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

Plethora Solutions
Lupus House
11-13 Macklin Street
London
WC2B 5NH
United Kingdom

Phone +44 (0)20 7269 8630
Email sheryl.caswell@plethorasolutions.co.uk

Study information

Study designMulticentre multinational randomised double-blind placebo-controlled parallel-group study
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Other
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details to request a patient information sheet
Scientific titleA 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 objectivesSymptoms 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) studiedMen with LUTS and BPE/BOO
InterventionPSD506 20 mg or matching placebo once daily for 4 weeks, with a two- to four-week run-in period, if required.
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Applicable
Drug / device / biological / vaccine name(s)PSD506
Primary outcome measureTo demonstrate the similarity in safety profiles between PSD506 and placebo as assessed by a urodynamic measure of bladder outlet obstruction (BOO).
Secondary outcome measures1. 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 date01/07/2006
Completion date31/03/2007

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexMale
Target number of participantsApproximately 88 to ensure a total of 80 subjects
Key inclusion criteria1. 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 criteria1. 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
Date of first enrolment01/07/2006
Date of final enrolment31/03/2007

Locations

Countries of recruitment

  • England
  • Germany
  • Ireland
  • United Kingdom

Study participating centre

Plethora Solutions
London
WC2B 5NH
United Kingdom

Sponsor information

Plethora Solutions Limited (UK)
Industry

Lupus House
11-12 Macklin Street
London
WC2B 5NH
United Kingdom

Email mail@plethorasolutions.co.uk
Website http://www.plethorasolutions.co.uk/index.php
ROR logo "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 shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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.