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    Summary
    EudraCT Number:2006-006911-60
    Sponsor's Protocol Code Number:42801PAI3001
    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:2007-05-15
    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 number2006-006911-60
    A.3Full title of the trial
    Randomised, double-blind, placebo-controlled, parallel-group trial to investigate the analgesic effect of OROS hydromorphone hydrochloride in comparison with placebo in subjects with moderate to severe pain induced by osteoarthritis of the hip or the knee
    A.3.2Name or abbreviated title of the trial where available
    HOP Trial
    A.4.1Sponsor's protocol code number42801PAI3001
    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 SponsorJanssen-Cilag International N.V.
    B.1.3.4CountryBelgium
    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 Jurnista 8mg
    D.2.1.1.2Name of the Marketing Authorisation holderJanssen-Cilag A/S
    D.2.1.2Country which granted the Marketing AuthorisationDenmark
    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 nameOROS hydromorphone hydrochloride
    D.3.4Pharmaceutical form Prolonged-release 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 INNhydromorphone hydrochloride
    D.3.9.1CAS number 71-68-1
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number8
    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 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 nameOROS hydromorphone hydrochloride
    D.3.4Pharmaceutical form Prolonged-release 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 INNhydromorphone hydrochloride
    D.3.9.1CAS number 71-68-1
    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.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboProlonged-release 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
    moderate to severe pain induced by osteoarthritis of the hip or the knee
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10003239
    E.1.2Term Arthralgia
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To compare the analgesic effect of OROS hydromorphone hydrochloride with placebo in subjects with moderate to severe pain induced by osteoarthritis (OA) of the hip or knee which has not been adequately controlled by previous treatment with nonsteroidal anti-inflammatory drugs (NSAIDs) or paracetamol. This will be assessed by the Brief Pain Inventory (BPI) item 5 “pain on average”.
    E.2.2Secondary objectives of the trial
    • To assess the drop-out rate due to adverse events
    • To assess the effect of treatment on subjects’ functionality using the total score of the WOMAC OA index
    • To assess the effect of treatment on pain using the pain subscales of the WOMAC OA index and the SF-36 and the items 3, 4 and 6 of the BPI
    • To assess the effect of treatment on subjects’ HRQoL, which will be assessed using all subscales, except pain, of the instrument SF-36
    • To assess the effect of treatment on subjects’ functional impairment and stiffness using these subscales of the WOMAC OA index
    • To assess the effect of treatment on subjects’ quality of sleep using a MOS sleep subscale score
    • To assess the overall safety and tolerability of the drug by measurement of vital signs and continuous monitoring of adverse events
    • To compare the drop-out rate due to adverse events in the active group with drop-out rates observed in other trials that have used a higher starting dose
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) Male or female older than 40 years of age
    2) Female subjects must be postmenopausal (for at least one year), surgically sterile, abstinent, or if sexually active, be practicing an effective method of birth control (e.g., prescription oral contraceptives, contraceptive injections, intrauterine device, double-barrier method, contraceptive patch, male partner sterilisation) before entry into the study and throughout the study’s duration; women of childbearing potential must have a negative serum beta human chorionic gonadotropin (beta-hCG) pregnancy test at screening, and a negative urine pregnancy test at visit 8 (week 16)
    3) Subjects must have signed an informed consent form indicating that they understand the procedures required for the study and their purposes, and are willing to participate in the study
    4) Documented OA of the hip or knee (as defined by the American College of Rheumatology [24, 25]), with radiological evidence of OA from the target joint
    5) Chronic pain for more than 3 months treated with daily analgesic for the last month
    6) Moderate to severe OA pain of the target joint, not adequately controlled with NSAIDs or paracetamol in the month before the beginning of the study
    7) The following inclusion criterion will be checked at baseline visit:
    Mean weekly score of ≥ 5 (on a scale of 0–10) in the BPI item 5 “pain on average” which will be calculated as a mean of the pain assessments collected at screening visit (week –1), telephone call (week -0,5) and baseline visit (week 0)
    E.4Principal exclusion criteria
    1) Regular treatment with an opioid in the 4 weeks before screening visit. (Infrequent use of tramadol, codeine, tilidine, or dihydrocodeine for no more than 10 days in the 4 weeks before the screening visit is acceptable. However, subjects should stop any use of weak opioids at screening visit).
    2) History of allergy or hypersensitivity to hydromorphone or other opioid analgesic drugs
    3) Diagnosis of major depression
    4) Treatment for epilepsy
    5) Treatment with sedative hypnotics, anaesthetics, neuroleptics, or muscle relaxants (the exception to this is low dose sedative hypnotics with the sole purpose of helping to aid night rest).
    6) Corticosteroid injections in the 3 months before the start of the study
    7) Documented or suspected alcohol or drug abuse, or are suspected of having an addictive personality in the investigator’s judgement
    8) Another type of continuous pain that stands out in comparison with OA pain such as fibromyalgia, cervical radiculopathy, or chronic low back pain
    9) Any of the following in the 6 months before entering the study:
    - Major trauma to the target joints
    - Infection in the target joints
    - Radiologically apparent avascular necrosis in the target joints
    - Hyaluronan injections in the target joints
    10) Major surgery in the 3 months before the start of the study
    11) Arthrodesis in the year or arthroscopy in the 2 months before entering the study
    12) Subjects who have started any form of physiotherapy, psychological therapy for pain, massage, use of a transcutaneous electrical nerve stimulation (TENS) machine, acupuncture, or physical therapy in the 3 weeks before the run-in period. Such therapies can continue if they were started more than 3 weeks before the start of the run-in period and must be continued at the same frequency of administration throughout the study and must be recorded on subjects’ case report forms (CRFs)
    13) Planned treatment that could alter the degree of pain within the study period
    14) Subjects known to have any of the following:
    - Chronic obstructive respiratory symptoms or susceptibility to respiratory depression
    - Significantly abnormal renal or hepatic function documented in medical records (a significant laboratory result, no older than 6 months for severe renal impairment: twice the upper limit of normal serum creatinine or creatinine clearance < 10 mL/min, or for severe hepatic impairment five times the upper limit of normal serum transaminases [ALT or AST]. In the absence of laboratory data for renal or hepatic function or if data is older than 6 months, the tests should be done at screening)
    - Any disease or condition that may compromise the function of those body systems that could result in altered absorption, excess accumulation, impaired metabolism, or impaired excretion of the study drug
    15) Received an experimental drug or used an experimental medical device within the 30 days before entering the study
    16) Unable to comply with the study assessments and complete the questionnaires
    17) Female subjects who are pregnant or breastfeeding
    18) Subjects who have had GI resection or this kind of surgery planned during the trial
    19) Subjects who are being treated with buprenorphine, nalbuphine, or pentazocine
    20) Subjects who are being treated with monoamine oxidase (MAO) inhibitors or if treatment discontinued within 14 days of the start of the study
    21) Subjects with acute life-threatening or poorly controlled diseases
    22) Relatives of the investigator and his team and employees of the study centre
    E.5 End points
    E.5.1Primary end point(s)
    Efficacy will be assessed by recording the subjects’ mean score in the BPI item 5 “pain on average”, which will be recorded at each study visit. This will be recorded at each study visit and analysed using a mixed model for repeated measures (MMRM).
    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 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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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.8.3 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 Yes
    E.8.5.1Number of sites anticipated in the EEA20
    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 months4
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months4
    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 state60
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 270
    F.4.2.2In the whole clinical trial 270
    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 Decision2007-05-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-07-12
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2008-04-16
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    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.

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