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

September 17, 2014 updated by: Astellas Pharma Inc

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

973

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Antwerp, Belgium
      • Brugge, Belgium
      • Brussels, Belgium
      • Gent, Belgium
      • Hasselt, Belgium
      • Kortrijk, Belgium
      • Leuven, Belgium
      • Liege, Belgium
  • Czech Republic
      • Ostrava, Czech Republic
      • Prague, Czech Republic
      • Zlin, Czech Republic
  • Egypt
      • Mansoura, Egypt
  • France
      • Lille, France
      • Lomme, France
      • Mulhouse, France
      • Nantes, France
      • Nimes, France
      • Paris, France
  • Germany
      • Aichach, Germany
      • Bad Neuenaher, Germany
      • Bamberg, Germany
      • Bautzen, Germany
      • Berlin, Germany
      • Dierdorf, Germany
      • Duelmen, Germany
      • Dusseldorf, Germany
      • Frankfurt, Germany
      • Henningsdorf, Germany
      • Munich, Germany
      • Neustadt, Germany
      • Nurnberg, Germany
      • Planegg, Germany
  • Greece
      • Athens, Greece
      • Crete, Greece
      • Ioannina, Greece
  • Hungary
      • Budapest, Hungary
      • Nyiregyhaza, Hungary
      • Pecs, Hungary
      • Szeged, Hungary
      • Tatabanya, Hungary
  • Italy
      • Bari, Italy
      • Catanzaro, Italy
      • Cinisello Balsamo, Italy
      • Magenta, Italy
      • Modena, Italy
      • Perugia, Italy
      • Turin, Italy
      • Udine, Italy
  • Poland
      • Bydgoszcz, Poland
      • Wroclaw, Poland
  • Portugal
      • Abrantes, Portugal
      • Lisbon, Portugal
      • Porto, Portugal
      • Santarem, Portugal
  • Russian Federation
      • Moscow, Russian Federation
  • Slovakia
      • Banska Bysterica, Slovakia
      • Martin, Slovakia
      • Zilina, Slovakia
  • Spain
      • Barcelona, Spain
      • Coana, Spain
      • Cordoba, Spain
      • Madrid, Spain
      • Merida, Spain
      • San Cristobal de la Laguna, Spain
      • Sevilla, Spain
  • United Kingdom
      • Birmingham, United Kingdom
      • Cottingham, United Kingdom
      • Croydon, United Kingdom
      • Edinburgh, United Kingdom
      • Huntingdon, United Kingdom
      • London, United Kingdom
      • Manchester, United Kingdom
      • Oldham, United Kingdom
      • Stoke on Trent, United Kingdom
      • Sunderland, United Kingdom
      • Torbay, United Kingdom
      • Welwyn Garden City, United Kingdom
      • Worthing, United Kingdom

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: I
Solifenacin succinate 5/10mg
Drug: Solifenacin succinate
oral
Other Names:
  • Vesicare
  • YM905
EXPERIMENTAL: II
Placebo
Drug: Placebo
oral

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Week 16

Secondary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in mean number of urgency episodes (PPIUS grades 1-4)
Time Frame: Week 16
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
Week 16
Change from baseline in patient perception of bladder condition (PBC)
Time Frame: Week 16
Week 16
Change from baseline in patient perception of urgency 'bother' (UB-VAS)
Time Frame: Week 16
Week 16
Percentage of patients requiring an increase in the dose of the study medication
Time Frame: Week 8
Week 8
Patient assessment of treatment satisfaction (TS-VAS)
Time Frame: Weeks 4, 8 and 12
Weeks 4, 8 and 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Astellas Pharma Inc

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2004

Primary Completion (ACTUAL)

October 1, 2005

Study Completion (ACTUAL)

October 1, 2005

Study Registration Dates

First Submitted

December 2, 2008

First Submitted That Met QC Criteria

December 2, 2008

First Posted (ESTIMATE)

December 4, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

September 18, 2014

Last Update Submitted That Met QC Criteria

September 17, 2014

Last Verified

September 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 905-EC-002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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