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    Summary
    EudraCT Number:2020-005985-33
    Sponsor's Protocol Code Number:402-C-319
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2020-12-16
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    H.4 THIRD COUNTRY IN WHICH THE TRIAL WAS FIRST AUTHORISED
    Expand All   Collapse All
    A. Protocol Information
    A.2EudraCT number2020-005985-33
    A.3Full title of the trial
    A Multicenter Study to Evaluate the Pharmacokinetics and Safety of
    EXPAREL for Postsurgical Analgesia in Pediatric Subjects Aged 6 to Less
    Than 17 Years
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Multicenter Study to Evaluate the Pharmacokinetics and Safety of
    EXPAREL for Postsurgical Analgesia in Pediatric Subjects Aged 6 to Less
    Than 17 Years
    A.3.2Name or abbreviated title of the trial where available
    Multicenter Study for Pediatric Subjects Evaluating Pharmacokinetics and Safety of EXPAREL (PLAY)
    A.4.1Sponsor's protocol code number402-C-319
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03682302
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/036/2020
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorPacira Pharmaceuticals, Inc.
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportPacira Pharmaceuticals, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPacira Pharmaceuticals, Inc.
    B.5.2Functional name of contact pointJennifer Gordon
    B.5.3 Address:
    B.5.3.1Street Address5 Sylvan Way
    B.5.3.2Town/ cityParsippany
    B.5.3.3Post code07054
    B.5.3.4CountryUnited States
    B.5.6E-mailjennifer.gordon@pacira.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name EXPAREL
    D.2.1.1.2Name of the Marketing Authorisation holderPacira Pharmaceuticals, Inc.
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Prolonged-release solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPInfiltration
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Postsurgical pain
    E.1.1.1Medical condition in easily understood language
    pain after surgery
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective is to evaluate the pharmacokinetics (PK) of EXPAREL in pediatric
    subjects aged 6 to less than 17 years undergoing surgery.
    E.2.2Secondary objectives of the trial
    The secondary objective is to evaluate the safety of EXPAREL in pediatric subjects aged 6 to
    less than 17 years undergoing surgery.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Male or female subjects 6 to less than 17 years of age on the day of surgery.
    Body mass index (BMI) at screening within the 5th to 95th percentile for age and sex.
    E.4Principal exclusion criteria
    - Contraindication to bupivacaine HCl or other amide-type local anesthetics or to opioid medication.
    - Administration of EXPAREL or bupivacaine HCl within 30 days prior to study drug
    administration.
    - Subjects with coagulopathies or immunodeficiency disorders.
    - History of, suspected, or known addiction to or abuse of drugs or alcohol within the past 2 years.
    E.5 End points
    E.5.1Primary end point(s)
    The following PK parameters were determined:
    a. Area under the plasma concentration-versus-time curve (AUC)
    b. Maximum plasma concentration (Cmax)
    c. The apparent terminal elimination half-life (t1/2el)
    d. Apparent clearance (CL/F)
    e. Apparent volume of distribution (Vd/F)
    E.5.1.1Timepoint(s) of evaluation of this end point
    a. 15, 30, 45 min, 1-1.25h, 2-4h, 10-18h, 24-36h, 42-60h (spine
    surgery) or 15, 30, 45 min, 1-1.25, 15-25, 30-40, 45-55, 64-72h
    (cardiac surgery)
    b. 15, 30, 45 min, 1-1.25h, 2-4h, 10-18h, 24-36h, 42-60h (spine
    surgery) or 15, 30, 45 min, 1-1.25, 15-25, 30-40, 45-55, 64-72h
    (cardiac surgery)
    c. 15, 30, 45 min, 1-1.25h, 2-4h, 10-18h, 24-36h, 42-60h (spine
    surgery) or 15, 30, 45 min, 1-1.25, 15-25, 30-40, 45-55, 64-72h
    (cardiac surgery)
    d. 15, 30, 45 min, 1-1.25h, 2-4h, 10-18h, 24-36h, 42-60h (spine
    surgery) or 15, 30, 45 min, 1-1.25, 15-25, 30-40, 45-55, 64-72h
    (cardiac surgery)
    e. 15, 30, 45 min, 1-1.25h, 2-4h, 10-18h, 24-36h, 42-60h (spine
    surgery) or 15, 30, 45 min, 1-1.25, 15-25, 30-40, 45-55, 64-72h
    (cardiac surgery)
    E.5.2Secondary end point(s)
    a. Vital signs (temperature, resting heart rate, respiratory rate, oxygen
    saturation, and blood
    pressure)
    b. Neurological assessment
    c. Clinical laboratory tests (hematology, chemistry, and urinalysis)
    E.5.2.1Timepoint(s) of evaluation of this end point
    a. screening; upon arrival in the post-anesthesia care unit (PACU); at
    2, 4, 8, 12,
    24, 36, 48, 60, 72, and 96 hours after the end of study drug
    administration; at hospital discharge; and on Day 30
    b. at 2, 4, 8, 12, 24, 36, 48, 60, 72, and 96 hours after the end of study
    drug administration; at hospital discharge; and on Day 30
    c. at screening; at baseline
    (on Day 1 prior to surgery) and at 96 hours after the end of study drug
    administration
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy No
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial4
    E.8.3 Will this trial be conducted at a single site globally? No
    E.8.4 Will this trial be conducted at multiple sites globally? Yes
    E.8.6 Trial involving sites outside the EEA
    E.8.6.2Trial being conducted completely outside of the EEA Yes
    E.8.6.3Specify the countries outside of the EEA in which trial sites are planned
    United States
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    Day 30 visit
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.2In all countries concerned by the trial days60
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 95
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 36
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 61
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 90
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None
    G. Investigator Networks to be involved in the Trial
    H.4 Third Country in which the Trial was first authorised
    H.4.1Third Country in which the trial was first authorised: United States
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