Overactive Bladder Syndrome (OABS)Phase 2NCT00409539
SMP-986 Phase 2 Proof of Concept in Patients With Overactive Bladder Syndrome (OABS)
A Phase 2 study testing SMP-986 in people with Overactive Bladder Syndrome (OABS), run by Sumitomo Pharma America, Inc. at 69 sites in 9 countries.
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. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Overactive Bladder Syndrome (OABS)
- What is being tested?
- SMP-986
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 550 participants
- Where
- 69 sitesin 9 countries
- Study dates
- Dec 2006to Jul 2008
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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),
Show all 21Show fewer
- 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
Trial locations and contacts
69 sites in 9 countries.
69 sites in 9 countries
United States21 sites
Atlanta Medical Research
Alpharetta, Georgia, 30005
Peninsula Urology Center
Atherton, California, 94027
South Florida Medical Research
Aventura, Florida, 33180
Visions Clinical Research
Boynton Beach, Florida, 33437
5920 Saratoga Boulevard
Corpus Christi, Texas, 78414
Accumed Research Associate
Garden City, New York, 11530
Unifour Medical Research
Hickory, North Carolina, 28601
Urological Surgeons of IL
Kankakee, Illinois, 60901
Hudson Valley Urology
Kingston, New York, 12401
Volunteer Research Group
Knoxville, Tennessee, 37920
New York Urological Associates, PC
New York, New York, 10022
Florida Healthcare Research
Ocala, Florida, 34474
University of Pittsburg, Dept Urology
Pittsburgh, Pennsylvania, 15213
Hudson Valley Urology
Poughkeepsie, New York, 12601
National Clinical Research Inc
Richmond, Virginia, 23294
San Bernadino Urological Association Medical Group
San Bernadino, California, 92404
9040 Friars Road
San Diego, California, 92108
Regional Urology
Shreveport, Louisiana, 71106
801 W. 5th Avenue
Spokane, Washington, 99202
Southern Research Group, Centre Point Boulevard
Tallahassee, Florida, 32308
Visions Clinical Research
Tuscon, Arizona, 85712
Germany16 sites
Gem. Praxis fur Urologie und Mannerheilkunde
Berlin, 10117
Klinische Forschung Berlin
Berlin, 10787
Urologische Praxis
Berlin, 12627
Urologische Praxis
Berlin, 14057
Urologische Praxis
Buchholz, 21244
Gem. Praxis Jacobi & Hellmis
Duisburg, 47179
Urologische Gem. Praxis
Düsseldorf, 40211
Urologische Praxis
Düsseldorf, 40470
Poststr. 25
Hagenow, 19230
Urologische Gem. Praxis
Hamburg, 20253
Urologische Praxisgemeinschaft
Hamburg, 22587
Urologische Praxis
Leipzig, 04105
Universitat Heidelberg
Mannheim, 68167
HauptstraBe 10
Markkleeberg, 04416
Josef-Retzer-Str. 46
München, 81241
Beckenboden Zentrum Munchen
München, 81679
Poland11 sites
Oddzial Urologii
Bydgoszcz, 85-168
Akdemickie Centrum Kliniczne
Gdansk, 80-402
Medical University of Selesia
Katowice, 40-752
Non-public Healthcare Unit
Kutno, 99-300
UI.G. Narutowicza 28
Lodz, 90-135
Instytut Zdrowia Matki Polki
Lodz, 93-338
University School of Medicine
Lublin, 20-950
Clinical Dept of Urology, Medical Postgraduate Education
Warsaw, 00-416
Military Institute of Medicine
Warsaw, 00-909
Klinika Urologii Akademii
Warsaw, 02-005
Ackademicki Szpital Klniczny
Wroclaw, 50-043
Spain5 sites
Hospital De Terrassa
Barcelona, 08227
Servicio de Ginecologia
Barcelona, 08500
Hospital Sant Joan De Deu
Barcelona, 08950
Fundacion Hospital Alcorcon
Madrid, 28922
Hospital Universitario
Santa Cruz de Tenerife, Canary Islands, 38320
United Kingdom5 sites
Aberdeen Royal Infirmary
Aberdeen, AB25 2NZ
Addenbrooke's Hospital
Cambridge, CB2 2QQ
Leighton Hospital
Crewe, CW1 4QJ
King's College Hospital
London, SE5 9RS
The Royal Hallamshire Hospital
Sheffield, S10 2JF
Estonia3 sites
East Tallinn Central Hospital
Tallinn, 10138
West Tallinn Central Hospital
Tallinn, 10611
Tartu University Clinic
Tartu, 51014
France3 sites
Hopital Rothschild
Paris, 75571
Hopital Tenon
Paris, 75970
Hopital Rangueil - CHU Toulouse
Toulouse, 31059
Lithuania3 sites
Kaunas 2nd Clinical Hospital
Kaunas, LT- 47144
Kaunas Hospital
Kaunas, LT- 50009
Vilnius Santariskes Clinics
Vilnius, LT-08661
Latvia2 sites
Medical Company ARS
Riga, LV-1001
P. Stradins Hospital
Riga, LV-1002
About this study
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
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.
