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

Completed · Phase 2 · Has a placebo group

Conditions studied: Overactive Bladder Syndrome (OABS)

In brief

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.

Key facts

Study ID

NCT00409539

Run by

Sumitomo Pharma America, Inc.

People needed

550

Starts

2006-12-01

Expected to finish

2008-07-01

Last updated by the study team

2014-12-10

Who can join

Age: 20 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Peninsula Urology Center — Atherton, California, United States
• San Bernadino Urological Association Medical Group — San Bernadino, California, United States
• 9040 Friars Road — San Diego, California, United States
• South Florida Medical Research — Aventura, Florida, United States
• Visions Clinical Research — Boynton Beach, Florida, United States
• Florida Healthcare Research — Ocala, Florida, United States
• Southern Research Group, Centre Point Boulevard — Tallahassee, Florida, United States
• Atlanta Medical Research — Alpharetta, Georgia, United States
• Urological Surgeons of IL — Kankakee, Illinois, United States
• Regional Urology — Shreveport, Louisiana, United States
• Accumed Research Associate — Garden City, New York, United States
• Hudson Valley Urology — Kingston, New York, United States
• New York Urological Associates, PC — New York, New York, United States
• Hudson Valley Urology — Poughkeepsie, New York, United States
• Unifour Medical Research — Hickory, North Carolina, United States
• University of Pittsburg, Dept Urology — Pittsburgh, Pennsylvania, United States
• Volunteer Research Group — Knoxville, Tennessee, United States
• 5920 Saratoga Boulevard — Corpus Christi, Texas, United States
• National Clinical Research Inc — Richmond, Virginia, United States
• 801 W. 5th Avenue — Spokane, Washington, United States
• East Tallinn Central Hospital — Tallinn, Estonia
• West Tallinn Central Hospital — Tallinn, Estonia
• Tartu University Clinic — Tartu, Estonia
• Hopital Rothschild — Paris, France
• Visions Clinical Research — Tuscon, Arizona, United States

Full record on ClinicalTrials.gov

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