Safety and Pharmacokinetics Study of Redosing EXPAREL in Healthy Volunteers

Sponsor
Pacira Pharmaceuticals, Inc (Industry)
Overall Status
Completed
CT.gov ID
NCT02210247
Collaborator
(none)
60
1
5
1
58.9

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

Study Type:
Interventional
Actual Enrollment :
60 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
An Open-Label Cohort Study to Evaluate the Safety and Pharmacokinetics of Redosing EXPAREL Via Local Subcutaneous Infiltration in Healthy Volunteers
Study Start Date :
Aug 1, 2014
Actual Primary Completion Date :
Sep 1, 2014
Actual Study Completion Date :
Sep 1, 2014

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:
  • bupivacaine liposome injectable suspension
  • 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:
  • bupivacaine liposome injectable suspension
  • 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:
  • bupivacaine liposome injectable suspension
  • 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:
  • bupivacaine liposome injectable suspension
  • 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:
  • bupivacaine liposome injectable suspension
  • Outcome Measures

    Primary Outcome Measures

    1. 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]

    2. 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]

    3. 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]

    4. 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]

    5. 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

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.
    Responsible Party:
    Pacira Pharmaceuticals, Inc
    ClinicalTrials.gov Identifier:
    NCT02210247
    Other Study ID Numbers:
    • 402-C-113
    First Posted:
    Aug 6, 2014
    Last Update Posted:
    Jul 6, 2021
    Last Verified:
    Jul 1, 2021
    Additional relevant MeSH terms:

    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

    1. Primary Outcome
    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)
    2. Primary Outcome
    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
    3. Primary Outcome
    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)
    4. Primary Outcome
    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)
    5. Primary Outcome
    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

    [Not Specified]

    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
    Email MedInfo@pacira.com
    Responsible Party:
    Pacira Pharmaceuticals, Inc
    ClinicalTrials.gov Identifier:
    NCT02210247
    Other Study ID Numbers:
    • 402-C-113
    First Posted:
    Aug 6, 2014
    Last Update Posted:
    Jul 6, 2021
    Last Verified:
    Jul 1, 2021