EUCTR2006-002055-32-GB
Active, not recruiting
Not Applicable
A double-blind, placebo controlled, pilot study to assess the safety and preliminary efficacy of PSD506 in treatment-naïve or previously treated (washed out) patients with benign prostatic obstruction (BPO) and lower urinary tract symptoms (LUTS) - PSD506-OAB-004
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- benign prostatic obstruction (BPO) and lower urinary tract symptoms (LUTS)
- Sponsor
- Plethora Solutions Limited
- Enrollment
- 80
- Status
- Active, not recruiting
- Last Updated
- 14 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •The study population is men with LUTS and BPE/bladder outlet obstruction (BOO):
- •1\. Males aged 18 years and above.
- •2\. Symptoms of LUTS for \=6 months prior to baseline.
- •3\. IPSS score of 8 \- 19 at baseline.
- •4\. Maximum urine flow \=5 mL/sec and \=12 mL/sec on 125 mL voided volume.
- •5\. Post\-void residual volume \<150 mL.
- •6\. Written informed consent.
- •7\. If male subject and partner are of child bearing potential, agree to use a secure form of contraception (e.g. oral or injectable contraceptive, condom).
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
Exclusion Criteria
- •1\. Uncontrolled hypertension \>160/95 mmHg (after sitting for 5 minutes).
- •2\. Concomitant or recent medication for BPE: 5a\-reductase inhibitors within 6 months prior to baseline or alpha\-adrenergic receptor blockers within 3 months prior to baseline.
- •3\. Use of anticholinergics in the two weeks prior to baseline (four weeks for solifenacen).
- •4\. Previous surgery for BOO.
- •5\. Acute urinary retention in the 12 months prior to baseline.
- •6\. Urinary tract infection within 6 weeks prior to baseline.
- •7\. History of significant hypotensive episodes or symptoms of fainting, dizziness, or lightheadedness.
- •8\. Unstable cardiovascular disease, particularly coronary artery disease, arrhythmias, atrial tachycardia, or congestive heart failure.
- •9\. Clinically significant central nervous system disease including: Parkinson’s disease, multiple sclerosis, transient ischemic attack, stroke, seizure disorder, depression, or behavioural disturbances.
- •10\. History of peripheral vascular or cerebrovascular disease.
Outcomes
Primary Outcomes
Not specified
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