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    Summary
    EudraCT Number:2009-013468-37
    Sponsor's Protocol Code Number:Protocol code BA7
    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:2010-03-17
    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 number2009-013468-37
    A.3Full title of the trial
    A short-term open-label single site pilot study evaluating the use of asasantin retard therapy in the management of Raynaud’s phenomenon.
    A.3.2Name or abbreviated title of the trial where available
    Asasantin retard therapy in the management of Raynaud's phenomenon
    A.4.1Sponsor's protocol code numberProtocol code BA7
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberNot applicable
    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 SponsorRoyal National Hospital for Rheumatic Disease
    B.1.3.4CountryUnited Kingdom
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    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 Yes
    D.2.1.1.1Trade name Asasantin Retard ®
    D.2.1.1.2Name of the Marketing Authorisation holderBoehringer Ingelheim
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 nameASASANTIN Retard
    D.3.4Pharmaceutical form Capsule*
    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 INNaspirin
    D.3.9.1CAS number 50-78-2
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNdipyridamole
    D.3.9.1CAS number 58-32-2
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    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*
    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
    Primary Raynaud's Phenomenon and Systemic Sclerosis
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.1
    E.1.2Level LLT
    E.1.2Classification code 10042953
    E.1.2Term Systemic Sclerosis
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.0
    E.1.2Level LLT
    E.1.2Classification code 10037917
    E.1.2Term Raynaud's phenomenon
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    An explorative study investigating the potential therapeutic effects of asasantin retard in patients with primary Raynaud's phenomenon and systemic sclerosis through assessment of treatment effects on:
    1) the clinical severity of Raynaud's phenomenon
    2) the finger blood flow response to cold stress test (assessed using thermal and laser speckle imaging)
    3) Platelet function testing assessed using aggregometry
    4) blood markers of platelet activation and endothelial damage
    5) level of oxidative stress
    E.2.2Secondary objectives of the trial
    1) Assessment of the reproducibility of the cold challenge test assessed using thermal imaging and laser contrast speckle imaging in patients with primary Raynaud's phenomenon and systemic sclerosis.

    2) Assessment of the "validity" of a series of biomarkers of platelet activation and aggregometry in predicting subtype and severity of disease, in patients with primary Raynaud's phenomenon and systemic sclerosis i.e. do levels of these markers correlate with disease type and severity in patients with Raynaud's phenomenon and systemic sclerosis.

    3) Comparison between platelet function in PRP vs SSc and response to asasantin retard therapy.

    4) Assessment of markers of oxidative stress in patients with primary Raynaud's and systemic sclerosis and the potential therpeutic effects of asasantin retard therapy
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Systemic Sclerosis (fulfilling ARA criteria)

    or

    Primary Raynaud's Phenomenon (defined as at least 2 episodes of fingertip localized notable blue and/or sequential blue and white discoloration, in conjunction with pain upon cold exposure or emotional stress within the one week of examination in the absence of other features of connective tissue disease.

    18 to 75 years of age
    E.4Principal exclusion criteria
    Subjects shall be excluded from all aspects of the study if:

    1) pregnant or breastfeeding (women of child bearing age will be required to practice a medically acceptable method of birth control throughout the study period)

    2) surgical sympathectomy performed in the last 12 months

    3) Administration of new medications used for the treatment of Raynaud's phenomenon or systemic sclerosis in the 2 months preceding, or during, the trial period.

    4) Vasodilators used for the treatment of hypertension must be maintained at a constant dose throughout the study period.

    5) Administration of a selective serotonin reuptake inhibitor in the 2 months preceding or during the study period.

    6) Refusal by participants for their General Practitioner to be informed of inclusion in the study

    Subjects shall remain eligible for the first part of the study but shall be excluded from participation in the second stage of the study if they are:

    1) current use of aspirin, dipyridamole or alternative antiplatelet agent

    2) primary bleeding diathesis or platelet disorder

    3) anticoagulation with warfarin

    4) history of peptic or duodenal ulceration

    5) history of intolerance or allergy to aspirin, dipyridamole or other nonsteroidal anti-inflammatory medications

    6) Current use of oral corticosteroids and/or non-steroidal anti-inflammatory drugs
    E.5 End points
    E.5.1Primary end point(s)
    The Raynaud's Condition Score (RCS) in patients with primary Raynaud's phenomenon and systemic sclerosis, before and during 2 weeks treatment with asasantin retard.
    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 No
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    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 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 Information not present in EudraCT
    E.8.1.2Open Yes
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    No treatment run-in phase.
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States No
    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
    The end of the trial will be defined as 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 months10
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    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 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 No
    F.3.3.1Women of childbearing potential not using contraception Information not present in EudraCT
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    F.3.3.3Pregnant women Information not present in EudraCT
    F.3.3.4Nursing women Information not present in EudraCT
    F.3.3.5Emergency situation Information not present in EudraCT
    F.3.3.6Subjects incapable of giving consent personally Information not present in EudraCT
    F.3.3.7Others Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state70
    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)
    This is a proof of concept exploratory phase 2 pilot study and has not been designed to comprehensively investigate the safety and efficacy of aspirin and dipyridamole in the treatment of Raynaud's phenomenon and systemic sclerosis. Participants will therefore not have continued provison of the study medication at the end of the study period. This will be made clear at the outset and has been included on the participant information sheet.

    Participants will be informed of the results of the st
    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 Decision2010-03-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-09-29
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2012-03-01
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