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    Summary
    EudraCT Number:2013-000875-33
    Sponsor's Protocol Code Number:PLATA
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2013-07-24
    Trial 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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2013-000875-33
    A.3Full title of the trial
    Prevention of Phantom Limb Pain After Transtibial Amputation (PLATA) - Randomized, double-blind, controlled, multi-center trial comparing Optimized intravenous pain control vs Optimized intravenous pain control plus Regional anesthesia
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Comparative study of two anesthetic techniques to prevent phantom pain after leg amputation
    A.3.2Name or abbreviated title of the trial where available
    PLATA
    A.4.1Sponsor's protocol code numberPLATA
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01626755
    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 SponsorAcademic Medical Center, University of Amsterdam
    B.1.3.4CountryNetherlands
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportEuropean Society of Anaesthesiology
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAcademic Medical Center
    B.5.2Functional name of contact pointDept. of Anesthesiology, Philipp Li
    B.5.3 Address:
    B.5.3.1Street AddressMeibergdreef 9
    B.5.3.2Town/ cityAmsterdam
    B.5.3.3Post code1105AZ
    B.5.3.4CountryNetherlands
    B.5.4Telephone number31205662533
    B.5.5Fax number31206979441
    B.5.6E-mailp.lirk@amc.uva.nl
    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 Bupivacaine
    D.2.1.1.2Name of the Marketing Authorisation holderAstra Zeneca
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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 nameBupivacaine
    D.3.4Pharmaceutical form Injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPPerineural use
    Route of administration not applicable
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNBupivacaine
    D.3.9.3Other descriptive nameBUPIVACAINE HYDROCHLORIDE
    D.3.9.4EV Substance CodeSUB00902MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number50 to 250
    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 placeboInjection
    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
    Phantom limb pain following amputation of the lower leg due to critical limb ischemia.
    E.1.1.1Medical condition in easily understood language
    Phantom limb pain following amputation of the lower leg because of vascular disease and subsequent insufficient blood flow
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10004227
    E.1.2Term Below knee amputation
    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 aim of this study is to test the hypothesis that a combination of optimized intravenous pain therapy and continuous sciatic nerve block decreases the point prevalence of phantom limb pain 12 months after transtibial amputation for peripheral vascular disease when compared to optimized intravenous pain therapy alone.
    E.2.2Secondary objectives of the trial
    Secondary objectives are to determine the Quality of Life of patients following amputation, and the Genotype of patients . Gene haplotype will be assayed for association with acute to chronic pain conversion using single nucleotide polymorphisms (SNPs) from known risk factor genes.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients undergoing elective transtibial amputation for peripheral vascular disease, age over 18 years, ASA* status II to IV.
    *ASA American Society of Anesthesiology.
    E.4Principal exclusion criteria
    - contraindication to peripheral regional anesthesia
    - confirmed allergy to local anesthetics
    - prior amputation resulting in current phantom limb pain
    - severe psychiatric disease
    - pregnancy or breastfeeding status
    - amputation for tumour surgery
    - traumatic amputation and
    - inability to give written and informed consent.
    E.5 End points
    E.5.1Primary end point(s)
    Point prevalence of phantom limb pain 12 months postoperatively
    defined as
    - Pain in the amputated area of the limb with a corresponding NRS score of ≥ 2 during the preceding 4 weeks (constant or at least three episodes) OR
    - Ingestion of drugs administered specifically to treat phantom limb pain during the preceding 4 weeks (classified as none, non-opiate, weak opiate, strong opiate, antidepressant, anticonvulsant, other).
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 months following amputation.
    E.5.2Secondary end point(s)
    - Quality of life assessed using the SF-12v2 Short form 12
    - Pain characterization using the McGill short Pain Questionnaire
    - Employment status (yes/no)
    - Incidence of stump pain
    - Vascular preoperative status
    - SIGAM mobility scale
    - Inventarization of rehabilitation methods applied during follow-up
    - Inventarization of drugs used to treat phantom limb pain
    - Incidence of reamputation and surgical complications
    - Intensity of postoperative pain and phantom limb pain assessed using the NRS scale twice daily at 08:00 and 20:00 during the first 7 days postoperatively
    - Overall Benefit of Analgesia Score (OBAS), determined daily at 20:00 from the day preceding surgery, until 7 days postoperatively
    - Recording of surgical handling of nerves / surgical technique
    - Genetic profile determined at end of study with blood drawn preoperatively
    E.5.2.1Timepoint(s) of evaluation of this end point
    Before surgery, during the first week after surgery, and after 1, 6, and 12 months.
    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 No
    E.6.5Efficacy No
    E.6.6Pharmacokinetic No
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    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 EEA20
    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
    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
    The end of the trials is defined as the last follow-up visit of the last patient one year after amputation.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months0
    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: 100
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 300
    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.4.1In the member state80
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 340
    F.4.2.2In the whole clinical trial 400
    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)
    The treatment plans investigated (perioperative analgesia using two techniques) are routine clinical practice in all participating sites, and have been tested in clinical trials multiple times. This is the first study investigating their efficacy in preventing Phantom limb pain. The treatment or care after perioperative analgesic treatment has been finished is not different from the normal treatment for this condition.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation European Society of Anaesthesiology (ESA)
    G.4.3.4Network Country Belgium
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2013-08-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-07-19
    P. End of Trial
    P.End of Trial StatusOngoing
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