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)

Naturex-Dbs0 sites116 target enrollmentJune 2016

ConditionsLower Urinary Tract Symptoms

InterventionsNDS-446 Placebo

DrugsNDS-446 Placebo

Overview

Phase: Phase 2
Intervention: NDS-446
Conditions: Lower Urinary Tract Symptoms
Sponsor: Naturex-Dbs
Enrollment: 116
Primary Endpoint: Change in total IPSS score between baseline and 6 months
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

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)

Registry

clinicaltrials.gov

Start Date

June 2016

End Date

September 2017

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Male

Investigators

Sponsor

Naturex-Dbs

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Men ≥45 years of age.
•LUTS, based on IPSS total score ≥8 and \<25
•Peak urinary flow rate (Qmax) ≥4 and ≤15 mL/sec at screening
•Post Void Residual (PVR) urine volume ≤ 200 mL at screening
•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
•Subjects who understand and speak English
•Able and willing to give informed consent and comply with all study protocol procedures (diaries and other study tools).

Exclusion Criteria

•Not suitable for medical intervention (e.g., requiring TURP, etc.)
•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
•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.
•Cancer of the prostate or bladder by history or current diagnosis.
•Prostate nodule(s) on screening digital rectal exam (DRE).
•Prior surgical procedure of the urinary tract such as TURP, laser prostatectomy, photovaporization of the prostate
•No minimally invasive surgery to the prostate such as TUMT or TUNA within the last 6 months.
•Active urinary tract infection.
•Unstable or uncontrolled medical or psychiatric condition.
•Abnormal screening labs \> 2 times the upper limit of normal (ULN) \[for all parameters other than those listed for exclusion criteria#3\]

Arms & Interventions

NDS-446

Intervention: NDS-446

Placebo

Intervention: Placebo

Outcomes

Primary Outcomes

Change in total IPSS score between baseline and 6 months

Time Frame: 6-month

Secondary Outcomes

Change in IPSS subscores (Storage, Voiding, Quality of Life) between baseline and 6 months(6-month)
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)
Uroflowmetry (Vol: Volume of urine voided, mL)(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)