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

This study has been completed.
Sponsor:
Collaborators:
Dainippon Sumitomo Pharma America
ICON Clinical Research
ClinPhone, Inc.
Covance
PPD
Information provided by (Responsible Party):
Sunovion
ClinicalTrials.gov Identifier:
NCT00409539
First received: December 8, 2006
Last updated: May 24, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention Phase
Overactive Bladder Syndrome (OABS)
Drug: Placebo
Drug: SMP-986
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Sunovion:

Primary Outcome Measures:
  • To quantify the extent of symptomatic relief provided by 20, 40, 80 and 120 mg SMP 986 (o.d) following 8-weeks of treatment in patients with OABS [ Time Frame: Study End ] [ Designated as safety issue: Yes ]

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 OABS [ Time Frame: Study End ] [ Designated as safety issue: Yes ]
  • To determine the most clinically appropriate dose range for SMP-986 in terms of treatment benefit (efficacy, safety, tolerability and Quality of Life outcomes) [ Time Frame: Study End ] [ Designated as safety issue: Yes ]

Enrollment: 551
Study Start Date: December 2006
Study Completion Date: July 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 1
Placebo run-in phase. 2 week duration.
Drug: Placebo
Placebo, 2 week duration.
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
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

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.

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00409539

  Show 69 Study Locations
Sponsors and Collaborators
Sunovion
Dainippon Sumitomo Pharma America
ICON Clinical Research
ClinPhone, Inc.
Covance
PPD
Investigators
Principal Investigator: Prof C Chappel Royal Hallamshire Hospital
  More Information

No publications provided

Responsible Party: Sunovion
ClinicalTrials.gov Identifier: NCT00409539     History of Changes
Other Study ID Numbers: D3601113
Study First Received: December 8, 2006
Last Updated: May 24, 2014
Health Authority: United States: Food and Drug Administration
European Union: European Medicines Agency
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
Latvia: State Agency of Medicines
Poland: Ministry of Science and Higher Education
Spain: Comité Ético de Investigación Clínica
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Urinary Bladder, Overactive
Syndrome
Urinary Bladder Diseases
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Disease
Pathologic Processes

ClinicalTrials.gov processed this record on October 19, 2014