SMP-986 Phase 2 Proof of Concept in Patients With Overactive Bladder Syndrome (OABS)
- Registration Number
- NCT00409539
- Lead Sponsor
- Sumitomo Pharma America, Inc.
- Brief 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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 550
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.
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 4 SMP-986 40mg dose of SMP-986 to be taken for 8 week duration. 2 Placebo To be taken for the 8 week duration, in parallel with alternative arms (doses of 20, 40, 80 or 120mg SMP-986). 3 SMP-986 20mg dose of SMP-986 to be taken once daily for 8 week duration. 5 SMP-986 80mg dose of SMP-986 to be taken for 8 week duration. 6 SMP-986 120mg dose of SMP-986 to be taken for 8 week duration. 1 Placebo Placebo run-in phase. 2 week duration.
- Primary Outcome Measures
Name Time Method Change From Baseline to Week 8 in the Number of Voids/24 Hours 8 Weeks
- Secondary Outcome Measures
Name Time Method 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 8 Weeks Treatment emergent adverse event summary
Trial Locations
- Locations (62)
Tartu University Clinic
🇪🇪Tartu, Estonia
Medical University of Selesia
🇵🇱Katowice, Poland
UI.G. Narutowicza 28
🇵🇱Lodz, Poland
Clinical Dept of Urology, Medical Postgraduate Education
🇵🇱Warsaw, Poland
Oddzial Urologii
🇵🇱Bydgoszcz, Poland
Akdemickie Centrum Kliniczne
🇵🇱Gdansk, Poland
University School of Medicine
🇵🇱Lublin, Poland
Ackademicki Szpital Klniczny
🇵🇱Wroclaw, Poland
Military Institute of Medicine
🇵🇱Warsaw, Poland
Klinika Urologii Akademii
🇵🇱Warszawa, Poland
Hospital Universitario
🇪🇸Tenerife, Canarias, Spain
Poststr. 25
🇩🇪Hagenow, Germany
South Florida Medical Research
🇺🇸Aventura, Florida, United States
Regional Urology
🇺🇸Shreveport, Louisiana, United States
9040 Friars Road
🇺🇸San Diego, California, United States
Hudson Valley Urology
🇺🇸Poughkeepsie, New York, United States
5920 Saratoga Boulevard
🇺🇸Corpus Christi, Texas, United States
San Bernadino Urological Association Medical Group
🇺🇸San Bernadino, California, United States
Atlanta Medical Research
🇺🇸Alpharetta, Georgia, United States
Hopital Rothschild
🇫🇷Paris, France
Volunteer Research Group
🇺🇸Knoxville, Tennessee, United States
Klinische Forschung Berlin
🇩🇪Berlin, Germany
Addenbrooke's Hospital
🇬🇧Cambridge, United Kingdom
The Royal Hallamshire Hospital
🇬🇧Sheffield, United Kingdom
Visions Clinical Research
🇺🇸Boynton Beach, Florida, United States
Urologische Gem. Praxis
🇩🇪Hamburg, Germany
Josef-Retzer-Str. 46
🇩🇪München, Germany
New York Urological Associates, PC
🇺🇸New York, New York, United States
Non-public Healthcare Unit
🇵🇱Kutno, Poland
Southern Research Group, Centre Point Boulevard
🇺🇸Tallahassee, Florida, United States
Instytut Zdrowia Matki Polki
🇵🇱Lodz, Poland
University of Pittsburg, Dept Urology
🇺🇸Pittsburg, Pennsylvania, United States
Aberdeen Royal Infirmary
🇬🇧Aberdeen, United Kingdom
East Tallinn Central Hospital
🇪🇪Tallinn, Estonia
Urologische Praxisgemeinschaft
🇩🇪Hamburg, Germany
Medical Company ARS
🇱🇻Riga, Latvia
P. Stradins Hospital
🇱🇻Riga, Latvia
Fundacion Hospital Alcorcon
🇪🇸Madrid, Spain
Urologische Praxis
🇩🇪Leipzig, Germany
Kaunas Hospital
🇱🇹Kaunas, Lithuania
Vilnius Santariskes Clinics
🇱🇹Vilnius, Lithuania
Gem. Praxis Jacobi & Hellmis
🇩🇪Duisburg, Germany
HauptstraBe 10
🇩🇪Markkleeberg, Germany
Beckenboden Zentrum Munchen
🇩🇪Munchen, Germany
Kaunas 2nd Clinical Hospital
🇱🇹Kaunas, Lithuania
Leighton Hospital
🇬🇧Crewe, United Kingdom
Hospital De Terrassa
🇪🇸Barcelona, Spain
King's College Hospital
🇬🇧London, United Kingdom
Urological Surgeons of IL
🇺🇸Kankakee, Illinois, United States
Accumed Research Associate
🇺🇸Garden City, New York, United States
Peninsula Urology Center
🇺🇸Atherton, California, United States
Unifour Medical Research
🇺🇸Hickory, North Carolina, United States
Florida Healthcare Research
🇺🇸Ocala, Florida, United States
National Clinical Research Inc
🇺🇸Richmond, Virginia, United States
West Tallinn Central Hospital
🇪🇪Tallinn, Estonia
Servicio de Ginecologia
🇪🇸Barcelona, Spain
Universitat Heidelberg
🇩🇪Mannheim, Germany
Hospital Sant Joan De Deu
🇪🇸Barcelona, Spain
Hopital Tenon
🇫🇷Paris, France
Hopital Rangueil - CHU Toulouse
🇫🇷Toulouse, France
Gem. Praxis fur Urologie und Mannerheilkunde
🇩🇪Berlin, Germany
801 W. 5th Avenue
🇺🇸Spokane, Washington, United States