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A Study to Evaluate Response of Over Active Bladder Symptom Score to Solifenacin Treatment (RESORT-2)

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.
 
ClinicalTrials.gov Identifier: NCT01318837
Recruitment Status : Completed
First Posted : March 21, 2011
Last Update Posted : July 10, 2014
Sponsor:
Collaborator:
Astellas Pharma Korea, Inc.
Information provided by (Responsible Party):
Astellas Pharma Inc

Tracking Information
First Submitted Date  ICMJE March 17, 2011
First Posted Date  ICMJE March 21, 2011
Last Update Posted Date July 10, 2014
Study Start Date  ICMJE April 2010
Actual Primary Completion Date September 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 17, 2011)
  • Changes from baseline to week 4 in Over-Active Bladder Symptom Score (OABSS) [ Time Frame: week 0 (baseline) and week 4 ]
  • Changes from baseline to week 12 in OABSS [ Time Frame: week 0 (baseline) and week 12 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 17, 2011)
  • Changes from baseline in International Prostate Symptom Score (IPSS) at week 4 [ Time Frame: week 0 (baseline) and week 4 ]
  • Changes from baseline in IPSS at week 12 [ Time Frame: week 0 (baseline) and week 12 ]
  • Changes from baseline in Quality of Life (QoL) Score at week 4 [ Time Frame: week 0 (baseline) and week 4 ]
  • Changes from baseline in QoL Score at week 12 [ Time Frame: week 0 (baseline) and week 12 ]
  • Changes from baseline in Patient Perception of Bladder Condition (PPBC) at week 4 [ Time Frame: week 0 (baseline) and week 4 ]
  • Changes from baseline in PPBC at week 12 [ Time Frame: week 0 (baseline) and week 12 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Evaluate Response of Over Active Bladder Symptom Score to Solifenacin Treatment
Official Title  ICMJE Reproducibility Study of OABSS and Its Response to Solifenacin Treatment (RESORT) and Validity in Korean Populations; Part 2: Responsiveness and Validity
Brief Summary This study is to evaluate change of over active bladder symptom scores (OABSS) between, before and after solifenacin treatment to OAB subjects.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Condition  ICMJE Over Active Bladder
Intervention  ICMJE Drug: solifenacin
oral
Other Name: Vesicare
Study Arms  ICMJE
  • Experimental: sofilenacin group
    Intervention: Drug: solifenacin
  • No Intervention: control group
    age and sex matched patients without OAB symptom who will answer demographic questionaire and OABSS once
Publications * Jeong SJ, Homma Y, Oh SJ. Reproducibility study of Overactive Bladder Symptom Score questionnaire and its response to treatment (RESORT) in Korean population with overactive bladder symptoms. Qual Life Res. 2014 Feb;23(1):285-92. doi: 10.1007/s11136-013-0440-7. Epub 2013 May 29.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 17, 2011)		 100
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2011
Actual Primary Completion Date September 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Symptoms of OAB for 3 months or longer
  • At least 1 urgency episode in last 3 days

  • Symptoms of OAB as verified by the screening 3-day bladder diary, defined by:

    • a. Number of micturition ≥8 times/day
    • b. Number of urgency episodes in 3 days ≥3

Exclusion Criteria:

  • Significant stress incontinence or mixed stress/urge incontinence
  • Subject with indwelling catheters or practicing intermittent self-catheterization
  • Symptomatic urinary tract infection, chronic inflammation
  • Diabetic neuropathy
  • Subjects who are prohibited from taking solifenacin as contraindications
  • Drug or non-drug treatment for OAB was started, quitted or changed in 4 weeks
  • Participation in any clinical trial in 30 days except for Part-1 of RESORT
  • Diabetic neuropathy
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01318837
Other Study ID Numbers  ICMJE OABSSVSK-002
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Astellas Pharma Inc
Study Sponsor  ICMJE Astellas Pharma Inc
Collaborators  ICMJE Astellas Pharma Korea, Inc.
Investigators  ICMJE
Principal Investigator: Use Central Contact Bundang Seoul National University Hospital, Seong Jin Jeong, MD.
PRS Account Astellas Pharma Inc
Verification Date July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP