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    Summary
    EudraCT Number:2012-003275-19
    Sponsor's Protocol Code Number:402-C-322
    National Competent Authority:Czechia - SUKL
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-11-19
    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
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedCzechia - SUKL
    A.2EudraCT number2012-003275-19
    A.3Full title of the trial
    A Phase 3, Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Assess the Efficacy and Safety of Intercostal Nerve Block with Liposome Bupivacaine in Subjects Undergoing Posterolateral Thoracotomy
    Multicentrické, randomizované, dvojitě slepé, placebem kontrolované klinické hodnocení paralelních skupin, fáze III, hodnotící účinnost a bezpečnost mezižeberní blokády nervů přípravkem lipozomální bupivakain u subjektů, které podstupují posterolaterální torakotomii.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A randomized, double-blind, placebo-controlled study to test the effect of liposome bupivacaine on postsurgical pain control following posterolateral thoracotomy chest surgery
    A.4.1Sponsor's protocol code number402-C-322
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    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 pointClinical Operations
    B.5.3 Address:
    B.5.3.1Street Address10450 Science Center Drive
    B.5.3.2Town/ citySan Diego, CA
    B.5.3.3Post code92121
    B.5.3.4CountryUnited States
    B.5.4Telephone number+ 1858625-2424
    B.5.5Fax number+1858625-0804
    B.5.6E-mailclinops@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., San Diego, California
    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.3.1Product nameLiposome Bupivacaine
    D.3.4Pharmaceutical form Suspension for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPPerineural use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNBUPIVACAINE
    D.3.9.1CAS number 38396-39-3
    D.3.9.2Current sponsor codeSKY0402
    D.3.9.4EV Substance CodeSUB05983MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number13.3
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for infusion
    D.8.4Route of administration of the placeboPerineural use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Intercostal Nerve Block for Posterolateral Thoracotomy
    E.1.1.1Medical condition in easily understood language
    Local anaesthesia for chest surgery with incision in the submammary fold, below the tip of the scapula
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10038286
    E.1.2Term Regional nerve block
    E.1.2System Organ Class 100000004865
    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 efficacy of intercostal nerve block using liposome bupivacaine compared with placebo in subjects undergoing posterolateral thoracotomy.
    E.2.2Secondary objectives of the trial
    The secondary objectives are to evaluate additional efficacy parameters, assess the PK profile of liposome bupivacaine when administered as an intercostal nerve block, and further characterize the safety profile of liposome bupivacaine.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female, ≥18 years of age.
    2. Scheduled to undergo a thoracotomy of at least 3 inches (7.6 cm) of intercostal incisional length or
    requiring insertion of an inter-rib spreader/retractor for a primary thoracic non-infectious indication
    under general anesthesia.
    3. American Society of Anesthesiologists (ASA) Physical Status 1 - 3.
    4. Able to provide informed consent, adhere to the study visit schedule, and complete all study
    assessments.
    5. Able to demonstrate sensory function by exhibiting sensitivity to cold anywhere within the dermatomes
    supplied by any of the nerves to which study drug will be administered
    E.4Principal exclusion criteria
    1. Currently pregnant, nursing, or planning to become pregnant during the study or within 1 month after
    study drug administration. Female subjects must be surgically sterile, at least 2 years menopausal, or
    using an acceptable method of birth control. If of childbearing potential, must have a documented
    negative pregnancy test within 24 hours before surgery.
    2. Any planned pleurodesis as part of the surgical procedure.
    3. Use of any of the following medications within the times specified before surgery: long-acting opioid
    medication, NSAID, or aspirin (except for low-dose aspirin used for cardioprotection) within 3 days and
    any opioid medication within 24 hours.
    4. Use of selective serotonin reuptake inhibitors (SSRIs), gabapentin, pregabalin (Lyrica®), or duloxetine
    (Cymbalta®) within 3 days of surgery.
    5. Concurrent painful physical condition or concurrent surgery that may require analgesic treatment
    (such as an NSAID or opioid) in the postsurgical period for pain that is not strictly related to the surgery,
    and which may confound the postsurgical assessments (e.g., cancer pain, chronic neuropathic pain,
    concurrent abdominal surgery).
    6. Current use of systemic glucocorticosteroids within 1 month of enrollment.
    7. Body weight < 50 kilograms (110 pounds) or a body mass index ≥ 35 kg/m2.
    8. Contraindication to any of the pain-control agents planned for surgical or postsurgical use (i.e., fentanyl,
    morphine, hydromorphone, oxycodone, or bupivacaine).
    9. Administration of an investigational drug within 30 days or 5 elimination half-lives of such
    investigational drug, whichever is longer, prior to study drug administration, or planned administration
    of another investigational product or procedure during the subject’s participation in this study.
    10. Previous participation in a liposome bupivacaine study.
    11. History of, suspected, or known addiction to or abuse of illicit drug(s), prescription medicine(s),
    or alcohol within the past 2 years.
    12. Uncontrolled anxiety, schizophrenia, or other psychiatric disorder that, in the opinion of the Investigator,
    could interfere with study assessments or compliance.
    13. Current or historical evidence of any clinically significant disease or condition, especially cardiovascular
    or neurological conditions that, in the opinion of the Investigator, may increase the risk of surgery or
    complicate the subject’s postsurgical course or interfere with the determination of pain intensity related
    solely to the surgery.
    14. Significant medical conditions (including widely disseminated metastatic disease) or laboratory results
    that, in the opinion of the Investigator, indicate an increased vulnerability to study drugs and procedures.
    15. Subjects who are planned to receive Entereg® (alvimopan).
    16. Subjects who will receive prophylactic antiemetics or planned postsurgical antiemetics given without
    regard to the subject's emesis needs.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint is the area under the plasma concentration-time curve (AUC) of the NRS-R pain intensity scores through 72 hours.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Through 72 hours
    E.5.2Secondary end point(s)
    • Total postsurgical opioid consumption (in mg) through 72 hours.
    • Time to first opioid rescue.
    E.5.2.1Timepoint(s) of evaluation of this end point
    - Through 72 hours
    - Time to first opioid rescue.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    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) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA11
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Bulgaria
    Czech Republic
    Georgia
    Poland
    United States
    E.8.7Trial has a data monitoring committee No
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months7
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months7
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    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) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 120
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 60
    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 Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    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.4.1In the member state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 140
    F.4.2.2In the whole clinical trial 180
    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)
    Standard of care
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2013-01-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-11-21
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-06-20
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