | 0 | 0/12 (0%) | 0 | 0/12 (0%) | 0 |
Respiratory, thoracic and mediastinal disorders | ||||||||||
Nasal congestion | 0/12 (0%) | 0 | 0/12 (0%) | 0 | 1/12 (8.3%) | 1 | 0/12 (0%) | 0 | 0/12 (0%) | 0 |
Sinus congestion | 0/12 (0%) | 0 | 1/12 (8.3%) | 1 | 0/12 (0%) | 0 | 0/12 (0%) | 0 | 0/12 (0%) | 0 |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title | Pacira Medical Information |
---|---|
Organization | Pacira Pharmaceuticals Inc. |
Phone | 1-855-793-9727 |
MedInfo@pacira.com |
- 402-C-113