Clinical trial NCT00409539: SMP-986 Phase 2 Proof of Concept in Patients With Overactive Bladder Syndrome (OABS)
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Overactive Bladder Syndrome (OABS)
Lead sponsor: Sumitomo Pharma America, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Dainippon Sumitomo Pharma America
name: ICON Clinical Research
name: ClinPhone, Inc.
name: Covance
name: PPD Development, LP
First posted: 2006-12-11
Enrollment: 550
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change From Baseline to Week 8 in the Number of Voids/24 Hours
timeFrame: 8 Weeks
Secondary outcomes:
measure: 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
timeFrame: 8 Weeks
Other outcomes:
Locations:
city: Tuscon
country: United States
facility: Visions Clinical Research
state: Arizona
city: Atherton
country: United States
facility: Peninsula Urology Center
state: California
city: San Bernadino
country: United States
facility: San Bernadino Urological Association Medical Group
state: California
city: San Diego
country: United States
facility: 9040 Friars Road
state: California
city: Aventura
country: United States
facility: South Florida Medical Research
state: Florida
city: Boynton Beach
country: United States
facility: Visions Clinical Research
state: Florida
city: Ocala
country: United States
facility: Florida Healthcare Research
state: Florida
city: Tallahassee
country: United States
facility: Southern Research Group, Centre Point Boulevard
state: Florida
city: Alpharetta
country: United States
facility: Atlanta Medical Research
state: Georgia
city: Kankakee
country: United States
facility: Urological Surgeons of IL
state: Illinois
city: Shreveport
country: United States
facility: Regional Urology
state: Louisiana
city: Garden City
country: United States
facility: Accumed Research Associate
state: New York
city: Kingston
country: United States
facility: Hudson Valley Urology
state: New York
city: New York
country: United States
facility: New York Urological Associates, PC
state: New York
city: Poughkeepsie
country: United States
facility: Hudson Valley Urology
state: New York
city: Hickory
country: United States
facility: Unifour Medical Research
state: North Carolina
city: Pittsburg
country: United States
facility: University of Pittsburg, Dept Urology
state: Pennsylvania
city: Knoxville
country: United States
facility: Volunteer Research Group
state: Tennessee
city: Corpus Christi
country: United States
facility: 5920 Saratoga Boulevard
state: Texas
city: Richmond
country: United States
facility: National Clinical Research Inc
state: Virginia
city: Spokane
country: United States
facility: 801 W. 5th Avenue
state: Washington
city: Tallinn
country: Estonia
facility: East Tallinn Central Hospital
city: Tallinn
country: Estonia
facility: West Tallinn Central Hospital
city: Tartu
country: Estonia
facility: Tartu University Clinic
city: Paris
country: France
facility: Hopital Rothschild
city: Paris
country: France
facility: Hopital Tenon
city: Toulouse
country: France
facility: Hopital Rangueil - CHU Toulouse
city: Berlin
country: Germany
facility: Gem. Praxis fur Urologie und Mannerheilkunde
city: Berlin
country: Germany
facility: Klinische Forschung Berlin
city: Berlin
country: Germany
facility: Urologische Praxis
city: Berlin
country: Germany
facility: Urologische Praxis
city: Buchholz
country: Germany
facility: Urologische Praxis
city: Duisburg
country: Germany
facility: Gem. Praxis Jacobi & Hellmis
city: Düsseldorf
country: Germany
facility: Urologische Gem. Praxis
city: Düsseldorf
country: Germany
facility: Urologische Praxis
city: Hagenow
country: Germany
facility: Poststr. 25
city: Hamburg
country: Germany
facility: Urologische Gem. Praxis
city: Hamburg
country: Germany
facility: Urologische Praxisgemeinschaft
city: Leipzig
country: Germany
facility: Urologische Praxis
city: Mannheim
country: Germany
facility: Universitat Heidelberg
city: Markkleeberg
country: Germany
facility: HauptstraBe 10
city: Munchen
country: Germany
facility: Beckenboden Zentrum Munchen
city: München
country: Germany
facility: Josef-Retzer-Str. 46
city: Riga
country: Latvia
facility: Medical Company ARS
city: Riga
country: Latvia
facility: P. Stradins Hospital
city: Kaunas
country: Lithuania
facility: Kaunas 2nd Clinical Hospital
city: Kaunas
country: Lithuania
facility: Kaunas Hospital
city: Vilnius
country: Lithuania
facility: Vilnius Santariskes Clinics
city: Bydgoszcz
country: Poland
facility: Oddzial Urologii
city: Gdansk
country: Poland
facility: Akdemickie Centrum Kliniczne
city: Katowice
country: Poland
facility: Medical University of Selesia
city: Kutno
country: Poland
facility: Non-public Healthcare Unit
city: Lodz
country: Poland
facility: UI.G. Narutowicza 28
city: Lodz
country: Poland
facility: Instytut Zdrowia Matki Polki
city: Lublin
country: Poland
facility: University School of Medicine
city: Warsaw
country: Poland
facility: Clinical Dept of Urology, Medical Postgraduate Education
city: Warsaw
country: Poland
facility: Military Institute of Medicine
city: Warszawa
country: Poland
facility: Klinika Urologii Akademii
city: Wroclaw
country: Poland
facility: Ackademicki Szpital Klniczny
city: Tenerife
country: Spain
facility: Hospital Universitario
state: Canarias
city: Barcelona
country: Spain
facility: Hospital De Terrassa
city: Barcelona
country: Spain
facility: Servicio de Ginecologia
city: Barcelona
country: Spain
facility: Hospital Sant Joan De Deu
city: Madrid
country: Spain
facility: Fundacion Hospital Alcorcon
city: Aberdeen
country: United Kingdom
facility: Aberdeen Royal Infirmary
city: Cambridge
country: United Kingdom
facility: Addenbrooke's Hospital
city: Crewe
country: United Kingdom
facility: Leighton Hospital
city: London
country: United Kingdom
facility: King's College Hospital
city: Sheffield
country: United Kingdom
facility: The Royal Hallamshire Hospital
Study officials:
affiliation: Royal Hallamshire Hospital
name: Prof C Chappel
role: PRINCIPAL_INVESTIGATOR
References: