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    Summary
    EudraCT Number:2011-002901-31
    Sponsor's Protocol Code Number:OXN2504
    National Competent Authority:Hungary - National Institute of Pharmacy
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2011-10-13
    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 ConcernedHungary - National Institute of Pharmacy
    A.2EudraCT number2011-002901-31
    A.3Full title of the trial
    A multicentre, double-blind, randomised, placebo controlled study to determine the efficacy and tolerability of OXN PR for the treatment of severe Parkinson’s disease associated pain
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    not applicable
    A.3.2Name or abbreviated title of the trial where available
    A randomised placebo controlled study of OXN PR for severe Parkinson’s disease associated pain
    A.4.1Sponsor's protocol code numberOXN2504
    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 SponsorMundipharma Research GmbH & Co. KG
    B.1.3.4CountryGermany
    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 supportMundipharma Research GmbH & Co. KG
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMundipharma Research GmbH & Co. KG
    B.5.2Functional name of contact pointMichael Hopp
    B.5.3 Address:
    B.5.3.1Street AddressHoehenstrasse 10
    B.5.3.2Town/ cityLimburg / Lahn
    B.5.3.3Post code65594
    B.5.3.4CountryGermany
    B.5.4Telephone number+496431701438
    B.5.5Fax number+4964317018438
    B.5.6E-mailmichael.hopp@mundipharma-rd.eu
    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 Targinact 5 mg/2.5 mg prolonged-release tablets
    D.2.1.1.2Name of the Marketing Authorisation holderNapp Pharmaceuticals Limited
    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 nameoxycodone/naloxone prolonged release tablets 5 mg /2.5 mg
    D.3.2Product code OXN 5 mg/2.5 mg PR
    D.3.4Pharmaceutical form Prolonged-release tablet
    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 INNOxycodone hydrochloride
    D.3.9.1CAS number 124-90-3
    D.3.9.3Other descriptive nameOXYCODONE HYDROCHLORIDE
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5.0
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNaloxone Hydrochloride Dihydrate
    D.3.9.1CAS number 357-08-4
    D.3.9.2Current sponsor code51481-60-8
    D.3.9.3Other descriptive nameNALOXONE HYDROCHLORIDE DIHYDRATE
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2.5
    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.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 Yes
    D.2.1.1.1Trade name Targinact 10 mg/5 mg prolonged-release tablets
    D.2.1.1.2Name of the Marketing Authorisation holderNapp Pharmaceuticals Limited
    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 nameoxycodone/naloxone prolonged release tablets 10 mg /5 mg
    D.3.2Product code OXN 10 mg / 5 mg PR
    D.3.4Pharmaceutical form Prolonged-release tablet
    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 INNOxycodone Hydrochloride
    D.3.9.1CAS number 124-90-3
    D.3.9.3Other descriptive nameOXYCODONE HYDROCHLORIDE
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10.0
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNaloxone Hydrochloride Dihydrate
    D.3.9.1CAS number 357-08-4
    D.3.9.2Current sponsor code51481-60-8
    D.3.9.3Other descriptive nameNALOXONE HYDROCHLORIDE DIHYDRATE
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5.0
    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.IMP: 3
    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 Targinact 20 mg/10 mg prolonged-release tablets
    D.2.1.1.2Name of the Marketing Authorisation holderNapp Pharmaceuticals Limited
    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 nameoxycodone/naloxone prolonged release tablets 20 mg /10 mg
    D.3.2Product code OXN 20 mg / 10 mg PR
    D.3.4Pharmaceutical form Prolonged-release tablet
    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 INNOXYCODONE HYDROCHLORIDE
    D.3.9.1CAS number 124-90-3
    D.3.9.3Other descriptive nameOXYCODONE HYDROCHLORIDE
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20.0
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNALOXONE HYDROCHLORIDE DIHYDRATE
    D.3.9.1CAS number 357-08-4
    D.3.9.2Current sponsor code51481-60-8
    D.3.9.3Other descriptive nameNALOXONE HYDROCHLORIDE DIHYDRATE
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10.0
    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.IMP: 4
    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 nameoxycodone/naloxone prolonged release tablets 15 mg/7.5 mg
    D.3.2Product code OXN 15 mg /7.5 mg PR
    D.3.4Pharmaceutical form Prolonged-release tablet
    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 INNOxycodone hydrochloride
    D.3.9.1CAS number 124-90-3
    D.3.9.3Other descriptive nameOXYCODONE HYDROCHLORIDE
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number15
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNaloxone hydrochloride dihydrate
    D.3.9.1CAS number 357-08-4
    D.3.9.2Current sponsor code51481-60-8
    D.3.9.3Other descriptive nameNALOXONE HYDROCHLORIDE DIHYDRATE
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number7.5
    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 placeboProlonged-release tablet
    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 placeboProlonged-release tablet
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 3
    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
    D.8 Placebo: 4
    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
    Subjects will have idiopathic Parkinson's disease and be suffering from severe PD associated pain.
