LOWER URINARY TRACT SYMPTOMS ASSOCIATED WITH BENIGN PROSTATIC HYPERPLASIA MedDRA version: 17.0 Level: PT Classification code 10004446 Term: Benign prostatic hyperplasia System Organ Class: 10038604 - Reproductive system and breast disorders
Conditions
Interventions
Product Name: NX-1207
Pharmaceutical Form: Lyophilisate for solution for injection
INN or Proposed INN: -
CAS Number: -
Current Sponsor code: NX-1207
Other descriptive name: NYM-4805
Concentration uni
Sponsors
Recordati S.p.A.
Eligibility
Sex/Gender
Male
Inclusion criteria
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 a-blocker for LUTS/BPH in the last 8 weeks; 5. LUTS/BPH not adequately controlled by medical therapy with a-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 =65 years) yes F.1.3.1 Number of subjects for this age range 200
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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 a-blockers, as assessed by a change from baseline in the International Prostate Symptom Score (IPSS) total score. ;Secondary Objective: 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 ;Primary 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 a-blockers, as assessed by a change from baseline in the total score (Questions 1 to 7) of the International Prostate Symptom Score (IPSS).;Timepoint(s) of evaluation of this end point: 12 months after randomisation. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary 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. ;Timepoint(s) of evaluation of this end point: Through 12, 18 and 24 months | — |
Countries
Czech Republic, France, Germany, Italy, Poland, Portugal, Romania, Russian Federation, Spain, United Kingdom
Contacts
Public ContactClin. Proj. Leader - Medical Dep.
Recordati S.p.A.
Outcome results
None listed