A double-blind, placebo-controlled study to assess the safety and preliminary efficacy of PSD506 in treatment-naïve or previously treated (washed out) patients with symptoms of overactive bladder

ISRCTN	ISRCTN97355181
DOI	https://doi.org/10.1186/ISRCTN97355181
Secondary identifying numbers	PSD506-OAB-005

Submission date: 15/02/2007
Registration date: 23/04/2007
Last edited: 22/05/2017

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

Miss 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 design	Multi-centre multi-national randomised double-blind placebo-controlled parallel-group study
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
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 study to assess the safety and preliminary efficacy of PSD506 in treatment-naïve or previously treated (washed out) patients with symptoms of overactive bladder
Study objectives	Overactive bladder (OAB) is treated currently by anti-muscarinic drugs. Anti-muscarinic drugs may have cardiovascular side effects (such as tachycardia) and Central Nervous System (CNS) side effects. These side effects result from non-selective muscarinic blockade and from CNS penetration. PSD506 is a novel anti-muscarinic agent that is being developed for the treatment of OAB. This is the first study in patients suffering from OAB and will establish the efficacy of PSD506 in this condition as well as further assessing safety and tolerability in practice.
Ethics approval(s)	Central and South Bristol REC, 04/08/2006, ref: 06/Q2006/61
Health condition(s) or problem(s) studied	Overactive bladder (OAB)
Intervention	Previously treated subjects will have a 4-week (28-day) washout period. All subjects will have a 1-week (7-day) run-in period. PSD506 20 mg or matching placebo daily for 4 weeks (plus 4-week follow-up period).
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	PSD506 (antimuscarinic agent)
Primary outcome measure	Change from baseline in average number of micturitions per day (urinary frequency)
Secondary outcome measures	1. Change from baseline in average number of urge urinary incontinence episodes 2. Change from baseline in average number of urinary urgency episodes 3. Change from baseline in average volume voided per micturition 4. Change from baseline in scores on ICIQ-FLUTS SF or ICIQ-MLUTS SF 5. Change from baseline in score on ICIQ-OABqol
Overall study start date	01/07/2006
Completion date	31/12/2007

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	100 subjects (50 subjects per group)
Key inclusion criteria	1. Age 18 years or over 2. If female, must be surgically sterile or post-menopausal for at least a year and confirmed by a negative hormone panel (luteinizing hormone [LH], follicle stimulating hormone [FSH], 17β estradiol). Women who are receiving HRT at the time of screening may be defined as post-menopausal provided there is documentation in their medical history to confirm that they had stopped menstruating for one year before starting the HRT 3. If male subject and partner is of childbearing potential must agree to use a secure form of contraception (e.g., pill, condom) 4. Involuntary detrusor contraction associated with urgency during filling cystometry in the last 12 months prior to study entry 5. Symptoms of OAB for at least 6 months prior to study entry. Subjects with concurrent Stress Urinary Incontinence (SUI) and OAB may be included provided the symptoms of OAB are dominant 6. Willing and able to provide written informed consent Inclusion criteria at baseline: 7. Completed appropriate washout period (for previously treated subjects) and 7 days run-in period for all subjects (both treated subjects and treatment naïve subjects) prior to baseline visit 8. Have an average of 10 micturitions and at least one episode of urinary urgency per day (during the 7 days of run-in period) 9. Have an average of 7 episodes of urge urinary incontinence per week (during the 7 days of the run-in period)
Key exclusion criteria	1. Female subject who is of childbearing potential 2. Uncontrolled hypertension, defined as mean systolic blood pressure [SBP] ≥160 mmHg or a diastolic blood pressure [DBP] ≥95 mmHg (after sitting for 5 minutes) 3. History of clinically significant hypotensive episodes or symptoms of fainting, dizziness or lightheadedness 4. Unstable cardiovascular disease, particularly coronary artery disease, arrhythmias, atrial tachycardia or congestive heart failure 5. Clinically significant central nervous system disease, including: Parkinsons disease, multiple sclerosis, transient ischemic attack, stroke, seizure disorder, depression or behavioral disturbances 6. History of peripheral vascular or cerebrovascular disease 7. History of narrow angle glaucoma or increased ocular pressure 8. Clinically significant bladder pathology (e.g., obstructive uropathy) or history of urinary retention 9. Clinically significant gastrointestinal disorder (e.g., gastroparesis, constipation, diarrhea, colitis, gastrointestinal tract obstruction, hiatal hernia with reflux oesophagitis, cholestasis) 10. History of clinically significant liver disease (e.g., hepatitis B) 11. Prohibited medications taken within the previous 2 weeks prior to baseline date (4 weeks for solifenacin) 12. Concomitant use of any agent that has a significant interaction with CYP3A4 or P glycoprotein (Pgp) 13. Clinically significant abnormalities in laboratory test results (including hepatic and renal panels, Complete Blood Count [CBC] and chemistry panel) at screening 14. Urinary tract infection within 6 weeks prior to baseline 15. Participation in an investigational drug or device study within 30 days prior to screening date 16. Known hypersensitivity to anti-cholinergic agents 17. 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 18. Unwillingness or inability to comply with the study protocol for any other reason 19. Unable to understand and complete the ICIQ-OABqol and ICIQ-FLUTS or ICIQ-MLUTS questionnaires or Micturition Diary 20. Any clinically significant abnormality on 12-lead ECG
Date of first enrolment	01/07/2006
Date of final enrolment	31/12/2007

Locations

Countries of recruitment

England
Germany
Ireland
United Kingdom

Study participating centre

Plethora Solutions

London
WC2B 5NH
United Kingdom

Sponsor information

Plethora Solutions Ltd (UK)
Industry

Lupus House
11-13 Maclklin Street
London
WC2B 5NH
United Kingdom

Phone	+44 (0)207 269 8630
Email	mail@plethorasolutions.co.uk
Website	http://www.plethorasolutions.co.uk/index.php
"ROR"	https://ror.org/02y9vw172

Funders

Funder type

Industry

Plethora Solutions Ltd (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

22/05/2017: No publications found, verifying study status with principal investigator.