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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT01318837 |
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Date of registration:
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17/03/2011 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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A Study to Evaluate Response of Over Active Bladder Symptom Score to Solifenacin Treatment
RESORT-2 |
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Scientific title:
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Reproducibility Study of OABSS and Its Response to Solifenacin Treatment (RESORT) and Validity in Korean Populations; Part 2: Responsiveness and Validity |
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Date of first enrolment:
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April 2010 |
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Target sample size:
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100 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01318837 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label
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Phase:
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Phase 4
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Countries of recruitment
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Korea, Republic of
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Contacts
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Name:
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Use Central Contact |
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Address:
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Telephone:
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Email:
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Affiliation:
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Bundang Seoul National University Hospital, Seong Jin Jeong, MD. |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Over Active Bladder
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Intervention(s)
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Drug: solifenacin
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Primary Outcome(s)
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Changes from baseline to week 4 in Over-Active Bladder Symptom Score (OABSS)
[Time Frame: week 0 (baseline) and week 4]
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Changes from baseline to week 12 in OABSS
[Time Frame: week 0 (baseline) and week 12]
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Secondary Outcome(s)
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Changes from baseline in Patient Perception of Bladder Condition (PPBC) at week 4
[Time Frame: week 0 (baseline) and week 4]
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Changes from baseline in International Prostate Symptom Score (IPSS) at week 4
[Time Frame: week 0 (baseline) and week 4]
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Changes from baseline in IPSS at week 12
[Time Frame: week 0 (baseline) and week 12]
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Changes from baseline in QoL Score at week 12
[Time Frame: week 0 (baseline) and week 12]
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Changes from baseline in Quality of Life (QoL) Score at week 4
[Time Frame: week 0 (baseline) and week 4]
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Changes from baseline in PPBC at week 12
[Time Frame: week 0 (baseline) and week 12]
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Secondary ID(s)
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OABSSVSK-002
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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