Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43871   clinical trials with a EudraCT protocol, of which   7290   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2015-002381-23
    Sponsor's Protocol Code Number:LOCAL/2012/PGC-01
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2015-09-11
    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 ConcernedFrance - ANSM
    A.2EudraCT number2015-002381-23
    A.3Full title of the trial
    Comparison of the efficacy of IV paracetamol and IV ketoprofen in the treatment of renal colic in emergency department : a two-center double blind randomized study.
    Comparaison de l’efficacité du paracétamol IV et du kétoprofène IV dans le traitement de la colique néphrétique en service d’accueil des urgences : essai thérapeutique bicentrique randomisé, en double aveugle.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Comparison of the efficacy of IV paracetamol and IV ketoprofen in the treatment of renal colic in emergency department : a two-center double blind randomized study.
    Comparaison de l’efficacité du paracétamol IV et du kétoprofène IV dans le traitement de la colique néphrétique en service d’accueil des urgences : essai thérapeutique bicentrique randomisé, en double aveugle.
    A.3.2Name or abbreviated title of the trial where available
    PIVKIV
    PIVKIV
    A.4.1Sponsor's protocol code numberLOCAL/2012/PGC-01
    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 SponsorCHU de Nîmes
    B.1.3.4CountryFrance
    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 supportCHU de Nîmes
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCHU de Nîmes
    B.5.2Functional name of contact pointChristophe MASSEGUIN
    B.5.3 Address:
    B.5.3.1Street AddressPlace du Pr Debré
    B.5.3.2Town/ cityNîmes
    B.5.3.3Post code30029
    B.5.3.4CountryFrance
    B.5.4Telephone number33466684025
    B.5.5Fax number33466683400
    B.5.6E-maildrc@chu-nimes.fr
    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 Profenid 100mg
    D.2.1.1.2Name of the Marketing Authorisation holderSanofi Aventis
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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 nameprofenid
    D.3.4Pharmaceutical form Lyophilisate for solution for injection
    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.IMP: 2
    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 Paracetamol MacoPharma
    D.2.1.1.2Name of the Marketing Authorisation holderMaco Pharma
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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 nameParacetamol marco pharma
    D.3.4Pharmaceutical form Solution for injection
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Comparison of the efficacy of IV paracetamol and IV ketoprofen in the treatment of renal colic
    Comparaison de l’efficacité du paracétamol IV et du kétoprofène IV dans le traitement de la colique néphrétique
    E.1.1.1Medical condition in easily understood language
    Comparison of the efficacy of IV paracetamol and IV ketoprofen in the treatment of renal colic
    Comparaison de l’efficacité du paracétamol IV et du kétoprofène IV dans le traitement de la colique néphrétique
    E.1.1.2Therapeutic area Diseases [C] - Symptoms and general pathology [C23]
    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 research hypothesis of our study is that there is no difference between paracetamol and ketoprofen in intravenous use interms of analgesic efficacy for the treatment of renal colic.
    The main objective of this study was to demonstrate non -inferiority of the efficacy of treatment with IV paracetamol vs treatment with IV ketoprofen in the treatment of renal colic at the emergency reception , measured by the difference between pain felt at T0 and after 30 minutes of treatment mesured by numeric pain rating scale.
    L'hypothèse de recherche de notre étude est qu'il n'y a pas de différence entre le paracétamol IV et le kétoprofène IV, en termes d'efficacité antalgique, pour le traitement des CN.
    L’objectif principal de cette étude est de démontrer la non-infériorité de l’efficacité d’un traitement à base de paracétamol IV vs un traitement à base de kétoprofène IV dans la prise en charge des coliques néphrétiques au service d’accueil des urgences, évaluée par la différence entre une EVA de douleur ressentie à T0 et une EVA à 30 minutes de traitement.
    E.2.2Secondary objectives of the trial
    The secondary objectives of this study are :
    A- To compare the noninferiority of IV paracetamoland IV ketoprofen pain on 90 minutes of treatment assessed by NRS
    B- To compare between the two groups the use of another molecule for pain relief
    C- To observe and compare the side effects between the two groups : cutaneous manifestation , edema, bronchospasm , nausea, vomiting , headache, palpitation , chest pain, dizziness, impairment of consciousness , dyspnea, acute retention of urine.
