SMP-986 Phase 2 Proof of Concept in Patients With Overactive Bladder Syndrome (OABS)

Study Overview
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Brief Summary
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SMP-986 is a compound being developed for the treatment of overactive bladder syndrome (OABS). This clinical study is designed to test the hypothesis that SMP-986 at doses of 20mg, 40mg, 80mg or 120mg provides greater symptom relief in OABS compared to placebo. The hypothesis will be tested by measuring the change in mean voids/24 hrs after treatment with SMP-986 compared to placebo, as well comparing the change in: the severity of urgency episodes, mean number of urgency episodes/24 hr, mean number of incontinence episodes/24 hr and the mean void volume/void between SMP-986 and placebo.

Detailed Description
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A multicenter study conducted in patients with OABS comprising a 2-week single blind placebo run-in period followed by an 8-week randomized, double-blind, placebo controlled treatment period with patients randomized to receive 20 mg, 40 mg, 80 mg or 120 mg SMP 986 or placebo in a 1:1:1:1:1 ratio in parallel groups on an outpatient basis with study center visits.

Official Title
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A 10-week Randomised, DB, PG, PC Phase 2 Study to Investigate the Extent of Symptom Relief and the Safety and Tolerability of SMP-986 (20, 40, 80 and 120 mg) Administered Once Daily for 8 Weeks to Patients With Overactive Bladder Syndrome

Conditions
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Overactive Bladder Syndrome (OABS)

Intervention / Treatment
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* Drug: Placebo
* Drug: Placebo
* Drug: SMP-986


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Main Inclusion Criteria: Males, or females who are not of child-bearing potential Aged 20-80 years (inclusive) with a diagnosis of OABS based on symptomatic reporting over a period of 6 months (micturition frequency, and urgency with or without incontinence) prior to screening. Exclusion Criteria: Main Exclusion Criteria: Patients will be excluded if there is an indication of any bladder outlet obstruction or polyuria Patients with the following conditions, or who have undergone the following procedures, will be excluded: stress urinary incontinence pelvic organ prolapse ( stage 2) genitourinary or lower bowel surgery (within 12 months prior to screening), pathological conditions including poorly controlled diabetes, painful bladder syndrome/interstitial cystitis or history of chronic urinary tract infection neurological conditions including multiple sclerosis, Parkinson's disease or neuropathy) Patients will also be excluded if they have an indwelling catheter or perform intermittent self catheterisation Patients should not have a current or past medical condition contraindicating the use of antimuscarinics and must have discontinued use of the following drugs: drugs used to treat OABS or urinary incontinence cholinergics anticholinergics alpha adrenergic antagonists opioid analgesics compound analgesics containing an opioid warfarin Patients with a current or past malignancy (within the last 5 years) Patients who have ever had a tumour affecting the genitourinary tract (not including benign prostatic hyperplasia) will be excluded. 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. Patients will be excluded if they are unable to complete the study diary

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: 1<br>Placebo run-in phase. 2 week duration. | Drug: Placebo<br>* Placebo, 2 week duration.<br>|
| Placebo Comparator: 2<br>To be taken for the 8 week duration, in parallel with alternative arms (doses of 20, 40, 80 or 120mg SMP-986). | Drug: Placebo<br>* Taken for the 8 week duration, in parallel with alternative arms (doses of 20, 40, 80 or 120mg SMP-986).<br>|
| Experimental: 3<br>20mg dose of SMP-986 to be taken once daily for 8 week duration. | Drug: SMP-986<br>* Comparison of varying dosages (20, 40, 80 or 120mg) of SMP-986 against placebo. Dosing is to occur once daily, in the morning, for a duration of 8 weeks<br>|
| Experimental: 4<br>40mg dose of SMP-986 to be taken for 8 week duration. | Drug: SMP-986<br>* Comparison of varying dosages (20, 40, 80 or 120mg) of SMP-986 against placebo. Dosing is to occur once daily, in the morning, for a duration of 8 weeks<br>|
| Experimental: 5<br>80mg dose of SMP-986 to be taken for 8 week duration. | Drug: SMP-986<br>* Comparison of varying dosages (20, 40, 80 or 120mg) of SMP-986 against placebo. Dosing is to occur once daily, in the morning, for a duration of 8 weeks<br>|
| Experimental: 6<br>120mg dose of SMP-986 to be taken for 8 week duration. | Drug: SMP-986<br>* Comparison of varying dosages (20, 40, 80 or 120mg) of SMP-986 against placebo. Dosing is to occur once daily, in the morning, for a duration of 8 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline to Week 8 in the Number of Voids/24 Hours |  | 8 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Over Active Bladder Syndrome | Treatment emergent adverse event summary | 8 Weeks |