Study of VESIcare® In Overactive Bladder (OAB) Subjects to Evaluate Symptom Bother and Health Related Quality of Life

Completed · Phase 4 · Has a placebo group

Conditions studied: Urinary Bladder, Overactive

In brief

Evaluate the effect of VESIcare® on symptom bother for subjects with OAB

Key facts

Study ID

NCT00573508

Run by

Astellas Pharma Inc

People needed

768

Starts

2007-08-01

Expected to finish

2008-07-01

Last updated by the study team

2010-10-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Ambulatory male or female subject ≥ 18 years of age and able to use the toilet without difficulty
• History of OAB symptoms for ≥ 3 months
• An average of ≥ 8 micturitions per 24 hours and ≥ 1 urgency episode (with or without incontinence) per 24 hours as documented in a 3-day micturition diary
• Subjects are bothered by symptoms as reflected by PPBC ≥3

You may not qualify if…

• Evidence of chronic urologic inflammation such as interstitial cystitis and bladder stones; uncontrolled narrow angle glaucoma; urinary or gastric retention
• Recurrent urinary tract infection (UTI) of > 3 episodes within the last 3 months or evidence of a urinary tract infection at Baseline Visit (Visit 2)
• Significant stress incontinence or mixed stress/urge incontinence where stress is the predominant factor as determined by the investigator
• History of renal or hepatic impairment(2 x Upper Limit of Normal(ULN) values in parameters and considered clinically significant by the investigator
• History of diagnosed gastrointestinal obstruction disease
• Subject has a known diagnosis or history of carcinoma (including prostate cancer) except non metastatic basal or squamous cell carcinoma of the skin that has been successfully treated or previous pelvis radiation within the past five years
• Known or suspected hypersensitivity to solifenacin succinate, any components, or other anticholinergics

Where it is running

• Study site — Phoenix, Arizona, United States
• Study site — Tucson, Arizona, United States
• Study site — Buena Park, California, United States
• Study site — Carmichael, California, United States
• Study site — Fresno, California, United States
• Study site — Sacramento, California, United States
• Study site — San Bernardino, California, United States
• Study site — San Diego, California, United States
• Study site — Aurora, Colorado, United States
• Study site — Denver, Colorado, United States
• Study site — Denver, Colorado, United States
• Study site — Englewood, Colorado, United States
• Study site — Waterbury, Connecticut, United States
• Study site — Clearwater, Florida, United States
• Study site — Plantation, Florida, United States
• Study site — Tallahassee, Florida, United States
• Study site — Tampa, Florida, United States
• Study site — Tampa, Florida, United States
• Study site — Wellington, Florida, United States
• Study site — Roswell, Georgia, United States
• Study site — Idaho Falls, Idaho, United States
• Study site — Melrose Park, Illinois, United States
• Study site — Jeffersonville, Indiana, United States
• Study site — Shreveport, Louisiana, United States
• Study site — Montgomery, Alabama, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.