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    Summary
    EudraCT Number:2016-002210-46
    Sponsor's Protocol Code Number:LiSA
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2016-07-28
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2016-002210-46
    A.3Full title of the trial
    Study: Reduces intravenous lidocaine the need for alfentanyl during colonoscopy under Procedural Sedation and Analgesia?
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Reduces intravenous lidocaine the need for alfentanyl during colonoscopy under Procedural Sedation and Analgesia?
    A.4.1Sponsor's protocol code numberLiSA
    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 Medical Centre RadboudUMC
    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 supportRadboudUMC
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationRadboudUMC
    B.5.2Functional name of contact pointTwan Aalbers
    B.5.3 Address:
    B.5.3.1Street AddressGeert Grooteplein zuid 10
    B.5.3.2Town/ citynijmegen
    B.5.3.3Post code6525 GA
    B.5.3.4CountryNetherlands
    B.5.4Telephone number0031243614406
    B.5.6E-mailtwan.aalbers@radboudumc.nl
    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 Yes
    D.2.1.1.1Trade name Lidocaïnehydrochloride 10 mg/ml
    D.2.1.1.2Name of the Marketing Authorisation holderFresenius Kabi Nederland BV
    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 nameLidocaine
    D.3.2Product code RVG 51673
    D.3.4Pharmaceutical form Infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous bolus use (Noncurrent)
    Intravenous use
    Auricular use
    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 placeboInfusion
    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 with IBD, between 18 and 65 years, which are scheduled for a colonoscopy with PSA.
    E.1.1.1Medical condition in easily understood language
    patients with IBD, between 18 and 65 years, which are scheduled for a colonoscopy with PSA.
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
    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
    te evaluate whether continuous infusion of lidocaïne reduces the need for alfentanyl in diagnostic colonoscopy in patients with Crohn disease or ulcerative colitis.
    E.2.2Secondary objectives of the trial
    To evaluate the differences in side effects like respiratory depression, hypotension, postoperative nausea and vomiting (PONV) and post procedural pain between placebo and intravenous lidocaïne.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Colonoscopy performed under PSA
    Age 18-65 years
    Inflammatory bowel disease: Crohn’s disease or ulcerative colitis
    Informed consent
    ASA classification 1 or 2
    E.4Principal exclusion criteria
    Pregnancy.
    Emergency colonoscopy.
    Known allergies for study medication
    Known rhythm disorders i.e. second or third degree AV block
    BMI >35
    Obstructive sleep apnea syndrome
    Uncontrolled hypertension
    E.5 End points
    E.5.1Primary end point(s)
    The primary objective of this study is to evaluate whether intravenously lidocaine reduces the need for alfentanyl during colonoscopy in patients with IBD
    E.5.1.1Timepoint(s) of evaluation of this end point
    postprocedural
    E.5.2Secondary end point(s)
    Incidence of hypotension (a mean arterial pressure (MAP < 60 mmHg), is recorded as an adverse event if an intervention is performed to improve the blood pressure.
    These interventions include administration of:
    - IV Fluid challenge
    - Medications
    Incidence of oxygen desaturation (<92%), is recorded as an adverse event if an intervention is performed to improve the oxygen saturation.
    These interventions include the following:
    - Vigorous tactile stimulation
    - Airway repositioning
    - Suctioning
    - Increased oxygen delivery
    - Oral or nasal airway placement
    - Application of positive pressure or ventilation with bag mask
    Incidence of unpleasant recall of the procedure.
    Postprocedural NRS
    Incidence of PONV
    Incidence of adverse effects of lidocaine:
    light headedness, tinnitus, dizziness, blurred vision or double vision, metal taste.
    Total propofol dose
    Colonoscopy time
    E.5.2.1Timepoint(s) of evaluation of this end point
    postprocedural
    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) 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 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
    the end point of te trial is after te last patient has fully undergone the colonoscopy and is discharged.
    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 months0
    E.8.9.1In the Member State concerned 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: 76
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 76
    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 state76
    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 Decision2016-07-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-07-28
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-11-17
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