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

Primary Purpose

Overactive Bladder Syndrome (OABS)

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Placebo
Placebo
SMP-986
Sponsored by
Sumitomo Pharma America, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overactive Bladder Syndrome (OABS)

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Visions Clinical Research
  • Peninsula Urology Center
  • San Bernadino Urological Association Medical Group
  • 9040 Friars Road
  • South Florida Medical Research
  • Visions Clinical Research
  • Florida Healthcare Research
  • Southern Research Group, Centre Point Boulevard
  • Atlanta Medical Research
  • Urological Surgeons of IL
  • Regional Urology
  • Accumed Research Associate
  • Hudson Valley Urology
  • New York Urological Associates, PC
  • Hudson Valley Urology
  • Unifour Medical Research
  • University of Pittsburg, Dept Urology
  • Volunteer Research Group
  • 5920 Saratoga Boulevard
  • National Clinical Research Inc
  • 801 W. 5th Avenue
  • East Tallinn Central Hospital
  • West Tallinn Central Hospital
  • Tartu University Clinic
  • Hopital Rothschild
  • Hopital Tenon
  • Hopital Rangueil - CHU Toulouse
  • Gem. Praxis fur Urologie und Mannerheilkunde
  • Klinische Forschung Berlin
  • Urologische Praxis
  • Urologische Praxis
  • Urologische Praxis
  • Gem. Praxis Jacobi & Hellmis
  • Urologische Gem. Praxis
  • Urologische Praxis
  • Poststr. 25
  • Urologische Gem. Praxis
  • Urologische Praxisgemeinschaft
  • Urologische Praxis
  • Universitat Heidelberg
  • HauptstraBe 10
  • Beckenboden Zentrum Munchen
  • Josef-Retzer-Str. 46
  • Medical Company ARS
  • P. Stradins Hospital
  • Kaunas 2nd Clinical Hospital
  • Kaunas Hospital
  • Vilnius Santariskes Clinics
  • Oddzial Urologii
  • Akdemickie Centrum Kliniczne
  • Medical University of Selesia
  • Non-public Healthcare Unit
  • UI.G. Narutowicza 28
  • Instytut Zdrowia Matki Polki
  • University School of Medicine
  • Clinical Dept of Urology, Medical Postgraduate Education
  • Military Institute of Medicine
  • Klinika Urologii Akademii
  • Ackademicki Szpital Klniczny
  • Hospital Universitario
  • Hospital De Terrassa
  • Servicio de Ginecologia
  • Hospital Sant Joan De Deu
  • Fundacion Hospital Alcorcon
  • Aberdeen Royal Infirmary
  • Addenbrooke's Hospital
  • Leighton Hospital
  • King's College Hospital
  • The Royal Hallamshire Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Placebo Comparator

Placebo Comparator

Experimental

Experimental

Experimental

Experimental

Arm Label

1

2

3

4

5

6

Arm Description

Placebo run-in phase. 2 week duration.

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

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

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

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
December 8, 2006
Last Updated
December 5, 2014
Sponsor
Sumitomo Pharma America, Inc.
Collaborators
Dainippon Sumitomo Pharma America, ICON Clinical Research, ClinPhone, Inc., Covance, PPD
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1. Study Identification

Unique Protocol Identification Number
NCT00409539
Brief Title
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

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
December 2006 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
July 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sumitomo Pharma America, Inc.
Collaborators
Dainippon Sumitomo Pharma America, ICON Clinical Research, ClinPhone, Inc., Covance, PPD

