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    Summary
    EudraCT Number:2008-004794-18
    Sponsor's Protocol Code Number:KF6005/02
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2008-11-18
    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 ConcernedGermany - BfArM
    A.2EudraCT number2008-004794-18
    A.3Full title of the trial
    A randomized Phase IIa trial evaluating the safety and efficacy of a new centrally acting analgesic in subjects with pain due to diabetic polyneuropathy
    A.4.1Sponsor's protocol code numberKF6005/02
    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 SponsorGrünenthal GmbH
    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 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 nameGRT6005 hemi-citrate oral solution in Macrogol 400 (400 µg GRT6005 / mL)
    D.3.2Product code GRT6005
    D.3.4Pharmaceutical form Oral solution
    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.3.9.2Current sponsor codeGRT6005
    D.3.9.3Other descriptive name6’-Fluoro-4’,9’-dihydro-N,N-dimethyl-4-phenyl-spiro[cyclohexane-1,1’(3’H)-pyrano[3,4-b]indol]-4-amin
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number400
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name MST Continus
    D.2.1.1.2Name of the Marketing Authorisation holderMundipharma GmbH
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 nameOver-encapsulated Morphine sulphate prolonged-release capsules 60 mg (MST Continus®)
    D.3.4Pharmaceutical form Capsule*
    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 INNMORPHINE SULPHATE
    D.3.9.3Other descriptive nameMORPHINE SULPHATE
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number60
    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 placeboOral solution
    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 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
    painful diabetic polyneuropathy
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10012685
    E.1.2Term Diabetic polyneuropathy
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the analgesic efficacy of GRT6005 in subjects with moderate to severe pain due to diabetic polyneuropathy
    E.2.2Secondary objectives of the trial
    To evaluate the safety and tolerability of GRT6005 and to evaluate the relationship between plasma concentration and analgesic efficacy of GRT6005
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Subjects must already have signed an Informed Consent Form. Subjects willing to participate in DNA research must have signed the separate Informed Consent Form for DNA research (where local regulations permit).
    2. Male or female Caucasian or Hispanic subjects aged 18 years to 75 years inclusive.
    3. All subjects must have type 1 or type 2 diabetes mellitus, and must have a documented clinical diagnosis of painful DPN with symptoms and signs for at least 3 months, and pain present at the time of Enrollment.
    4. The Investigator considers the subject’s blood glucose to be well controlled by a diet, oral hypoglycemics, or insulin for at least 3 months prior to enrolling in the trial. This control should be documented by a concentration of glycosylated hemoglobin (HbA1C) no greater than 9.5% at the Enrollment Visit.
    5. Subjects that have been taking opioid or non opioid analgesic medication for the painful DPN before the Enrollment Visit must be dissatisfied with their current treatment.
    6. A daily average pain intensity score of ≥4 on the 11 point NRS on at least 3 consecutive days without the use of rescue medication within the 5 day Enrollment Pain Intensity Evaluation Period.
    7. Male subjects have to use barrier contraception (condom) during sexual intercourse with females, and no sexual intercourse with females who are pregnant or lactating will be allowed from the time of dosing of GRT6005 hemi-citrate until 1 month after the final Treatment Period.
    Sexually active female subjects must be postmenopausal for at least 2 years, surgically sterile, or practicing an effective method of birth control (e.g., prescription oral contraceptives, contraceptive injections, intrauterine device, double-barrier method, contraceptive patch, male partner sterilization) before entry and 1 month after the final Treatment Period.
    Women of childbearing potential must have a negative urine β-human chorionic gonadotropin (β-hCG) pregnancy test at the Enrollment Visit and at the Baseline Visit.
    E.4Principal exclusion criteria
    Subjects who meet any of the following criteria will be excluded from participating in the trial:
    General:
    1. Concurrent participation in another trial, or within 3 months of enrollment into this trial.
    2. Previous participation in this or other trials with GRT6005.
    3. History of or current alcohol or drug abuse according to the Investigator’s judgment, based on subject history and physical examination.
    4. Known or suspected of not being able to comply with the protocol and with the use of the IMP.
    5. Female subjects who are pregnant or breastfeeding.
    6. Any clinically significant disease that in the Investigator's opinion may affect efficacy or safety assessments or may compromise the subject’s safety during trial participation, such as, e.g., significant pulmonary, gastrointestinal, endocrine, metabolic (with the exception of diabetes mellitus), neurological, psychiatric disorders (for instance, Alzheimer’s disease, major depression and psychosis).