    E.1.1.1Medical condition in easily understood language
    Severe pain associated with Parkinson's disease.
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10013113
    E.1.2Term Disease Parkinson's
    E.1.2System Organ Class 100000004852
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To demonstrate superiority of OXN PR compared to placebo with respect to analgesic efficacy in subjects with chronic severe pain associated with Parkinson's disease (PD), as assessed by averaged 24 hour pain scores collected for 7 days prior to the clinic visits
    E.2.2Secondary objectives of the trial
     To demonstrate improvement in the subject's condition, relative to baseline, as measured on the Clinical Global Impression – Improvement scale (CGI-I) and separately the Patient Global Impression – Improvement scale (PGI-I)
     To assess the effect of OXN PR on motor symptoms of PD
     To assess the effect of OXN PR on non-motor symptoms of PD
     To assess the effect of OXN PR on dyskinesia
     To assess the effect of OXN PR on sleep
     To assess the effect of OXN PR on Quality of Life
     To assess the tolerability of OXN PR
     To assess the frequency of rescue medication intake
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Pharmacogenomic sub-study:
    Under a separate informed consent process, subjects will be invited to consent to blood sampling for pharmacogenomic testing. The collected blood samples will be anonymised and stored for future analysis. The consent to pharmacogenomic sampling is completely separate from the main study and subjects will be able to take part in the main study without consenting to pharmacogenomic blood sampling. Blood sampling must take place prior to receiving any dose of study medication.
    Pharmacogenomic samples will be stored at the Clinical Laboratory to provide a resource for future studies to investigate the influence of genetics on response to drugs. Variants in genes of drug targets (such as the opioid receptors) or genes involved in signalling pathways may affect drug efficacy. Similarly, variations in genes involved in the metabolism of compounds (e.g. Cytochrome P450 2D6), may have an influence on the bioavailability of compounds which could lead to increased side effects, or alteration of drug efficacy. Some drugs may therefore be more effective in certain subject groups, or may cause more side effects in certain subjects, depending on genetic makeup. All pharmacogenomic samples will be used by the Sponsor or designees and research will be monitored and reviewed by a committee of scientists and clinicians.
    E.3Principal inclusion criteria
    Screening/Double-Blind Phase Inclusion Criteria
    1. Males and females, age of 25 years or over (the Double-Blind Phase rescue medication is not licensed for use in under 25 year olds)
    2. Able to provide written informed consent
    3. Primary diagnosis of Parkinson‘s disease diagnosed by an expert as determined by the UK Parkinson's Disease Society Brain Bank Clinical Diagnostic Criteria (1992)
    4. Parkinson‘s disease Stage II-IV (Hoehn & Yahr staging system)
    5. Severe pain graded in at least 1 of the sub sections of the Chaudhuri and Schapira (2009) pain classification system
    6. An average pain score of 6 or above on an 11 point NRS, over the previous 7 days determined using diary scores of averaged 24 hour pain in the 7 days leading up to Randomisation (assessed at Visit 2)
    7. Female subjects less than one year post-menopausal must have a negative serum or urine pregnancy test recorded prior to the first dose of study medication, be non-lactating, and willing to use an adequate and highly effective method of contraception throughout the study. A highly effective method of birth control is defined as those which result in a low failure rate (i.e. less than 1% per year) when used consistently and correctly such as sterilisation, implants, injectables, combined oral contraceptives, some IUDs (hormonal), sexual abstinence or vasectomised partner. Subjects who have had a hysterectomy, sterilisation or who the Investigator is certain to be post-menopausal (e.g. are elderly) do not need to be tested.
