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    Summary
    EudraCT Number:2006-005967-25
    Sponsor's Protocol Code Number:BVT.115959-005
    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:2007-05-09
    Trial 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 number2006-005967-25
    A.3Full title of the trial
    A double-blind, placebo-controlled, randomized, parallel-group study evaluating the efficacy and tolerability of oral BVT.115959, a novel A2A agonist, versus placebo in the treatment of diabetic neuropathic pain
    A.4.1Sponsor's protocol code numberBVT.115959-005
    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 SponsorBiovitrum AB
    B.1.3.4CountrySweden
    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 nameBVT.115959
    D.3.2Product code BVT.115959
    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.3.9.2Current sponsor codeBVT.115959
    D.3.9.3Other descriptive name6-Amino-2-methoxy-9-β-D-ribofuranosylpurine hemihydrate, 2-methoxyadenosine,2-O-methylisoguanosine
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number7
    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*
    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
    Diabetic Neuropathic Pain
    MedDRA Classification
    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 properties of BVT.115959 in subjects with diabetic neuropathic pain against placebo following 4 weeks’ treatment.
    E.2.2Secondary objectives of the trial
    •To evaluate the effect of BVT.115959 on additional pain assessments.
    •To evaluate the effect of BVT.115959 on sleep disturbance related to neuropathic pain.
    •To evaluate the effect of BVT.115959 on quality of life and mood stability.
    •To evaluate the effect of BVT.115959 on time to withdrawal for subjects experiencing unacceptable pain or discomfort.
    •To evaluate the tolerability of BVT.115959 against placebo by monitoring adverse events (AEs), including cardiovascular side effects and effects on clinical laboratory parameters.
    •To evaluate the plasma concentration of BVT.115959 through plasma sampling and to relate plasma drug concentrations to AEs (including any cardiovascular dynamic changes, AEs, or laboratory abnormalities) in a sub population.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Male or female patients aged 18 years or older
    2.A diagnosis of type 1 or type 2 diabetes mellitus and documented distal and bilateral sensory polyneuropathy for at least 6 months prior to randomization. Pain must have begun in the feet with a relatively symmetric onset
    3.Female patients will be either post-menopausal (i.e., 12 months since last menstruation) or surgically sterile
    4.An average 24-hour pain intensity score ≥4 on an 11-point Likert NRS completed upon awakening on at least 5 out of 7 days during the 1 week baseline period
    5.A score ≥40 mm on the VAS of the SF-MPQ at both the screening and randomization visits
    6.The quality of pain must be burning (of at least 1 hour’s duration each day) and/or lancinating, sharp or throbbing pain which significantly affects quality of life or interferes with normal behaviour
    7.On standard, stable anti-diabetic medication for at least 4 weeks prior to randomization
    8.Glycolsylated hemoglobin ≤10% during the 1-week baseline period. Stable qlycemic control should be assessed by a physician investigator
    9.Either no analgesic medication or stable analgesic medication for at least 4 weeks prior to randomization. Treatment may include simple analgesia (including over the counter medicines) and/or peripherally and/or centrally acting prescribed drugs
    10.None or stable, alcohol intake for at least 4 weeks prior to randomization
    11.Signed informed consent to participate in the study
    E.4Principal exclusion criteria
    1.Female patients who are fertile and of child bearing potential
    2.Use of herbal or natural remedies which are undefined and thought to have analgesic and anti inflammatory properties within 4 weeks prior to randomization
    3.An estimated creatinine clearance (CrCl) <60 mL/min (calculated from serum creatinine using the Cockcroft-Gault formula) and serum creatinine >1.25 times the upper limit of normal of the laboratory range. A serum creatinine value or a CrCl value obtained in the month prior to randomization will be acceptable unless the investigator believes that there may have been a change in renal function. If this is the case, the investigator should obtain a new estimate of renal function
    4.Clinically significant or unstable hepatic, respiratory, renal, hematologic, cardiovascular or peripheral vascular disease which in the opinion of the investigator should preclude study entry and the ability of the patient to successfully complete the study, i.e., a patient meeting the criteria for grade IV or grade V according to the American Society of Anesthesiologists Physical Status Classification*
    *Grade I: normal healthy individual; Grade II: mild systemic disease that does not limit activity; Grade III: severe systemic disease that limits activity but is not incapacitating; Grade IV: a patient with incapacitating systemic disease that is a constant threat to life; Grade V: a moribund patient who is not expected to survive 24 hours with or without operation
    5.Other painful conditions that may confound the evaluation of neuropathic pain, e.g., pain related to trigeminal neuralgia, spinal cord injury, central post stroke pain, multiple sclerosis related pain, chronic spinal axis pain with radiculopathy, complex regional pain syndrome I and II, peripheral ischemic pain at rest (pain on exercise should be differentiated and would be allowable regarding study entry)
    6.Radiotherapy in the 3 months prior to study entry
    7.Herpes zoster in the preceding 6 months and/or coincidental postherpetic neuropathic pain
    8.Neurosurgical procedure or an invasive procedure for pain management e.g., continuing stimulation of the dorsal root ganglion or sympathectomy in the 3 months prior to study entry. Not including simple intramuscular or intravenous injection
    9.Amputations other than toes
    10.Suspected or known drug or alcohol abuse, where alcohol abuse is defined as
    more than 14 or 21 units per week for women and men, respectively
    11.Suspected or known allergy to any components of the study treatments
    12.Documented human immunodeficiency virus infection
    13.Enrollment in another concurrent investigational study or intake of investigational drug within the previous 3 months
    14.Any condition which in the opinion of the investigator makes the patient unsuitable for inclusion in the study
    15.Failure to cooperate with given instructions
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint is the change in mean 24-hour pain intensity score for Week 4 (weekly mean) or the last week of treatment from baseline (Visit 2 / Randomization) using an 11 point Likert numerical rating scale (NRS) ranging from 0 (No pain) to 10 (Worst imaginable pain) assessed over the preceding 24 hours immediately upon awakening in the morning, prior to the morning drug administration
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Information not present in EudraCT
    E.6.2Prophylaxis Information not present in EudraCT
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Information not present in EudraCT
    E.6.8Bioequivalence Information not present in EudraCT
    E.6.9Dose response Information not present in EudraCT
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic Information not present in EudraCT
    E.6.12Pharmacoeconomic Information not present in EudraCT
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.3 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.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA18
    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 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
    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 months11
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months11
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 128
    F.4.2.2In the whole clinical trial 300
    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)
    All subjects, including those who discontinue study treatment prematurely, should attend a Follow-up Visit scheduled 1 week after ceasing treatment with study medication.
    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 Decision2007-04-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-06-20
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2007-12-27
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