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    The EU Clinical Trials Register currently displays   37979   clinical trials with a EudraCT protocol, of which   6230   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2017-003835-12
    Sponsor's Protocol Code Number:AC17067
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2018-01-24
    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 ConcernedUK - MHRA
    A.2EudraCT number2017-003835-12
    A.3Full title of the trial
    A placebo controlled randomised trial of intravenous lidocaine in accelerating gastrointestinal recovery after colorectal surgery
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A placebo controlled randomised trial of intravenous lidocaine in accelerating gastrointestinal recovery after colorectal surgery
    A.3.2Name or abbreviated title of the trial where available
    ALLEGRO
    A.4.1Sponsor's protocol code numberAC17067
    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 SponsorThe University Of Edinburgh
    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 supportNational Institute of Health Research HTA programme
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity of Aberdeen
    B.5.2Functional name of contact pointSarah Cameron
    B.5.3 Address:
    B.5.3.1Street Address3rd floor HSB, foresterhill
    B.5.3.2Town/ cityAberdeen
    B.5.3.3Post codeAB25 2ZD
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number01224438189
    B.5.6E-mailsarah.cameron@abdn.ac.uk
    B.Sponsor: 2
    B.1.1Name of SponsorNHS Lothian
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationThe University of Aberdeen
    B.5.2Functional name of contact pointSarah Cameron
    B.5.3 Address:
    B.5.3.1Street Address3rd floor Health Sciences Building
    B.5.3.2Town/ cityAberdeen
    B.5.3.3Post codeAB25 2ZD
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number01224438189
    B.5.5Fax number01224438165
    B.5.6E-mailsarah.cameron@abdn.ac.uk
    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 No
    D.2.1.1.1Trade name Lidocaine 2%
    D.2.1.1.2Name of the Marketing Authorisation holderTayside Pharmaceuticals
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 nameLidocaine 2%
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous drip use (Noncurrent)
    Intravenous bolus use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLidocaine
    D.3.9.1CAS number 6108-05-0
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit % (W/V) percent weight/volume
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    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 injection/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
    Patients scheduled for elective colorectal resection for colorectal cancer or diverticular disease.
    E.1.1.1Medical condition in easily understood language
    Patients undergoing colorectal surgery for cancer or diverticular disease.
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10061451
    E.1.2Term Colorectal cancer
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10013534
    E.1.2Term Diverticular disease
    E.1.2System Organ Class 100000004856
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10067878
    E.1.2Term Bowel resection
    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 aim is an effectiveness analysis to measure whether intravenous lidocaine (given at time of surgery) achieves faster return of gut function for more patients after colorectal surgery. The primary outcome will be the proportion of randomised subjects compared between IV lidocaine and placebo that have achieved return of gut function at 72 hours after their surgery. This will be measured by ‘GI-3 recovery’ -an endpoint defined as achievement of both of the following two events: tolerating diet (defined as ingestion of food and drink without significant nausea or vomiting for 3 consecutive meals) and passage of flatus OR stool (whichever comes first).
    E.2.2Secondary objectives of the trial
    • to measure whether perioperative intravenous lidocaine is effective in achieving faster postoperative return of gut function measured by GI-2 recovery (defined as the time to the later of the following two events (both must be achieved): time to tolerating diet, and time to first passage of stool.
    • to detect an absolute reduction of 10% (from 20% to 10%) in the rate of Prolonged Postoperative Ileus (PPOI= failure to establish GI-3 by postoperative day 5)
    • to detect a reduction in postoperative nausea and vomiting
    • to measure any difference in analgesia requirements
    • to assess quality of postoperative recovery using multi-dimensional patient-reported outcome tools and quality of life tools, as well as assessing time to medically-defined and patient-defined readiness for discharge from hospital
    • To measure the impact on recovery of variation in perioperative care from Enhanced Recovery after Surgery guidelines
    • To assess whether perioperative intravenous lidocaine during colore
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients scheduled for elective colorectal resection for colorectal cancer or diverticular disease at participating UK colorectal surgery units.
    Right hemicolectomy, extended right hemicolectomy, left colectomy, sigmoid colectomy, subtotal colectomy with ileosigmoid or ileorectal anastomosis and high anterior resection are eligible
    E.4Principal exclusion criteria
    Planned epidural anaesthesia
    Planned regional or local infiltration of lidocaine at the same time as lidocaine infusion
    Current pregnancy or breast feeding
    Age <18 years
    Patients lacking capacity to give informed consent.
    Known or suspected allergy to lidocaine or amide-type local anaesthetics
    Current complete heart block
    Current severe liver dysfunction (Child’s A or greater)
    Current renal failure (eGFR<30)
    Patients participating in the active intervention phase of another therapeutic clinical trial (or other interventional trial) unless a co-enrollment agreement is in place
    Patients having surgery for indications other than colorectal cancer/diverticular disease
    Rectal cancer below the peritoneal reflection in which total mesorectal excision is anticipated
    Rectal cancer patients who have received any neoadjuvant radiotherapy
    A preoperative surgical plan to form any new stoma during the primary procedure
    E.5 End points
    E.5.1Primary end point(s)
    The primary outcome will be the proportion of randomised subjects compared between IV lidocaine and placebo that have achieved return of gut function at 72 hours postoperatively.
    E.5.1.1Timepoint(s) of evaluation of this end point
    72 hours
    E.5.2Secondary end point(s)
    Time to return of gut function using the GI-3 recovery definition (a composite endpoint defined as time from surgery to the later time to establish both of the following two events: time to tolerating diet without significant nausea or vomiting for 3 consecutive meals and time to first passage of flatus or stool)
    time from start of operation to event

