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

Phase 1

• Conditions: benign prostatic obstruction (BPO) and lower urinary tract symptoms (LUTS); MedDRA version: 8.1 Level: LLT Classification code 10055026 Term: Prostatic obstruction

• Registration Number: EUCTR2006-002055-32-IE
• Lead Sponsor: Plethora Solutions Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-08-14
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 80

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:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 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.
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 clinical trial of medicinal product
• Study Design: Not specified