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The European Union Clinical Trials Register allows you to search for protocol and results information on:
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    The EU Clinical Trials Register currently displays   41189   clinical trials with a EudraCT protocol, of which   6743   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 in adults and that are not part of an agreed PIP are not public in the EU CTR (refer to European Guidance 2008/C 168/02   Art. 3 par. 2 and   Commission Guideline 2012/C 302/03,   Art. 5) .
     
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    Summary
    EudraCT Number:2010-021604-16
    Sponsor's Protocol Code Number:etoricoxib-fast-track-2010
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2010-10-13
    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 ConcernedGermany - BfArM
    A.2EudraCT number2010-021604-16
    A.3Full title of the trial
    A double-blind, randomized, placebo controlled study to evaluate the effectiveness of etoricoxib as an additive analgesic to epidural analgesia in colon or rectum fast-track surgery
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A controlled study to evaluate the effectiveness of etoricoxib as an additive analgesic to epidural analgesia in colon or rectum fast-track surgery
    A.3.2Name or abbreviated title of the trial where available
    Etoricoxib fast-track
    A.4.1Sponsor's protocol code numberetoricoxib-fast-track-2010
    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 SponsorCharité Universitätsmedizin Berlin
    B.1.3.4CountryGermany
    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 supportCharité Universitätsmedizin Berlin
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCharité Universitaetsmedizin Berlin
    B.5.2Functional name of contact pointUniv. - Prof. Dr. Claudia Spies
    B.5.3 Address:
    B.5.3.1Street AddressAugustenburger Platz 1, Campus Virchow Klinikum
    B.5.3.2Town/ cityBerlin
    B.5.3.3Post code13353
    B.5.3.4CountryGermany
    B.5.4Telephone number+4930551102
    B.5.5Fax number+4930551909
    B.5.6E-mailclaudia.spies@charite.de
    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 Arcoxia 120mg
    D.2.1.1.2Name of the Marketing Authorisation holderMSD SHARP & DOHME GMBH
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 nameEtoricoxib
    D.3.4Pharmaceutical form Capsule
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNETORICOXIB
    D.3.9.1CAS number 0
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number120
    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 placeboTablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Post-operative pain after laparoscopic colon or rectum surgery in fast-track design
    E.1.1.1Medical condition in easily understood language
    Post-operative pain after colon or rectum 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 14.1
    E.1.2Level LLT
    E.1.2Classification code 10036236
    E.1.2Term Postoperative pain relief
    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
    To demonstrate that the administration of etoricoxib 120mg additionally to the clinical routine therapy (epidural catheter) reduces the post-operative pain level during movement at the thrid day after laparoscopic colon or rectum surgery in the fast-track design.
    E.2.2Secondary objectives of the trial
    To demonstrate that the administration of etoricoxib 120mg additionally to the clinical routine therapy (epidural catheter):
    1. reduces the post-operative pain level during movement in the first 2 days after laparoscopic colon or rectum surgery in the fast-track design.
    2. reduces the post-operative pain level during rest in the first 2 days after laparoscopic colon or rectum surgery in the fast-track design.
    3. reduces the post-operative pain level during rest and movement from the third until the fifth day after laparoscopic colon or rectum surgery (one day after epidural catheter removal)
    4. reduces the incidence of pain events and the average pain intensity in body parts outside of the area of operations.
    5. reduces the incidence of new organ dysfuntions, side effects, frequency and amount of intake of rescue medication
    6. reduces postoperative LOS
    7. increases the patients level of satisfaction.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - age >= 18 years
    - written informed consent
    - no inclusion in other medical studies according to the AMG (German drug law) during the study period
    - realization of planned colon or rectum surgery in the fast track design after clinical standards including an epidural catheter
    E.4Principal exclusion criteria
    - ASA status IV-V
    - allergy against etoricoxib, other components or other NSAID
    - coronary heart disease
    - heart insufficiency NYHA II-IV
    - cerebrovascular disease
    - peripheral arterial occlusive disease
    - untreated arterial hypertonus
    - active peptic ulcera or active gastrointestinal bleeding
    - light to severe liver dysfunction (beginning from Child - Plugh - Classification A)
    - kidney insufficiency
    - inflammatory bowl disease
    - pregnancy or lactation
    - placement in an institution on order of an official authority
    - missing consent for saving and passing on pseudonymous data
    - hereditary galactose-intolerance, lactase deficit, glucose-galactose-malabsorption
    - no correct epidural catheter placement within 48 h after surgery

    E.5 End points
    E.5.1Primary end point(s)
    Primary end point of the study is the average pain level (scale 0-10) in the area of surgery during movement (walking a fixed number of steps) under active epidural analgesia, at the third day following laparoscopic colon or rectum surgery.
    E.5.1.1Timepoint(s) of evaluation of this end point
    third postoperative day
    E.5.2Secondary end point(s)
    1. Post-operative pain level during movement in the first 2 days after laparoscopic colon or rectum surgery.
    2. Post-operative pain level during rest in the first 2 days after laparoscopic colon or rectum surgery.
    3. Post-operative pain level during rest and movement from the third until the fifth day after laparoscopic colon or rectum surgery (one day after epidural catheter removal)
    4. Incidence of pain events and the average pain intensity in body parts outside of the area of operations.
    5. Incidence of new organ dysfunctions, side effects, frequency and amount of intake of rescue medication.
    6. Postoperative LOS/ postoperative ICU stay
    7. Patients level of satisfaction
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. In the first 2 days after laparoscopic colon or rectum surgery
    2. In the first 2 days after laparoscopic colon or rectum surgery
    3. One day after epidural catheter removal
    4. and 5. study period
    6. period of hospital stay/ICU stay
    7. study period




    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 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 concerned4
    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
    Hospital discharge of the last patient.
    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 months7
    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: 70
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    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 Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    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 state90
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 0
    F.4.2.2In the whole clinical trial 0
    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)
    To ensure patient safety, the patients will be regularly visited by study personnel for 5 days after the last administration of study medication. This time span of 5 days is longer than 5 times the halflife timespan of the study medication (verum).
    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 Decision2010-11-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-12-08
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2014-04-25
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