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
- Conditions
- Overactive bladder (OAB)Urological and Genital Diseases
- Registration Number
- ISRCTN97355181
- Lead Sponsor
- Plethora Solutions Ltd (UK)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 100
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], 17ß 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)
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: 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change from baseline in average number of micturitions per day (urinary frequency)
- Secondary Outcome Measures
Name Time Method 1. Change from baseline in average number of urge urinary incontinence episodes <br>2. Change from baseline in average number of urinary urgency episodes <br>3. Change from baseline in average volume voided per micturition <br>4. Change from baseline in scores on ICIQ-FLUTS SF or ICIQ-MLUTS SF <br>5. Change from baseline in score on ICIQ-OABqol