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    Summary
    EudraCT Number:2012-002451-41
    Sponsor's Protocol Code Number:NX1207-IT-CL0414
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2013-03-26
    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 ConcernedGermany - BfArM
    A.2EudraCT number2012-002451-41
    A.3Full title of the trial
    EFFICACY AND SAFETY OF A SINGLE TRUS-GUIDED INTRAPROSTATIC INJECTION OF NX-1207 IN PATIENTS WITH LOWER URINARY TRACT SYMPTOMS ASSOCIATED WITH BENIGN PROSTATIC HYPERPLASIA:
    A PHASE III EUROPEAN CLINICAL STUDY
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    NOVEL INJECTION THERAPY FOR PATIENT WITH LOWER URINARY TRACT SYMPTOMS ASSOCIATED WITH BENIGN PROSTATIC HYPERPLASIA
    A.4.1Sponsor's protocol code numberNX1207-IT-CL0414
    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 SponsorRecordati S.p.A.
    B.1.3.4CountryItaly
    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 supportRecordati S.p.A.
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationRecordati S.p.A.
    B.5.2Functional name of contact pointClin. Proj. Leader - Medical Dep.
    B.5.3 Address:
    B.5.3.1Street AddressVia Matteo Civitali, 1
    B.5.3.2Town/ cityMilan
    B.5.3.3Post code20148
    B.5.3.4CountryItaly
    B.5.4Telephone number+39(0)248787183
    B.5.5Fax number+39(0)248787668
    B.5.6E-mailmiotto.f@recordati.it
    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.2.5The 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 nameNX-1207
    D.3.4Pharmaceutical form Lyophilisate for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntraprostatic use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INN-
    D.3.9.1CAS number -
    D.3.9.2Current sponsor codeNX-1207
    D.3.9.3Other descriptive nameNYM-4805
    D.3.9.4EV Substance CodeSUB117036
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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: 2
    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 Omexel L.p.
    D.2.1.1.2Name of the Marketing Authorisation holderAstellas Pharma
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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 Film-coated tablet
    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 INNTAMSULOSIN HYDROCHLORIDE
    D.3.9.1CAS number 106463-17-6
    D.3.9.4EV Substance CodeSUB04673MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.4
    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 placeboFilm-coated tablet
    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
    LOWER URINARY TRACT SYMPTOMS ASSOCIATED WITH BENIGN PROSTATIC HYPERPLASIA
    E.1.1.1Medical condition in easily understood language
    BENIGN PROSTATIC HYPERPLASIA
    E.1.1.2Therapeutic area Diseases [C] - Male diseases of the urinary and reproductive systems [C12]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.0
    E.1.2Level PT
    E.1.2Classification code 10004446
    E.1.2Term Benign prostatic hyperplasia
    E.1.2System Organ Class 10038604 - Reproductive system and breast disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of the core of the study is to demonstrate that a single TRUS-guided intraprostatic injection of NX-1207 provides a long lasting therapeutic improvement of LUTS associated with benign prostatic hyperplasia (LUTS/BPH) in patients not adequately controlled by medical therapy with α-blockers, as assessed by a change from baseline in the International Prostate Symptom Score (IPSS) total score.
    E.2.2Secondary objectives of the trial
    Secondary objectives are to evaluate:
    - the effects on storage and voiding LUTS
    - the effects on Quality of Life (QoL)
    - the effects on maximum urinary flow rate (Qmax), post void residual volume and prostate volume
    - the safety profile of the procedure and of the study drug
    - the patient’s global assessment of treatment
    - the persistence of the treatment effects at 18 and 24 months after the NX-1207 injection
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Signed informed consent;
    2. Age 45 or older;
    3. Medical history of lower urinary tract symptoms (LUTS) associated with Benign Prostatic Hyperplasia (BPH);
    4. Use of a marketed α-blocker for LUTS/BPH in the last 8 weeks;
    5. LUTS/BPH not adequately controlled by medical therapy with α-blockers;
    6. Presence of moderate-severe LUTS (IPSS ≥ 15) at screening and at baseline (after a 4 week run-in period with tamsulosin 0.4 mg QD);
    7. Prostate Volume ≥ 30 mL and ≤ 70 mL (as assessed by TRUS);
    8. Qmax < 15 mL/sec based on a minimum void of 125 mL;
    9. Agree not to use any other approved or experimental BPH or overactive bladder (OAB) medication anytime during the core study;
