Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00004137

Trial Description

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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

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

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.

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Brief Summary in Scientific Language

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.

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Organizational Data

  •   DRKS00004137
  •   2012/10/17
  •   2006/12/08
  •   no
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Secondary IDs

  •   NCT00409539  (ClinicalTrials.gov)
  •   D3601113  (Dainippon Sumitomo Pharma Europe LTd.)
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Health Condition or Problem studied

  •   Overactive Bladder Syndrome (OABS)
  •   N32.8 -  Other specified disorders of bladder
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Interventions/Observational Groups

  •   Drug: Placebo
  •   Drug: Placebo
  •   Drug: SMP-986
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Blinded
  •   patient/subject, caregiver, investigator/therapist, assessor
  •   Placebo
  •   Treatment
  •   Parallel
  •   II
  •   [---]*
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Primary Outcome

- Change From Baseline to Week 8 in the Number of Voids/24 Hours; time frame: 8 Weeks

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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; Treatment emergent adverse event summary

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Countries of Recruitment

  •   United States
  •   Estonia
  •   France
  •   Germany
  •   Latvia
  •   Lithuania
  •   Poland
  •   Spain
  •   United Kingdom
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Locations of Recruitment

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Recruitment

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  •   2006/12/31
  •   551
  •   Multicenter trial
  •   International
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Inclusion Criteria

  •   Both, male and female
  •   20   Years
  •   80   Years
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Additional 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.

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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

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Addresses

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    • Sunovion
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    • Royal Hallamshire Hospital
    • Prof C Chappel 
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    • Royal Hallamshire Hospital
    • Prof C Chappel 
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Sources of Monetary or Material Support

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    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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Status

  •   Recruiting complete, follow-up complete
  •   2008/07/01
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Trial Publications, Results and other Documents

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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   5
  •   2016/01/14


* This entry means the parameter is not applicable or has not been set.