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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01318837
Other study ID # OABSSVSK-002
Secondary ID
Status Completed
Phase Phase 4
First received March 17, 2011
Last updated July 9, 2014
Start date April 2010
Est. completion date September 2011

Study information

Verified date July 2014
Source Astellas Pharma Inc
Contact n/a
Is FDA regulated No
Health authority Korea: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

Status Completed
Enrollment 100
Est. completion date September 2011
Est. primary completion date September 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label


Related Conditions & MeSH terms


Intervention

Drug:
solifenacin
oral

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Astellas Pharma Inc Astellas Pharma Korea, Inc.

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (1)

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Changes from baseline to week 4 in Over-Active Bladder Symptom Score (OABSS) week 0 (baseline) and week 4 No
Primary Changes from baseline to week 12 in OABSS week 0 (baseline) and week 12 No
Secondary Changes from baseline in International Prostate Symptom Score (IPSS) at week 4 week 0 (baseline) and week 4 No
Secondary Changes from baseline in IPSS at week 12 week 0 (baseline) and week 12 No
Secondary Changes from baseline in Quality of Life (QoL) Score at week 4 week 0 (baseline) and week 4 No
Secondary Changes from baseline in QoL Score at week 12 week 0 (baseline) and week 12 No
Secondary Changes from baseline in Patient Perception of Bladder Condition (PPBC) at week 4 week 0 (baseline) and week 4 No
Secondary Changes from baseline in PPBC at week 12 week 0 (baseline) and week 12 No
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