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    Summary
    EudraCT Number:2012-003241-15
    Sponsor's Protocol Code Number:SCH/12/043
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2012-09-13
    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 number2012-003241-15
    A.3Full title of the trial
    NeSST2: A multi-stage clinical study to develop a non-invasive Short Synacthen Test (SST) with nasally administered Synacthen and salivary cortisol. The validated non-invasive SST will be used to establish normative data in children and to detect adrenal suppression in asthmatic children.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to develop a non-invasive version of the diagnostic test of the body's ability to produce enough stress hormone.
    A.3.2Name or abbreviated title of the trial where available
    NeSST2: The development of a non-invasive Short Synacthen Test
    A.4.1Sponsor's protocol code numberSCH/12/043
    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 SponsorSheffield Children's NHS Foundation Trust
    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 organisationSheffield Children's NHS Foundation Trust
    B.5.2Functional name of contact pointDr Gillian Gatenby
    B.5.3 Address:
    B.5.3.1Street AddressR&D Department, Western Bank
    B.5.3.2Town/ citySheffield
    B.5.3.3Post codeS10 2TH
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number01143053219
    B.5.5Fax number01142267844
    B.5.6E-mailgillian.gatenby@sch.nhs.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 No
    D.2.1.1.1Trade name Synacthen
    D.2.1.1.2Name of the Marketing Authorisation holderAlliance Pharmaceuticals Ltd
    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 name100mcg tetracosactide (in a 1:1 mix with chitosan)
    D.3.4Pharmaceutical form Nasal spray, solution
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntranasal use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTetracosactide
    D.3.9.1CAS number 16960-16-0
    D.3.9.3Other descriptive nameCorticotropin, cosyntropin (USAN), ACTH (1-24)
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.5
    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.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.3.1Product name500 mcg tetracosactide
    D.3.4Pharmaceutical form Nasal spray, solution
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntranasal use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTetracosactide
    D.3.9.1CAS number 16960-16-0
    D.3.9.3Other descriptive nameCorticotropin, cosyntropin (USAN), ACTH (1-24)
    D.3.9.4EV Substance CodeAS4
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2.5
    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.IMP: 3
    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 name500 mcg tetracosactide (in a mix 1:1 with chitosan)
    D.3.4Pharmaceutical form Nasal spray, solution
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntranasal use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTetracosactide
    D.3.9.1CAS number 16960-16-0
    D.3.9.3Other descriptive nameCorticotropin, cosyntropin (USAN), ACTH (1-24)
    D.3.9.4EV Substance CodeAS5
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2.5
    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.IMP: 4
    D.1.2 and D.1.3IMP RoleComparator
    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 Synacthen
    D.2.1.1.2Name of the Marketing Authorisation holderAlliance Pharmaceuticals Ltd
    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 name1 mcg Synacthen
    D.3.4Pharmaceutical form Suspension for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTetracosactide
    D.3.9.1CAS number 16960-16-0
    D.3.9.3Other descriptive nameCorticotropin, cosyntropin (USAN), ACTH (1-24)
    D.3.9.4EV Substance CodeAS3
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number250ng/ml
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    In stages 1+2 of the study healthy volunteers will be used to determine the bioequivalence of nasal Synacthen with 1 microgram of intravenous synacthen. Stage 3 will use healthy children to establish normal ranges for the adrenal response to a low-dose synacthen test. In stage 4 adrenal function in asthmatic individuals on inhaled corticosteroids will be studied.
    E.1.1.1Medical condition in easily understood language
    Inability to produce the stress hormone, cortisol, is known as adrenal insufficiency. It can cause serious illness and even death. Inhaled steroids taken for asthma can cause adrenal insufficiency.
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 15.0
    E.1.2Level LLT
    E.1.2Classification code 10064973
    E.1.2Term Allergic bronchospasm
    E.1.2System Organ Class 10038738 - Respiratory, thoracic and mediastinal disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 15.0
    E.1.2Level PT
    E.1.2Classification code 10001367
    E.1.2Term Adrenal insufficiency
    E.1.2System Organ Class 10014698 - Endocrine disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To establish whether nasally administered Synacthen (with chitosan), combined with salivary cortisol sampling, can be used effectively to investigate potential adrenal suppression and therefore be a valid non-invasive alternative to the current, intravenous, 1mcg Short Synacthen Test.
