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

• ClinicalTrials.gov Identifier: NCT00801944
• Recruitment Status: Completed
• First Posted: December 4, 2008
• Last Update Posted: September 18, 2014
• Sponsor: Astellas Pharma Inc
• Information provided by (Responsible Party): Astellas Pharma Inc

Tracking Information

• First Submitted Date: December 2, 2008
• First Posted Date: December 4, 2008
• Last Update Posted Date: September 18, 2014
• Study Start Date: April 2004
• Actual Primary Completion Date: October 2005 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: December 2, 2008): 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 ]
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: December 2, 2008)

• 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 ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Solifenacin Succinate 5mg or 10mg Once Daily in the Treatment of Urgency Symptoms
• Official Title: Solifenacin in the Treatment of Urgency Symptoms of Overactive Bladder in a Rising Dose, Randomized, Placebo-controlled, Double-blind Trial
• Brief Summary: Prospective, double-blind, double-randomised, 2-arm parallel group study. Optimal dose increase. Primary efficacy assessment of OAB symptoms by patient diaries.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment
• Condition: Urinary Bladder, Overactive

Intervention

• Drug: Solifenacin succinate
  oral
  Other Names:

  • YM905
  • Vesicare
• Drug: Placebo
  oral

Study Arms

• Experimental: I
  Solifenacin succinate 5/10mg
  Intervention: Drug: Solifenacin succinate
• Experimental: II
  Placebo
  Intervention: Drug: Placebo

• Publications *: Cardozo L, Hessdorfer E, Milani R, Arano 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: December 2, 2008): 973
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: October 2005
• Actual Primary Completion Date: October 2005 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Belgium, Czech Republic, Egypt, France, Germany, Greece, Hungary, Italy, Poland, Portugal, Russian Federation, Slovakia, Spain, United Kingdom

Administrative Information

• NCT Number: NCT00801944
• Other Study ID Numbers: 905-EC-002
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Astellas Pharma Inc
• Original Responsible Party: Disclosure Office Europe, Astellas Pharma Europe BV
• Current Study Sponsor: Astellas Pharma Inc
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Chair: Central Contact; Astellas Pharma Europe B.V.

• PRS Account: Astellas Pharma Inc
• Verification Date: September 2014