Lower Urinary Tract Symptoms
Conditions
Brief summary
Prospective, Randomized, Double-Blind, Placebo Controlled clinical trial to study the efficacy and the safety of NDS-446 (500 mg/cap) in Men 45 years of age or older with moderate to severe lower urinary tract symptoms (LUTS)
Interventions
DRUGNDS-446
DRUGPlacebo
Sponsors
Naturex-Dbs
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
MALE
Age
45 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Men ≥45 years of age. 2. LUTS, based on IPSS total score ≥8 and \<25 3. Peak urinary flow rate (Qmax) ≥4 and ≤15 mL/sec at screening 4. Post Void Residual (PVR) urine volume ≤ 200 mL at screening 5. PSA level at screening \< 10 ng/mL. Subjects with a PSA \> 4ng/mL and \< 10 ng/mL are eligible only if prostate cancer has been ruled out 6. Subjects who understand and speak English 7. Able and willing to give informed consent and comply with all study protocol procedures (diaries and other study tools).
Exclusion criteria
1. Not suitable for medical intervention (e.g., requiring TURP, etc.) 2. History of interstitial cystitis, bladder stones, urethral stricture, current prostatitis, acute urinary retention requiring catheterization in the last 3 months, or any other condition suspected to be the cause of LUTS other than BPH 3. Screening serum Creatinine (Cr) or liver function tests \[ALT (SGPT), AST (SGOT)\] \> 3 times the upper limit of normal (ULN) confirmed on a second measurement. 4. Cancer of the prostate or bladder by history or current diagnosis. 5. Prostate nodule(s) on screening digital rectal exam (DRE). 6. Prior surgical procedure of the urinary tract such as TURP, laser prostatectomy, photovaporization of the prostate 7. No minimally invasive surgery to the prostate such as TUMT or TUNA within the last 6 months. 8. Active urinary tract infection. 9. Unstable or uncontrolled medical or psychiatric condition. 10. Abnormal screening labs \> 2 times the upper limit of normal (ULN) \[for all parameters other than those listed for
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in total IPSS score between baseline and 6 months | 6-month |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Patient Global Impression of Improvement/Severity Score (PGIS) between baseline and 6 months | 6-month | — |
| Uroflowmetry (Qmax: maximum urinary flow rate, mL/sec) | 6-month | — |
| Uroflowmetry (PVR: Post Void Residual Volume, mL) | 6-month | — |
| Change in IPSS subscores (Storage, Voiding, Quality of Life) between baseline and 6 months | 6-month | — |
| Sexual performance (SHIM: Sexual Health Inventory for Men) | 6-month | — |
| Blood and urine laboratory analysis and incidence of treatment emergent adverse events [Safety and Tolerability] | 6-month | Blood samples will be collected to measure: Prostate Specific Antigen (PSA) Hematology: CBC (complete blood count), differential; reticulocyte count, platelets Serum Chemistries: BUN (blood urea nitrogen), Creatinine, Fasting Blood Glucose, Uric acid, AST (aspartate aminotransferase), ALT (alanine aminotransferase), ALP (alkaline phosphatase), LDH (lactate dehydrogenase), Total and Direct Bilirubin; Total Protein, Albumin, Calcium, Magnesium, Cholesterol, Triglycerides Coagulation: PT (prothrombin time) /PTT (partial thromboplastin time)/ INR (International Normalized Ratio) Urine samples will be collected to measure: Urinalysis: Urine Protein, Glucose, Microscopic for RBCs (Red blood cell counts), WBCs (white blood cell counts) Assessment of adverse events: collection of adverse events on a diary and spontaneously reported adverse events (either via phone calls to the site or during the visits) |
| Uroflowmetry (Vol: Volume of urine voided, mL) | 6-month | — |
Contacts
Primary ContactEmilie A Fromentin, Ph.D.
Outcome results
None listed