Read the 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)
- Being tested
- Placebo, SMP-986
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Placebo, 2 week duration.
PlaceboDrug
Taken for the 8 week duration, in parallel with alternative arms (doses of 20, 40, 80 or 120mg SMP-986).
SMP-986Drug
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
| Study group | Role | What they receive |
|---|---|---|
| 1 | Placebo comparator | Placebo run-in phase. 2 week duration. Receives: 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). Receives: Drug: Placebo |
| 3 | Experimental | 20mg dose of SMP-986 to be taken once daily for 8 week duration. Receives: Drug: SMP-986 |
| 4 | Experimental | 40mg dose of SMP-986 to be taken for 8 week duration. Receives: Drug: SMP-986 |
| 5 | Experimental | 80mg dose of SMP-986 to be taken for 8 week duration. Receives: Drug: SMP-986 |
| 6 | Experimental | 120mg dose of SMP-986 to be taken for 8 week duration. Receives: Drug: SMP-986 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline to Week 8 in the Number of Voids/24 Hours
Measured: 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
Treatment emergent adverse event summary
Measured: 8 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2006 (estimated)
- Study startDec 2006
- Primary completionJun 2008
- Study completionJul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Overactive Bladder Syndrome (OABS)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 550 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sumitomo Pharma America, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Dainippon Sumitomo Pharma America, ICON Clinical Research, ClinPhone, Inc., Covance, PPD Development, LP
- Responsible party
- Sponsor
- Investigators
- Prof C Chappel, Principal investigator, Royal Hallamshire Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00409539
- Sponsor's protocol ID
- D3601113
- Status last verified
- Dec 2014
- First submitted
- 8 Dec 2006
- Last updated
- 10 Dec 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00409539
- Acronym / sponsor ID
- D3601113
- Conditions
- Overactive Bladder Syndrome (OABS)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 550 participants (actual)
- Lead sponsor
- Sumitomo Pharma America, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Dainippon Sumitomo Pharma America, ICON Clinical Research, ClinPhone, Inc., Covance, PPD Development, LP
- Study start
- Dec 2006
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 11 Dec 2006 (estimated)
- Results
- Posted 10 Dec 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 1 | Placebo comparator | Drug: PlaceboPlacebo run-in phase. 2 week duration. |
| 2 | Placebo comparator | Drug: PlaceboTo be taken for the 8 week duration, in parallel with alternative arms (doses of 20, 40, 80 or 120mg SMP-986). |
| 3 | Experimental | Drug: SMP-98620mg dose of SMP-986 to be taken once daily for 8 week duration. |
| 4 | Experimental | Drug: SMP-98640mg dose of SMP-986 to be taken for 8 week duration. |
| 5 | Experimental | Drug: SMP-98680mg dose of SMP-986 to be taken for 8 week duration. |
| 6 | Experimental | Drug: SMP-986120mg dose of SMP-986 to be taken for 8 week duration. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (21 listed)
- 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:
- 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:
- Patients with a current or past malignancy (within the last 5 years)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboPlacebo, 2 week duration. | Drug | 1 |
| PlaceboTaken for the 8 week duration, in parallel with alternative arms (doses of 20, 40, 80 or 120mg SMP-986). | Drug | 2 |
| SMP-986Comparison 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 | Drug | 3, 4, 5, 6 |
Primary outcome
Change From Baseline to Week 8 in the Number of Voids/24 Hours
Time frame: 8 Weeks
1 secondary outcome
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
Time frame: 8 Weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Prof C Chappel principal investigator
Royal Hallamshire Hospital
69 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SMP-986 in people with Overactive Bladder Syndrome (OABS), run by Sumitomo Pharma America, Inc. at 69 sites in 9 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 69 sites in United States, Germany, Poland, Spain, United Kingdom and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Dec 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline to Week 8 in the Number of Voids/24 Hours (time frame: 8 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2014.