Contact information
Type
Scientific
Primary contact
Ms Sheryl Caswell
ORCID ID
Contact details
Plethora Solutions
Lupus House
11-13 Macklin Street
London
WC2B 5NH
United Kingdom
+44 (0)20 7269 8630
sheryl.caswell@plethorasolutions.co.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
PSD506-OAB-004
Study information
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
Acronym
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, 13/07/2006, ref: 06/MRE03/32
Study design
Multicentre multinational randomised double-blind placebo-controlled parallel-group study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
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
Phase
Not Applicable
Drug names
PSD506
Primary outcome measures
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 trial start date
01/07/2006
Overall trial end date
31/03/2007
Reason abandoned
Eligibility
Participant 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)
Participant type
Patient
Age group
Adult
Gender
Male
Target number of participants
Approximately 88 to ensure a total of 80 subjects
Participant 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
Recruitment start date
01/07/2006
Recruitment end date
31/03/2007
Locations
Countries of recruitment
Germany, Ireland, United Kingdom
Trial participating centre
Plethora Solutions
London
WC2B 5NH
United Kingdom
Sponsor information
Organisation
Plethora Solutions Limited (UK)
Sponsor details
Lupus House
11-12 Macklin Street
London
WC2B 5NH
United Kingdom
-
mail@plethorasolutions.co.uk
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
Plethora Solutions Limited (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary