overactive bladder (OAB) MedDRA version: 8.1 Level: LLT Classification code 10059617 Term: Overactive bladder
Conditions
Interventions
Product Name: PSD506
Product Code: PSD506
Pharmaceutical Form: Capsule, soft
Current Sponsor code: PSD506
Other descriptive name: R032-02904/000
Concentration unit: mg milligram(s)
Concentration type:
Sponsors
PLETHORA SOLUTIONS LIMITED
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: The study population is subjects with symptoms of overactive bladder (OAB) as defined by the International Continence Society (ICS). 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], 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 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) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Female subject who is of child-bearing potential. 2. Uncontrolled hypertension, defined as mean systolic blood pressure [SBP] =160mmHg or a diastolic blood pressure [DBP] =95mmHg (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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary Objective: To measure the change from baseline in average number of micturitions per day (urinary frequency) ;Secondary Objective: Secondary Objective(s): To measure the change from baseline in average number of urge urinary incontinence episodes To measure the change from baseline in average number of urinary urgency episodes To measure the change from baseline in average volume voided per micturition To measure the change from baseline in scores on ICIQ-FLUTS SF (International Consultation on Incontinence Questionnaire-Female Lower Urinary Tract Symptoms Short Form) or ICIQ-MLUTS SF (International Consultation on Incontinence Questionnaire-Male Lower Urinary Tract Symptoms Short Form) To measure the change from baseline in score on ICIQ-OABqol (International Consultation on Incontinence Questionnaire-Overactive Bladder Quality of Life);Primary end point(s): Efficacy: The primary efficacy endpoint is the change from Baseline (visit 2) to Week 4 (Visit 6) in the average number of micturitions per day (urinary frequency). The secondary efficacy endpoints are the change from Baseline (Visit 2) to Week 4 (Visit 6) in the average number of urge urinary incontinence and urinary urgency episodes per day, average volume voided per micturition, ICIQ-OABqol and ICIQ-FLUTS SF (female subjects) or ICIQ-MLUTS SF (male subjects) scores. Safety: Adverse events, ECG (mean change in heart rate from baseline and the mean change in QTc interval from baseline), anti- muscarinic adverse events, and vital signs. Pharmacokinetics: Weekly trough level blood samples will be taken prior to dosing with study drug and at Visit 6 and the Follow-up Visit 7 (4 weeks after the last treatment dose) or an early withdrawal visit in order to further delineate the pharmacokinetics of PSD506 in human subjects. | — |
Countries
Ireland, United Kingdom
Outcome results
None listed