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    Summary
    EudraCT Number:2008-001518-26
    Sponsor's Protocol Code Number:DFI10569
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2008-12-12
    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 number2008-001518-26
    A.3Full title of the trial
    Efficacy and safety of oral ataciguat (HMR1766) 200 mg administered once daily for 28 days on pain reduction in patients with Neuropathic Pain. A randomized, double-blind, placebo-controlled, cross-over study.
    A.3.2Name or abbreviated title of the trial where available
    SERENEATI
    A.4.1Sponsor's protocol code numberDFI10569
    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.3.1Product nameAtaciguat
    D.3.2Product code HMR1766
    D.3.4Pharmaceutical form Capsule, soft
    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 INNataciguat
    D.3.9.1CAS number 254-976-06-2
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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, soft
    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
    The proposed study is planned to demonstrate that ataciguat 200 mg/day could be effective in reducing neuropathic pain with a good safety profile
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10054095
    E.1.2Term 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 ataciguat administered as 200 mg once daily for 28 days in comparison to placebo in reducing pain intensity in patients with chronic neuropathic pain.
    E.2.2Secondary objectives of the trial
    • To investigate the safety and tolerability of 200 mg ataciguat once daily in comparison to placebo.
    • To compare the effects of ataciguat with placebo on the change of pain intensity versus baseline by using the following scales and clinical tests:
     The Visual Analog Scale Pain Relief Scale,
     The Visual Analog Scale Pain Intensity Scale,
     The Neuropathic Pain Symptom Inventory.
    • To evaluate the effects of ataciguat in comparison to placebo on the change in pain intensity of mechanical allodynia.
    • To evaluate the use of rescue medication (paracetamol) in ataciguat-treated patients in comparison to placebo-treated patients.
    • To assess the exposure to ataciguat.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    The study will include adult patients of either gender, 18 – 75 years of age, who have signed the informed consent form, and presenting with chronic neuropathic pain due to diabetic polyneuropathy or a peripheral nerve lesion following a surgical intervention such as inguinal hernia repair, thoracotomy, coronary artery bypass surgery or orthopedic limb surgery. The neuropathic pain must have a distinct neuroanatomically plausible distribution demonstrated by at least one confirmatory test (e.g. clinical sensory examination, electrophysiology) and be present for more than 3 months.
    E.4Principal exclusion criteria
    7.3.1 Exclusion criteria related to study methodology

    • Patients age at time of screening below limit of legal majority or older than 75 years;
    • 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;
    • Patients with a history of multiple allergic reactions to drugs;
    • Patients with short life expectancy;
    • Patients with severe or unstable hepatic, gastrointestinal, cardiovascular, respiratory, neurological (other than neuropathy), psychiatric, hematological, renal, or dermatological disease, or any other medical condition that might interfere with the evaluation of study medication according to investigator’s medical judgment;
    • Serum creatinine >150 µmol/L;
    • Presence of signs of clinically significant abnormalities on a standard electrocardiogram (ECG) recording at the screening visit according to investigator’s medical judgment (e.g., QTc ≥ 500 ms);
    • Presence or history of cancer within the past five years with the exception of adequately treated localized basal cell skin cancer or in situ uterine cervical cancer;
    • Patients with a history of HIV infection;
    • Patients with active hepatitis B or C;
    • Patients with abnormal folate, vitamin B12 or elevated TSH (hypothyroidism) that could be the cause of the neuropathic pain, and need to be corrected;
    • Patients with diabetes mellitus and time between diagnosis of diabetes and enrolment <6 months;
    • Patients with diabetes mellitus and HbA1c >11%;
    • Patients with an average daily pain intensity for their neuropathic pain <4 on the 11-point NRS over the last 3 days before randomization;
    • Patients with any pain other than the neuropathic pain of equal or greater severity;
    • Sensory polyneuropathy post chemotherapy or in the context of cancer or AIDS;
    • Patients with previous treatment failure to several approved treatment regimens for neuropathic pain of adequate doses and duration;
    • Patients with a complex regional pain syndrome;
    • Patients with chronic post-radiculopathic syndrome;
    • Patients with trigeminus neuralgia;
    • Neurologic deficits diagnosed within one month prior to the study and considered to be progredient throughout the duration of the study;
    • Pregnant or breastfeeding women;
    • Women of child-bearing potential are excluded unless they meet one of the following criteria:
     Women of child-bearing potential must commit to use a double barrier method of contraception during the entire study, including the screening period, according to the following algorithm: [intrauterine device or hormonal contraception] plus [condom or diaphragm or spermicidal]. Women using oral contraception must also have done so for 3 months 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.

    7.3.2 Exclusion criteria related to background therapy and rescue medication

    • Patients with contraindications for paracetamol treatment, e.g., chronic alcohol consumption (e.g., alcoholic drinks every day for male: ≥3; for female ≥2), ALAT and/or ASAT >3 x ULN, hepatocellular insufficiency (Child Pugh ≥9), Morbus Meulengracht (Gilbert-Syndrom; increased bilirubin due to increased unconjugated / indirect bilirubin, poor nutritional status;

    • Use of 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 that are known to be used in neuropathic pain;
     Acetyl salicylic acid (ASA) more than 325 mg/day and not indicated for myocardial infarction or transient ischemic attack prophylaxis;
     benzodiazepines other than indicated at low doses for sleep disorders
     muscle relaxants, capsaicine;
    • Electroconvulsive therapy within 30 days of baseline evaluation (Visit 3);
    • Physiotherapy if not stable 1 month before and during the study;
    • Antidiabetics if not stable in the month before the study (because of unstable glycemic control);
    • Use of any investigational drug product within 3 months prior to the study;

    7.3.3 Exclusion criteria related to ataciguat

    • Treatment with medications which are substrates to the CYP2C9 enzymatic system (e.g. warfarin, fluvastatin); if close blood glucose monitoring is ensured, patients with stable glycemic control and on stable dosing with glyburide/glibenclamide, glipizide, glimepiride or nateglinide are eligible;
    • ALAT and/or ASAT >3 x ULN;
    E.5 End points
    E.5.1Primary end point(s)
    Primary endpoint:
    Change in the average daily pain intensity defined as the mean of the last 7 days of each treatment period compared to baseline.
    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 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 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) 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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA15
    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 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
    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 months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2008-12-12. Yes
    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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 60
    F.4.2.2In the whole clinical trial 60
    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 Decision2009-03-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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