Study to Evaluate Efficacy and Safety of NDS-446 in Men With Lower Urinary Tract Symptoms (LUTS)

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)

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)

Study Overview

• Status: Unknown
• Conditions: Lower Urinary Tract Symptoms
• Intervention / Treatment: Drug: Placebo; Drug: NDS-446

• Study Type: Interventional
• Enrollment (Anticipated): 116
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Emilie A Fromentin, Ph.D.; Phone Number: 253 2014405000; Email: e.fromentin@naturex.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo
Experimental: NDS-446	Drug: NDS-446

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in total IPSS score between baseline and 6 months	6-month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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]	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)	6-month

Collaborators and Investigators

• Sponsor: Naturex-Dbs

Study record dates

Study Major Dates

• Study Start: June 1, 2016
• Primary Completion (Anticipated): September 1, 2017

Study Registration Dates

• First Submitted: May 31, 2016
• First Submitted That Met QC Criteria: June 16, 2016
• First Posted (Estimate): June 21, 2016

Study Record Updates

• Last Update Posted (Estimate): June 21, 2016
• Last Update Submitted That Met QC Criteria: June 16, 2016
• Last Verified: June 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urological Manifestations; Lower Urinary Tract Symptoms
• Other Study ID Numbers: NDB 2015-001