SMP-986 Phase 2 Proof of Concept in Patients With Overactive Bladder Syndrome (OABS)
Condition: Overactive Bladder Syndrome (OABS)
MeSH terms: Urinary Bladder, Overactive; Syndrome
Intervention: Placebo; Placebo; SMP-986
Intervention description: Placebo, 2 week duration.; Taken for the 8 week duration, in parallel with alternative arms (doses of 20, 40, 80 or 120mg SMP-986).; 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
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 550.0
Sex: All
Minimum age: 20 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      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.
    

Eligibility criteria:

        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