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    Summary
    EudraCT Number:2012-000400-14
    Sponsor's Protocol Code Number:ESTEVE-SIGM-204
    National Competent Authority:Romania - National Agency for Medicines and Medical Devices
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2014-05-30
    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 ConcernedRomania - National Agency for Medicines and Medical Devices
    A.2EudraCT number2012-000400-14
    A.3Full title of the trial
    An exploratory, randomized, double blind, placebo controlled, parallel groups Phase II clinical trial to evaluate the efficacy and safety of E-52862 (400 mg) by oral route, in patients with painful diabetic neuropathy.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to evaluate the efficacy and safety of E-52862 ( 400 mg) by oral route, in patients with painful diabetic neuropathy.
    A.4.1Sponsor's protocol code numberESTEVE-SIGM-204
    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 SponsorLaboratorios del Dr. Esteve. S.A
    B.1.3.4CountrySpain
    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 supportLaboratorios del Dr. Esteve
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationLaboratorios del Dr. Esteve
    B.5.2Functional name of contact pointStudy Medical Monitor
    B.5.3 Address:
    B.5.3.1Street AddressAvda Mare de Déu de Montserrat, 221
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08041
    B.5.3.4CountrySpain
    B.5.4Telephone number+34934466000NA
    B.5.5Fax number+34934568774NA
    B.5.6E-mailamorte@esteve.es
    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 nameNA
    D.3.2Product code E-52862
    D.3.4Pharmaceutical form Capsule, hard
    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 INN.
    D.3.9.1CAS number 878141-96-9
    D.3.9.2Current sponsor codeE-52862
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    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) 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 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
    painful diabetic neuropathy
    E.1.1.1Medical condition in easily understood language
    painful diabetic neuropathy
    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 17.0
    E.1.2Level LLT
    E.1.2Classification code 10067547
    E.1.2Term Diabetic peripheral neuropathic pain
    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
    The primary objective of this study is to assess the analgesic efficacy of E-52862 in subjects with moderate to severe painful diabetic neuropathy.
    E.2.2Secondary objectives of the trial
    To describe the safety and tolerability profile of E-52862 when administered during 28 days to patients with moderate to severe painful diabetic neuropathy.
    To assess E-52862 plasma exposure associated with a pharmacodynamic response, after administration of repeated oral doses for 28 days, in patients with moderate to severe painful diabetic neuropathy.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male and female ≥ 18 years of age
    2. Pain due to polyneuropathy caused by type 1 or type 2 diabetes mellitus. Pain must be present for a minimum of 6 months, but less than 5 years
    3. Pain began in the feet with relatively symmetrical onset
    4. Painful diabetic neuropathy diagnosis confirmed by a score of at least 3 on the Michigan Neuropathy Screening Instrument (MNSI)
    5. Patients at screening visit must have a moderate to severe pain intensity measured by a score ≥ 4 on the NPRS
    6. Patients must have a moderate to severe pain intensity (i.e., a mean score ≥ 4 on the NPRS) during 7 days prior to Visit 2 (Day -1). Patients must record at least five assessments of the 24-hour average daily pain intensity score during the seven-day run-in period
    7. Patients with glycosylated haemoglobin A1c of ≤ 10.0% at screening
    8. Patients with stable diabetes treatment within the last month with no anticipated changes in medication regimen
    9. Patients who provide a signed informed consent prior to study entry
    10. Subjects must agree to use acceptable methods of contraception (see section 5.1)
    11. Willingness to understand and comply with protocol requirements for the duration of study participation
    E.4Principal exclusion criteria
    1. Pregnant or nursing women.
    2. Patients with conditions that might interfere with the assessment of the PDN such as peripheral vascular disease, neurological disorders unrelated to diabetic neuropathy, patients with other types of severe neuropathies, skin condition in the area of the neuropathy that could alter sensation or other painful conditions.
    3. Patients having severe pain related to other causes
    4. Exposure in the previous 30 days to drugs known to cause neuropathy (as described in section 6.2.2 Prohibited medication)
    5. Major psychiatric disorder
    6. Serious or unstable cardiovascular disease that could compromise participation or cause hospitalization during the study
    7. Second or third degree atrioventricular blockade not corrected with a pacemaker or any clinically significant abnormality in the 12 lead ECG as determined by the investigator
    8. Subjects taking the following drug classes and individual drugs which cannot discontinue their use, are excluded:
    • benzodiazepines (except short half-life sleep agents)
    • skeletal muscle relaxants
    • orally administered steroids
    • centrally acting analgesics (dextromethorphan, tramadol)
    • opiates
    • topical lidocaine or capsaicin
    • NSAID
    • anticonvulsants
    • tricyclic, selective serotonin reuptake inhibitor (SSRI) or serotonin and noradrenalin reuptake inhibitor (SNRI) antidepressants
    • NMDA antagonists
    • Thalidomide
    • Nitrous oxide
    • Ca++/Mg++ infusions
    In case of discontinuation, these drugs require a minimum washout period of at least 5 times the half life and should be tapered appropriately using product label instructions as a guide before inclusion in the study
    9. History of any active serious medical conditions that, in the investigator's opinion, can compromise the subject's safety or interfere with the study assessments.
