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    Summary
    EudraCT Number:2013-005398-32
    Sponsor's Protocol Code Number:STRIDER
    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:2015-02-09
    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 ConcernedUK - MHRA
    A.2EudraCT number2013-005398-32
    A.3Full title of the trial
    A randomised controlled trial of sildenafil therapy in dismal prognosis early-onset intrauterine growth restriction
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    STRIDER - Sildenafil therapy for treatment of intrauterine growth restriction
    A.3.2Name or abbreviated title of the trial where available
    STRIDER version 2.0
    A.4.1Sponsor's protocol code numberSTRIDER
    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 SponsorLiverpool Women's NHSFT
    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 organisationLiverpool Cancer Trials Unit
    B.5.2Functional name of contact pointCharlotte Rawcliffe
    B.5.3 Address:
    B.5.3.1Street AddressBlock C Waterhouse Building, 3 Brownlow Street
    B.5.3.2Town/ cityLiverpool
    B.5.3.3Post codeL693GL
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number01517948167
    B.5.6E-mailc.rawcliffe@liverpool.ac.uk
    B.Sponsor: 2
    B.1.1Name of SponsorUniversity of Liverpool
    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 supportNIHR/MRC EME GRANT
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationLiverpool Cancer Trials Unit
    B.5.2Functional name of contact pointCharlotte Rawcliffe
    B.5.3 Address:
    B.5.3.1Street AddressBlock C Waterhouse Building, 3 Brownlow Street
    B.5.3.2Town/ cityLiverpool
    B.5.3.3Post codeL693GL
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number01517948167
    B.5.6E-mailc.rawcliffe@liverpool.ac.uk
    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 Sildenafil
    D.2.1.1.2Name of the Marketing Authorisation holderActavis
    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 nameSildenafil
    D.3.4Pharmaceutical form Capsule
    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 INNsildenafil
    D.3.9.1CAS number 171599-83-0
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number75
    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
    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
    Early onset intrauterine growth restriction
    E.1.1.1Medical condition in easily understood language
    The poor growth of a baby while in a mother's womb during pregnancy
    E.1.1.2Therapeutic area Body processes [G] - Reproductive physiologi cal processes [G08]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.1
    E.1.2Level LLT
    E.1.2Classification code 10022819
    E.1.2Term Intrauterine growth retardation
    E.1.2System Organ Class 100000004868
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The overarching aim is to determine whether maternal treatment of oral sildenafil citrate improves perinatal outcomes in pregnancies complicated by severe early-onset IUGR without increasing risks to the mother.

    This study has a specific objective to evaluate the clinical efficacy of sildenafil i.e. its ability to lead to a delay of a clinical indication for delivery on fetal grounds by at least one week. The other specific objective is to add to our understanding of the mechanism of action of sildenafil by monitoring changes in the maternal, utero-placental and fetal circulation.
    E.2.2Secondary objectives of the trial
    i) to investigate impact on fetal growth and fetal well-being by comparing differential effect on the vascular resistance in the uterine arteries, umbilical, fetal middle cerebral artery and fetal ductus venosus and differences in birth weight centiles in infants treated in-utero with sildenafil and placebo.
    ii) to examine, through collaboration with an international consortium, the hypothesis that sildenafil therapy compared to placebo therapy increases the rate of infant survival free of major handicap.
    iii) to report frequency of adverse and serious adverse events associated with sildenafil use.
    iv) to investigate the impact on maternal cardiovascular parameters by measurements of maternal heart rate and peripheral blood pressure before and one hour following administration of study medication, 48-72 hours later and once after delivery.
    v)to elucidate the precise mechanism and location of action of sildenafil
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    1) Women with singleton pregnancy and fetus diagnosed with severe, early onset intrauterine growth restriction (IUGR) between 22+0 and 29+6 weeks of gestation and clinical decision to manage pregnancy expectantly.
    2) IUGR is defined as estimated fetal weight or abdominal circumference <10th centile and absent or reversed end diastolic velocity Doppler in the umbilical artery.
    3) 16 years of age or older
    4) Consent to take part in the trial
    E.4Principal exclusion criteria
    1) Multiple pregnancy
    2) Known or suspected structural or chromosomal fetal abnormality
    3) Maternal illness (eg pre-eclampsia) thatis expected to require delivery for maternal reasons within the next 72 hours
    4) Maternal wish not to have active management of the pregnancy, or to have pregnancy termination weeks
    5) Inability to give informed consent
    6) Cocaine use
    7) Contraindication to sildenafil therapy, eg known maternal cardiac disease, left ventricular outflow tract obstruction, concommitant treatment with nitrates or previous allergy to sildenafil
    E.5 End points
    E.5.1Primary end point(s)
    Primary outcome is average prolongation of pregnancy for one week (i.e. one week difference in the mean randomisation to birth interval).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Randomisation:
    Gestational age is determined by early pregnancy dating ultrasound examination and recorded at the point of randomisation (days.
    Delivery:
    Gestational age at birth (days).
    E.5.2Secondary end point(s)
    i) Fetal outcomes - estimated fetal weight, abdominal circumference growth velocity,serial measurements of Doppler pulsatility index in the umbilical artery, middle cerebral artery and ductusvenosus and uterine arteries, serial measurements of short term variability of the fetal heart rate.

    ii) Infant outcomes - gestational age at birth, survival at discharge, birth weight centile, length of admission on the neonatal intensive care unit, oxygen dependency at day 28 and 36 weeks corrected age, necrotising enterocolitis, retinopathy of prematurity, significant (grade III/IV) cerebral haemorrhage detected by cerebral ultrasound, number of doses of surfactant, ventilator days, supplemental oxygen days, number of days of full feeds.

    iii) Maternal outcomes - mode of delivery, standardised blood pressure and pulse monitoring during treatment, pre-eclampsia, postpartum haemorrhage, recording of the side effects eg headaches, facial flushing
    E.5.2.1Timepoint(s) of evaluation of this end point
    Fetal Outcomes:
    All assessments will be conducted at baseline amd weekly thereafter until birth.

    Infant Outcomes:
    All assessements to be conducted at birth and daily until hospital discharge

    Maternal outcomes:
    Assessment will be conducted during and directly after birth and on hospital discharge
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy Yes
    E.6.4Safety No
    E.6.5Efficacy No
    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 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) Yes
    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 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 concerned18
    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 No
    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
    The trial will end when the last woman and her baby are discharged from hospital after birth
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days30
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months11
    E.8.9.2In all countries concerned by the trial days30
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) No
    F.1.2.1Number of subjects for this age range: 112
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 0
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    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 No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state112
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 112
    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)
    There is no provision for continued treatment beyond the end of the trial. For those taking Sildenafil there will be no withdrawal effects of stopping the drug.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation Cheshire & Merseyside CLRN
    G.4.3.4Network Country United Kingdom
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2014-07-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-03-20
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-02-13
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