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 and lower urinary tract symptoms
- Conditions
- Men with LUTS and BPE/BOOUrological and Genital DiseasesBenign prostatic obstruction and lower urinary tract symptoms
- Registration Number
- ISRCTN71613863
- Lead Sponsor
- Plethora Solutions Limited (UK)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Male
- Target Recruitment
- 88
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 a minimum of 125 ml voided volume
5. Post-void residual volume <150 mL
6. Written informed consent
7. If male subject and partner are of childbearing potential, agree to use a secure form of contraception (e.g. oral or injectable contraceptive, condom)
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
11. History of narrow angle glaucoma or increased ocular pressure
12. Clinically significant gastrointestinal disorder (e.g., gastroparesis, constipation, diarrhoea, colitis, gastrointestinal tract obstruction, hiatal hernia with reflux oesophagitis, cholestasis).
13. History of clinically significant liver disease, e.g., hepatitis B
14. Prohibited medications taken within two weeks prior to baseline
15. Concomitant use of any agent that has a significant interaction with CYP3A4 or P glycoprotein (Pgp)
16. Clinically significant abnormalities in laboratory test results (including hepatic and renal panels, complete blood count [CBC], chemistry panel)
17. Participation in an investigational drug or device study within 30 days prior to screening
18. Concomitant urological disorders: bladder neck stenosis, urethral stricture, bladder stones, bladder diverticulum, recurrent urinary tract infections, neurogenic bladder
19. Diagnosed or suspected prostate cancer
20. Known hypersensitivity to anti-cholinergic agents
21. Unwillingness or inability to comply with the study protocol for any other reason
22. Concomitant disease or condition that could interfere with, or for which the treatment might interfere with, the conduct of the study; or that would, in the opinion of the investigator, pose an unacceptable risk to the subject in this study. This would include, but is not limited to, cancer, alcoholism, drug dependency or abuse, or psychiatric disease
23. Any clinically significant abnormality on 12-lead ECG
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To demonstrate the similarity in safety profiles between PSD506 and placebo as assessed by a urodynamic measure of bladder outlet obstruction (BOO).
- Secondary Outcome Measures
Name Time Method <br> 1. To measure the change in Post Void Residual volumes (PVR) and other urodynamic parameters<br> 2. To obtain a preliminary assessment of efficacy by measuring the change in International Prostatic Symptom Score (IPSS) from baseline<br> 3. To demonstrate the overall safety of PSD506 in this subject population<br>