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    Summary
    EudraCT Number:2008-007978-38
    Sponsor's Protocol Code Number:V3381-2DPNP-02
    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:2009-01-07
    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 ConcernedUK - MHRA
    A.2EudraCT number2008-007978-38
    A.3Full title of the trial
    A Randomised, Double-Blind, Placebo-Controlled, Multicentre, Parallel Group Study of the Safety, Tolerability and Efficacy of V3381 for Up to 13 Weeks in Patients with Diabetic Peripheral Neuropathic Pain (DPNP)
    A.3.2Name or abbreviated title of the trial where available
    IN-STEP (Indantadol - Safety Tolerability and Efficacy in Pain)
    A.4.1Sponsor's protocol code numberV3381-2DPNP-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 SponsorVernalis (R & D) Limited
    B.1.3.4CountryUnited Kingdom
    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 nameV3381
    D.3.2Product code V3381
    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 INNIndantadol
    D.3.9.1CAS number 202844-10-8
    D.3.9.2Current sponsor codeV3381
    D.3.9.3Other descriptive name2-[(2,3-dihydro-1H-inden-2-yl)amino]-acetamide monohydrochloride
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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
    Diabetic Peripheral Neuropathic Pain (DPNP)
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10012683
    E.1.2Term Diabetic peripheral neuropathy
    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 safety objective of the study is to investigate the safety and tolerability of V3381 in patients with diabetic peripheral neuropathic pain at doses of up to 400 mg bid.

    The primary efficacy objective of the study is to determine the efficacy of V3381 in the treatment of diabetic peripheral neuropathic pain at doses of up to 400 mg bid.
    E.2.2Secondary objectives of the trial
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) Signed written informed consent
    2) Male or female 18 – 75 years of age
    3) Diagnosis of diabetes mellitus (Type I or II)
    4) No change in diabetes medications within 4 weeks before screening
    5) Daily pain attributed to diabetic neuropathy present for at least 6 months immediately prior to study entry
    6) Presents with pain due to bilateral peripheral neuropathy caused by Type I or Type II diabetes mellitus. Pain must have begun in the feet, with relatively symmetrical onset. The diagnosis must be confirmed by a score of at least 2 on Section B (Physical Assessment) of the Michigan Neuropathy Screening Instrument (MNSI)
    7) Judged to be reliable and agree to keep all appointments for clinic visits, tests, and procedures required by the protocol
    8) Females should be of non child-bearing potential (i.e., surgically sterilized or at least 1 year post-menopause). Male subjects who are sexually active with a female partner of child bearing potential must agree to use a barrier method of contraception (eg condom, diaphragm or cervical cap in the female partner) for the duration of the study (until the follow up visit).


    Final Inclusion Criteria
    Before patients are randomised to double-blind study drug treatment, the following additional inclusion criteria fulfillment must be established at the baseline visit:

    9) A mean average pain intensity of at least 4, but less than or equal to 9, on an 11 point Likert NPRS recorded twice daily (in the morning and evening) during the two week placebo run-in before randomisation (baseline); however, any patient who experiences a >30% decrease in the mean pain score compared to Day -16 (Screening) score, during placebo run-in will be excluded, regardless of whether their final score is greater than or equal to 4
    10) Full completion of the daily diaries for at least 11 of the placebo run-in days.
    11) Compliance in taking study medication twice daily for at least 11 of the placebo run-in days
    E.4Principal exclusion criteria
    1) Any clinically significant neurologic disorders (with the exception of diabetic peripheral neuropathic pain)
    2) Any clinically significant or unstable medical or psychiatric condition that would interfere with the patient’s ability to participate in the study
    3) Prior renal transplant, current renal dialysis
    4) Pernicious anemia
    5) Untreated hypothyroidism
    6) Amputations or persistent ulceration due to diabetes mellitus
    7) Any cardiovascular condition that would be a contraindication to the use of sympathomimetic amines (e.g., active angina)
    8) Uncontrolled hypertension (i.e., >140/90 mm Hg despite adequate medical therapy)
    9) Known or at high risk of human immunodeficiency virus (HIV) infection
    10) Any anticipated need for surgery during the study
    11) Increased risk of seizures (defined as a history of seizure disorder (including alcoholic seizures), family history of seizures and history of head trauma that resulted in loss of consciousness or concussion).
    12) Any malignancy in the past 2 years (with the exception of basal cell carcinoma)
    13) Pain that cannot be clearly differentiated from, or conditions that interfere with, the assessment of diabetic neuropathic pain. Examples of painful conditions that could be confused with diabetic neuropathic pain include: peripheral vascular disease (ischemic pain); neurological disorders unrelated to diabetic neuropathy (e.g., phantom limb pain from amputation); skin condition in the area of the neuropathy that could alter sensation (e.g., plantar ulcer); other painful conditions (e.g., arthritis)
    14) Use of anticonvulsants, antidepressants (particularly MAO inhibitors), or prescription membrane-stabilizing agents, including topical therapies. Patients currently taking drugs in these classes may have them discontinued prior to entry into the placebo run-in period. Selective serotonin reuptake inhibitors should be discontinued at least 4 weeks prior to the run-in period; all other prohibited medications should be discontinued 2 weeks prior to run-in.
    15) Use of opioids, especially meperidine (pethidine)
    16) History of substance abuse or dependence within the past year, excluding nicotine and caffeine
    17) Frequent and/or severe allergic reactions with multiple medications
    18) Historical exposure to drugs known to cause neuropathy (for example, vincristine), or a history of a medical condition, including pernicious anemia and hypothyroidism, that could have been responsible for neuropathy
    19) Patients taking excluded medications that cannot be stopped at the baseline visit
    20) Participation in any clinical trial within 30 days before screening

    Final Exclusion Criteria
    Before patients are randomised to double-blind study drug treatment, the following additional exclusion criteria fulfillment must be established at the baseline visit:

    21) A score of 20 or more on the Beck Depression Inventory-II
    22) Glycosylated haemoglobin (HbA1c) >11.0%
    23) Serum creatinine laboratory value greater than 1.5 x upper limit of normal (ULN) reference range (after adjustment for age) or estimated creatinine clearance <60 mL/min
    24) Total bilirubin greater than upper limit of normal reference range (with the exception of Gilbert’s syndrome) and/or alanine transaminase (ALT) >1.5 times upper limit of normal reference ranges (after adjustment for age)
    25) Any clinically significant abnormal laboratory test result(s) that would jeopardize the patient’s capacity to undergo investigative study treatment
    E.5 End points
    E.5.1Primary end point(s)
    a) Primary safety endpoint: safety of V3381 compared to placebo determined by clinical assessment, AEs, vital signs, ECG, safety laboratory tests and Beck Depression Inventory II.

    b) Primary efficacy endpoint: Change from baseline in the mean average pain severity score from the diary entries for the last week of the 13-week study drug treatment period.
    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 Information not present in EudraCT
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Information not present in EudraCT
    E.6.7Pharmacodynamic Information not present in EudraCT
    E.6.8Bioequivalence Information not present in EudraCT
    E.6.9Dose response Yes
    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 Information not present in EudraCT
    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 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 concerned8
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA16
    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 months13
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months15
    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 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 state48
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 118
    F.4.2.2In the whole clinical trial 150
    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)
    Usual care
    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 Decision2009-01-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-02-12
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2009-12-30
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