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

Home

Study Topics

Glossary


	Full Text View


	Tabular View


	Contacts and Locations


	No Study Results Posted


	Related Studies

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

This study has been completed.

Study NCT00573508. Last updated on September 11, 2008. Information provided by Astellas Pharma Inc

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields

Brief Title ^†

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

Official Title ^†

A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Phase 4, Multi-Center Study of VESIcare® (Solifenacin Succinate) in Overactive Bladder (OAB) Subjects to Evaluate Symptom Bother and Health Related Quality of Life VIBRANT: VESIcare® Investigation of BotheR And Quality of Life iN subjecTs With OAB

Brief Summary

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

Detailed Description

Phase 4, multi-center, randomized, double-blind, placebo-controlled, parallel group study. All subjects that meet the baseline criteria will be randomized in a 1:1 ratio into VESIcare® (solifenacin succinate) or placebo group.

The study duration consists of a screening period which includes a minimum of a 14 day treatment free wash-out period. Subjects meeting the baseline criteria will have a 12 week treatment period. Maximum total study duration is 15 weeks: 2 3 week screening / washout period; 12 week double-blind treatment.

Primary efficacy will be based on OAB-q symptom bother score.

Study Phase

Phase IV

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Primary Outcome Measure ^†

Change from baseline to end of treatment in OAB-q score [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measure ^†

Evaluate the effect of 12 weeks of treatment of solifenacin succinate over time on the symptom bother domain in subjects with Overactive Bladder (OAB) syndrome as assessed by the overactive bladder questionnaire (OAB-q) [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
Evaluate the effect of 12 weeks of treatment of solifenacin succinate over time on the health related quality of life (HRQL) in subjects with OAB as assessed by the subject reported HRQL utilizing the OAB-q [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
Evaluate the effect of 12 weeks of treatment of solifenacin succinate on a global assessment of bladder condition as measured by the Patient Perception of Bladder Condition (PPBC) [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
Evaluate subject satisfaction with treatment of solifenacin succinate using a Treatment Satisfaction Visual Analog Scale (TS-VAS) [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
Evaluate the effect of 12 weeks of treatment of solifenacin succinate on the symptoms of OAB as assessed by 3-day micturition diary [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]

Condition ^†

Urinary Bladder, Overactive

Intervention ^†

Drug: Solifenacin succinate
Drug: Placebo

MEDLINE PMIDs

Links

Recruitment Information Fields

Recruitment Status ^†

Completed

Enrollment ^†

768

Start Date ^†

August 2007

Completion Date

July 2008

Eligibility Criteria ^†

Inclusion Criteria:

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

Exclusion Criteria:

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

United States

Administrative Information Fields

NCT ID ^†

NCT00573508

Organization ID

905-UC-010

Secondary IDs ^††

Study Sponsor ^†

Astellas Pharma Inc

Collaborators ^††

Investigators ^†

Study Director:

Central Contact

Astellas Pharma US, Inc.

Information Provided By

Astellas Pharma Inc

Verification Date

September 2008

First Received Date ^†

December 12, 2007

Last Updated Date

September 11, 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.