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    Summary
    EudraCT Number:2009-015066-61
    Sponsor's Protocol Code Number:ACT10776
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2009-10-14
    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 ConcernedAustria - BASG
    A.2EudraCT number2009-015066-61
    A.3Full title of the trial
    Efficacy and safety of SAR407899A in patients with painful diabetic neuropathy. A 28-day, randomized, double-blind, placebo-controlled, parallel-group study.
    A.4.1Sponsor's protocol code numberACT10776
    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 SponsorSanofi-Aventis Recherche & Développement
    B.1.3.4CountryFrance
    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.3.2Product code SAR407899A
    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.3.9.1CAS number 923262-96-8
    D.3.9.2Current sponsor codeSAR407899A
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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 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.3.2Product code SAR407899A
    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.3.9.1CAS number 923262-96-8
    D.3.9.2Current sponsor codeSAR407899A
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.0
    E.1.2Level LLT
    E.1.2Classification code 10067547
    E.1.2Term Diabetic peripheral neuropathic pain
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the efficacy of SAR407899A administered at 15 mg twice daily for 28 days in comparison to placebo in reducing pain intensity in patients with painful diabetic neuropathy as measured on the 11 point numerical rating scale (NRS).
    E.2.2Secondary objectives of the trial
    To investigate the safety and tolerability of 15 mg SAR407899A twice daily in comparison to placebo.

    To compare the effects of SAR407899A with placebo on the change of pain intensity versus baseline by using the following scales and clinical tests:
    - The Visual Analog Scale Pain Intensity Scale,
    - The Visual Analog Scale Pain Relief Scale,
    - The Neuropathic Pain Symptom Inventory.

    To evaluate the effects of SAR407899A in comparison to placebo on the change in pain intensity of mechanical allodynia.

    To evaluate the use of rescue medication (paracetamol) in SAR407899A-treated patients in comparison to placebo-treated patients.

    To assess the exposure to SAR407899A.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patients with painful diabetic neuropathy
    The neuropathic pain must have a distinct, neuroanatomically plausible distribution demonstrated by at least one confirmatory test (e.g., clinical sensory examination, electrophysiology);

    2. Having given written informed consent prior to any procedure related to the study.
    E.4Principal exclusion criteria
    Related to study metho
    1. Patients < 18 years or ≥ 70 years of age;
    2. Average daily pain intensity for neuropathic pain < 4 on the 11-point NRS over the last 3 days before rando;
    3. Patients in whom the time between diagnosis of diabetic neuropathy and study start is < 6 mths;
    4. Patients with HbA1c > 10 %;
    5. Patients with history of hypoglycaemia unawareness;
    6. Patients with a history of hypoglycaemia with unconsciousness during the last 3 mths prior to the study, ketoacidosis, hyperosmolar coma, major changes in diabetes therapy
    7. Patients with any conditions other than the diabetic neuropathic pain that cause pain of equal or greater severity;
    8. Patients with abnormal folate and/or vitamin B12 that could be the cause of the neuropathic pain, and need to be corrected;
    9. Patients with hypothyreosis as shown by elevated TSH;
    10. Patients receiving analgesic medication for conditions other than diabetic neuropathic pain;
    11. Patients with previous treatment failure to > 2 approved treatment regimens for neuropathic pain of adequate doses and duration;
    12. Patients not willing to washout of all analgesic medications prior to the start of study treatment (except paracetamol/acetaminophen);
    13. Patients with severe or unstable hepatic, gastrointestinal, cardiovascular, respiratory, neurological psychiatric, hematological, renal, dermatological disease, progressive malignancy, hepatobiliary disease or any other medical condition that might interfere with the evaluation of study medication according to investigator’s medical judgment;
    14. Laboratory parameters outside the normal range unless the investigator considers an abnormality as clinically not relevant for these patients;
    15. Patients with contraindications for paracetamol treatment
    16. Creatinine clearance < 60 mL/min;
    17. Presence of significant abnormalities on a standard electrocardiogram recording at the screening visit according to investigator’s medical judgment (e.g., QTc ≥ 500 ms);
    18. Patients with uncontrolled hypertension defined as systolic blood pressure > 160 mmHg and/or diastolic blood pressure > 100 mmHg at screening; if on antihypertensive treatment: treatment should have been stable during the last 3 mths prior to the study;
    19. Patients using the following drugs within 5-times the half-life prior to start with the baseline pain intensity assessment (Visit 1 or 2) before the randomization visit: antidepressants, anticonvulsants or mexiletine for the treatment of pain, opioids or morphinomimetics, fatty acid supplements, primrose oil, myoinositol, chromium picolinate, alpha-lipoic acid, benfotiamin that are known to be used in neuropathic pain, acetyl salicylic acid more than 325 mg/day and not indicated for myocardial infarction or transient ischemic attack prophylaxis, NSAIDs for the treatment of pain, benzodiazepines other than indicated at low doses for sleep disorders, muscle relaxants, any drugs containing paracetamol/acetaminophen, OCT2 inhibitors such as cimetidine, ofloxacin, levofloxacin, phenazopyridine, piliscainide, quinidine, quinine, ranitidine
    20. Electroconvulsive therapy within 30 days of baseline evaluation (Visit 3);
    21. Regular use of capsaicin in the 6 mths before the study;
    22. Prior neurolytic treatment or intrathecal pumps for treatment of pain;
    23. Physiotherapy if not stable 1 mth before and during the study;
    24. Patients with short life expectancy;
    25. Patients with a history of HIV infection and/or with active hepatitis B or C;
    26. Use of any investigational drug product within 3 mths or within 5 half-lives prior to the study whichever is longer;
    27. Patients who are illiterate or are judged by the investigator to be unable or unlikely to understand the nature, scope and possible consequences of the study;
    28. Patients under any administrative or legal supervision.
    Related to SAR407899A
    29. Patients with symptomatic hypotension whatever the decrease in blood pressure, or asymptomatic postural hypotension defined by a decrease in systolic blood pressure ≥ 20 mmHg within three minutes when changing from the supine to the standing position;
    30. Patients with AST and/or ALT > 3 x upper laboratory norms;
    31. Pregnant or breastfeeding women;
    32. Women of child-bearing potential, unless they meet one of the following criteria: Committed to use a double barrier method of contraception during the entire study, including the screening period, including [intrauterine device or hormonal contraception] plus [condom or diaphragm or spermicidal].
    Women using oral contraception must also have done so for 3 mths prior to the randomization (Visit 3), To be considered not of child-bearing potential, women must be post-menopausal for at least 2 years or surgically sterile.
    E.5 End points
    E.5.1Primary end point(s)
    Change in the average daily pain intensity as measured on the 11 point NRS defined as the mean of the last 7 days of the treatment period compared to baseline.
    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 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 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.8.4.1Number of sites anticipated in Member State concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA24
    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
    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 months9
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months9
    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) No
    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 state8
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 80
    F.4.2.2In the whole clinical trial 80
    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 Decision2009-11-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-11-26
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2010-01-15
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