Clinical trial NCT02808013: Study to Evaluate Efficacy and Safety of NDS-446 in Men With Lower Urinary Tract Symptoms (LUTS)
Official title: Prospective Randomized, Double-Blind, Placebo Controlled Study of NDS-446 (500 mg/Cap) in Men 45 Years of Age or Older With Moderate to Severe Lower Urinary Tract Symptoms (LUTS)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Lower Urinary Tract Symptoms
Lead sponsor: Naturex-Dbs
Sponsor class: INDUSTRY
First posted: 2016-06-21
Enrollment: 116
Sex: MALE
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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)


Eligibility criteria: 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) \[for all parameters other than those listed for exclusion criteria#3\]
11. Myocardial infarction or CVA within the past 90 days.
12. Requiring ongoing administration of antibiotics, antifungals, antiviral, chemotherapy, steroidal or immunosuppressive treatments.
13. Requiring chronic administration of aspirin at a dose \>81 mg/day.
14. Known hypersensitivity to study drug ingredient(s) or allergy to berries.
15. Use of the following medications: alpha blockers (28 days of screening), herbal or nutritional BPH supplements (28 days of screening), OAB medications (28 days of screening), 5 alpha reductase inhibitors (175 days of screening), PDE5 inhibitors (permitted as needed for erectile dysfunction only, but not to exceed 1 dose per week and not to be dosed within 5 days of a visit)
16. Use of an investigational agent (drug, biologic, device, etc.) within 30 days of screening
17. Any reason or condition that in the judgment of the Clinical Investigator(s) may put the subject at unacceptable risk or that may preclude the subject from understanding or complying with the study's requirements.

Primary outcomes:
measure: Change in total IPSS score between baseline and 6 months
timeFrame: 6-month
Secondary outcomes:
measure: Change in IPSS subscores (Storage, Voiding, Quality of Life) between baseline and 6 months
timeFrame: 6-month
measure: Change in Patient Global Impression of Improvement/Severity Score (PGIS) between baseline and 6 months
timeFrame: 6-month
measure: Uroflowmetry (Qmax: maximum urinary flow rate, mL/sec)
timeFrame: 6-month
measure: Uroflowmetry (PVR: Post Void Residual Volume, mL)
timeFrame: 6-month
measure: Uroflowmetry (Vol: Volume of urine voided, mL)
timeFrame: 6-month
measure: Sexual performance (SHIM: Sexual Health Inventory for Men)
timeFrame: 6-month
measure: Blood and urine laboratory analysis and incidence of treatment emergent adverse events [Safety and Tolerability]
timeFrame: 6-month
Other outcomes:
Locations:
Study officials:
References: