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

NCT02808013 | Unknown Phase 2

• 1 other identifier: NDB 2015-001
• Study Type: interventional
• Target: 116
• Locations: 0 countries
• Sites: N/A

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)

Conditions

Lower Urinary Tract Symptoms

Outcome Measures

Primary Outcomes (1)

• Change in total IPSS score between baseline and 6 months

  6-month

Secondary Outcomes (7)

• 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

Study Arms (2)

NDS-446

EXPERIMENTAL

NDS-446

Drug: NDS-446

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

NDS-446 DRUG

NDS-446

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 45 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.
• Myocardial infarction or CVA within the past 90 days.
• Requiring ongoing administration of antibiotics, antifungals, antiviral, chemotherapy, steroidal or immunosuppressive treatments.
• Requiring chronic administration of aspirin at a dose \>81 mg/day.
• Known hypersensitivity to study drug ingredient(s) or allergy to berries.
• 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)
• Use of an investigational agent (drug, biologic, device, etc.) within 30 days of screening

Sponsors & Collaborators

• Naturex-Dbs: lead

MeSH Terms

Conditions

Lower Urinary Tract Symptoms

Condition Hierarchy (Ancestors)

Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Emilie A Fromentin, Ph.D.

CONTACT

2014405000; e.fromentin@naturex.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 31, 2016
• First Posted: June 21, 2016
• Study Start: June 1, 2016
• Primary Completion: September 1, 2017
• Last Updated: June 21, 2016

Record last verified: 2016-06