    10. History of drug abuse or dependence (drug categories defined by DSM IV) within the past year, excluding nicotine and caffeine.
    11. Subjects who, in the previous 30 days, received treatment with a drug that had not received regulatory approval for any indication at the time of study entry.
    12. History of severe gastroparesis or gastric bypass surgery.
    13. Previous neurolytic or neurosurgical treatment for the studied neuropathic pain.
    14. Injected anaesthetics or steroid use within 30 days of Visit 1.
    15. Malignancy within past 2 years.
    16. Has a known history of a positive Human Immunodeficiency Virus (HIV) antibody test or known HIV infection
    17. Has a known history of positive Hepatitis B or C virus serology indicative of active acute or chronic infection
    18. Unable to comply with the study procedures
    19. Patients with the following laboratory values abnormalities:
    • ALT, AST and GGT > 2 x ULN
    • Neutrophils < 1500/mm3
    • Lymphocytes < 1000/ mm3
    • Haemoglobin < 10 g/dL
    • Platelets < 100.000 / mm3
    • Prothrombin time: > 1.25 X ULN
    • Creatinine clearance according to the Cockroft-Gault equation: < 70 mL/min
    • Any other laboratory abnormality that is judged by the investigator to be clinically relevant
    E.5 End points
    E.5.1Primary end point(s)
    Efficacy
    • Time specific change from baseline to day 28 in mean pain intensity in the previous 7 days interval measured by a Numerical Pain Rating Scale (NPRS) included in a patient diary (average and worst 24 hour pain included in the short form of the Brief Pain Inventory [SF-BPI])
    • 50%-responder rates at day 7, 14, 21 and 28, defined as the proportion of patients with a reduction from baseline of at least 50% of the mean 24 hour average pain score in the previous 7 days (measured by a NPRS included in a patient diary)
    • 30%-responder rates at day 7, 14, 21 and 28, defined as the proportion of patients with a reduction from baseline of at least 30% of the mean 24 hour average pain score in the previous 7 days (measured by a NPRS included in a patient diary)
    • Time specific change from baseline to day 7, 14 and 21 in mean pain intensity in the corresponding previous 7 days measured by a NPRS included in a patient diary (average and worst 24h hour pain)
    • Time to onset of sustained therapeutic improvement, defined as first day on which patients demonstrated a ≥1-point reduction in mean pain NPRS score from baseline in patients with a ≥30 and ≥50% reduction in mean pain score at day 28
    • Percentage of subjects needing rescue medication and amount of rescue medication used
    • Change from baseline to day 28 in short form of McGill Pain Questionnaire (SF-MPQ)
    • Change from baseline to day 7, 14, 21 and 28 in SF-BPI
    • Change from baseline to day 7, 14, 21 and 28 in Neuropathic Pain Symptom Inventory (NPSI)
    • Change from baseline to day 7, 14, 21 and 28 in allodynia and hyperalgesia, measured by VAS after stimulus (brushing and pinprick)
    • Assessment of post-treatment pain by measurement of efficacy endpoints at day 35
    • Change from baseline to day 28 in SF-36
    • Patient Global Impression of Change at day 28
    E.5.1.1Timepoint(s) of evaluation of this end point
    28 days
    E.5.2Secondary end point(s)
    Safety
    • Adverse Events (AEs) reported
    • The percentage of patients reporting one or more AEs
    • Laboratory tests at screening visit and Day 28 (+ follow up tests if necessary)
    • Vital signs and ECG findings at each visit
    E.5.2.1Timepoint(s) of evaluation of this end point
    28 days
    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 No
    E.6.10Pharmacogenetic No
    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 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.8.2.4Number 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 concerned14
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA22
    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 patient last visit
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months10
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months10
    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.1.2.1Number of subjects for this age range: 70
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 50
    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 state120
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 120
    F.4.2.2In the whole clinical trial 120
    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)
    Expected normal treatment
    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 Decision2014-07-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-07-10
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-12-04
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