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    Summary
    EudraCT Number:2020-000154-10
    Sponsor's Protocol Code Number:SOC.12/19-20
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:GB - no longer in EU/EEA
    Date on which this record was first entered in the EudraCT database:2020-08-19
    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 ConcernedUK - MHRA
    A.2EudraCT number2020-000154-10
    A.3Full title of the trial
    Paramedic Analgesia Comparing Ketamine and MorphiNe in trauma
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Paramedic given pain relief comparing the use of ketamine and morphine in trauma
    A.3.2Name or abbreviated title of the trial where available
    PACKMaN
    A.4.1Sponsor's protocol code numberSOC.12/19-20
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberISRCTN14124474
    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 SponsorUniversity of Warwick
    B.1.3.4CountryUnited Kingdom
    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 supportNIHR Evaluation, Trials and Studies Coordinating Centre (NETSCC)
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity of Warwick Clinical Trials Unit
    B.5.2Functional name of contact pointTrial Manager
    B.5.3 Address:
    B.5.3.1Street AddressWMS Clinical Trials Unit
    B.5.3.2Town/ cityCoventry
    B.5.3.3Post codeCV4 7AL
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number02476150478
    B.5.6E-mailpackman@warwick.ac.uk
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleComparator
    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 No
    D.2.1.1.1Trade name Ketamine
    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 nameKetamine
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntraosseous use
    Intravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNKetamine hydrochloride
    D.3.9.1CAS number 1867-66-9
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number15
    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.IMP: 2
    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 No
    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 nameMorphine sulfate
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntraosseous use
    Intravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMorphine sulphate
    D.3.9.1CAS number 6211-15-0
    D.3.9.4EV Substance CodeAS2
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Severe pain after traumatic injury
    E.1.1.1Medical condition in easily understood language
    Severe pain after traumatic injury
    E.1.1.2Therapeutic area Diseases [C] - Injuries, poisonings, and occupational diseases [C21]
    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 of this trial is to determine whether paramedic administered ketamine or morphine provides more effective pain relief for patients reporting severe pain following trauma. This will be measured by using a 0-10 numeric rating scale and the Sum of Pain Intensity Difference (SPID).
    E.2.2Secondary objectives of the trial
    Secondary objectives of the trial are to assess the effects of the paramedic administered ketamine and morphine on patient outcomes up to 6 months post injury. Specifically on overall pain relief and patient experience, including tolerability and longer term outcomes. We will review the resource used and cost effectiveness of each drug.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Age 16 years or over
    - Patient reports a pain score ≥7/10 on a 0-10 NRS following acute traumatic injury
    - Intravenous or intraosseous access obtained
    - Determined by a paramedic to require IV morphine or equivalent
    E.4Principal exclusion criteria
    - Known or suspected pregnancy
    - Unable to articulate severity of pain using the 0-10 NRS
    - Lack of capacity due to a reason other than pain
    - Ketamine or opioid analgesia prior to randomisation
    - Known contraindication to either ketamine or morphine as per the SmPC
    - Patient declines participation
    - Known prisoner
    E.5 End points
    E.5.1Primary end point(s)
    Effectiveness of pain relief from randomisation to arrival at hospital as measured by Sum of Pain Intensity Difference (SPID) score (using a 0-10 numerical rating scale).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Following arrival at hospital.
    E.5.2Secondary end point(s)
    Effectiveness of pain relief and overall patient experience from randomisation to arrival at hospital
    - Total Pain Relief (TOTPAR) score
    - Time to perceptible analgesia
    - Time to meaningful analgesia
    - Time to peak analgesia
    - Duration of analgesia
    - Requirement for rescue analgesia
    - Proportion of patients with a pain intensity score below 4/10 (0-10 numerical rating scale (NRS)) on arrival at hospital
    - Vital signs (oxygen saturation, blood pressure, heart rate, respiration rate, Glasgow Coma Scale)
    - Patient Global Impression of Change on arrival at hospital

    Incidence of side effects and adverse events
    - Airway: vomiting, aspiration, advanced airway management
    - Respiratory: desaturation, need for ventilatory support
    - Cardiovascular: arrhythmia, hypotension and hypertension
    - Neurologic: sedation, excitatory movements, adverse behavioural reactions
    - Other: nausea, allergic reaction

    Resource use
    - Ambulance job cycle time (scene arrival to arrival at hospital)
    - Number of ambulance resources (technicians, paramedics, doctors and vehicles) in attendance
    - Cumulative IMP doses administered
    - CT scan use
    - Hospital or ICU admission
    - Length of stay ED, ICU, Hospital

    Longer term outcomes
    - Chronic pain using BPI-SF at 3 & 6 months from randomisation
    - Health-related quality of life EQ-5D-5L and CSRI at 3 and 6 months from randomisation
    - Cost-effectiveness expressed in terms of incremental cost per quality-adjusted life year (QALY) gained using EQ-5D 5L and CSRI (at 3 and 6 months post randomisation)
    E.5.2.1Timepoint(s) of evaluation of this end point
    After the 6 month follow up.
    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 Yes
    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) 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 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 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 concerned2
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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
    End of collection of secondary outcome data.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months9
    E.8.9.1In the Member State concerned days31
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months9
    E.8.9.2In all countries concerned by the trial days31
    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: 100
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 100
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 246
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 100
    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 No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation Yes
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Participants will lack the capacity to consent prior to the IMP being administered due to severe pain.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state446
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 446
    F.4.2.2In the whole clinical trial 446
    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)
    Morphine is currently used routinely in this patient population, ketamine is available to prehospital doctors and specialist paramedics already. If the use of ketamine is found to be beneficial then we hope the use of ketamine would become more widespread.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2020-10-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-10-14
    P. End of Trial
    P.End of Trial StatusGB - no longer in EU/EEA
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