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    Summary
    EudraCT Number:2009-014734-16
    Sponsor's Protocol Code Number:B0541004
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2009-11-06
    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 ConcernedSweden - MPA
    A.2EudraCT number2009-014734-16
    A.3Full title of the trial
    A PHASE 2A RANDOMIZED, DOUBLE-BLINDED, DOUBLE DUMMY, PLACEBO AND ACTIVE CONTROLLED, TWO-WAY CROSS-OVER, FLARE-ENRICHED MULTI-CENTRE CLINICAL TRIAL TO EXAMINE THE PAIN RELIEF PRODUCED BY 2 WEEKS OF DAILY ORAL ADMINISTRATION OF A FATTY ACID AMIDE HYDROLASE (FAAH) INHIBITOR PF-04457845 IN PATIENTS WITH OSTEOARTHRITIS OF THE KNEE.
    A.4.1Sponsor's protocol code numberB0541004
    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 SponsorPfizer Limited, Ramsgate Road, Sandwich, Kent CT13 9NJ
    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.3.2Product code PF-04457845
    D.3.4Pharmaceutical form 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 INNPF-04457845
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number4
    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.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 Naproxen
    D.2.1.1.2Name of the Marketing Authorisation holderAmneal Pharmaceuticals
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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 nameNaproxen
    D.3.4Pharmaceutical form 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 INNNAPROXEN
    D.3.9.1CAS number 22204-53-1
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    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) Information not present in EudraCT
    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 placeboTablet
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    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
    OSTEOARTHRITIS OF THE KNEE
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.0
    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 evaluate the efficacy of PF-04457845 (administered QD) versus placebo in relieving pain in patients with osteoarthritis of the knee.
    •To evaluate the safety and tolerability of PF-04457845 in patients with osteoarthritis.
    E.2.2Secondary objectives of the trial
    •To understand the relationship between fatty acid amide (FAA) elevation and efficacy.
    •To examine the pharmacokinetics of PF-04457845 in patients with osteoarthritis.
    •To compare the FAAH activation in leukocytes and the elevation of FAA in patients
    treated with PF-04457845 with that observed previously in normal healthy volunteers.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Subject eligibility should be reviewed and documented by an appropriately qualified member of the investigator’s study team before subjects are included in the study.
    Subjects must meet the following criteria to be eligible for enrollment into the study:
    1. Evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the study.
    2. Male or female subjects not of child bearing potential between the ages of 18 and 75 years inclusive at the time of entering the study.
    3. Diagnosis of OA of the knee based on American College of Rheumatology criteria
    with X-ray confirmation (a Kellgren-Lawrence X-ray grade of ≤2
    (Kellgren J, Lawrence J. Radiological assessment of osteo-arthrosis. Ann Rheum Dis.
    1957; 16: 494-501 [1]). X-rays taken within the last 12 months may be used for
    confirmation.
    4. Willing and able to discontinue all current analgesic therapy, including OTC pain
    medications and topical analgesics for OA pain, for period beginning at washout phase and continuing for the entire duration of study.
    5. Acetaminophen may be used for non-joint related pain at doses ≤1 g/day at the discretion of a qualified member of the Pfizer study team.
    6. QTc interval ≤470 ms and a PR interval ≤210 msec based on the screening ECG.
    7. Subjects who are willing and able to comply with scheduled visits, treatment plan, llaboratory tests, and other study procedures.
    E.4Principal exclusion criteria
    1. Evidence or a history of clinically significant endocrine, pulmonary, gastrointestinal,
    cardiovascular, renal, psychiatric, or neurological disease that the investigator is unable to confirm have been stable for ≤4 weeks under control.
    2. Body mass index (BMI) of <40 kg/m2.
    3. Clinical evidence of existing hepatic disease or a medical history of such a condition in the last year.
    4. Pregnant or lactating females, and women of childbearing potential.
    5. Participation in a clinical trial for an investigational drug and/or agent within 30 days prior to randomization.
    6. Any history of alcohol or illicit drug abuse within 1 year of screening.
    7. A positive urine drug screen.
    8. Active malignancy of any type or history of a malignancy within 10 years (with the
    exception of subjects with a history of treated basal cell carcinoma).
    9. Symptomatic OA of the hip ipsilateral to index knee which the patient considers more painful than the knee.
    10. History of diseases other than OA that may involve the index knee, including:
    •Inflammatory joint diseases.
    •Crystalline diseases.
    •Endocrinopathies.
    •Metabolic diseases.
    •Infections.
    •Neuropathic disorders.
    •Avascular necrosis.
    •Paget’s disease, or
    •Tumors.
    11. Subjects with a history of HIV
    12. Subjects with a history of Hepatitis B or Hepatitis C infection.
    13. Symptomatic anserine bursitis or acute joint trauma of the index knee within 1 year.
    14. Arthroscopy performed on index knee within 1 year.
    15. Other severe pain which that impairs the assessment of OA pain.
    16. Any condition affecting drug absorption, eg, gastrectomy or any active GI disease
    (including any relevant surgery).
    17. First degree or higher AV block, defined as PR interval >210 msec, complete left or right bundle branch block, or clinically relevant abnormality on screening ECG.
    18. Use of prohibited medications as listed below, in the absence of appropriate washout period (greater of 2d or 5 half-lives):
    •NSAIDs and COX-2 inhibitors.
    •Acetaminophen (as an exception acetaminophen may be used for non-joint related
    pain at doses ≤1g/day).
    •Opioids.
    •Aspirin (≤325 mg/day for cardiovascular prophylaxis permitted).
    •Oral or IM corticosteroids within 4 weeks. IA steroids within 12 weeks in study
    joint or any other joints within 4 weeks, or IA hyaluronic acid within 24 weeks prior
    to baseline.
    •Concomitant medications that are CYP3A inhibitors or CYP3A inducers, or that are
    P-glycoprotein substrates, within 48 hours or 5 half lives prior to baseline.
    19. Subjects that have previously received any cannabinoid therapy (eg, nabilone, marinol, dronabinol, sativex).
    20. Other severe acute or chronic medical or psychiatric conditions or pre-dispositions or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with interpretation of and, in the judgment of the investigator, would make the subject inappropriate for entry into this study eg, active tuberculosis.
    21. Subjects with any personal or family history of psychosis.
    22. Evidence of suicidality as determined by Columbia – Suicide Severity Rating Scale
    (C-SSRS) assessment.
    23. Subjects:
    • Who have previously exhibited allergy to naproxen sodium
    • With known hypersensitivity to the active substance naproxen (including naproxen sodium) or any of the excipients.
    • Wih a history of asthma, urticaria, or allergic-type reactions after taking acetylsalicylic acid (ASA) or other NSAIDs (ie, complete or partial syndrome of ASA-intolerance-rhinosinusitis, urticaria/angioedema, nasal polyps, asthma).
    E.5 End points
    E.5.1Primary end point(s)
    Western Ontario & McMaster (WOMAC) Osteoarthritis Index (48 hour recall, categorical version - see Appendix 2) Pain score:
    •Baseline is defined as the pre-dose assessments on Day 1 for Period 1 and Day 36 for Period 2.
    •The more painful knee joint will be identified at screening as the index joint, and this
    joint will be used for all pain assessments.
    •Range 0-20.
    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 No
    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) 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 Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Yes
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Flare-enriched, Multi-centre
    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.8.6 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 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
    Internal DMC to be used
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months11
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months11
    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 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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 20
    F.4.2.2In the whole clinical trial 145
    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)
    This is not different from the expected normal treatment of that condition.
    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 Decision2009-12-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-01-04
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2010-05-13
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