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    Summary
    EudraCT Number:2005-001970-29
    Sponsor's Protocol Code Number:SP777
    National Competent Authority:Czechia - SUKL
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2005-09-26
    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 ConcernedCzechia - SUKL
    A.2EudraCT number2005-001970-29
    A.3Full title of the trial
    Multinational, prospective, randomized, double-blind, placebo-controlled, parallel groups study to assess the efficacy and safety of Prostaglandin E1 in subjects with circulatory disturbance of a limb
    A.3.2Name or abbreviated title of the trial where available
    ESPECIAL
    A.4.1Sponsor's protocol code numberSP777
    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 SponsorSchwarz Pharma Deutschland GmbH
    B.1.3.4CountryGermany
    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 Information not present in EudraCT
    D.2.1.1.1Trade name Prostavasin
    D.2.1.1.2Name of the Marketing Authorisation holderSchwarz Pharma GmbH, Monheim
    D.2.1.2Country which granted the Marketing AuthorisationCzech Republic
    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.3.4Pharmaceutical form
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntravenous use
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    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 Information not present in EudraCT
    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 placeboIntravenous infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Peripheral arterial occlusive disease (PAOD) Fontaine stage IV
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 7.1
    E.1.2Level LLT
    E.1.2Classification code 10062585
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Primary objective of this study is to show a superior effect of Prostavasin® compared to placebo on the rate of complete healing of ischemic necroses and ulcerations at 12 weeks after the end of treatment as well as on the frequency and height of major amputations in subjects suffering from PAOD Fontaine stage IV at 24 weeks after the end of treatment.
    E.2.2Secondary objectives of the trial
    Secondary objectives will be to show a superior effect of Prostavasin® compared to placebo on the rate of complete healing of ischemic necroses and ulcerations at 24 weeks after the end of treatment.
    Furthermore, a superior effect of Prostavasin® on pain induced by ischemic lesions, perfusion pressure at ankle (big toe) level and prognostic factors as minor amputations, revascularization procedures, all-cause and cardiovascular mortality, cardiovascular morbidity (myocardial infarction, stroke, cardiac death) shall be demonstrated.
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    1. Subject is informed and given ample time and opportunity to think about her/his
    participation and has given her/his written informed consent.
    2. Subject is willing and able to comply with all trial requirements.
    3. Male or female subjects of at least 45 years of age.
    4. Non-diabetic as well as diabetic subjects (type II) with macro-angiopathy, each
    with proven PAOD and presenting up to 2 ischemic skin lesions for more than 2
    weeks with or without rest pain (PAOD Fontaine stage IV). Skin lesions may not
    exceed an area of 6 cm2 and at least one lesion has to be larger than 1 cm2.
    5. Subject has a last complete angiography (conventional or better) of the pelvis,
    the thigh and the calf performed within one month of inclusion.
    6. Systolic ankle pressure ≤70 mmHg in subjects without media sclerosis of the
    lower limb artery or systolic big toe pressure ≤50 mmHg in diabetics with media
    sclerosis of the lower limb artery.
    7. Subject’s life expectancy is ≥180 days (investigator’s judgment).
    8. Subject is not in the position to be primarily revascularized (ie, subjects for whom
    revascularization will in the investigator’s opinion most probably only bring
    incomplete perfusion, or subjects with a high risk of failure/amputation or any
    other safety risk associated with the revascularization procedure. The
    investigator’s opinion should be in agreement with surgeons/interventional
    radiologists present at the location) OR Subject is in the position to be primarily
    revascularized but refuses surgery (refusal will be documented and signed by the
    subject).
    E.4Principal exclusion criteria
    1. Subject has an imminent or foreseeable amputation.
    2. Subject has a major amputation on the affected extremity.
    3. Subject has previously participated in this trial or subject has previously been
    assigned to treatment in a trial of the drug under investigation in this trial.
    4. Subject has participated in another trial of an investigational drug or a medical
    device within the last 30 days or is currently participating in another trial of an
    investigational drug or a medical device.
    5. Subject has a history of chronic alcohol or drug abuse.
    6. Subject has any medical or psychiatric condition that in the opinion of the
    investigator can jeopardize or would compromise the subject’s ability to
    participate in this trial.
    7. Subject has a known hypersensitivity to any components of the investigational
    product(s) as stated in this protocol.
    8. Subject has more than two ischemic ulcerations (persistent, non-healing
    ulcerations or gangrene).
    9. Subject presents at least one ulcer ≥6 cm2, both ulcers ≤1 cm2 or at least one
    ulcer affecting the bone or tendons.
    10. Subject has acute ischemia and peripheral vascular disorders of inflammatory or
    immunologic origin.
    11. Subject has venous ulcers.
    12. Subject has neuropathic ulcers.
    13. Subject has Buerger's disease.
    14. Subject has septic gangrene.
    15. Subject concomitantly uses vasoactive medication (eg, naftidrofuryl,
    pentoxifylline, buflomedil, cilostazol) or other prostaglandins.
    16. Subject was treated with prostanoids within 3 months prior to inclusion in this
    study.
    17. Subject presents laboratory values outside the normal range unless considered
    not clinically relevant by the investigator.
    18. Subject had surgical or other interventional measures performed on the affected
    extremity within 3 months prior to commencement of study drug treatment.
    19. Subject had a myocardial infarction within 6 months prior to commencement of
    study drug treatment.
    20. Subject with mental or psychiatric conditions which suggest inability to
    understand written and verbal instructions, in particular regarding the risks and
    inconveniences he/she will be exposed to as a result of their participation in the
    study.
    21. Subject has a known or suspected uncooperative behavior.
    22. Subject has a clinically significant hepatic disease or dysfunction or renal
    dysfunction (creatinine >2.0 mg/dl).
    23. Subject has an increased risk of hemorrhage.
    24. Subject has a diabetic nephropathy with albuminuria (protein >1.5 g).
    25. Subject is pregnant or breast feeding.
    26. Subject uses an inadequate method of contraception.
    27. Subject has to undergo ongoing dialysis.
    28. Subject has an inadequately controlled angina pectoris.
    29. Subject has an inadequately controlled cardiac failure (NYHA grade III and IV).
    30. Subject has an inadequately controlled cardiac arrhythmia.
    31. Subject has upper grade cardiac valve disorders.
    32. Subject has a history and/or suspicion of pulmonary edema or pulmonary
    infiltration.
    33. Subject has a severe chronic obstructive pulmonary disease.
    34. Subject has a venoocclusive lung disease.
    35. Subject has paralyzed extremities.
    36. Subject has frostbite.
    37. Subject is treated with epidural spinal cord stimulation.
    E.5 End points
    E.5.1Primary end point(s)
    Two primary efficacy endpoints will be tested:

    (1) complete healing of all necroses and ulcerations at 12 weeks after the end of
    treatment (Study Day 112)
    (2) major amputation at 24 weeks after the end of treatment (Study Day 196).
    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 Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Information not present in EudraCT
    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) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    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.8.6 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 Information not present in EudraCT
    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 months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months6
    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 Information not present in EudraCT
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    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 state100
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 500
    F.4.2.2In the whole clinical trial 500
    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 Decision2005-10-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2005-07-13
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-07-30
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