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overactive Bladder Syndrome (OABS)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
550 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Placebo Comparator
Arm Description
Placebo run-in phase. 2 week duration.
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
To be taken for the 8 week duration, in parallel with alternative arms (doses of 20, 40, 80 or 120mg SMP-986).
Arm Title
3
Arm Type
Experimental
Arm Description
20mg dose of SMP-986 to be taken once daily for 8 week duration.
Arm Title
4
Arm Type
Experimental
Arm Description
40mg dose of SMP-986 to be taken for 8 week duration.
Arm Title
5
Arm Type
Experimental
Arm Description
80mg dose of SMP-986 to be taken for 8 week duration.
Arm Title
6
Arm Type
Experimental
Arm Description
120mg dose of SMP-986 to be taken for 8 week duration.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo, 2 week duration.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Taken for the 8 week duration, in parallel with alternative arms (doses of 20, 40, 80 or 120mg SMP-986).
Intervention Type
Drug
Intervention Name(s)
SMP-986
Intervention Description
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
Primary Outcome Measure Information:
Title
Change From Baseline to Week 8 in the Number of Voids/24 Hours
Time Frame
8 Weeks
Secondary Outcome Measure Information:
Title
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
Description
Treatment emergent adverse event summary
Time Frame
8 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Prof C Chappel
Organizational Affiliation
Royal Hallamshire Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Visions Clinical Research
City
Tuscon
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
Facility Name
Peninsula Urology Center
City
Atherton
State/Province
California
ZIP/Postal Code
94027
Country
United States
Facility Name
San Bernadino Urological Association Medical Group
City
San Bernadino
State/Province
California
ZIP/Postal Code
92404
Country
United States
Facility Name
9040 Friars Road
City
San Diego
State/Province
California
ZIP/Postal Code
92108
Country
United States
Facility Name
South Florida Medical Research
City
Aventura
State/Province
Florida
ZIP/Postal Code
33180
Country
United States
Facility Name
Visions Clinical Research
City
Boynton Beach
State/Province
Florida
ZIP/Postal Code
33437
Country
United States
Facility Name
Florida Healthcare Research
City
Ocala
State/Province
Florida
ZIP/Postal Code
34474
Country
United States
Facility Name
Southern Research Group, Centre Point Boulevard
City
Tallahassee
State/Province
Florida
ZIP/Postal Code
32308
Country
United States
Facility Name
Atlanta Medical Research
City
Alpharetta
State/Province
Georgia
ZIP/Postal Code
30005
Country
United States
Facility Name
Urological Surgeons of IL
City
Kankakee
State/Province
Illinois
ZIP/Postal Code
60901
Country
United States
Facility Name
Regional Urology
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71106
Country
United States
Facility Name
Accumed Research Associate
City
Garden City
State/Province
New York
ZIP/Postal Code
11530
Country
United States
Facility Name
Hudson Valley Urology
City
Kingston
State/Province
New York
ZIP/Postal Code
12401
Country
United States
Facility Name
New York Urological Associates, PC
City
New York
State/Province
New York
ZIP/Postal Code
10022
Country
United States
Facility Name
Hudson Valley Urology
City
Poughkeepsie
State/Province
New York
ZIP/Postal Code
12601
Country
United States
Facility Name
Unifour Medical Research
City
Hickory
State/Province
North Carolina
ZIP/Postal Code
28601
Country
United States
Facility Name
University of Pittsburg, Dept Urology
City
Pittsburg
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Volunteer Research Group
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37920
Country
United States
Facility Name
5920 Saratoga Boulevard
City
Corpus Christi
State/Province
Texas
ZIP/Postal Code
78414
Country
United States
Facility Name
National Clinical Research Inc
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23294
Country
United States
Facility Name
801 W. 5th Avenue
City
Spokane
State/Province
Washington
ZIP/Postal Code
99202
Country
United States
Facility Name
East Tallinn Central Hospital
City
Tallinn
ZIP/Postal Code
10138
Country
Estonia
Facility Name
West Tallinn Central Hospital
City
Tallinn
ZIP/Postal Code
10611
Country
Estonia
Facility Name
Tartu University Clinic
City
Tartu
ZIP/Postal Code
51014
Country
Estonia
Facility Name
Hopital Rothschild
City
Paris
ZIP/Postal Code
75571
Country
France
Facility Name
Hopital Tenon
City
Paris
ZIP/Postal Code
75970
Country
France
Facility Name
Hopital Rangueil - CHU Toulouse
City
Toulouse
ZIP/Postal Code
31059
Country
France
Facility Name
Gem. Praxis fur Urologie und Mannerheilkunde
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Klinische Forschung Berlin
City
Berlin
ZIP/Postal Code
10787
Country
Germany
Facility Name
Urologische Praxis
City
Berlin
ZIP/Postal Code
12627
Country
Germany
Facility Name
Urologische Praxis
City
Berlin
ZIP/Postal Code
14057
Country
Germany
Facility Name
Urologische Praxis
City
Buchholz
ZIP/Postal Code
21244
Country
Germany
Facility Name
Gem. Praxis Jacobi & Hellmis
City
Duisburg
ZIP/Postal Code
47179
Country
Germany
Facility Name
Urologische Gem. Praxis
City
Düsseldorf
ZIP/Postal Code
40211
Country
Germany
Facility Name
Urologische Praxis
City
Düsseldorf
ZIP/Postal Code
40470
Country
Germany
Facility Name
Poststr. 25
City
Hagenow
ZIP/Postal Code
19230
Country
Germany
Facility Name
Urologische Gem. Praxis
City
Hamburg
ZIP/Postal Code
20253
Country
Germany
Facility Name
Urologische Praxisgemeinschaft
City
Hamburg
ZIP/Postal Code
22587
Country
Germany
Facility Name
Urologische Praxis
City
Leipzig
ZIP/Postal Code
04105
Country
Germany
Facility Name
Universitat Heidelberg
City
Mannheim
ZIP/Postal Code
68167
Country
Germany
Facility Name
HauptstraBe 10
City
Markkleeberg
ZIP/Postal Code
04416
Country
Germany
Facility Name
Beckenboden Zentrum Munchen
City
Munchen
ZIP/Postal Code
81679
Country
Germany
Facility Name
Josef-Retzer-Str. 46
City
München
ZIP/Postal Code
81241
Country
Germany
Facility Name
Medical Company ARS
City
Riga
ZIP/Postal Code
LV-1001
Country
Latvia
Facility Name
P. Stradins Hospital
City
Riga
ZIP/Postal Code
LV-1002
Country
Latvia
Facility Name
Kaunas 2nd Clinical Hospital
City
Kaunas
ZIP/Postal Code
LT- 47144
Country
Lithuania
Facility Name
Kaunas Hospital
City
Kaunas
ZIP/Postal Code
LT- 50009
Country
Lithuania
Facility Name
Vilnius Santariskes Clinics
City
Vilnius
ZIP/Postal Code
LT-08661
Country
Lithuania
Facility Name
Oddzial Urologii
City
Bydgoszcz
ZIP/Postal Code
85-168
Country
Poland
Facility Name
Akdemickie Centrum Kliniczne
City
Gdansk
ZIP/Postal Code
80-402
Country
Poland
Facility Name
Medical University of Selesia
City
Katowice
ZIP/Postal Code
40-752
Country
Poland
Facility Name
Non-public Healthcare Unit
City
Kutno
ZIP/Postal Code
99-300
Country
Poland
Facility Name
UI.G. Narutowicza 28
City
Lodz
ZIP/Postal Code
90-135
Country
Poland
Facility Name
Instytut Zdrowia Matki Polki
City
Lodz
ZIP/Postal Code
93-338
Country
Poland
Facility Name
University School of Medicine
City
Lublin
ZIP/Postal Code
20-950
Country
Poland
Facility Name
Clinical Dept of Urology, Medical Postgraduate Education
City
Warsaw
ZIP/Postal Code
00-416
Country
Poland
Facility Name
Military Institute of Medicine
City
Warsaw
ZIP/Postal Code
00-909
Country
Poland
Facility Name
Klinika Urologii Akademii
City
Warszawa
ZIP/Postal Code
02-005
Country
Poland
Facility Name
Ackademicki Szpital Klniczny
City
Wroclaw
ZIP/Postal Code
50-043
Country
Poland
Facility Name
Hospital Universitario
City
Tenerife
State/Province
Canarias
ZIP/Postal Code
38320
Country
Spain
Facility Name
Hospital De Terrassa
City
Barcelona
ZIP/Postal Code
08227
Country
Spain
Facility Name
Servicio de Ginecologia
City
Barcelona
ZIP/Postal Code
08500
Country
Spain
Facility Name
Hospital Sant Joan De Deu
City
Barcelona
ZIP/Postal Code
08950
Country
Spain
Facility Name
Fundacion Hospital Alcorcon
City
Madrid
ZIP/Postal Code
28922
Country
Spain
Facility Name
Aberdeen Royal Infirmary
City
Aberdeen
ZIP/Postal Code
AB25 2NZ
Country
United Kingdom
Facility Name
Addenbrooke's Hospital
City
Cambridge
ZIP/Postal Code
CB2 2QQ
Country
United Kingdom
Facility Name
Leighton Hospital
City
Crewe
ZIP/Postal Code
CW1 4QJ
Country
United Kingdom
Facility Name
King's College Hospital
City
London
ZIP/Postal Code
SE5 9RS
Country
United Kingdom
Facility Name
The Royal Hallamshire Hospital
City
Sheffield
ZIP/Postal Code
S10 2JF
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

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

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