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

Overactive Bladder Syndrome (OABS) Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00409539
• Other study ID #: D3601113
• Status: Completed
• Phase: Phase 2
• First received: December 8, 2006
• Last updated: December 5, 2014
• Start date: December 2006
• Est. completion date: July 2008

Study information

• Verified date: December 2014
• Source: Sunovion
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 550
• Est. completion date: July 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Overactive Bladder Syndrome (OABS)
• Syndrome
• Urinary Bladder, Overactive

Intervention

Drug:
• Placebo
Placebo, 2 week duration.
• Placebo
Taken for the 8 week duration, in parallel with alternative arms (doses of 20, 40, 80 or 120mg SMP-986).
• 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

Locations

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

Sponsors (6)

Lead Sponsor	Collaborator
Sunovion	ClinPhone, Inc., Covance, Dainippon Sumitomo Pharma America, ICON Clinical Research, PPD

Countries where clinical trial is conducted

United States,  Estonia,  France,  Germany,  Latvia,  Lithuania,  Poland,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline to Week 8 in the Number of Voids/24 Hours		8 Weeks
Secondary	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