    Time to return of gut function using the GI-2 recovery definition (a composite endpoint defined as time from surgery to the later time to establish both of the following two events: tolerating solid food without significant nausea or vomiting for 3 consecutive meals and first passage of stool)
    a) Yes/No outcome at 96 hours after start of operation; b) time to event
    proportion of participants achieving GI-2 recovery at 96 hours;
    96 hours after start of operation

    Prolonged Postoperative Ileus (PPOI= failure to establish GI-3 by 120 hours after surgery (postoperative day 5))
    Measurement variable: GI-3 recovery 120 hours after start of operation

    Nausea and vomiting
    Measurement variables: daily PONV score; number of episodes of vomiting/day (defined as episodes of expulsion of gastric content); total dosage of rescue antiemetic
    PONV questionnaire: total number episodes vomiting within 72 hours of operation; total dose rescue antiemetic within 72 hours of operation
    daily until 72 hours after start of operation

    Quality of analgesia
    Measured by OBAS score daily in-hospital up to and including postoperative day 7.

    Total postoperative opioid consumption
    morphine equivalent doses, cumulative total until 72 hours after start of operation

    Quality of Recovery
    Quality of recovery score (15-question patient-reported outcome measure) daily while in hospital until discharge; also days 7 and 30 by post


    Quality of life assessment- EQ-5D daily in hospital, day 7, 30 days and 90 days after date of surgery

    Measurement of specific enhanced recovery guideline variables that have been shown to impact GI recovery
    Enhanced Recovery After Surgery protocol compliance measured by recording specific variables relevant to return of gut function. These are:
    Avoidance of long-acting opioids for maintaining anaesthesia
    Prescribed PONV prophylaxis for 48 hours
    Restrictive IV fluid policy- aiming for euvolaemia, assessed by total IV fluid administration in 24 hours from start of anaesthesia and measuring patient weight pre- and 24 hours post op.
    Early feeding- carbohydrate supplement drink on day of surgery and solid food from postoperative day 1 onwards
    Early mobilisation- patients should be out of bed for 2 hours on day of surgery and 4-6 hours every day thereafter AND walking
    Routine postoperative laxative prescription
    No NGT immediately after surgery

    Time to achievement of medical criteria for discharge
    Time (days) to meeting medically-defined hospital discharge criteria (independent hydration/nutrition, adequate analgesia by oral route, independent mobilisation, return of gut function by GI-3 definition, no medical contraindication)
    time to event (days)

    Patient-reported assessment of readiness for discharge
    Time (days) to patient-reported readiness for discharge (must also have achieved medical criteria for discharge as noted above)- assessed daily from day 2 onward

    Tertiary Endpoints:
    Total length of hospital stay
    Complications/ safety analysis
    Record linkage analysis of survival

    E.5.2.1Timepoint(s) of evaluation of this end point
    up to 90 days
    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 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 concerned14
    E.8.5The trial involves multiple Member States No
    E.8.5.1Number of sites anticipated in the EEA14
    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
    The end of the study is the last clinical follow-up which is defined as the last participants last clinical data collection (day 90)
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days1
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months11
    E.8.9.2In all countries concerned by the trial days9
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    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) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 187
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 561
    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 state748
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 748
    F.4.2.2In the whole clinical trial 748
    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)
    Patients receive a one off dose of Lidocaine/placebo. Participants will have further clinical treatment/ surgery as required as per any other NHS patient.
    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 Decision2018-03-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-10-09
    P. End of Trial
    P.End of Trial StatusOngoing
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
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