Overactive Bladder Syndrome MedDRA version: 8.1 Level: LLT Classification code 10059617 Term: Overactive bladder
Conditions
Interventions
Product Name: SMP-986
Product Code: SMP-986
Pharmaceutical Form: Film-coated tablet
CAS Number: 500593-73-7
Current Sponsor code: SMP-986
Concentration unit: mg milligram(s)
Concentration type: equal
Sponsors
Dainippon Sumitomo Pharma Europe Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: To be eligible for inclusion patients must: 1. Have given written informed consent to participate in the study 2. Be>= 20== 12 months of spontaneous amenorrhea or >= 6 - == 6 months prior to screening 4. Have had an average of >= 8 micturition episodes/ 24 hrs during the 3 days prior to randomisation 5. Have experienced >= 3 episodes of urgency with or without urgency incontinence during the 3 days prior to randomisation 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: Patients are not eligible for this study if they fulfil any of the following criteria: 1. Have a cardiac arrhythmia that requires treatment 2. Have a post-void residual volume >150 mL at screening 3. Have a maximum urine flow rate of = 14 days prior to randomisation: any drugs used to treat OABS or urinary incontinence, cholinergics, anti cholinergics, alpha adrenergic antagonists, opioid analgesics, compound analgesics containing an opioid, warfarin or other substrates of cytochrome P450 2C9 which have a narrow therapeutic index, potent cytochrome P450 3A4 and 2D6 inhibitors or inducers 6. Are not willing or able to complete a study diary during the 8-week study (patients capabilities’ in this respect will be assessed by the clinical site staff using patients’ diary data from the placebo run-in phase) 7. Have a drug compliance of = 14 days prior to screening: electro-stimulation therapy for OABS, bladder training programme if not stabilised before screening 9. Have an indwelling catheter or perform intermittent self catheterisation 10. Have participated in another clinical trial with an investigational drug within 8 weeks prior to randomisation 11. Have polyuria (a documented medical history and/or a study diary recording of an average of >= 3L urine passed/ 24 hrs during the 3 days prior to randomisation) 12. Have stress urinary incontinence or mixed urinary incontinence for which stress is the predominant factor 13. Have a neurological cause of OABS symptoms e.g. multiple sclerosis, Parkinson’s disease, full or partial spinal cord injury 14. Have painful bladder syndrome/interstitial cystitis, bladder stones or a symptomatic calculous disease (e.g. kidney stones) affecting the lower urinary tract 15. Have poorly controlled diabetes as indicated by an HbA1c result of >7% at screening 16. Have a documented past medical history of peripheral, autonomic or diabetic neuropathy 17. Have ever received any specialist pharmacological treatment for OABS e.g. treatment with botulinum toxin A, resiniferatoxin or capsaicin 18. Have a urinary tract infection (UTI) or, have had proven diagnoses of >= 3 episodes of UTI within the 12 months prior to screening 19. Have, or have had a malignancy with or without metastases within the last 5 years or have ever had a malignant tumour affecting the genitourinary tract or who currently have benign prostatic hyperplasia with bladder outlet obstruction 20. Have had genitourinary surgery or lower bowel surgery within the 12 months prior to screening or have ever received pelvic radiation 21. Have >= stage 2 pelvic organ prolapse (as defined by the ICS pelvic organ prolapse quantification system) 22. Concomitant use of hormone replacement therapy or diuretics if the dose has not been stable for a period of >= 12 weeks prior to screening 23. Have, in the opinion of the Investigator, a significant history of constipation or have an active bowel disease (e.g. inflammatory bowel disease, colitis, di
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To quantify the extent of symptomatic relief provided by 20, 40, 80 and 120 mg SMP 986 (o.d) following 8-weeks of treatment in patients with OABS;Secondary Objective: To assess the safety and tolerability of 20, 40, 80 and 120 mg SMP 986 (o.d) following 8-weeks of treatment in patients with OABS To determine the most clinically appropriate dose range for SMP-986 in terms of treatment benefit (efficacy, safety, tolerability and QOL outcomes);Primary end point(s): The change from baseline to week 8 in mean number of voids/24 hrs | — |
Countries
Estonia, France, Germany, Latvia, Lithuania, Spain, United Kingdom
Outcome results
None listed