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

This study has been completed.
Sponsor:
Information provided by:
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT00801944
First received: December 2, 2008
Last updated: NA
Last verified: December 2008
History: No changes posted
  Purpose

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


Condition Intervention Phase
Urinary Bladder, Overactive
Drug: Solifenacin succinate
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline in mean number of urgency episodes (PPIUS grades 1-4) [ Time Frame: Week 16 ] [ Designated as safety issue: No ]
  • Change from baseline in the mean number of micturition, incontinence and urge incontinence (PPIUS grade 4) episodes per 24 hours [ Time Frame: Week 16 ] [ Designated as safety issue: No ]
  • Change from baseline in patient perception of bladder condition (PBC) [ Time Frame: Week 16 ] [ Designated as safety issue: No ]
  • Change from baseline in patient perception of urgency 'bother' (UB-VAS) [ Time Frame: Week 16 ] [ Designated as safety issue: No ]
  • Percentage of patients requiring an increase in the dose of the study medication [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
  • Patient assessment of treatment satisfaction (TS-VAS) [ Time Frame: Weeks 4, 8 and 12 ] [ Designated as safety issue: No ]

Enrollment: 973
Study Start Date: April 2004
Study Completion Date: October 2005
Primary Completion Date: October 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: I
Solifenacin succinate 5/10mg
Drug: Solifenacin succinate
oral
Other Names:
  • YM905
  • Vesicare
Experimental: II
Placebo
Drug: Placebo
oral

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00801944

  Show 78 Study Locations
Sponsors and Collaborators
Astellas Pharma Inc
Investigators
Study Chair: Central Contact Astellas Pharma Europe B.V.
  More Information

No publications provided

Responsible Party: Disclosure Office Europe, Astellas Pharma Europe BV
ClinicalTrials.gov Identifier: NCT00801944     History of Changes
Other Study ID Numbers: 905-EC-002
Study First Received: December 2, 2008
Last Updated: December 2, 2008
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products
Czech Republic: State Institute for Drug Control
Germany: Ministry of Health
Egypt: Ministry of Health and Population
Spain: Ministry of Health
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Greece: Ministry of Health and Welfare
Hungary: National Institute of Pharmacy
Italy: National Institute of Health
Poland: Ministry of Health
Portugal: Ethics Committee for Clinical Research
Russia: Ministry of Health of the Russian Federation
Slovakia: State Institute for Drug Control

Keywords provided by Astellas Pharma Inc:
Overactive Bladder

Additional relevant MeSH terms:
Urinary Bladder, Overactive
Urinary Bladder Diseases
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Solifenacin
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Urological Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 28, 2014