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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02667470
Other study ID # ATH-002
Secondary ID
Status Completed
Phase Phase 4
First received January 26, 2016
Last updated January 26, 2016
Start date September 2009
Est. completion date May 2013

Study information

Verified date January 2016
Source Astellas Pharma Inc
Contact n/a
Is FDA regulated No
Health authority Thailand: Ethical Committee
Study type Interventional

Clinical Trial Summary

The objective of this study is to evaluate change of Overactive Bladder (OAB) Symptom Score (OABSS) scores between before and after Solifenacin treatment to OAB patients and to evaluate correlation between change of OABSS scores and other measures for OAB symptoms.


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date May 2013
Est. primary completion date May 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- At screening visit (Week -2):

- Symptoms of OAB = 3 months

- Number of urgency episodes in last 3 days = 3

- Based on the 3-day micturition diary prior to Visit 1 (Week 0):

- Number of micturition per day = 8

- Number of urgency episodes in 3 days = 3

Exclusion Criteria:

- At screening visit (Week -2):

- Stress is the predominant factor as determined by the investigator

- Indwelling catheters or practicing intermittent self-catheterization

- Symptomatic urinary tract infection, chronic inflammation

- Treatment for OAB was started, quitted or changed in 4 weeks

- Diabetic neuropathy

- At Visit 1 (Week 0):

- Patient who did not complete the 3-day micturition diary according to the instruction

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Solifenacin
Oral

Locations

Country Name City State
Thailand Site: 1 Bangkok

Sponsors (1)

Lead Sponsor Collaborator
Astellas Pharma Inc

Country where clinical trial is conducted

Thailand, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in OABSS scores from prior to treatment and after treatment Prior to treatment and after treatment (up to 12 weeks) No
Secondary Correlation of change between OABSS scores and number of micturitions per day Prior to treatment and after treatment (up to 12 weeks) No
Secondary Correlation of change between OABSS scores and number of incontinence episodes per day Prior to treatment and after treatment (up to 12 weeks) No
Secondary Correlation of change between OABSS scores and number of urgency episodes per day Prior to treatment and after treatment (up to 12 weeks) No
Secondary Correlation of change between OABSS scores and number of nocturia episodes per day Prior to treatment and after treatment (up to 12 weeks) No
Secondary Correlation of change between OABSS scores and number of total voided volume per day Prior to treatment and after treatment (up to 12 weeks) No
Secondary Correlation of change between OABSS scores and number of pads per day Prior to treatment and after treatment (up to 12 weeks) No
Secondary Correlation of change between OABSS scores and total International Prostate Symptom Score (IPSS) score Prior to treatment and after treatment (up to 12 weeks) No
Secondary Correlation of change between OABSS scores and IPSS Quality of Life (QoL) score Prior to treatment and after treatment (up to 12 weeks) No
Secondary Correlation of change between OABSS scores and Patient Perception of Bladder Condition (PPBC) total score Prior to treatment and after treatment (up to 12 weeks) No
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