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 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN71613863 |
| EudraCT/CTIS number | 2006-002055-3 |
| Secondary identifying numbers | PSD506-OAB-004 |
- Submission date
- 15/02/2007
- Registration date
- 20/04/2007
- Last edited
- 21/11/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Urological and Genital Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Ms Sheryl Caswell
Scientific
Scientific
Plethora Solutions
Lupus House
11-13 Macklin Street
London
WC2B 5NH
United Kingdom
| Phone | +44 (0)20 7269 8630 |
|---|---|
| sheryl.caswell@plethorasolutions.co.uk |
Study information
| Study design | Multicentre multinational randomised double-blind placebo-controlled parallel-group study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific 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 |
| Study objectives | 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(s) | Northern and Yorkshire Multi-centre REC, 13/07/2006, ref: 06/MRE03/32 |
| Health condition(s) or problem(s) studied | Men with LUTS and BPE/BOO |
| Intervention | PSD506 20 mg or matching placebo once daily for 4 weeks, with a two- to four-week run-in period, if required. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | PSD506 |
| Primary outcome measure | 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 | 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 |
| Overall study start date | 01/07/2006 |
| Completion date | 31/03/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Male |
| Target number of participants | Approximately 88 to ensure a total of 80 subjects |
| Key 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 childbearing potential, agree to use a secure form of contraception (e.g. oral or injectable contraceptive, condom) |
| Key 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: Parkinsons 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 |
| Date of first enrolment | 01/07/2006 |
| Date of final enrolment | 31/03/2007 |
Locations
Countries of recruitment
- England
- Germany
- Ireland
- United Kingdom
Study participating centre
Plethora Solutions
London
WC2B 5NH
United Kingdom
WC2B 5NH
United Kingdom
Sponsor information
Plethora Solutions Limited (UK)
Industry
Industry
Lupus House
11-12 Macklin Street
London
WC2B 5NH
United Kingdom
| mail@plethorasolutions.co.uk | |
| Website | http://www.plethorasolutions.co.uk/index.php |
"ROR" |
https://ror.org/02y9vw172 |
Funders
Funder type
Industry
Plethora Solutions Limited (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Editorial Notes
21/11/2019: No publications found. Verifying results with principal investigator. EudraCT number added.
12/05/2017: No publications found, verifying study status with principal investigator.
