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| [ Print-friendly version ] |
| 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 |
| ISRCTN | ISRCTN71613863 |
| ClinicalTrials.gov identifier | |
| Public title | 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 |
| Scientific title | |
| Acronym | N/A |
| Serial number at source | PSD506-OAB-004 |
| Study hypothesis | Symptoms of lower urinary tract dysfunction are associated with Bladder Outlet Obstruction (BOO) as a result of Benign Prostatic Enlargement (BPE). The symptoms experienced may be characteristic of OverActive Bladder (OAB) or secondary to Detrusor Overactivity (DO). OAB symptoms may be exacerbated by BOO that results from BPE. Treating the bothersome symptoms of OAB is, therefore, an important goal for the management of comorbid symptomatic DO and BOO. PSD506 is a novel antimuscarinic agent that is being studied for the treatment of OAB. This study aims to assess the safety of PSD506 in men with Lower Urinary Tract Symptoms (LUTS) and BPE/BOO and an International Prostatic Symptom Score (IPSS) of 8 -19, in line with American Urological Association recommendations. |
| Ethics approval | Northern and Yorkshire Multi-centre REC, approved on 13/07/06, ref: 06/MRE03/32 |
| Study design | Multicentre, multinational, randomised, double-blind, placebo controlled, parallel group study |
| Countries of recruitment | Germany, Ireland, United Kingdom |
| Disease/condition/study domain | Men with LUTS and BPE/BOO |
| Participants - inclusion criteria |
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 child bearing potential, agree to use a secure form of contraception (e.g. oral or injectable contraceptive, condom) |
| Participants - exclusion criteria |
1. Uncontrolled hypertension >160/95 mmHg (after sitting for 5 minutes)
2. Concomitant or recent medication for BPE: 5α-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 |
| Anticipated start date | 01/07/2006 |
| Anticipated end date | 31/03/2007 |
| Status of trial | Completed |
| Patient information material | |
| Target number of participants | Approx 88 to ensure total of 80 subjects |
| Interventions | PSD506 20 mg or matching placebo once daily for 4 weeks, with a two- to four-week run-in period, if required. |
| Primary outcome measure(s) | To demonstrate the similarity in safety profiles between PSD506 and placebo as assessed by a urodynamic measure of bladder outlet obstruction (BOO). |
| Secondary outcome measure(s) |
1. To measure the change in Post Void Residual volumes (PVR) and other urodynamic parameters
2. To obtain a preliminary assessment of efficacy by measuring the change in International Prostatic Symptom Score (IPSS) from baseline 3. To demonstrate the overall safety of PSD506 in this subject population |
| Sources of funding | Plethora Solutions Limited (UK) |
| Trial website | |
| Publications | |
| Contact name | Ms Sheryl Caswell |
| Address |
Plethora Solutions
Lupus House 11-13 Macklin Street |
| City/town | London |
| Zip/Postcode | WC2B 5NH |
| Country | United Kingdom |
| Tel | +44 (0)20 7269 8630 |
| sheryl.caswell@plethorasolutions.co.uk | |
| Sponsor | Plethora Solutions Limited (UK) |
| Address |
Lupus House
11-12 Macklin Street |
| City/town | London |
| Zip/Postcode | WC2B 5NH |
| Country | United Kingdom |
| mail@plethorasolutions.co.uk | |
| Sponsor website: | http://www.plethorasolutions.co.uk/index.php |
| Date applied | 15/02/2007 |
| Last edited | 06/08/2008 |
| Date ISRCTN assigned | 20/04/2007 |
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