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    Summary
    EudraCT Number:2016-003144-36
    Sponsor's Protocol Code Number:NAC.TEP16
    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:2017-07-19
    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 number2016-003144-36
    A.3Full title of the trial
    Pilot study: postoperative pain reduction by pre emptive N-Acetylcysteine
    Pilot studie: postoperatieve pijn reductie door pre emptief N-Acetylcysteine
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    reduction in pain after surgery by giving N-Acetylcysteïne before surgery
    vermindering van postoperatieve pijn door voor de operatie NAcetylcysteïne
    te geven
    A.4.1Sponsor's protocol code numberNAC.TEP16
    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 SponsorRadboud University Medical Centre
    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 supportRadboud University Medical Centre
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationRadboud UMC
    B.5.2Functional name of contact pointHead of department Anesthesiology
    B.5.3 Address:
    B.5.3.1Street AddressGeert Grooteplein-Zuid 10
    B.5.3.2Town/ cityNijmegen
    B.5.3.3Post code6525GA
    B.5.3.4CountryNetherlands
    B.5.6E-mailKris.Vissers@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 acetylcysteine
    D.2.1.1.2Name of the Marketing Authorisation holderZambon 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 nameAcetylcysteine
    D.3.2Product code RVG 10903
    D.3.4Pharmaceutical form Infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous 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
    postoperative pain
    postoperatieve pijn
    E.1.1.1Medical condition in easily understood language
    pain after surgery
    pijn na operatie
    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
    To evaluate the efficacy of intravenous N-Acetylcysteine in comparison
    with placebo in terms of pain relief after unilateral inguinal hernia repair
    measured by a visual analogue scale (VAS 0-100) at day 1 after surgery
    Geeft N-Acetylcysteine, indien dit is toegediend voor de operatie, minder
    postoperatieve pijn na een unilaterale liesbreuk operatie dan wanneer
    patiënten placebo toegediend krijgen, gemeten op dag 1 na de operatie
    middels visuele analoge schaal (VAS 0-100).
    E.2.2Secondary objectives of the trial
    Secondary Objective(s):
    1. Difference in pain scores between NAC and placebo direct after
    surgery, before discharge and in following 3 days postoperative.
    2. Difference in time before first pain medication is administered
    postoperative between NAC and placebo.
    3. Difference in total consumption of opiates in the hospital (mg)
    between NAC and placebo.
    4. Difference in time from surgery to discharge between NAC and
    placebo.
    5. Difference in postoperative pain medication at home necessary to
    reach adequate pain relief between NAC and placebo ( Acetaminophen
    /NSAID's/opiates).
    6. If there is a difference in 5, is there also a difference in adverse
    effects of pain medication (like nausea, obstipation) between NAC and
    placebo.
    Secundaire onderzoeksvragen:
    1. is er een verschil in pijnscores tussen de NAC en placebo groep direct
    na de operatie, voor ontslag en in de 3 dagen na de operatie?
    2. is er een verschil in tijd voor de eerste pijnmedicatie moet worden
    gegeven tussen NAC en placebo?
    3. Is er een verschil in consumptie van opiaten na de operatie tussen NAC en placebo?
    4. Is er een verschil in opnameduur tussen NAC en placebo?
    5. Is er een verschil in ingenomen pijnmedicatie door de patienten thuis
    om de pijn adequaat onder controle te krijgen
    (paracetamol/diclofenac/opiaten) tussen NAC en placebo?
    6. Als er een verschil is in vraag 5, uit dit zich dan ook in verschil in
    bijwerkingen van de pijnmedicatie (zoals sufheid en misselijkheid)?
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Subjects scheduled for laparoscopic unilateral inguinal hernia repair.
    - ASA 1 or 2.
    - Age >18 years.
    Om mee te mogen doen aan dit onderzoek moeten patiënten voldoen aan
    alle van onderstaande criteria:
    - ingepland staan voor laparoscopische unilaterale hernia inguinalis
    (liesbreuk) operatie.
    - ASA 1 of 2.
    - Leeftijd >18 jaar
    E.4Principal exclusion criteria
    Exclusion criteria
    A potential subject who meets any of the following criteria will be
    excluded from participation in this study:
    - Pregnancy or lactating
    - Allergy to NAC
    - History of chronic pain
    - Use of opioids or neuropathic analgesics
    - Use of NAC prior to trial (< 1 month of planned surgery)
    - Alcoholism
    - Diabetes Mellitus
    - Asthma or Chronic Obstructive Pulmonary Disease
    - Known renal function disorders (MDRD <60)
    - Known liver failure (bilirubine >1.5x upper limit of normal)
    - No written IC by patient
    Een mogelijke kandidaat die voldoet aan een van onderstaande criteria
    zal worden geëxcludeerd:
    - zwangerschap of het geven van borstvoeding
    - allergie voor NAC
    - bekend met chronische pijn
    - gebruik van opiaten of neuropathische analgetica
    - gebruik van NAC voor de trial (<1 maand van de geplande operatie
    datum)
    - alcoholisme
    - diabetes mellitus
    - astma of COPD
    - bekende nierfunctiestoornis (MDRD<60)
    - bekend leverfalen (bilirubine> 1.5 keer de normaalwaarde)
    - geen geschreven informed consent formulier
    E.5 End points
    E.5.1Primary end point(s)
    Primary objective is to evaluate the efficacy of intravenous NAC in
    comparison with placebo in terms of pain relief after unilateral inguinal
    hernia repair measured by a visual analogue scale (VAS 0-100) at day 1
    after surgery.
    Primaire uitkomst is om te kijken of preoperatief intraveneus NAC in
    vergelijking met placebo leidt tot vermindering van postoperatieve pijn
    na een unilaterale laparoscopische liesbreuk operatie, gemeten middels
    een visual analogue scale (VAS 1-100 mm) op dag 1 postoperatief
    E.5.1.1Timepoint(s) of evaluation of this end point
    1 day after surgery
    1 dag na de operatie
    E.5.2Secondary end point(s)
    • Pain scores (VAS 1-100) direct postoperatively , before discharge and
    in following 3 days postoperative.
    • Time to first necessity of pain medication after surgery (in minutes).
    • Total consumption of in hospital opiates (in mg).
    • Time to discharge (in minutes).
    • Analgesic medication taken at home by patient (registered by patients
    in diary) (in mg).
    • Adverse effect of analgesic medication (nausea, obstipation, sedation)
    (in numbers).
    • pijnscores scores (VAS 1-100) direct postoperatief , voor ontslag en in
    de 3 opeenvolgende postoperatieve dagen.
    • tijd tot inname van eerste pijnmedicatie na de operatie (in minuten).
    • totale consumptie van opiaten tijdens verblijf in het ziekenhuis (in
    mg).
    • tijd tot ontslag (in minuten).
    • Pijnmedicatie door patiënt thuis ingenomen (geregistreerd in dagboek
    door patiënten)(in mg).
    • Bijwerkingen van pijnmedicatie (misselijkheid, obstipatie, sedatie) (in
    aantallen).
    E.5.2.1Timepoint(s) of evaluation of this end point
    on the day of surgery and the 3 following days
    op de dag van de operatie en de 3 opeenvolgende dagen
    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 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 the trial is after the last patient has fully undergone
    the research procedure.
    Het eindpunt van de studie is nadat de laatste patient de volledige
    studieprocedure heeft ondergaan
    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 months8
    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: 50
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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
    geen
    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 Decision2020-11-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-07-10
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-10-29
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