    8. Subjects who, based on the Investigators‘ judgement, are likely to benefit from WHO step III opioid therapy for the duration of the study (see Appendix 18.3. )
    9. Subjects must not have received opioid containing medication in the last 6 months on a regular basis (i.e. prescribed medication or more than occasional self medication use for cough, cold etc.)
    10. Receiving stable treatment for Parkinson‘s disease for at least 4 weeks prior to randomisation, the dose of which is expected to remain consistent throughout the Double-Blind Phase
    11. In the Investigator‘s opinion, the subject does not have visual or auditory impairments that would reduce their ability to complete study questionnaires or be unable to receive instructions for these
    12. Concomitant medication (including co-analgesic) use anticipated to remain stable throughout the Double-Blind Phase of the study
    13. Subjects willing and able to participate in all aspects of the study and comply with the use of study medication.

    Open-Label Extension Inclusion Criteria
    The aim of the Open-Label Phase is to ensure a safe transfer of all subjects to a subsequent pain treatment after the study. Subjects must:
    1. Still meet general inclusion criteria for Double-Blind Phase; subjects do not have to meet inclusion 5, 6, 9 & 12
    2. Have completed the Double-Blind Phase or discontinued early but have had at least 8 weeks treatment with study medication.
    E.4Principal exclusion criteria
    Medical Conditions
    1. Cognitive impairment as assessed with the MMSE scoring 24 or less
    2. History of psychosis (hallucinations, delusions, etc.)
    3. History of drug or alcohol abuse or current compulsive addictive use of drugs or alcohol
    4. Parkinsonian-like disease secondary to drug therapy side-effects e.g. due to exposure to medications that deplete dopamine (reserpine, tetrabenazine) or block dopamine receptors (neuroleptics, antiemetics)
    5. Parkinson-plus syndromes e.g. progressive supranuclear palsy (PSP) and the multiple system atrophies (MSA)
    6. Females who are pregnant (positive β-hCG test) or lactating
    7. Any other contraindications to use of the opioid study medication(s) as per the SmPC/IB:
     Hypersensitivity to the active substances or to any of the excipients
     Any situation where opioids are contraindicated
     Severe respiratory depression with hypoxia and/or hypercapnia
     Severe chronic obstructive pulmonary disease
     Cor pulmonale
     Severe bronchial asthma
     Non-opioid induced paralytic ileus
     Moderate to severe hepatic impairment (see exclusion criterion 16)
    8. Any other contraindications to use of the study Double-Blind Phase rescue medication as per the SmPC:
     known hypersensitivity to levodopa or benserazide
     contra-indicated in narrow-angle glaucoma (it may be used in wide-angle glaucoma provided that the intra-ocular pressure remains under control); severe psychoneuroses or psychoses; severe endocrine, renal, hepatic or cardiac disorders
     should not be given in conjunction with, or within 2 weeks of withdrawal of, monoamine oxidase (MAO) inhibitors, except selective MAO-B inhibitors (e.g. selegiline) or selective MAO-A inhibitors (e.g. moclobemide) unless selective MAO inhibitors are given in combination in which case it is contraindicated
     not be used in persons who have a history of, or who may be suffering from, a malignant melanoma
    9. Subjects with any of the following as determined by medical history, clinical laboratory tests, ECG results, and physical examination, that would place the subject at risk upon exposure to the study medication:
     myxoedema
     untreated hypothyroidism
     Addison`s disease
     increase of intracranial pressure
     uncontrolled seizures or convulsive disorder
     evidence of clinically significant cardiovascular, renal, hepatic, gastrointestinal (e.g. paralytic ileus), or psychiatric disease (subjects with controlled co-morbidities may be included following agreement with the Medical Monitor)
    Contraindicated Treatments
    10. Treatment with Deep Brain Stimulation
    11. Subjects receiving hypnotics or other central nervous system (CNS) depressants that, in the Investigator‘s opinion, may pose a risk of additional CNS depression with opioids study medication
    12. Subjects presently taking, or who have taken, naloxone or naltrexone  30 days prior to the Screening Visit
    13. Subjects who have received an investigational medicinal product within 30 days of study entry (defined as the start of the Screening Phase)
    14. Any current use of an opioid other than the study medication provided
    15. Subjects with a positive urine drug test at Screening Visit 1, which indicates unreported illicit drug use or unreported use of a concomitant medication not required to treat the Subjects‘ medical condition(s)
    Laboratory Exclusions
    16. Abnormal parameters as defined:
     aspartate aminotransferase (AST; SGOT) > 3 times the upper limit of normal
