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    Summary
    EudraCT Number:2006-003602-26
    Sponsor's Protocol Code Number:CBA106191
    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:2007-03-09
    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 ConcernedUK - MHRA
    A.2EudraCT number2006-003602-26
    A.3Full title of the trial
    A double-blind, two-period, placebo controlled cross-over study of the effects of the CB2 agonist GW842166 on pain and sensitisation in patients with osteoarthritis.
    A.4.1Sponsor's protocol code numberCBA106191
    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 SponsorGlaxoSmithKline Research & Development Ltd
    B.1.3.4CountryUnited Kingdom
    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 No
    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 nameGW842166
    D.3.2Product code GW842166
    D.3.4Pharmaceutical form Capsule, hard
    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.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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 No
    D.3.11.3.2Gene therapy medical product No
    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 placeboCapsule, hard
    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
    Osteoarthritis
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 8.1
    E.1.2Level LLT
    E.1.2Classification code 10023476
    E.1.2Term Knee osteoarthritis
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    • To investigate the effects of the CB2 agonist GW842166X on Pain Intensity and sensory endpoints in patients with painful osteoarthritis (OA) of one index knee
    • To assess the value of experimental endpoints (capsaicin-evoked hyperalgesia, quantitative sensory testing, contact heat-evoked potentials and quantitative sensory tests) as markers of sensitisation in OA arthralgia and/or pharmacodynamic (PD) markers for CB2 agonists
    E.2.2Secondary objectives of the trial
    • To evaluate the safety and tolerability of GW842166X in patients with OA
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    A patient will be eligible for inclusion in this study only if all of the following criteria apply:
    1. Male or female patients, 50 to 80 years of age.
    2. A female is eligible to participate in this study if she is of: a) non-childbearing potential (i.e., physiologically incapable of becoming pregnant, including any female who is post-menopausal (more than 1 year since last menstrual cycle), had a tubal ligation or is surgical sterilised); or, b) child-bearing potential, has a negative pregnancy test (urine) at screen and baseline, and agrees to one of the following:
    • Male partner who is sterile prior to the female subject’s entry into the study and is the sole sexual partner for that female subject; or
    • Implants of levonorgestral; or
    • Injectable progestogen; or
    • Oral contraception (combined or progestogen only); or
    • Any intrauterine device (IUD) with published data showing that the highest expected failure rate is less than 1% per year; or
    • Barrier method only if used with any of the above acceptable methods.
    3. A diagnosis of primary osteoarthritis of the knee at least 3 months in symptom duration prior to screen. For patients with OA in both knees, an index knee will be specified.
    4. Meets American College of Rheumatology (ACR) criteria for symptomatic osteoarthritis of the knee as defined by knee pain and radiographic evidence of osteophytes (Altman 1986)
    5. Global functional status I, II or III according to ACR classification.
    6. Patient has a minimum of 40mm on the 100mm VAS (WOMAC pain subscale) at baseline / randomisation. In addition, baseline pain must be stable for at least 72 hours prior to randomisation based on patient’s assessment.
    7. Patient has a maximum of 80mm on the 100mm VAS (WOMAC pain subscale) at screening.
    E.4Principal exclusion criteria
    Exclusion criteria – general:
    1. Intolerance of paracetamol.
    2. Any clinical or biological abnormality found at screening (other than those related to the disease under investigation) which, in the opinion of the investigator, is clinically significant and would preclude safe participation in this study (e.g. current
    malignancy, human immunodeficiency virus (HIV) infection, significant mental
    illness).
    3. QTc ≥450msecs based on a 12-lead ECG obtained over a brief recording period. This applies to QTc intervals measured either by Bazzett’s or Fridericia’s formula
    (machine or manual over-read, male or female subjects).
    4. Subjects with any one of creatinine, bilirubin, alanine aminotransferase (ALT) or
    aspartate aminotransfarase (AST) > 1.5 times the upper limit of normal (ULN) at
    screen are excluded. Subjects with two or more of bilirubin, ALT or AST above the
    ULN are excluded.
