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   43865   clinical trials with a EudraCT protocol, of which   7286   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:2010-022873-32
    Sponsor's Protocol Code Number:MRK008b-2010
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2010-10-19
    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 number2010-022873-32
    A.3Full title of the trial
    An Enriched Enrollment, Double Blind, Placebo-Controlled, Parallel Group, Randomized Withdrawal Trial to Evaluate the Efficacy, Tolerability and Safety of Etoricoxib (Arcoxia) in Patients with Moderate to Severe Neuropathic Pain
    A.3.2Name or abbreviated title of the trial where available
    Arcoxia in Patients with Moderate to Severe Neuropathic Pain Version 1
    A.4.1Sponsor's protocol code numberMRK008b-2010
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorAnalgesic Solutions
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    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 organisation
    B.5.2Functional name of contact point
    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
    D.2.1.1.2Name of the Marketing Authorisation holderMerck Sharp & Dohme Limited
    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 nameArcoxia
    D.3.2Product code N/A
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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, a COX2 inhibitor
    D.3.9.1CAS number 202409-33-4
    D.3.9.2Current sponsor codeMRK008b
    D.3.9.3Other descriptive nameArcoxia
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number90
    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) Information not present in EudraCT
    D.3.11.3.1Somatic cell therapy medicinal product Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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 placeboFilm-coated tablet
    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
    Patients with Neuropathic Pain. In the first instance, the investigator will aim to recruit patients with post herpetic neuralgia. If insufficient patients with post herpetic neuralgia are recruited, then patients with painful diabetic neuropathy, small fibre predominant neuropathy and idiopathic sensory neuropathy will also be recruited.
    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 primary objective is to measure the efficacy of etoricoxib compared to placebo in reducing pain intensity in patients with neuropathic pain, as measured by Time to Efficacy Failure during the double-blind phase.
    E.2.2Secondary objectives of the trial
    The secondary objectives are to:

    Evaluate the efficacy of etoricoxib in neuropathic pain by:

    - Mean pain intensity score at bedtime on 0-10 Numerical Rating Scale [NRS] scores captured by Actiwatch

    - Mean sleep interference score in the morning on 0-10 NRS scores captured by Actiwatch

    - Mean pain intensity score captured In-Clinic (0-10 NRS)

    - Patient Global Impression of Change (PGIC)

    - Brief Pain Intensity-Short Form (BPI-SF)

    - Activity (actigraphy) measured by Actiwatch)

    - Pain-activity composite measure

    - Pain Matching (Pain Matcher)

    - Pain Quality Assessment Scale (PQAS)

    - Cumulative distribution for responders

    - Time to onset of analgesia (in the Open-Label Period only)

    - Time to dropout for all causes (in the Double-Blind Period only)

    To examine the Time to Efficacy Failure by PHN subgroup based on sensory testing results.

    To evaluate the safety and tolerability of etoricoxib in patients with Neuropathic Pain (NP).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Subjects must meet all of the following criteria to participate in the study:
    1. Be a man or a non-pregnant, non-lactating woman 18 years and older. Women of childbearing potential should be willing to use adequate birth control methods (at the investigator's discretion) during the study to avoid pregnancy
    2. Have voluntarily provided written informed consent
    3. Be able to speak, read, write, and understand English, understand the consent form, complete study related procedures, and communicate with the study staff
    4. Have a clinical diagnosis of PHN by history or objective findings in the opinion of Investigator for a minimum of six months.
    5. Have a pain intensity score averaging ≥3 on a 0-10 NRS for average daily recall over past 24 hours (at Visit 1)
    6. Be, in the opinion of the investigator, in generally good health (other than PHN) at screening, based upon the results of a medical history, physical examination, and laboratory profile.

    Inclusion criteria for enrollment into Double-Blind Period: Have at least a 30% reduction in the average 0-10 NRS pain scores measured over the last seven days prior to Randomization compared to Baseline pain scores (average 0-10 NRS pain scores over the 7-day Baseline Period), and have completed at least 60% of the NRS Pain measurements for each of the 7-day period.