    10. Agree to perform follow-up visits even in case of oral treatment discontinuation before study end;
    11. Satisfactory compliance to run-in medication at Visit 2 (baseline).
    E.4Principal exclusion criteria
    1. Previous surgical or invasive prostate treatments such as TURP, TUMT, TUNA, laser or any other minimally invasive treatment;
    2. Acute or chronic prostatitis or suspected prostatitis including chronic pain, intermittent pain or abnormal sensation in the penis, testis, anal or pelvic area in the past 12 months;
    3. PSA ≥ 10 ng/mL. In case of a PSA between 4.0 and 10.0 ng/mL, prostate cancer must have been ruled out to the satisfaction of the clinical Investigator by an historical biopsy;
    4. Prostate or bladder cancer, history of pelvic irradiation;
    5. Active or recurrent urinary tract infections (more than 1 episode in the last 12 months);
    6. History of neurogenic bladder or LUTS secondary to neurologic disease;
    7. Use of self-catheterization for urinary retention;
    8. Post-void residual urine volume > 200 mL;
    9. Hematuria which has not been appropriately evaluated to determine safe subject participation;
    10. Renal insufficiency (serum creatinine >2.0 mg/dL);
    11. Liver insufficiency (any liver function tests [LFTs]>2x upper limit of normal [ULN]);
    12. Poorly controlled diabetes (type 1 or type 2), as determined by HbA1c >7% and/or glycosuria;
    13. Any bleeding disorder such as hemophilia, clotting factor(s) deficiency or bleeding diathesis;
    14. Immunosuppressive disorders, such as Human Immunodeficiency (HIV) Virus, Acquired Immune Deficiency Syndrome (AIDS), lymphoproliferative disorders;
    15. Acute or chronic intestinal disease, such as ulcerative colitis, Crohn’s disease, acute gastroenteritis in the run-in period; acute painful perianal disorder;
    16. Unstable cardiovascular or cerebrovascular disease (including acute myocardial infarction, unstable angina pectoris, by-pass, Percutaneous Transluminal Coronary Angioplasty (PTCA), congestive heart failure NYHA Class III-IV, stroke, transient ischemic attack and episodes of cardiac arrhythmia requiring treatment in the last 6 months);
    17. Any condition that would interfere with the subject’s ability to provide informed consent, to comply with study instructions, or that might confound the interpretation of the study results, such as dementia, psychosis, manic depressive disorder, post traumatic stress disorder, stroke, Alzheimer’s, depression, psychiatric illness, history or current evidence of drug or alcohol abuse within the last 12 months etc.;
    18. Participation in a study of any investigational drug or device within the previous 6 months;
    19. Hypersensitivity or contraindication to tamsulosin use (see Appendix 15.6);
    20. Use of prohibited medications that could endanger subjects performing the intraprostatic injection or that could interfere with the evaluation of study parameters (please refer to Section 6.7);
    21. Men planning to have children in the future;
    22. Any other condition that may interfere with the study or endanger the subject.
    E.5 End points
    E.5.1Primary end point(s)
    Improvement of lower urinary tract symptoms associated with benign prostatic hyperplasia (LUTS/BPH) in patients not adequately controlled by medical therapy with α-blockers, as assessed by a change from baseline in the total score (Questions 1 to 7) of the International Prostate Symptom Score (IPSS).
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 months after randomisation.
    E.5.2Secondary end point(s)
    • Change from baseline in subscores for storage symptoms and voiding symptoms at 12 months;
    • Change from baseline in question 8 of IPSS at 12 months;
    • Response rate by IPSS at 12 months;
    • Time to treatment failure;
    • Change from baseline in BII at 12 months;
    • Patient-rated global assessment of treatment BSW to continue at 12 months (or in case of early termination);
    • Change from baseline in EQ-5D-5L at 12 months (or in case of early termination);
    • Change from baseline in IPSS total score at 1, 3, 6 and 9 months;
    • Change from baseline in subscores for storage symptoms and voiding symptoms at 1, 3, 6 and 9 months,
    • Change from baseline in question 8 of IPSS at, 1,3,6 and 9 months;
    • Response rate by IPSS at 1, 3, 6 and 9 months;
    • Change from baseline in BII at 1, 3, 6, 9 months;
    • Change from baseline in the no. of voids (day/night/24 hours) and min/max/mean voided volume at 12 months;
    • Change from baseline in Maximum Urinary Flow (Qmax) at 3, 6, 9, 12 months (blinded centralized reading);
    • Change from baseline in TRUS assessed prostate volume at 3 and 12 months (or in case of early termination);
    • Percentage of subjects requiring medical therapy, MIST, TURP or surgery for LUTS/BPH and time to treatment failure;
    • Change from baseline in the total score (questions 1 to 7) of the IPSS;
    • Change from baseline in QoL due to urinary symptoms (question 8 of IPSS and BII);
    • Change from baseline in general health-related QoL (EQ-5D-5L);
    • SAEs and episodes of acute urinary retention.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Through 12, 18 and 24 months
    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 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 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) Yes
    E.8.2.2Placebo No
    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 concerned13
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA50
    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 No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Czech Republic
    France
    Germany
    Italy
    Poland
    Portugal
    Romania
    Russian Federation
    Spain
    United Kingdom
    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
    LVLS
    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 months9
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months9
    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 No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 140
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 200
    F.2 Gender
    F.2.1Female No
    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 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 state102
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 310
    F.4.2.2In the whole clinical trial 340
    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)
    At the end of the 12-month core period (or in case of premature dicontinuation), subejct will enter in the follow up period and will be treated as needed according to current clinical practice.
    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 Decision2013-08-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-05-21
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-01-29
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