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    Summary
    EudraCT Number:2014-003466-25
    Sponsor's Protocol Code Number:13.024
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2014-10-07
    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 ConcernedDenmark - DHMA
    A.2EudraCT number2014-003466-25
    A.3Full title of the trial
    Randomized, double-blind, prospective, placebo-controlled trial of the effect of intravenous lidocaine infusion for postoperative pain management and bowel function in robot assisted laparoscopic colon surgery.
    Randomiseret, dobbeltblindet, prospektivt, placebo-kontrolleret undersøgelse af effekten af intravenøs lidokain infusion for postoperativ smertebehandling og tarmfunktion ved robot-assisteret laparoskopisk colonkirurgi.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Randomized, double-blind, prospective, placebo-controlled trial of the effect of intravenous lidocaine infusion for postoperative pain management and bowel function in robot assisted laparoscopic colon surgery.
    A.4.1Sponsor's protocol code number13.024
    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 SponsorAnders Gadegaard Jensen,Anesthesia and Intensive Care Unit, Odense University Hospital
    B.1.3.4CountryDenmark
    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 supportAnesthesia and Intensive Care Unit, Odense University Hospital
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationJan Herzog,Anesthesia and Intensive Care Unit, Odense University Hospital
    B.5.2Functional name of contact pointJan Herzog
    B.5.3 Address:
    B.5.3.1Street AddressSøndre Boulevard 29
    B.5.3.2Town/ cityOdense
    B.5.3.3Post code5000
    B.5.3.4CountryDenmark
    B.5.4Telephone number004560709164
    B.5.6E-mailjan.herzog@rsyd.dk
    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 Lidocain SAD
    D.2.1.1.2Name of the Marketing Authorisation holderAmgros I/S, Denmark
    D.2.1.2Country which granted the Marketing AuthorisationDenmark
    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 nameLidocain SAD
    D.3.2Product code 6730
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLIDOCAINE HYDROCHLORIDE
    D.3.9.1CAS number 137-58-6
    D.3.9.2Current sponsor codeAmgros A/S
    D.3.9.3Other descriptive nameLidokain SAD
    D.3.9.4EV Substance CodeSUB88133
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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 placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Postoperative pain after colon rectal cancer surgery are mainly intended to relieve as well resting as activity-induced pain. Secondarily, the choice of pain management should take into consideration how to ensure the earliest possible mobilization and rapid fluid and food intake. There are now some evidence in laparoscopic gastrointestinal surgery that supports that perioperative infusion of lidocaine intravenously can reduce opioid consumption and length of postoperative ileus.
    E.1.1.1Medical condition in easily understood language
    Pain after colon rectal cancer surgery is common. By this experiment we wish to provide better pain relief by providing a local anesthetic(lidocaine) in a vein during colon rectal cancer surgery.
    E.1.1.2Therapeutic area Diseases [C] - Digestive System Diseases [C06]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.1
    E.1.2Level LLT
    E.1.2Classification code 10018017
    E.1.2Term Gastrointestinal tract cancer NOS
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The main purpose of the trial is to investigate whether intravenous lidocaine administered perioperatively can significantly reduce postoperative morphine consumption during the first 24 hours postoperatively by robot-assisted laparoscopic colon rectal cancer surgery.
    E.2.2Secondary objectives of the trial
    Secondarily, we will examine whether this administration also significantly reduces morphine consumption up to 72 hours and reduces the duration of post-operative gastrointestinal dysfunction including reducing the incidence of post-operative nausea and vomiting as compared to placebo.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients undergoing robotic assisted laparoscopic colon rectal cancer surgery and giving their informed consent to participate in the trial. Age ≥ 18years of age. Danish-speaking patient.
    E.4Principal exclusion criteria
    Known hypersensitivity to the drug or local anesthetics of the amide type
    AV block
    Hepatic or renal impairment (ALT, AST, Bili> 2.5 x upper limit and CrCl <60ml / min)
    Durable consumption of opioids and NSAIDs
    Pregnancy or women of childbearing age without adequate contraception, breastfeeding women.Pregnancy test must be negative.
    Treatment with beta blockers
    Patients with known porphyria
    E.5 End points
    E.5.1Primary end point(s)
    Reduction in pain intensity after the operation in terms of reduction in morphine consumption during the first 24 hours postoperatively.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The first 24 hours postoperatively for each patient included in the trial.
    E.5.2Secondary end point(s)
    Reduction in numerical rating scale (NRS), compared to placebo.
    Reduction in the duration of postoperative gastrointestinal dysfunction including a reduction in the consumption of anti-emetic therapy, as well as reduction in morphine consumption up to 72 hours postoperatively.
    Incidence of adverse reactions to the study drug are also recorded, if present.
    E.5.2.1Timepoint(s) of evaluation of this end point
    72 hours postoperatively for each patient included in the trial.
    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 Yes
    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) 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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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
    60 patients for robotic assisted laparoscopic colon rectal cancer surgery are to be included in the trial. The trial will be completed when the calculated number of patients are included and followed up in 72 hours. The trial also be terminated if new, unexpected knowledge that make it dangerous to participate in the trial turns out.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    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: 30
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 30
    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 state60
    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
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2014-11-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-12-18
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-05-01
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