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

Naturex

Status and phase: Unknown; Phase 2

Conditions: Lower Urinary Tract Symptoms

Treatments: Drug: NDS-446; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02808013

NDB 2015-001

Details and patient eligibility

About

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)

Enrollment: 116 estimated patients

Sex: Male

Ages: 45+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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116 participants in 2 patient groups, including a placebo group

NDS-446

Experimental group

Description:

NDS-446

Treatment:

Drug: NDS-446

Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo