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

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

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.

Study Overview

• Status: Completed
• Conditions: Overactive Bladder Syndrome (OABS)
• Intervention / Treatment: Drug: Placebo; Drug: Placebo; Drug: SMP-986

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.

• Study Type: Interventional
• Enrollment (Actual): 550
• Phase: Phase 2

Contacts and Locations

Study Locations

• Estonia
  • Tallinn, Estonia, 10138
    • East Tallinn Central Hospital
  • Tallinn, Estonia, 10611
    • West Tallinn Central Hospital
  • Tartu, Estonia, 51014
    • Tartu University Clinic
• France
  • Paris, France, 75970
    • Hopital Tenon
  • Paris, France, 75571
    • Hôpital Rothschild
  • Toulouse, France, 31059
    • Hôpital Rangueil - CHU Toulouse
• Germany
  • Berlin, Germany, 10117
    • Gem. Praxis fur Urologie und Mannerheilkunde
  • Berlin, Germany, 10787
    • Klinische Forschung Berlin
  • Berlin, Germany, 12627
    • Urologische Praxis
  • Berlin, Germany, 14057
    • Urologische Praxis
  • Buchholz, Germany, 21244
    • Urologische Praxis
  • Duisburg, Germany, 47179
    • Gem. Praxis Jacobi & Hellmis
  • Düsseldorf, Germany, 40211
    • Urologische Gem. Praxis
  • Düsseldorf, Germany, 40470
    • Urologische Praxis
  • Hagenow, Germany, 19230
    • Poststr. 25
  • Hamburg, Germany, 20253
    • Urologische Gem. Praxis
  • Hamburg, Germany, 22587
    • Urologische Praxisgemeinschaft
  • Leipzig, Germany, 04105
    • Urologische Praxis
  • Mannheim, Germany, 68167
    • Universität Heidelberg
  • Markkleeberg, Germany, 04416
    • HauptstraBe 10
  • Munchen, Germany, 81679
    • Beckenboden Zentrum München
  • München, Germany, 81241
    • Josef-Retzer-Str. 46
• Latvia
  • Riga, Latvia, LV-1001
    • Medical Company ARS
  • Riga, Latvia, LV-1002
    • P. Stradins hospital
• Lithuania
  • Kaunas, Lithuania, LT- 47144
    • Kaunas 2nd Clinical Hospital
  • Kaunas, Lithuania, LT- 50009
    • Kaunas Hospital
  • Vilnius, Lithuania, LT-08661
    • Vilnius Santariskes Clinics
• Poland
  • Bydgoszcz, Poland, 85-168
    • Oddzial Urologii
  • Gdansk, Poland, 80-402
    • Akdemickie Centrum Kliniczne
  • Katowice, Poland, 40-752
    • Medical University of Selesia
  • Kutno, Poland, 99-300
    • Non-public Healthcare Unit
  • Lodz, Poland, 90-135
    • UI.G. Narutowicza 28
  • Lodz, Poland, 93-338
    • Instytut Zdrowia Matki Polki
  • Lublin, Poland, 20-950
    • University School of Medicine
  • Warsaw, Poland, 00-416
    • Clinical Dept of Urology, Medical Postgraduate Education
  • Warsaw, Poland, 00-909
    • Military Institute of Medicine
  • Warszawa, Poland, 02-005
    • Klinika Urologii Akademii
  • Wroclaw, Poland, 50-043
    • Ackademicki Szpital Klniczny
• Spain
  • Barcelona, Spain, 08227
    • Hospital de Terrassa
  • Barcelona, Spain, 08500
    • Servicio de Ginecologia
  • Barcelona, Spain, 08950
    • Hospital Sant Joan De Deu
  • Madrid, Spain, 28922
    • Fundación Hospital Alcorcón
  • Canarias
    • Tenerife, Canarias, Spain, 38320
      • Hospital Universitario
• United Kingdom
  • Aberdeen, United Kingdom, AB25 2NZ
    • Aberdeen Royal Infirmary
  • Cambridge, United Kingdom, CB2 2QQ
    • Addenbrooke's Hospital
  • Crewe, United Kingdom, CW1 4QJ
    • Leighton Hospital
  • London, United Kingdom, SE5 9RS
    • King's College Hospital
  • Sheffield, United Kingdom, S10 2JF
    • The Royal Hallamshire Hospital
• United States
  • Arizona
    • Tuscon, Arizona, United States, 85712
      • Visions Clinical Research
  • California
    • Atherton, California, United States, 94027
      • Peninsula Urology Center
    • San Bernadino, California, United States, 92404
      • San Bernadino Urological Association Medical Group
    • San Diego, California, United States, 92108
      • 9040 Friars Road
  • Florida
    • Aventura, Florida, United States, 33180
      • South Florida Medical Research
    • Boynton Beach, Florida, United States, 33437
      • Visions Clinical Research
    • Ocala, Florida, United States, 34474
      • Florida Healthcare Research
    • Tallahassee, Florida, United States, 32308
      • Southern Research Group, Centre Point Boulevard
  • Georgia
    • Alpharetta, Georgia, United States, 30005
      • Atlanta Medical Research
  • Illinois
    • Kankakee, Illinois, United States, 60901
      • Urological Surgeons of IL
  • Louisiana
    • Shreveport, Louisiana, United States, 71106
      • Regional Urology
  • New York
    • Garden City, New York, United States, 11530
      • Accumed Research Associate
    • Kingston, New York, United States, 12401
      • Hudson Valley Urology
    • New York, New York, United States, 10022
      • New York Urological Associates, PC
    • Poughkeepsie, New York, United States, 12601
      • Hudson Valley Urology
  • North Carolina
    • Hickory, North Carolina, United States, 28601
      • Unifour Medical Research
  • Pennsylvania
    • Pittsburg, Pennsylvania, United States, 15213
      • University of Pittsburg, Dept Urology
  • Tennessee
    • Knoxville, Tennessee, United States, 37920
      • Volunteer Research Group
  • Texas
    • Corpus Christi, Texas, United States, 78414
      • 5920 Saratoga Boulevard
  • Virginia
    • Richmond, Virginia, United States, 23294
      • National Clinical Research inc
  • Washington
    • Spokane, Washington, United States, 99202
      • 801 W. 5th Avenue

