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    Summary
    EudraCT Number:2013-001970-33
    Sponsor's Protocol Code Number:167700-002CL
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2013-06-14
    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 number2013-001970-33
    A.3Full title of the trial
    A Double-Blind, Randomised, Exploratory Study to Investigate the Safety, Efficacy and Pharmacokinetics of PRX167700 in Subjects with Knee Osteoarthritis.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical trial to investigate the safety and effect of a drug called PRX167700 on painful chronic conditions such as osteoarthritis in the knees.
    A.4.1Sponsor's protocol code number167700-002CL
    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 SponsorProximagen Limited
    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 supportProximagen Limited
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationProximagen Limited
    B.5.2Functional name of contact pointClinical Trial Information
    B.5.3 Address:
    B.5.3.1Street Address91-93 Farringdon Rd
    B.5.3.2Town/ cityLondon
    B.5.3.3Post codeEC1M 3LN
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number004402074007700
    B.5.5Fax number004402078315387
    B.5.6E-mailinfo@proximagen.com
    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 namePRX167700
    D.3.2Product code PRX167700
    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 INNPRX167700
    D.3.9.2Current sponsor codePRX167700
    D.3.9.4EV Substance CodeSUB36484
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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 placeboCapsule
    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
    E.1.1.1Medical condition in easily understood language
    Pain and stiffness in the knee joint
    E.1.1.2Therapeutic area Diseases [C] - Musculoskeletal Diseases [C05]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.1
    E.1.2Level LLT
    E.1.2Classification code 10023476
    E.1.2Term Knee osteoarthritis
    E.1.2System Organ Class 100000004859
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the effect of PRX167700 treatment on Pain Intensity after walking and at rest in subjects with moderate to severe pain caused by osteoarthritis (OA) of the knee.
    E.2.2Secondary objectives of the trial
    To assess the safety of PRX167700 over a 15 day dosing period.

    To investigate the pharmacokinetics of PRX167700 in male and female subjects with OA.

    To investigate the inhibition of plasma semicarbazide-sensitive amine oxidase (SSAO) activity by PRX167700.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    The study inclusion criteria are:

    1. Male or female subjects aged between 45 and 75 years inclusive.

    Female subjects are eligible to participate in the study if they are not of child-bearing potential or, if of child-bearing potential, are not pregnant or lactating; agree to use an acceptable method of contraception during the study. Female subjects should have a negative pregnancy test at Screening and Visit 2.

    2. Body Mass Index (BMI) between 20 and 35 kg/m2, inclusive.

    3. Symptomatic primary OA of the knee for at least 3 months prior to Screening according to the American College of Rheumatology (ACR) criteria.

    4. Diagnosis of OA of the knee based on ACR criteria with X-ray confirmation (a Kellgren-Lawrence X-ray grade of ≥2) in the target knee joint. One knee should be designated as the target joint. The pain in the target knee joint should exceed the pain experienced in other joints (including the contralateral knee joint and/or ipsilateral hip joint) and pain experienced from any concomitant medical condition.

    ACR Clinical and radiographic diagnostic criteria consist of knee pain plus osteophytes, plus at least 1 of the following 3 criteria:
    i. Age >50 years
    ii. Morning stiffness <30 minutes in duration
    iii. Crepitus on active motion of the weight-bearing knee.

    5. Use of analgesics for the treatment of knee OA for at least 4 out of 7 days in each of the 4 weeks preceding the Screening visit.

    6. Willing and able to discontinue all current analgesic therapy, including over the counter (OTC) pain medications and topical analgesics for OA pain, for a period beginning at Screening and continuing for the entire duration of the study.

    7. Able to walk 100 metres on a flat course without rest and unaided. A single simple walking stick/cane is permitted (tripod designs and those with forearm support not permitted).

    8. A self-rated PI score in the target knee joint of between 3 and 8, inclusive at Screening, immediately after a timed 100 metres walk on a flat course.

    9. Able to provide written informed consent to participate in the study and, in the opinion of the investigator, able to read, comprehend and record information as required by the protocol.

    10. An increase in Screening Pain Intensity score of at least 1 point in the target knee joint immediately after a timed 100 metres walk on a flat course at Visit 2.

    11. Compliant with placebo dosing instructions during Washout Period.
    E.4Principal exclusion criteria
    1. Secondary causes of arthritis of the knee, including septic arthritis, inflammatory joint disease, crystalline diseases, articular fracture, and inherited disorders.