    E.2.2Secondary objectives of the trial
    Stage 1a: To establish the bioequivalence of nasal Synacthen (with chitosan) with 1mcg of intravenous Synacthen in adults. To determine the bioavailability and pharmacokinetics of nasally administered Synacthen and the subsequent peak cortisol response. To determine the inter-individual variability of nasally administered Synacthen. Stage 1b: To determine the intra-individual variability of nasally administered Synacthen. Stage 2: To establish whether peak cortisol response, bioavailability and pharmacokinetics are similar in the paediatric population to that of adult males. Stage 3: To establish the first normative data for the 1mcg SST in the healthy paediatric population. Stage 4: To establish which children on inhaled corticosteorids are at greatest risk of adrenal suppression.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Stage 1: Healthy, male volunteers aged between 18-64, with no exclusion criteria listed below. Stage 2: Healthy children of either sex, aged between 2 and 15 years (up to their 16th birthday), with none of the exclusion criteria listed below. Stage 3: Healthy children of both sexes, aged between 6 months and 15 years, with none of the exclusion criteria listed below. Stage 4: Children of both sexes, aged between 6 months and 15 years, with asthma taking varying doses of inhaled corticosteroids, with none of the exclusion criteria except numbers 2,4,5 and 6.
    E.4Principal exclusion criteria
    1. Past or present history of an endocrinopathy (all stages) 2. Past or present history of asthma (stages 1,2,3) 3. Past or present history of allergic rhinitis (stages 1,2,3) 4. Past or present history of peptic ulcer disease/GI bleed/significant dyspepsia (stages 1+2) 5. Past history of intra-cranial or renal/adrenal pathology (all stages) 6. Presently on any medication (stages 1,2,3) 7. Presently, or within the last 3 months, been prescribed any type of corticosteroid (oral, inhaled, nasal, rectal, intravenous, intramuscular, intra-articular, intra-ocular, topical) (stages 1,2,3) 8. Ever been prescribed a prolonged course of oral corticosteroids (more than 1 month) (stages 1,2,3) 9. Previous adverse reaction (including mild hypersensitivity) to ACTH or Synacthen (all stages) 10. Previous severe allergic reaction or anaphylaxis (all stages) 11. Coryzal symptoms within the last week (and will be asked to report any new symptoms occurring within 24 hours of the test) (all stages) 12. Current smoker (all stages) 13. Body Mass Index less than 18.5 or more than 30kg/m2 (stages 1+2) 14. Currently pregnant (stages 2,3,4) 15. Currently anaemic (stages 1+2)
    E.5 End points
    E.5.1Primary end point(s)
    A validated non-invasive test of adrenal function (stages 1+2). Normative data for the low-dose short Synacthen test in children (stage 3). The dose of inhaled corticosteroids that causes adrenal suppression in children (stage 4).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Stages 1+2 are anticipated to take 18 months to complete. Stage 3 it is anticipated will take 8 months to complete. Stage 4 it is anticipated will take 10 months to complete
    E.5.2Secondary end point(s)
    Stage 1a: To establish the bioequivalence of an i.n SST with the 1mcg i.v SST. To establish the first bioavailability and pharmacokinetic data of nasal Synacthen, enhanced by the addition of chitosan, in humans. To establish the inter-individual variability of nasal Synacthen in man. Stage 1b: To establish the intra-individual variability of the selected nasal Synacthen dose in humans. Stage 2: To establish that the chosen dose, peak cortisol response, bioavailability and pharmacokinetics are similar in the paediatric population compared with adult males tested in stage 1. Stage 3: To establish, by use of the validated non-invasive SST, the first normative data for the low-dose SST in the paediatric population. Stage 4: To establish, with a validated test and normative data, which asthmatic children on inhaled corticosteroids are at risk of adrenal suppression and whether dose, age, gender or pubertal stage impact on the risk.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Stages 1+2 are anticipated to take 18 months to complete. Stage 3 it is anticipated will take 8 months to complete. Stage 4 it is anticipated will take 10 months to complete
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety No
    E.6.5Efficacy No
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence Yes
    E.6.9Dose response Yes
    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) Yes
    E.7.1.1First administration to humans Yes
    E.7.1.2Bioequivalence study Yes
    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) 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 No
    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 No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    1 mcg intravenous Synacthen
    E.8.2.4Number of treatment arms in the trial4
    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 No
    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
    Each stage will be completed after the final visit of the last subject. The study will be completed at the end of the final visit of the final subject in stage 4. Interim analysis will be performed after each volunteer has completed three visits in stage 1a and after 10 subjects have completed stage 2, if the data is adequate for the pharmacokinetic modelling required stage 2 will be prematurely discontinued.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months3
    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 Yes
    F.1.1Number of subjects for this age range: 240
    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: 20
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 140
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 80
    F.1.2Adults (18-64 years) No
    F.1.2.1Number of subjects for this age range: 18
    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 Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    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 state258
    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)
    Only children with detectable or borderline adrenal suppression will require any type of follow up. These children will be referred onto the paediatric endocrinology service at Sheffield Children's Hospital for further management.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2012-09-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-10-09
    P. End of Trial
    P.End of Trial StatusOngoing
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