    7. Employees of the Investigator or trial site, with direct involvement in the proposed trial or other trials under the direction of that Investigator or trial site, as well as family members of employees or the Investigator.
    8. Subjects with impaired hepatic function determined by international normalized ratio of prothrombin time greater than 1.7 and bilirubin greater than 2.0 mg/dL and albumin lower than 2.8 g per dL or impaired hepatic function with alanine aminotransferase (ALT) or aspartate aminotransferase (AST) greater than 3-fold the upper limit of normal (ULN).
    9. History of moderate to severe hepatic impairment; chronic hepatitis B or C, presence of active hepatitis B or C within the past 3 months.
    10. Subjects with impaired renal function as determined by chronic kidney disease stage higher than 2 (K/DOQI Clinical Practice Guidelines for Chronic Kidney Disease 2002).
    11. Any chronic gastrointestinal disease or previous major abdominal surgery (e.g., Billroth procedure or enteroanastomosis) that might affect drug absorption, or excretion.
    12. Significant cardiac disease (e.g., unstable angina pectoris, angina pectoris Canadian Cardiovascular Society (CCS) Class III IV, acute myocardial infarction within the last 3 months, cardiac insufficiency New York Heart Association (NYHA) Class III IV).
    13. At the Enrollment Visit and the Baseline Visit, electrocardiogram (ECG) with clinically relevant findings, e.g., marked repolarization abnormality (e.g., suspicious or definite congenital long QT syndrome) and/or QT values of: QTcF for females ≥450 ms, QTcF for males ≥430 ms, uncorrected QT ≥500 ms.
    14. Any of the following within 1 year: mild/moderate traumatic brain injury, stroke, transient ischemic attack, brain neoplasm. Severe traumatic brain injury within the last 15 years (consisting of 1 or more of the following: brain contusion, intracranial hematoma, either unconsciousness or posttraumatic amnesia lasting more than 24 h) or residual sequelae suggesting transient changes in consciousness. Life long history of seizure disorder or epilepsy.
    15. History of malignancy within the past 2 years, with the exception of basal cell carcinoma that has been treated and is no longer present.
    16. Subjects unable to discontinue, due to deterioration of the underlying disease or withdrawal symptoms, any of the prohibited medications.
    17. Subjects whose body weight is lower than 50 kg.
    Trial specific
    1. Past or pending litigation due to chronic pain or disability.
    2. Any scheduled surgery or painful procedure during the course of the trial that, in the opinion of the Investigator, may affect efficacy or safety assessments.
    3. Clinically relevant history of hypersensitivity, allergy, or contraindications to opioids, paracetamol and Macrogol 400 Ph.Eur.
    4. Presence of conditions other than painful DPN that could contribute to pain or confound the assessment of self-evaluation of pain, for instance fibromyalgia, complex regional pain syndrome, phantom pain, significant skin conditions such as abscesses, significant osteoarthritis, low back pain, inflammation (e.g., rheumatoid arthritis, ankylosing spondylitis), and vasculitis.
    5. Significant vascular disease (e.g., peripheral occlusive arterial disease, Fontaine Class III–IV; venous insufficiency, post thrombotic syndrome, Stage III/IV).
    6. Severe or extensive diabetic ulcers or amputations (more than 2 toes) of the limbs, or Charcot joints.
    7. Conditions which require treatment with prohibited medication.
    E.5 End points
    E.5.1Primary end point(s)
    Reduction from Baseline in average daily pain intensity score (over the last 24 h) measured with the 11 point NRS at the final treatment day of each treatment period, in comparison to placebo.
    On the basis of data from different doses, a dose response relationship will be assessed. When plasma levels are above the lower limit of quantification, the concentration response relationship will be assessed as well.
    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 No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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) 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 No
    E.8.1.6Cross over Yes
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA6
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    last patient last visit
    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.1.1.1In 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.1.3Elderly (>=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 state78
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 108
    F.4.2.2In the whole clinical trial 108
    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 return to normal treatment end of the trial.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2009-03-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-04-06
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2010-05-25
    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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