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    Summary
    EudraCT Number:2006-004514-40
    Sponsor's Protocol Code Number:KF5503/33-R331333-PAI-3002
    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:2006-11-22
    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 number2006-004514-40
    A.3Full title of the trial
    A Randomized, Double-Blind, Active- And Placebo-Controlled, Parallel Group, Multicenter Study To Evaluate The Efficacy And Safety of Multiple Doses of CG5503 Immediate Release Formulation In Subjects Awaiting Primary Joint Replacement Surgery for End-Stage Joint Disease
    A.3.2Name or abbreviated title of the trial where available
    n.a.
    A.4.1Sponsor's protocol code numberKF5503/33-R331333-PAI-3002
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) Numbern.a.
    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 SponsorJohnson & Johnson Pharamceutical Research & Development, L.L.C.
    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 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 nameCG5503; R331333
    D.3.2Product code CG5503; R331333
    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.3.8INN - Proposed INNtapentadol
    D.3.9.1CAS number 175591-09-0
    D.3.9.2Current sponsor codeCG5503; R331333
    D.3.9.3Other descriptive name(-)-(1R,2R)-3-(3-Dimethylamino-1-ethyl- 2-methyl-propyl)-phenol hydrochloride
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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 nameCG5503; R331333
    D.3.2Product code CG5503; R331333
    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.3.8INN - Proposed INNtapentadol
    D.3.9.1CAS number 175591-09-0
    D.3.9.2Current sponsor codeCG5503; R331333
    D.3.9.3Other descriptive name(-)-(1R,2R)-3-(3-Dimethylamino-1-ethyl- 2-methyl-propyl)-phenol hydrochloride
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number75
    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: 3
    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 OxyNorm 5, 10, 20 mg
    D.2.1.1.2Name of the Marketing Authorisation holderNAPP Pharmaceuticals
    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 nameOxyNorm
    D.3.2Product code n.a.
    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.3.8INN - Proposed INNOxycodone
    D.3.9.2Current sponsor coden.a.
    D.3.9.3Other descriptive namen.a.
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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
    Pain
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 8.1
    E.1.2Level LLT
    E.1.2Classification code 10033371
    E.1.2Term Pain
    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 of this study is to determine the efficacy of CG5503 immediate-release (IR) using the sum of pain intensity difference (SPID) over 5 days compared with placebo, and to assess the safety and tolerability of multiple doses of CG5503 IR in subjects who are eligible for elective primary total or partial joint replacement of the hip or knee due to chronic osteoarthritis.
    The null hypothesis is that all CG5503 IR dosage efficacy results are equal to placebo based on 5 day SPID in the treatment of chronic pain from end-stage degenerative joint disease of the hip or knee. The alternative hypothesis is that at least one CG5503 IR dose effect will be different from placebo effect.
    E.2.2Secondary objectives of the trial
    The secondary objectives include:
    • Compare the effect of CG5503 IR with placebo in time to the first rescue pain medication during the double blind treatment period
    • Evaluate the effect of CG5503 IR with the distribution of responder rates based on percent change from baseline in pain intensity (PI) for each of the time point (Day 2, 5, and 10)
    • Demonstrate the efficacy of CG5503 IR using total pain relief (TOTPAR) and sum of total pain relief and sum of pain intensity difference (SPRID) over 2, 5, and 10 days; and SPID over 2 and 10 days
    • Evaluate patient global impression of change (PGIC) of study treatment at the end of the double blind treatment period
    • Evaluate the adverse event rates across treatment groups (especially nausea and vomiting)
    • Explore sleep quality and bowel movement using questionnaires
    • Explore the efficacy of oxycodone IR in comparison with CG5503 IR and placebo
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Subjects must satisfy the following criteria before entering the study:
    • Man or woman, between 18 and 80 years of age, inclusive
    • Signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study
    • In countries where pharmacogenomics testing is allowed, signed an informed consent for genetic testing, indicating whether they do or do not wish to participate in the genetic part of the study. Participation in the genetic testing component is not mandatory for participation in the study
    • Able to complete all study-related procedures and requirements throughout the double-blind treatment period
    • Clinical diagnosis of osteoarthritis of the hip or the knee based on clinical and radiographic criteria defined by standard accepted guidelines; radiographic evidence of osteoarthritis of the target joint must be recorded within the previous 12 months. NOTE: the same target joint must be evaluated throughout the study
    • Subjects with noninflammatory, end-stage degenerative joint disease who should need and be waiting for primary unilateral total or partial joint replacement surgery in the opinion of the investigator. Subjects who were offered joint replacement surgery but declined for reasons not associated with exclusion criteria are allowed. (NOTE: the same target joint must be evaluated throughout the study)
    • Require daily doses of analgesic medication for chronic pain that is consistent with or makes them candidates for treatment at Step 2 or higher of the WHO Pain Relief Ladder, including subjects who require daily analgesia but cannot tolerate taking daily nonopioid analgesic medication. The subject should be dissatisfied with their current analgesic treatment.