    From D- highlight predictors of the use of IV morphine in the treatment of simple renal colic
    E- To compare the rate of hospitalization in the two groups
    F- To evaluate patient satisfaction
    G- To observe and compare the evolution of a complicated renal colic ( obstructive pyelonephritis , hyperalgesia , urinary tract rupture , need for surgical drainage , sepsis , death)
    Les objectifs secondaires de cette étude sont :
    A- De comparer l’efficacité du paracétamol IV et du kétoprofène IV en non infériorité sur la douleur à 90 minutes de traitement évaluée par une EVA
    B- De comparer entre les deux groupes le recours à l’administration d’une autre molécule à visée antalgique (morphinique, tramadol, néfopam, phloroglucinol, alfuzosine).
    C- D’observer et de comparer les effets secondaires entre les deux groupes : manifestation cutanée, œdème, bronchospasme, nausée, vomissement, céphalée, palpitation, douleur thoracique, vertige, trouble de la conscience, dyspnée, rétention aigüe d'urine.
    D- De mettre en évidence des facteurs prédictifs de l’utilisation de la morphine IV dans le traitement des CN simples.
    E- De comparer le taux d’hospitalisation dans les deux groupes
    F- De comparer la satisfaction des patients vis-à-vis de leur prise en charge dans les deux groupes
    G- D’observer et de comparer l'évolution vers une colique néphrétique compliquée
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • informed consent
    • The patient is available for telephone follow-up to one week
    • The patient is at least 18 years old.
    • suspected renal colic
    • Le patient doit avoir donné son consentement libre et éclairé et signé le consentement
    • Le patient est disponible pour un suivi téléphonique à 1 semaine
    • Le patient est âgé d’au moins 18 ans.
    • Le patient se présente au SAU pour suspicion de colique néphrétique simple comme définie ci-dessus.
    E.4Principal exclusion criteria
    • The patient has contreindication for a necessary treatment in this study.
    • The patient has an allergy to ketoprofen or paracetamol , of gastric or intestinal ulcer , bleeding disorders, a history of asthma triggered by taking ketoprofen or similar activity substances
    • The patient has hyperthermia, hemodynamic instability, oligoanuria .
    • The patient has an initial pain assessed by NRS 10/10 .
    • The patient has a history of aneurysm or aortic dissection, kidney transplant , single kidney, liver or kidney failure .
    • ketoprofen or paracetamol administration four hours before treatment to emergencies.aracétamol 4 heures avant le traitement en structure d'urgence.
    • Le patient a une contre-indication (ou une association médicamenteuse incompatible) concernant un traitement nécessaire à cette étude.
    • Le patient présente une allergie au paracétamol ou au kétoprofène, des antécédents d’ulcère gastrique ou intestinal, des troubles de la coagulation, des antécédents d’asthme déclenché par la prise de kétoprofène ou de substances d’activité proche telles qu’autres AINS ou aspirine.
    • Le patient présente une hyperthermie, une instabilité hémodynamique, une oligo-anurie.
    • Le patient présente une douleur initiale évaluée par EVA à 10/10.
    • Le patient présente des antécédents d'anévrysme ou de dissection aortique, de transplantation rénale, de rein unique, d'insuffisance hépatique ou rénale.
    • Prise de kétoprofène ou de paracétamol 4 heures avant le traitement aux urgences.
    E.5 End points
    E.5.1Primary end point(s)
    pain assessment 30 minutes after injection
    évaluation de la douleur à 30 minutes après l'injection
    E.5.1.1Timepoint(s) of evaluation of this end point
    30 minutes
    30 min
    E.5.2Secondary end point(s)
    pain assessment 90 minutes after injection
    Administration of another painkiller
    Summary of adverse events
    hospitalization
    Patient satisfaction
    Evaluation de la douleur à 90 minutes de l'injection
    Administration d’une autre molécule
    Relevé des effets secondaires : manifestation cutanée, œdème, bronchospasme, nausée, vomissement, céphalée, palpitation, douleur thoracique, vertige, trouble de la conscience, dyspnée, rétention aigüe d'urine
    Hospitalisation
    Satisfaction du patient
    E.5.2.1Timepoint(s) of evaluation of this end point
    T0, 30 min, 90 min, end of hospitalization, 1 week
    T0, 30 min, 90 min, Sortie du SAU, 1 semaine
    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 No
    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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Ketoprophen
    Ketoprophen
    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 No
    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 trial correspond to database freezing
    La fin de la partie clinique de cette recherche correspond à la date de la dernière visite de la dernière personne qui se prête à la recherche.
    La fiche de fin d’essai sera complétée pour tout patient ayant terminé normalement l’étude ou étant sorti prématurément.
    Après la fin d’essai, le suivi habituel sera effectué.
    La fin de la recherche correspond à la date du gel de la base de données
    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 months18
    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: 338
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 338
    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 state338
    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
    aucun
    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 Decision2015-10-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-09-21
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Sat May 04 13:02:00 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA