Lower Urinary Tract SymptomsPhase 2NCT02808013
Study to Evaluate Efficacy and Safety of NDS-446 in Men With Lower Urinary Tract Symptoms (LUTS)
A Phase 2 study testing NDS-446 in people with Lower Urinary Tract Symptoms, run by Naturex-Dbs.
Trial 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) Read more about this study
- Who is it for?
- Ages 45 years and older, men only
- Conditions the study is for
- Lower Urinary Tract Symptoms
- What is being tested?
- NDS-446
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 116 participants
- Where
- No sites listed yet
- Study dates
- Jun 2016to Sep 2017
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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
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- 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]
- 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
- 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 locations and contacts
No sites are listed yet.
About this study
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)
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
- Being tested
- NDS-446, Placebo
- Medical subject headings
- Lower Urinary Tract Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NDS-446Drug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| NDS-446 | Experimental | NDS-446 Receives: Drug: NDS-446 |
| Placebo | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in total IPSS score between baseline and 6 months
Measured: 6-month
Secondary outcomes (7)
Change in IPSS subscores (Storage, Voiding, Quality of Life) between baseline and 6 months
Measured: 6-month
Change in Patient Global Impression of Improvement/Severity Score (PGIS) between baseline and 6 months
Measured: 6-month
Uroflowmetry (Qmax: maximum urinary flow rate, mL/sec)
Measured: 6-month
Uroflowmetry (PVR: Post Void Residual Volume, mL)
Measured: 6-month
Uroflowmetry (Vol: Volume of urine voided, mL)
Measured: 6-month
Sexual performance (SHIM: Sexual Health Inventory for Men)
Measured: 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)
Measured: 6-month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2016 (estimated)
- Study startJun 2016
- Primary completionSep 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lower Urinary Tract SymptomsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 116 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Naturex-Dbs
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02808013
- Sponsor's protocol ID
- NDB 2015-001
- Status last verified
- Jun 2016
- First submitted
- 31 May 2016
- Last updated
- 21 Jun 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT02808013
- Acronym / sponsor ID
- NDB 2015-001
- Conditions
- Lower Urinary Tract Symptoms
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 116 participants (estimated)
- Lead sponsor
- Naturex-DbsIndustry (pharma, biotech, devices)
- Study start
- Jun 2016
- Primary completion
- Sep 2017 (estimated)
- First posted
- 21 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NDS-446 | Experimental | Drug: NDS-446NDS-446 |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 45 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (17 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NDS-446 | Drug | NDS-446 |
| Placebo | Drug | Placebo |
Primary outcome
Change in total IPSS score between baseline and 6 months
Time frame: 6-month
7 secondary outcomes
Change in IPSS subscores (Storage, Voiding, Quality of Life) between baseline and 6 months
Time frame: 6-month
Change in Patient Global Impression of Improvement/Severity Score (PGIS) between baseline and 6 months
Time frame: 6-month
Uroflowmetry (Qmax: maximum urinary flow rate, mL/sec)
Time frame: 6-month
Uroflowmetry (PVR: Post Void Residual Volume, mL)
Time frame: 6-month
Uroflowmetry (Vol: Volume of urine voided, mL)
Time frame: 6-month
Sexual performance (SHIM: Sexual Health Inventory for Men)
Time frame: 6-month
Blood and urine laboratory analysis and incidence of treatment emergent adverse events [Safety and Tolerability]
Time frame: 6-month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing NDS-446 in people with Lower Urinary Tract Symptoms, run by Naturex-Dbs.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Emilie A Fromentin, Ph.D. (2014405000 ext. 253, e.fromentin@naturex.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in total IPSS score between baseline and 6 months (time frame: 6-month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2016.