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: 1; Placebo run-in phase. 2 week duration.	Drug: Placebo; Placebo, 2 week duration.; Drug: Placebo; Taken for the 8 week duration, in parallel with alternative arms (doses of 20, 40, 80 or 120mg SMP-986).
Placebo Comparator: 2; To be taken for the 8 week duration, in parallel with alternative arms (doses of 20, 40, 80 or 120mg SMP-986).	Drug: Placebo; Placebo, 2 week duration.; Drug: Placebo; Taken for the 8 week duration, in parallel with alternative arms (doses of 20, 40, 80 or 120mg SMP-986).
Experimental: 3; 20mg dose of SMP-986 to be taken once daily for 8 week duration.	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
Experimental: 4; 40mg dose of SMP-986 to be taken for 8 week duration.	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
Experimental: 5; 80mg dose of SMP-986 to be taken for 8 week duration.	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
Experimental: 6; 120mg dose of SMP-986 to be taken for 8 week duration.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change From Baseline to Week 8 in the Number of Voids/24 Hours	8 Weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Sunovion
• Collaborators: PPD; ICON Clinical Research; Covance; Dainippon Sumitomo Pharma America; ClinPhone, Inc.
• Investigators: Principal Investigator: Prof C Chappel, Royal Hallamshire Hospital

Study record dates

Study Major Dates

• Study Start: December 1, 2006
• Primary Completion (Actual): June 1, 2008
• Study Completion (Actual): July 1, 2008

Study Registration Dates

• First Submitted: December 8, 2006
• First Submitted That Met QC Criteria: December 8, 2006
• First Posted (Estimate): December 11, 2006

Study Record Updates

• Last Update Posted (Estimate): December 10, 2014
• Last Update Submitted That Met QC Criteria: December 5, 2014
• Last Verified: December 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Urologic Diseases; Urinary Bladder Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Disease; Urinary Bladder, Overactive; Syndrome
• Other Study ID Numbers: D3601113

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No