    Should we decide to expand the recruitment to PDN, ISN, and SFN patients, the inclusion for these patients will be the same as for PHN patients except for inclusion criteria no.4 which will be replaced by the following inclusion criterion:

    4. Have a clinical diagnosis of NP (PDN, ISN, or SFN) by history or objective findings in the opinion of the Investigator for a minimum of 6 months.
    E.4Principal exclusion criteria
    Subjects who meet any of the following criteria will not be eligible to participate in the study:

    1. Are pregnant and/or lactating
    2. Having been diagnosed as having any inflammatory arthritis, gout, pseudo-gout, Paget’s disease, fibromyalgia or any chronic pain syndrome that in the Investigator’s opinion would interfere with the assessment of pain and other symptoms of PHN
    3. Have evidence for multiple causes of pain in the neuropathic pain area, such as lumbar radiculopathy in an area of lumbosacral PHN
    4. Have any bodily moderate to severe pain (e.g. osteoarthritis) that could confound assessment or self-evaluation of pain due to PHN
    5. Use NSAID compounds (oral and topical) within 1 week of the study and for the duration of the study;
    6. Use opioids including tramadol within 1 week of the study and for the duration of the study. (Other NP medications are allowed, provided that the doses have been stable for at least one month prior to Visit 1)
    7. Have had neuro-ablation or neurosurgical intervention for their PHN
    8. Have received nerve block or intrathecal analgesia within six weeks of study
    9. Have a history of congestive heart failure, unstable coronary artery disease, stroke, or uncontrolled hypertension
    10. Have a history of significant gastrointestinal disease, including active gastro-duodenal ulcerations, perforations, or bleeds
    11. Have abnormal clinical laboratory test results or vital signs unless deemed not clinically significant by the investigator
    12. Have skin lesions or damage in the area where BSTK measurements are conducted (only applicable to PHN patients)
    13. Are undergoing active treatment for cancer, are known to be infected by HIV, or are being acutely and intensively immunosuppressed following transplantation
    14. Have a history of alcohol or other substance abuse (not including nicotine or tobacco) within five years
    15. Known to have a condition that in the investigator’s judgement precludes participation in the study
    16. Have a significant psychiatric disorder in the opinion of the Investigator
    17. Have received an investigational drug or have used an investigational device in the 30 days prior to study entry
    18. Have previously been admitted to this study
    19. Are allergic to Arcoxia.
    Should recruitment be expanded to PDN, ISN, and SFN patients, the exclusion criteria for these patients will remain the same.
    E.5 End points
    E.5.1Primary end point(s)
    The primary outcome measure is Time to Efficacy Failure.
    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 Yes
    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 Yes
    E.6.13.1Other scope of the trial description
    Tolerability
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    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 Yes
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Enriched Enrollment Randomised Withdrawal Trial
    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.8.3 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 concerned2
    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 Information not present in EudraCT
    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
    Completion of all trial procedures by all participants.
    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 months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    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 Information not present in EudraCT
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    F.3.3.3Pregnant women Information not present in EudraCT
    F.3.3.4Nursing women Information not present in EudraCT
    F.3.3.5Emergency situation Information not present in EudraCT
    F.3.3.6Subjects incapable of giving consent personally Information not present in EudraCT
    F.3.3.7Others Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state120
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 120
    F.4.2.2In the whole clinical trial 120
    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 who enroll in the study will no longer receive study medication once their participation in the study ends. However patients are not asked to discontinue their pre-study analgesia (except other NSAIDs and opioids including tramadol) and will therefore return to their normal care. As routine, we will write to the patient's primary care physician informing them of the outcome of the open label part of the study, hence a patient who has benefited from etoricoxib, may get this prescribed by
    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 Decision2010-11-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-12-14
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2012-07-24
    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-Mon Apr 29 00:07:35 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA