Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00004059

Trial Description

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Title

Solifenacin in the Treatment of Urgency Symptoms of Overactive Bladder in a Rising Dose, Randomized, Placebo-controlled, Double-blind Trial

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Trial Acronym

SUNRISE

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URL of the Trial

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Brief Summary in Lay Language

Prospective, double-blind, double-randomised, 2-arm parallel group study. Optimal dose
increase. Primary efficacy assessment of OAB symptoms by patient diaries.

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Brief Summary in Scientific Language

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Organizational Data

  •   DRKS00004059
  •   2012/10/30
  •   2008/12/02
  •   no
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Secondary IDs

  •   NCT00801944  (ClinicalTrials.gov)
  •   905-EC-002  (Astellas Pharma Inc)
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Health Condition or Problem studied

  •   Urinary Bladder, Overactive
  •   N32.8 -  Other specified disorders of bladder
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Interventions/Observational Groups

  •   Drug: Solifenacin succinate
  •   Drug: Placebo
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Blinded
  •   patient/subject, investigator/therapist
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  •   Treatment
  •   Parallel
  •   III
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Primary Outcome

- Change from baseline in mean number of urgency episodes/24 hours at EOS -from the Patient Perception of Intensity of Urgency Scale at void (PPIUS) grades 3 and 4; time frame: Week 16

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Secondary Outcome

- Change from baseline in mean number of urgency episodes (PPIUS grades 1-4); time frame: Week 16
- Change from baseline in the mean number of micturition, incontinence and urge incontinence (PPIUS grade 4) episodes per 24 hours; time frame: Week 16
- Change from baseline in patient perception of bladder condition (PBC); time frame: Week 16
- Change from baseline in patient perception of urgency 'bother' (UB-VAS); time frame: Week 16
- Percentage of patients requiring an increase in the dose of the study medication; time frame: Week 8
- Patient assessment of treatment satisfaction (TS-VAS); time frame: Weeks 4, 8 and 12

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Countries of Recruitment

  •   Belgium
  •   Czech Republic
  •   Egypt
  •   France
  •   Germany
  •   Greece
  •   Hungary
  •   Italy
  •   Poland
  •   Portugal
  •   Russian Federation
  •   Slovakia
  •   Spain
  •   United Kingdom
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Locations of Recruitment

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Recruitment

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  •   2004/04/30
  •   973
  •   Multicenter trial
  •   International
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

- Patient is willing and able to complete the micturition diary correctly.

- Symptoms of overactive bladder (including urinary frequency, urgency with/without
urge incontinence) for >= 3 months

- At least 3 episodes of urgency with or without incontinence in last 3 days

- At least three episodes of urgency with or without incontinence (PPIUS grade 3 or 4)
during the 3-day micturition diary period

- Patient must experience frequency of micturition on average >= 8 times per 24-hour
period during the 3-day micturition diary period

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Exclusion Criteria

- Pregnant women or women who intend to become pregnant during the study or women of
childbearing potential who are sexually active and practising an unreliable method of
birth control or will be lactating during the study. Reliable contraceptive methods
are intra-uterine devices, contraceptive pills of combination type, hormonal implants
and injectable or patch contraceptives

- Clinically significant outflow obstruction (at the discretion of the investigator)

- Significant post void residual volume (PVR>200ml)

- Significant stress incontinence or mixed stress/urge incontinence where stress is the
predominant factor as determined by the investigator

- Patient with indwelling catheters or practising intermittent self-catheterisation

- Evidence of a symptomatic urinary tract infection, chronic inflammation such as
interstitial cystitis, bladder stones, previous pelvic radiation therapy or previous
or current malignant disease of the pelvic organs

- Hypersensitivity to solifenacin or to any of the excipients, uncontrolled narrow
angle glaucoma, myasthenia gravis, urinary or gastric retention, severe renal
impairment (GFR ≥30 ml/min), moderate or severe hepatic impairment, chronic
intestinal disease, megacolon, requirement for dialysis, concomitant use of a strong
CYP3A4 inhibitor, e.g. ketoconazole

- Non drug OAB treatment such as bladder-training, biofeedback and pelvic floor
exercises are permissible if established at least 4 weeks prior to study start and
intended to be continued throughout the study; electrostimulation therapy is not
permissible at any time

- Use of drugs intended to treat urinary incontinence

- Diabetic neuropathy

- Any clinically significant condition, which in the opinion of the investigator makes
the patient unsuitable for the trial

- Participation in any clinical trial within 30 days prior to randomisation

- Employees of the Yamanouchi Group, third parties associated with the study, or the
study site

- Patient who did not complete the micturition diary according to the instructions

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Astellas Pharma Inc
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    • Astellas Pharma Europe B.V.
    • Central Contact 
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  • start of 1:1-Block address public-contact
    • Astellas Pharma Europe B.V.
    • Central Contact 
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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
  •   2005/10/01
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Trial Publications, Results and other Documents

  •   Link to Results on JAPIC - enter 140585 in the JapicCTI-RNo. field
  •   Cardozo L, Hessdörfer E, Milani R, Arañó P, Dewilde L, Slack M, Drogendijk T, Wright M, Bolodeoku J; SUNRISE Study Group. Solifenacin in the treatment of urgency and other symptoms of overactive bladder: results from a randomized, double-blind, placebo-controlled, rising-dose trial. BJU Int. 2008 Nov;102(9):1120-7. doi: 10.1111/j.1464-410X.2008.07939.x. Epub 2008 Oct 6.; 18990175
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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.