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

NCT00409539 | Completed Phase 2 Results

• 1 other identifier: D3601113
• Study Type: interventional
• Target: 550
• Locations: 8 countries
• Sites: 66

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.

Conditions

Overactive Bladder Syndrome (OABS)

Outcome Measures

Primary Outcomes (1)

• Change From Baseline to Week 8 in the Number of Voids/24 Hours

  8 Weeks

Secondary Outcomes (1)

• 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

Study Arms (6)

1

PLACEBO COMPARATOR

Placebo run-in phase. 2 week duration.

Drug: Placebo

2

PLACEBO COMPARATOR

To be taken for the 8 week duration, in parallel with alternative arms (doses of 20, 40, 80 or 120mg SMP-986).

Drug: Placebo

3

EXPERIMENTAL

20mg dose of SMP-986 to be taken once daily for 8 week duration.

Drug: SMP-986

4

EXPERIMENTAL

40mg dose of SMP-986 to be taken for 8 week duration.

Drug: SMP-986

5

EXPERIMENTAL

80mg dose of SMP-986 to be taken for 8 week duration.

Drug: SMP-986

6

EXPERIMENTAL

120mg dose of SMP-986 to be taken for 8 week duration.

Drug: SMP-986

Interventions

Placebo DRUG

Placebo, 2 week duration.

1

SMP-986 DRUG

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

3; 4; 5; 6

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:

• 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

Sponsors & Collaborators

• Sumitomo Pharma America, Inc.: lead
• Dainippon Sumitomo Pharma America: collaborator
• ICON Clinical Research: collaborator
• ClinPhone, Inc.: collaborator
• Covance: collaborator
• PPD Development, LP: collaborator

Study Sites (69)

Visions Clinical Research

Tuscon, Arizona, 85712, United States

Location

Peninsula Urology Center

Atherton, California, 94027, United States

Location

San Bernadino Urological Association Medical Group

San Bernadino, California, 92404, United States

Location

9040 Friars Road

San Diego, California, 92108, United States

Location

South Florida Medical Research

Aventura, Florida, 33180, United States

Location

Visions Clinical Research

Boynton Beach, Florida, 33437, United States

Location

Florida Healthcare Research

Ocala, Florida, 34474, United States

Location

Southern Research Group, Centre Point Boulevard

Tallahassee, Florida, 32308, United States

Location

Atlanta Medical Research

Alpharetta, Georgia, 30005, United States

Location

Urological Surgeons of IL

Kankakee, Illinois, 60901, United States

Location

Regional Urology

Shreveport, Louisiana, 71106, United States

Location

Accumed Research Associate

Garden City, New York, 11530, United States

Location

Hudson Valley Urology

Kingston, New York, 12401, United States

Location

New York Urological Associates, PC

New York, New York, 10022, United States

Location

Hudson Valley Urology

Poughkeepsie, New York, 12601, United States

Location

Unifour Medical Research

Hickory, North Carolina, 28601, United States

Location

University of Pittsburg, Dept Urology

Pittsburgh, Pennsylvania, 15213, United States

Location

Volunteer Research Group

Knoxville, Tennessee, 37920, United States

Location

5920 Saratoga Boulevard

Corpus Christi, Texas, 78414, United States

Location

National Clinical Research Inc

Richmond, Virginia, 23294, United States

Location

801 W. 5th Avenue

Spokane, Washington, 99202, United States

Location

East Tallinn Central Hospital

Tallinn, 10138, Estonia

Location

West Tallinn Central Hospital

Tallinn, 10611, Estonia

Location

Tartu University Clinic

Tartu, 51014, Estonia

Location

Hopital Rothschild

Paris, 75571, France

Location

Hopital Tenon

Paris, 75970, France

Location

Hopital Rangueil - CHU Toulouse

Toulouse, 31059, France

Location

Gem. Praxis fur Urologie und Mannerheilkunde

Berlin, 10117, Germany

Location

Klinische Forschung Berlin

Berlin, 10787, Germany

Location

Urologische Praxis

Berlin, 12627, Germany

Location

Urologische Praxis

Berlin, 14057, Germany

Location

Urologische Praxis

Buchholz, 21244, Germany

Location

Gem. Praxis Jacobi & Hellmis

Duisburg, 47179, Germany

Location

Urologische Gem. Praxis

Düsseldorf, 40211, Germany

Location

Urologische Praxis

Düsseldorf, 40470, Germany

Location

Poststr. 25

Hagenow, 19230, Germany

Location

Urologische Gem. Praxis

Hamburg, 20253, Germany

Location

Urologische Praxisgemeinschaft

Hamburg, 22587, Germany

Location

Urologische Praxis

Leipzig, 04105, Germany

Location

Universitat Heidelberg

Mannheim, 68167, Germany

Location

HauptstraBe 10

Markkleeberg, 04416, Germany

Location

Josef-Retzer-Str. 46

München, 81241, Germany

Location

Beckenboden Zentrum Munchen

München, 81679, Germany

Location

Medical Company ARS

Riga, LV-1001, Latvia

Location

P. Stradins Hospital

Riga, LV-1002, Latvia

Location

Kaunas 2nd Clinical Hospital

Kaunas, LT- 47144, Lithuania

Location

Kaunas Hospital

Kaunas, LT- 50009, Lithuania

Location

Vilnius Santariskes Clinics

Vilnius, LT-08661, Lithuania

Location

Oddzial Urologii

Bydgoszcz, 85-168, Poland

Location

Akdemickie Centrum Kliniczne

Gdansk, 80-402, Poland

Location

Medical University of Selesia

Katowice, 40-752, Poland

Location

Non-public Healthcare Unit

Kutno, 99-300, Poland

Location

UI.G. Narutowicza 28

Lodz, 90-135, Poland

Location

Instytut Zdrowia Matki Polki

Lodz, 93-338, Poland

Location

University School of Medicine

Lublin, 20-950, Poland

Location

Clinical Dept of Urology, Medical Postgraduate Education

Warsaw, 00-416, Poland

Location

Military Institute of Medicine

Warsaw, 00-909, Poland

Location

Klinika Urologii Akademii

Warsaw, 02-005, Poland

Location

Ackademicki Szpital Klniczny

Wroclaw, 50-043, Poland

Location

Hospital Universitario

Santa Cruz de Tenerife, Canary Islands, 38320, Spain

Location

Hospital De Terrassa

Barcelona, 08227, Spain

Location

Servicio de Ginecologia

Barcelona, 08500, Spain

Location

Hospital Sant Joan De Deu

Barcelona, 08950, Spain

Location

Fundacion Hospital Alcorcon

Madrid, 28922, Spain

Location

Aberdeen Royal Infirmary

Aberdeen, AB25 2NZ, United Kingdom

Location

Addenbrooke's Hospital

Cambridge, CB2 2QQ, United Kingdom

Location

Leighton Hospital

Crewe, CW1 4QJ, United Kingdom

Location

King's College Hospital

London, SE5 9RS, United Kingdom

Location

The Royal Hallamshire Hospital

Sheffield, S10 2JF, United Kingdom

Location

Results Point of Contact

• Title: Medical Director, Urology
• Organization: Sunovion

1-866-503-6351

Study Officials

• Prof C Chappel

  Royal Hallamshire Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2006
• First Posted: December 11, 2006
• Study Start: December 1, 2006
• Primary Completion: June 1, 2008
• Study Completion: July 1, 2008
• Last Updated: December 10, 2014
• Results First Posted: December 10, 2014

Record last verified: 2014-12

Locations

ES (5); GB (5); FR (3); DE (16); LI (3); PL (11); LA (2); US (21)