OverActive Bladder Syndrome (OABS) Urological and Genital Diseases Bladder disorders
Conditions
Interventions
Added 06/08/2008: Patient follow-up was completed on the 05/06/2008.
SMP-986 (20mg, 40mg, 80mg, 120 mg) or placebo. The treatment is delivered as tablets taken orally for a total of t
Sponsors
Dainippon Sumitomo Pharma Europe Ltd (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Males, or females who are not of child bearing potential. Female subjects must be either postmenopausal, surgically sterile or using a highly effective non oral form of contraception. 2. Aged 20 to 80 years (inclusive) 3. Diagnosis of OABS based on symptomatic reporting over a period of more than six months (micturition frequency, and urgency with or without incontinence) prior to screening.
Exclusion criteria
Exclusion criteria: 1. Patients with an indication of any bladder outlet obstruction or polyuria 2. Patients with the following conditions, or who have undergone the following procedures, will be excluded: 2.1. Stress urinary incontinence 2.2. Pelvic organ prolapse (more than stage two) 2.3. Genitourinary or lower bowel surgery (within 12 months prior to screening), 2.4. Pathological conditions including poorly controlled diabetes, painful bladder syndrome/interstitial cystitis or history of chronic urinary tract infection 2.5. Neurological conditions including multiple sclerosis, Parkinson's disease or neuropathy) 3. Patients will also be excluded if they have an indwelling catheter or perform intermittent self catheterisation 4. Patients should not have a current or past medical condition contraindicating the use of antimuscarinics and must have discontinued use of the following drugs: 4.1. Drugs used to treat OABS or urinary incontinence 4.2. Cholinergics 4.3. Anticholinergics 4.4. Alpha adrenergic antagonists 4.5. Opioid analgesics 4.6. Compound analgesics containing an opioid 4.7. Warfarin 5. Patients with a current or past malignancy (within the last five years), and patients who have ever had a tumour affecting the genitourinary tract (not including benign prostatic hyperplasia) 6. Patients will be ineligible if they have a clinically significant cardiac, neurological, hepatic, renal, respiratory, haematological or gastrointestinal disorder (including, a significant history of constipation or an active bowel disease e.g. inflammatory bowel disease) or any other illness which in the opinion of the Investigator would preclude the safe or compliant participation of a subject 7. Patients unable to complete the study diary
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To quantify the extent of symptomatic relief provided by 20, 40, 80 and 120 mg SMP 986 (once daily [o.d.]) following eight-weeks of treatment in patients with OABS. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To assess the safety and tolerability of 20, 40, 80 and 120 mg SMP 986 (o.d.) following eight-weeks of treatment in patients with OABS 2. To determine the most clinically appropriate dose range for SMP-986 in terms of treatment benefit (efficacy, safety, tolerability and Quality of Life outcomes) | — |
Countries
Estonia, France, Germany, Latvia, Lithuania, Poland, Spain, United Kingdom, United States of America
Outcome results
None listed