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

December 5, 2014 updated by: Sunovion

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
550

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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
        • Hôpital Tenon
      • Paris, France, 75571
        • Hôpital Rothschild
      • Toulouse, France, 31059
        • Hopital 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 Déu
      • Madrid, Spain, 28922
        • Fundacion Hospital Alcorcon
    • 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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Change From Baseline to Week 8 in the Number of Voids/24 Hours
Time Frame: 8 Weeks
8 Weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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
Time Frame: 8 Weeks
Treatment emergent adverse event summary
8 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sunovion

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
PPD
ICON Clinical Research
Covance
Dainippon Sumitomo Pharma America
ClinPhone, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Prof C Chappel, Royal Hallamshire Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2006

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2008

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2008

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 8, 2006

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 8, 2006

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 11, 2006

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 10, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 5, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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