    2. Disease of the spine or of lower extremity joints (other than OA) which may affect the assessment of pain in the target knee joint.

    3. Pain relating to target knee joint that has characteristics of neuropathic pain (e.g. shooting or burning pain, pins and needles, allodynia).

    4. Has had lower extremity surgery (including arthroscopy) within 6 months prior to Screening or scheduled for surgery of any kind during the study.

    5. Significant injury to the target knee joint within 12 months prior to Screening.

    6. Known history of hypersensitivity or intolerance to paracetamol or lactose.

    7. Corticosteroid injections before Screening:
    i. Intra-articular into the target knee joint within 3 months
    ii. Intra-articular into any site other than the target knee joint within 1 month
    iii. Intra-muscular within 3 months

    8. Oral corticosteroids within 1 month of Screening.

    9. Other therapeutic injections into the target knee joint within previous 3 months.

    10. Use of any anti-inflammatory biological therapy within 12 months or methotrexate within 1 month prior to Visit 2.

    11. Start or change in dosing regimen of other therapies for OA within 3 months of Screening.

    12. Start or change in an established physiotherapy programme within 2 weeks of Screening or during the course of the study. An established physiotherapy program may be continued throughout the study period if unchanged in frequency and intensity.

    13. Any clinical or biological abnormality found at screening (other than those related to OA) 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).

    14. Clinically significant illness other than OA within 3 months prior to Screening.

    15. History of malignancy within past 5 years (except for basal cell carcinoma or carcinoma-in-situ of the cervix treated with curative intent). Subjects with a history of melanoma, leukaemia, lymphoma, or myeloproliferative disease are ineligible for the study regardless of the time since treatment.

    16. QTc ≥450 msec or, for subjects with bundle branch block, QTc >480 msec.

    17. Uncontrolled hypertension at Screening: systolic blood pressure (SBP) >160 mmHg and/or sitting diastolic blood pressure (DBP) >90 mmHg. Hypertension controlled by medications is acceptable, as long as stable for at least one month prior to Screening.

    18. Presence of congestive heart failure (New York Heart Association [NYHA] functional class II-IV).

    19. Bilirubin, alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >1.5 times the upper limit of normal (ULN) or two or more of bilirubin, ALT or AST above the ULN at Screening.

    20. Chronic Hepatitis B or C, as evidenced by positive Hepatitis B surface antigen (HbsAg) or Hepatitis C antibody at Screening.

    21. History of chronic alcoholic liver disease, drug or alcohol dependence.

    22. Renal dysfunction at Screening, defined as estimated glomerular filtration rate <30 ml/min.

    23. Use of potent inducers or inhibitors of CYP3A4 or inhibitors of CYP2D6 within 48 hours or 5 half-lives prior to Visit 2.

    24. Receipt of an investigational product within 30 days or 5 half-lives or twice the duration of the biological effect of the investigational product, whichever is the longer, prior to Visit 2.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is pain at rest and after walking 100 m on a flat course, measured using the 11-point numerical rating scale (NRS).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Study days 0, 1, 3, 7 and 14.
    E.5.2Secondary end point(s)
    Efficacy: WOMAC total score and subscales; Patient Global Impression of Change, time to complete walks, serum CRP levels, and rescue medication use.

    Safety: Safety and tolerability will be evaluated by assessing adverse events (AEs), clinical laboratory data, physical examinations, vital signs, and electrocardiograms (ECGs).

    Pharmacokinetics: The plasma concentration-time profile and pharmacokinetics (PK) parameters of PRX167700 will be determined from plasma samples collected on Day 15 (Visit 7) and from the single plasma sample collected at the end of each visit. Plasma concentration-time profiles and PK parameters, including (but not limited to) Cmax, tmax, area under the plasma concentration vs. time curve from time zero over the dosing interval to 6 hours post-dose (AUC0 tau), AUC0 ∞, and, if possible, t½.will be determined.

    Pharmacodynamics: The inhibition of plasma SSAO activity will be determined and the relationship between plasma drug concentrations, SSAO activity and clinical effects of PRX167700 will be investigated, as data permit.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Study days 0, 1, 3, 7, 14 and 15.
    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 Yes
    E.6.7Pharmacodynamic Yes
    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) 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 Yes
    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 concerned3
    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
    LVLS
    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 months9
    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: 37
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 37
    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 state74
    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)
    Subjects will resume their usual NSAID/simple analgesic therapy.
    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 Decision2013-07-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-07-17
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-08-26
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