A Double-Blind, Paralleled Study Comparing Efficacy/Safety of Solifenacin to Tolterodine in Overactive Bladder Patients

Urinary Bladder, Overactive Clinical Trial

Official title:

A Randomized, Double-Blind, Paralleled, Active Controlled, Multi-Center Study of the Efficacy and Safety of 5mg Solifenacin Succinate Compared to Tolterodine in Patients With Overactive Bladder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00368706
• Other study ID #: 90506/CHoTD01
• Status: Completed
• Phase: Phase 3
• First received: August 24, 2006
• Last updated: April 9, 2008
• Start date: September 2006
• Est. completion date: March 2008

Study information

• Verified date: April 2008
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

To evaluate the efficacy and safety of solifenacin succinate (Vesicare) 5mg OD in subjects with overactive bladder compared to tolterodine wmg, bid

Recruitment information / eligibility

• Status: Completed
• Enrollment: 246
• Est. completion date: March 2008
• Est. primary completion date: March 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Patients willing and able to complete the micturition diary correctly

• Patients experiencing frequency of micturition as verified in the diary

• Patients experiencing significant post void residual volume

• OAB symptoms including urinary frequency, urgency or urge incontinence for 3 months or more.

Exclusion Criteria:

• Significant post void residual volume

• Patients with indwelling catheters or practicing intermittent self- catheterization

• Known or suspected hypersensitivity to solifenacin succinate or other anticholinergics or lactose

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Urinary Bladder, Overactive

Intervention

Drug:
• solifenacin succinate
Oral
• tolterodine
oral

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Astellas Pharma Inc

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in mean number of micturitions per 24 hours		8 Weeks	No
Secondary	Change from baseline in mean volume voided per micturition		8 Weeks	No
Secondary	Change from baseline in mean number of incontinence episodes per 24 hours		8 Weeks	No
Secondary	Change from baseline in mean urgency frequency per 24 hours		8 Weeks	No
Secondary	Change from baseline in mean nocturia episodes per 24 hours		8 Weeks	No