    • Before randomization on Day 1, pain is not adequately controlled with the current stable analgesic regimen based on the following criteria:
    – Mean PI is equal or greater than 5 (after rounding 4.5 and above to an integer) on an 11-point (0 to 10) NRS during the last 3 days of pain assessments during the run-in period
    – Minimum single assessment PI score is equal or greater than 3 during the last 3 days of pain assessments during the run-in period
    • Women must be postmenopausal, surgically sterile, or practicing or agree to practice an effective method of birth control if they are sexually active before entry and throughout the study (effective methods of birth control include prescription hormonal contraceptives, intrauterine devices, double-barrier method, and male partner sterilization). Women of childbearing potential must have a negative serum
    ß human chorionic gonadotropin (ß-hCG) pregnancy test at screening and a negative urine pregnancy test at randomization on Day 1
    • Subjects must use satisfactory contraception from first dose up to 7 days after last dose of study treatment
    E.4Principal exclusion criteria
    • History of seizure disorder or epilepsy suggested by the presence of any of the following:
    – Mild or moderate traumatic brain injury, stroke, transient ischemic attack, or brain neoplasm within 1 year of screening, or
    – Severe traumatic brain injury, episode(s) of unconsciousness of more than 24 hours duration or posttraumatic amnesia of more than 24 hours duration within 15 years of screening
    • Received an experimental drug or used an experimental medical device within 28 days before screening or have participated in a previous study of CG5503
    • Participated in 3 or more clinical trials of analgesics before this study
    • History of alcohol and/or drug abuse in the investigator's judgment based on subject history and physical examination
    • Pending litigation due to history of chronic pain or disability
    • History of chronic hepatitis B and C or human immunodeficiency virus, or presence of active hepatitis B and C within the past 3 months before screening
    • Treated with anticonvulsants, monoamine oxidase inhibitors, tricyclic antidepressant, neuroleptics, or serotonin norepinephrine reuptake inhibitors within two weeks prior to screening (selective serotonin reuptake inhibitors treatments are allowed if taken for at least 28 days before screening at an unchanged dose)
    • Received treatment with a controlled-release opioid analgesic (e.g., extended-release) within 28 days before screening
    • Received treatment with an IR opioid analgesic taken 5 days or more each week during the previous 28 days before screening. Products containing IR opioid analgesics taken 4 days each week or less are allowed
    • Products containing IR opioid analgesics must be discontinued prior to the run-in period. The non-opioid component of combination products may be continued during the study.
    • History of malignancy within the past 2 years, with the exception of basal cell carcinoma
    • Concomitant autoimmune inflammatory conditions involving the target joint
    • Acute crystal-induced arthropathy within the past 6 months before screening
    • Systemic steroid therapy, excluding inhalers, within 4 weeks before screening
    • Presence of any of the following:
    – Major trauma to the target joint in the 6 months preceding study screening
    – Infection in the target joint in the 6 months preceding study screening
    – Apparent avascular necrosis in the target joint in the 6 months preceding study screening
    – Intra-articular injections of corticosteroids or hyaluronan injections in the target joint in the 3 months preceding study entry
    • Women who plan to become pregnant during the study, or who are breast feeding
    • Laboratory values reflecting moderate or severe renal insufficiency
    • Moderately or severely impaired hepatic function, or subjects with alanine aminotransaminase (ALT) or aspartate aminotransferase (AST) greater than 3 times the upper limit of normal (ULN)
    • Contraindication to, or history of allergy to, or hypersensitivity to CG5503, oxycodone, or their excipients
    • Plan to undergo surgery or other procedures during the course of the study
    • Has a clinically significant disease that in the investigator's opinion may affect efficacy or safety assessments
    • Employees of the investigator or study center, with involvement in the proposed study or other studies under the direction of that investigator or study center, including family members of the employees or the investigator
    E.5 End points
    E.5.1Primary end point(s)
    The measurements used for the efficacy evaluations in this study include PI, pain relief, and the PGIC. The details are presented below.
    • Pain Intensity – 11 Point Numerical Rating Scale
    The subject will indicate the current PI on a 11-point (0 to 10) NRS in response to the following question: “What is your pain level for the past 12 hours?”
    • Pain Relief – 5-Point Numerical Rating Scale
    The subject will indicate their pain relief on a 5-point (0 to 4) NRS at the same time points as PI in response to the following question: “How much relief have you had from your starting pain?”
    • Patient Global Impression of Change
    The subjects will indicate their response (1 to 7) to the following statement: "Since I began study medication, my overall status is:"
    The primary efficacy variable is the 5-day SPID.
    • Pain Intensity Difference
    The pain intensity difference (PID) will be calculated at each assessment time point, using the following formula: PID=Baseline PI-Current PI, where baseline PI is the mean PI collected during the last 3 days of pain assessments during the run-in period.
    • Sum of Pain Intensity Difference
    The SPID will be calculated over 5, days using the following formula: SPID=∑Wi*PIDi;
    where the sum includes all observations collected from baseline to the end of Day 5 and Wi is the time elapsed from the previous observation (PIDi-1) to the current observation (PIDi).
    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 Yes
    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) 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) Yes
    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 concerned6
    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 Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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
    The study is considered completed with the last visit of the last subject undergoing the study.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    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 months7
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2006-11-22. Yes
    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 state100
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 100
    F.4.2.2In the whole clinical trial 624
    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)
    After a subject has ended his/her participation in the trial, standard treatment will be administered, if treatment is required.
    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 Decision2006-12-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-02-14
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2007-08-22
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
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