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NCT00189800 Clinical Trial

A Study of Solifenacin Succinate Compared to Tolterodine in Patients With Overactive Bladder

Overactive Bladder Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00189800
Other study ID # 90502/KOoTD01
Secondary ID
Status Completed
Phase Phase 3
First received September 13, 2005
Last updated November 15, 2011

Study information
Verified date October 2006
Source Astellas Pharma Inc
Contact n/a
Is FDA regulated No
Health authority Korea: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

The purpose of this study is to ascertain the clinical results of solifenacin succinate of PIII study conducted in the original country using Korean patients with an overactive bladder.

Recruitment information / eligibility
Status Completed
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Symptoms of overactive bladder

- Must be able to complete the micturition diary

Exclusion Criteria:

- Pregnant or lactating

- Clinically significant outflow obstruction

- Significant post void residual urine

- Significant stress incontinence

- Urinary tract infection

- Chronic inflammation

- Bladder stones

- Previous pelvic radiation therapy

- Previous or current malignant disease of the pelvic organs

- Uncontrolled narrow angle glaucoma

- Urinary or gastric retention

- Electrostimulation therapy

- Bladder training

- Diabetic neuropathy

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Solifenacin succinate

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)

EU Shi-liang, et al. Efficacy and safety of solifenacin in the treatment of patients with urgency and urge incontinence. Chin J Urol (2009) 30(9); 1-5

See also
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Not yet recruiting NCT01423838 - Comparison of Solifenacin and Oxybutynin in the Treatment of Overactive Bladder Phase 4
Completed NCT01458197 - A Phase 2 Study to Compare the Efficacy and Tolerability of Tarafenacin 0.2 mg and Tarafenacin 0.4 mg to Placebo in Patients Suffering From Overactive Bladder. Phase 2
Not yet recruiting NCT01409512 - Evaluation of Autonomic System Before and After Anticholinergic Treatment in Women With Overactive Bladder N/A
Terminated NCT01758848 - Physical Therapy for Overactive Bladder N/A
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Completed NCT01122550 - Reproducibility Study of Overactive Bladder Symptom Score [OABSS] N/A