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| 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 |
| Source of record | UK Clinical Trials Gateway |
| ISRCTN | ISRCTN97355181 |
| Date ISRCTN assigned | 23/04/2007 |
| Local reference number(s) | PSD506-OAB-005 |
| Public 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 |
| Scientific title | |
| Acronym | N/A |
| Disease/condition/study domain | Overactive bladder (OAB) |
| Study hypothesis | 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. |
| Design/methodology | A multi-centre, multi-national, randomised, double-blind, placebo controlled, parallel group study. |
| Research ethics review | Central and South Bristol REC, approved on 04/08/06, ref: 06/Q2006/61 |
| Countries of trial | United Kingdom, Ireland and Germany |
| Participants - 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 child bearing 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) |
| Participants - exclusion criteria | 1. Female subject who is of child-bearing 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: Parkinson¿s 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 |
| Patient information material | |
| Anticipated start date | 01/07/2006 |
| Anticipated end date | 31/12/2007 |
| Status of trial | Completed |
| Target number of participants | 100 subjects (50 subjects per group) are required |
| Interventions | Previously treated subjects will have a 4 week (28 days) washout period. All subjects will have a one week (7 days) run-in period. PSD506 20 mg or matching placebo daily for four weeks (plus four-week follow up period). |
| Primary outcome measure(s) | To measure the change from baseline in average number of micturitions per day (urinary frequency). |
| Secondary outcome measure(s) | 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 |
| Sources of funding | Plethora Solutions Ltd (UK) |
| Sponsor name | Plethora Solutions Ltd (UK) |
| Sponsor details | Lupus House 11-13 Maclklin Street London United Kingdom WC2B 5NH |
| Sponsor telephone | +44 (0)207 269 8630 |
| Sponsor email | mail@plethorasolutions.co.uk |
| Sponsor website | http://www.plethorasolutions.co.uk/index.php |
| Contact name | Miss Sheryl Caswell |
| Contact details | Plethora Solutions Lupus House 11-13 Macklin Street London United Kingdom WC2B 5NH |
| Contact telephone | +44 (0)20 7269 8630 |
| Contact email | sheryl.caswell@plethorasolutions.co.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN97355181 |
| Date last extracted from ISRCTN register | 17/04/2008 |
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