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

NCT ID: NCT00409539

Last Updated: 2014-12-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 550 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-12-31
• Study Completion Date: 2008-07-31

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.

Conditions

Overactive Bladder Syndrome (OABS)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

1

Placebo run-in phase. 2 week duration.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo, 2 week duration.

2

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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

3

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

Group Type: EXPERIMENTAL

SMP-986

Intervention Type: 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

4

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

Group Type: EXPERIMENTAL

SMP-986

Intervention Type: 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

5

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

Group Type: EXPERIMENTAL

SMP-986

Intervention Type: 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

6

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

Group Type: EXPERIMENTAL

SMP-986

Intervention Type: 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

Interventions

Placebo

Placebo, 2 week duration.

Intervention Type: DRUG

Placebo

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

Intervention Type: DRUG

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

Intervention Type: DRUG

Eligibility Criteria

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

• 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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dainippon Sumitomo Pharma America

INDUSTRY

Sponsor Role: collaborator

ICON Clinical Research

INDUSTRY

Sponsor Role: collaborator

ClinPhone, Inc.

INDUSTRY

Sponsor Role: collaborator

Covance

INDUSTRY

Sponsor Role: collaborator

PPD Development, LP

INDUSTRY

Sponsor Role: collaborator

Sumitomo Pharma America, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Prof C Chappel

Role: PRINCIPAL_INVESTIGATOR

Royal Hallamshire Hospital

Locations

Visions Clinical Research

Tuscon, Arizona, United States

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

Hopital Tenon

Paris, , France

Hopital Rangueil - CHU Toulouse

Toulouse, , France

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

Josef-Retzer-Str. 46

München, , Germany

Beckenboden Zentrum Munchen

München, , Germany

Medical Company ARS

Riga, , Latvia

P. Stradins Hospital

Riga, , Latvia

Kaunas 2nd Clinical Hospital

Kaunas, , Lithuania

Kaunas Hospital

Kaunas, , Lithuania

Vilnius Santariskes Clinics

Vilnius, , Lithuania

Oddzial Urologii

Bydgoszcz, , Poland

Akdemickie Centrum Kliniczne

Gdansk, , Poland

Medical University of Selesia

Katowice, , Poland

Non-public Healthcare Unit

Kutno, , Poland

UI.G. Narutowicza 28

Lodz, , Poland

Instytut Zdrowia Matki Polki

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

Warsaw, , Poland

Ackademicki Szpital Klniczny

Wroclaw, , Poland

Hospital Universitario

Santa Cruz de Tenerife, Canary Islands, Spain

Hospital De Terrassa

Barcelona, , Spain

Servicio de Ginecologia

Barcelona, , Spain

Hospital Sant Joan De Deu

Barcelona, , Spain

Fundacion Hospital Alcorcon

Madrid, , Spain

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 Kingdom

Countries

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

Other Identifiers

D3601113

Identifier Type: -

Identifier Source: org_study_id