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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

Study Description
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Brief Summary:
This study is to evaluate change of over active bladder symptom scores (OABSS) between, before and after solifenacin treatment to OAB subjects.

Condition or disease Intervention/treatment Phase
Over Active Bladder Drug: solifenacin Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: Reproducibility Study of OABSS and Its Response to Solifenacin Treatment (RESORT) and Validity in Korean Populations; Part 2: Responsiveness and Validity
Study Start Date : April 2010
Actual Primary Completion Date : September 2011
Actual Study Completion Date : September 2011

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Arms and Interventions
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Arm Intervention/treatment
Experimental: sofilenacin group Drug: solifenacin
oral
Other Name: Vesicare
No Intervention: control group
age and sex matched patients without OAB symptom who will answer demographic questionaire and OABSS once


Outcome Measures
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Primary Outcome Measures :
  1. Changes from baseline to week 4 in Over-Active Bladder Symptom Score (OABSS) [ Time Frame: week 0 (baseline) and week 4 ]
  2. Changes from baseline to week 12 in OABSS [ Time Frame: week 0 (baseline) and week 12 ]

Secondary Outcome Measures :
  1. Changes from baseline in International Prostate Symptom Score (IPSS) at week 4 [ Time Frame: week 0 (baseline) and week 4 ]
  2. Changes from baseline in IPSS at week 12 [ Time Frame: week 0 (baseline) and week 12 ]
  3. Changes from baseline in Quality of Life (QoL) Score at week 4 [ Time Frame: week 0 (baseline) and week 4 ]
  4. Changes from baseline in QoL Score at week 12 [ Time Frame: week 0 (baseline) and week 12 ]
  5. Changes from baseline in Patient Perception of Bladder Condition (PPBC) at week 4 [ Time Frame: week 0 (baseline) and week 4 ]
  6. Changes from baseline in PPBC at week 12 [ Time Frame: week 0 (baseline) and week 12 ]

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

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
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT01318837


Locations
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Korea, Republic of
Seoul, Korea, Republic of
Sungnam, Korea, Republic of
Sponsors and Collaborators
Astellas Pharma Inc
Astellas Pharma Korea, Inc.
Investigators
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Principal Investigator: Use Central Contact Bundang Seoul National University Hospital, Seong Jin Jeong, MD.
More Information
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Additional Information:

Publications:

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Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT01318837    
Other Study ID Numbers: OABSSVSK-002
First Posted: March 21, 2011    Key Record Dates
Last Update Posted: July 10, 2014
Last Verified: July 2014
Keywords provided by Astellas Pharma Inc:
OABSS
IPSS
PPBC
Solifenacin
Additional relevant MeSH terms:
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Urinary Bladder, Overactive
Urinary Bladder Diseases
Urologic 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