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    Summary
    EudraCT Number:2008-004226-16
    Sponsor's Protocol Code Number:ACOT 2.0
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2008-06-23
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2008-004226-16
    A.3Full title of the trial
    A prospective, multi-center, randomized, controlled, single-blinded study to evaluate the safety and efficacy of AdvaCoat Mx sinus gel for treatment of chronic rhinosinusitis without nasal polyps.
    A.3.2Name or abbreviated title of the trial where available
    AdvaCoat Mx sinus gel study for chronic rhinosinusitis without nasal polyps
    A.4.1Sponsor's protocol code numberACOT 2.0
    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 SponsorCarbylan BioSurgery, Inc.
    B.1.3.4CountryUnited States
    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 Yes
    D.2.1.1.1Trade name Kenalog
    D.2.1.1.2Name of the Marketing Authorisation holderBristol-Meyers Squibb
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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 nameAdvaCoat Mx
    D.3.2Product code AdvaCoat Mx
    D.3.4Pharmaceutical form Injection*
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNTRIAMCINOLONE ACETONIDE
    D.3.9.1CAS number 76255
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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 Yes
    D.3.11.13.1Other medicinal product typecorticosteroid
    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 placeboSolution for injection
    D.8.4Route of administration of the placeboIntranasal use (Noncurrent)
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Subjects with chronic rhinosinusitis without nasal polyps, who have not had previous sinus surgery might be eligible for participation in this trial.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10052106
    E.1.2Term Rhinosinusitis
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The purpose of this study is to evaluate the safety and efficacy of AdvaCoat Mx sinus gel for the treatment of symptoms associated with chronic rhinosinusitis without nasal polyps that is refractory to conventional medical therapy. The AdvaCoat™ Mx is a bioresorbable hyaluronan-based gel that conforms and adheres to mucosal surfaces. The admixed TA is held within the gel and slowly released over approximately 30 days as the gel degrades. The current treatment of rhinosinusitis (nasal corticosteroid spray) cannot reach the ostiomeatal complex and will thus not result in optimal relieve. The sponsor and teh investigators hope to prove that the product is safe and effective in reducing the symptoms of chronic rhinosinusitis.
    E.2.2Secondary objectives of the trial
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Diagnosis of CRS defined as:
    - Symptoms present for >12 weeks
    - Two of the following:
    Anterior and/or posterior mucoid drainage
    Nasal congestion
    Facial pain / pressure / fullness
    - Both of the following:
    Nasal endoscopic examination confirming inflammation and/or edema of the ostiomeatal complex without the rpesence of polyps and/or previous sinus surgical procedures
    Evidence of CRS on CT (minimum score of 4 with at least two points coming from the sinuses). Images should be acquired or reformatted into coronal section, with a maximum thickness of 3 mm. Follow-up CT should be performed using a similar protocol to the original scan
    2. Average Score of 40-80 mm on the Patient Subjective Symptom Score (PSSS)
    3. 18 – 85 years of age
    4. Adequate access for application of approximately 1.5mL of material on to Ostiomeatal Complex (OMC)
    5. Willing and able to return for all required follow-up study visits.
    6. Signed an informed consent form
    7. Females of childbearing potential are not pregnant or lactating and agree not to become pregnant for the duration of the study
    E.4Principal exclusion criteria
    1. Unilateral sinus disease
    2. Evidence of polyps within or beyond the middle meatus by nasal endoscopy
    3. Samter’s Triad
    4. Previous or planned nasal or sinus surgery, including sinuplasty
    5. Steroid dependent asthma
    6. A known sensitivity to hyaluronan products, corticosteroids or any excipients contained within the formulation of Kenacort A-10
    7. Cystic fibrosis or any immune deficiency that may interfere with wound healing
    8. Any disease or condition that interferes with safe completion of initial or follow-up assessments
    9. Anatomical abnormalities within middle meatus by endoscopy
    10. Current evidence of sinus muccocele
    11. Nasal intubation within 4 weeks of study run-in period (Day -7)
    12. Wegener’s granulomatosis or sarcoidosis
    13. Suspicion of sinonasal neoplasm
    14. Use of nasal irrigation during study duration
    15. Use of systemic corticosteroids within 4 weeks of study run-in period (Day -7)
    16. Pregnant or planning to get pregnant
    17. Current use of orally inhaled corticosteroids
    18. Active sinus infection as evidence by frank purulence/pus
    19. Current use of systemic antibiotics
    20. PRN use of nasal corticosteroids, oral and/or nasal decongestants/antihistamines, leukotriene inhibitors, and/or mastcell stabilizers (i.e.,all medications must be stable dosing for 14 days prior to study run-in period (Day -7)).
    E.5 End points
    E.5.1Primary end point(s)
    Safety;
    - number, timing, severity, duration and resolution of product and non-product related adverse events.

    Efficacy;
    - percent change-from-baseline in the individual and total of subjective symptom evaluations, each measured on a 100 mm visua analog scale.
    - change-from-baseline in CT-scan score.
    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 No
    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 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) 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 Yes
    E.8.1.4Double blind No
    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 Information not present in EudraCT
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA10
    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 months0
    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 months0
    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 Information not present in EudraCT
    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 2008-06-23. 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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 100
    F.4.2.2In the whole clinical trial 100
    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 Decision2008-09-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-10-07
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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