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Solifenacin Succinate 5mg or 10mg Once Daily in the Treatment of Urgency Symptoms (SUNRISE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00801944
Recruitment Status : Completed
First Posted : December 4, 2008
Last Update Posted : September 18, 2014
Information provided by (Responsible Party):
Astellas Pharma Inc

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

Condition or disease Intervention/treatment Phase
Urinary Bladder, Overactive Drug: Solifenacin succinate Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 973 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Solifenacin in the Treatment of Urgency Symptoms of Overactive Bladder in a Rising Dose, Randomized, Placebo-controlled, Double-blind Trial
Study Start Date : April 2004
Actual Primary Completion Date : October 2005
Actual Study Completion Date : October 2005

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: I
Solifenacin succinate 5/10mg
Drug: Solifenacin succinate
Other Names:
  • YM905
  • Vesicare

Experimental: II
Drug: Placebo

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Change from baseline in mean number of urgency episodes (PPIUS grades 1-4) [ Time Frame: Week 16 ]
  2. Change from baseline in the mean number of micturition, incontinence and urge incontinence (PPIUS grade 4) episodes per 24 hours [ Time Frame: Week 16 ]
  3. Change from baseline in patient perception of bladder condition (PBC) [ Time Frame: Week 16 ]
  4. Change from baseline in patient perception of urgency 'bother' (UB-VAS) [ Time Frame: Week 16 ]
  5. Percentage of patients requiring an increase in the dose of the study medication [ Time Frame: Week 8 ]
  6. Patient assessment of treatment satisfaction (TS-VAS) [ Time Frame: Weeks 4, 8 and 12 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00801944

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Sponsors and Collaborators
Astellas Pharma Inc
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Study Chair: Central Contact Astellas Pharma Europe B.V.
Additional Information:
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Responsible Party: Astellas Pharma Inc Identifier: NCT00801944    
Other Study ID Numbers: 905-EC-002
First Posted: December 4, 2008    Key Record Dates
Last Update Posted: September 18, 2014
Last Verified: September 2014
Keywords provided by Astellas Pharma Inc:
Overactive Bladder
Additional relevant MeSH terms:
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Urinary Bladder, Overactive
Urinary Bladder Diseases
Urologic Diseases
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Male Urogenital Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Solifenacin Succinate
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Urological Agents