     alanine aminotransferase (ALT; SGPT) > 3 times the upper limit of normal
     alkaline phosphatase levels > 3 times the upper limit of normal
     gamma glutamyl transpeptidase (GGT or GGTP) > 3 times the upper limit of normal
     Abnormal total bilirubin and/or creatinine level(s) > 1.5 times the upper limit of normal. Subjects whose total bilirubin levels or creatinine levels are below the lower limit of normal can participate in the study if they meet the criteria below:
    Bilirubin as well as creatinine values below the lower limit of normal are not necessarily a criterion for an impairment of organ function. Therefore values out of the lower normal range do not automatically lead to an exclusion of the subject from the study. The decision to exclude/discontinue a subject from the study due to bilirubin as well as creatinine levels below the lower limit of normal should be based on the medical judgment of the Investigator and based on the presence or absence of pathophysiological impairment of the respective organs.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint for the primary comparison of OXN PR vs. placebo:
     Averaged 24 hour pain scores collected for 7 days preceding the study clinic visit (week 16)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Evaluation after study end. No interim analysis planned
    E.5.2Secondary end point(s)
    The following key secondary endpoints for the primary comparison of OXN PR vs. placebo will be tested in a hierarchical testing strategy:
     Averaged 24 hour pain scores collected for the 7 days preceding individual clinic visits during the Double-Blind Phase
     Percentage of responders (defined as a ≥30% reduction from baseline) in averaged 24 hour pain scores collected for 7 days preceding the study clinic visit at week 16
     CGI-I: Percentage of responders (defined as a response of 'Much improved‘ or 'Very much improved‘) on the CGI-I scale (as defined by the Investigator)

    Other exploratory endpoints:
     Percentage of responders (defined as a response of ‘Much improved’ or ‘Very much improved’) on the PGI-I scale (as defined by the subject)
     Change from baseline in the total score and domains of the Non Motor Symptom Assessment Scale for Parkinson’s Disease to the end of the Double-Blind Phase (week 16)
     Change from baseline in the total score of the UPDRS Part III/IV Motor Examination to the end of the Double-Blind Phase (week 16)
     Change from baseline in percentage of subjects meeting wearing off criteria (defined as the presence of at least one symptom in the WOQ-9 with improvement after the next dose of anti-Parkinsonian medication)
     Change from baseline in the total score of the CISI-PD to the end of the Double-Blind Phase (week 16)
     Frequency of rescue medication use during the Double-Blind Phase
     Change from baseline in the total score of the PDSS-2 to the end of the Double-Blind Phase (week 16)
     Change from baseline in the total score of the PDQ-8 to the end of the Double-Blind Phase (week 16)
     Change from baseline in EQ-5D index score to the end of the Double-Blind Phase (week 16)
     Change from baseline in the anxiety domain score of the HADS to the end of the Double-Blind Phase (week 16)
     Change from baseline in the depression domain score of the HADS to the end of the Double-Blind Phase (week 16)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Evaluation after study end. No interim analysis planned
    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 Yes
    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 Yes
    E.8.1.7.1Other trial design description
    Double-blind phase is followed by open-label phase
    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 concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA59
    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
    last visit of last subject
    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 months6
    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 months6
    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.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 105
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 105
    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 state70
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 210
    F.4.2.2In the whole clinical trial 210
    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)
    The aim of the Open-Label Phase is to ensure a safe transfer of all subjects to a subsequent pain treatment after the study. All subjects will start the Open-Label Phase on a dose of OXN5/2.5 mg PR twice daily. Subjects will be supplied OxyIR for immediate relief from exacerbation of pain and to avoid any symptoms of opioid withdrawal. Subjects may titrate to a maximum daily dose of OXN20/10 mg PR twice daily.
    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 Decision2011-12-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-12-14
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-11-05
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