    5. Chronic Hepatitis B and C, as evidenced by positive Hepatitis B surface antigen
    (HbsAg) or Hepatitis C antibody
    6. History of chronic alcoholic liver disease
    7. Impaired renal function (estimated GFR<30mL/min)
    8. Use of potent CYP3A4 inhibitors (e.g. amiodarone, cyclosporine, diltiazem, elfinavir, indinavir, ritonavir, cimetidine, clarithromycin, erythromycin, fluconazole,
    itraconazole, ketoconazole, miconazole, nefazodone, verapamil)
    9. Use of methotrexate.
    10. Use of anticoagulants (warfarin, heparin) or anti-platelet aggregation agents
    (excluding low-dose aspirin) or a condition associated with decreased haemostasis
    11. Abuse of alcohol defined as an average weekly intake of greater than 21 units or an average daily intake of greater than 3 units (males) or defined as an average weekly intake of greater than 14 units or an average daily intake of greater than 2 units (females). 1 unit is equivalent to a half-pint (220mL) of beer or 1 (25ml) measure of spirits or 1 glass (125ml) of wine.
    12. A history of clinically significant drug or alcohol abuse, as defined by Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria.
    13. Participation in another investigational drug or device study during the 3 months prior to the Baseline/Randomisation Visit
    14. Inability or unwillingness to comply with study restrictions

    Exclusion criteria related to OA:
    1. Secondary causes of arthritis of the knee including septic arthritis, inflammatory
    joint disease, articular fracture, major dysplasias or congenital abnormality,
    ochronosis, acromegaly, hemochromatosis, Wilson’s disease, and primary
    osteochondromatosis
    2. Had lower extremity surgery (including arthroscopy) within 6 months prior to
    screening or scheduled for surgery of any kind during the study period
    3. Significant prior injury to the index knee within 12 months prior to screen
    4. Use of lower extremity assistive devices other than a cane or knee brace (use of a
    ‘shoe lift’ is permitted)
    5. Disease of the spine or other lower extremity joints of sufficient degree to affect the index knee
    6. Any other musculoskeletal or arthritic condition that may affect the interpretation of clinical efficacy and/or safety data or otherwise contraindicates participation in this
    clinical study (i.e., currently symptomatic fractures or any concurrent rheumatic
    disease such as but not limited to fibromyalgia, rheumatoid arthritis, and Reiter’s
    syndrome are excluded)
    7. Use of any analgesic, COX-2 inhibitor or NSAID [including topical NSAIDs;
    excluding low-dose aspirin (≤325mg per day)], other than protocol defined rescue
    therapy (paracetamol), within 5× half-life (in hours) prior to the first dosing day or
    during the study
    8. Corticosteroid use prior to baseline as follows:
    • Intra-articular injection of steroids to the index knee within the previous 3 months
    • Intra-articular steroid injections into any site other than the index knee within the
    previous 1 month
    • Intra-muscular corticosteroid injections within the previous 3 months
    • Oral corticosteroids within the previous 1 month
    9. Received hyaluronan injections into index knee within the previous six months prior to baseline
    10. Initiation of or change to an established physiotherapy program within 2 weeks prior to baseline or during the study period. An established physiotherapy program may be continued throughout the study period if unchanged in frequency and intensity
    11. Recent start or change in dose regimen (≤3 months prior to baseline) of any
    OA-specific therapies (i.e., nutraceutical products) including but not limited to
    chondroitin or keratin sulfate, s-adenosyl methionine (SAMe) and glucosamine
    preparations
    E.5 End points
    E.5.1Primary end point(s)
    • Change in Pain Intensity from baseline to the end of treatment using Western Ontario and McMasters Universities Osteoarthritis Index (WOMAC) pain subscore.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Information not present in EudraCT
    E.6.2Prophylaxis Information not present in EudraCT
    E.6.3Therapy Information not present in EudraCT
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Information not present in EudraCT
    E.6.8Bioequivalence Information not present in EudraCT
    E.6.9Dose response Information not present in EudraCT
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic Information not present in EudraCT
    E.6.12Pharmacoeconomic Information not present in EudraCT
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Biomarkers
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 Yes
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Two period
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Yes
    E.8.2.3Other Information not present in EudraCT
    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.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States No
    E.8.5.1Number of sites anticipated in the EEA1
    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
    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
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    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 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 state45
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 45
    F.4.2.2In the whole clinical trial 45
    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)
    As GW842166 is not a licensed drug no further treatment will be provided, However, standard medical care will be provided.
    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 Decision2007-03-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-05-04
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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