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

Sponsor:	Astellas Pharma Inc
Information provided by:	Astellas Pharma Inc
ClinicalTrials.gov Identifier:	NCT00573508

Purpose

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

Condition	Intervention	Phase
Urinary Bladder, Overactive	Drug: Solifenacin succinate Drug: Placebo	Phase IV

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

Resource links provided by NLM:

Drug Information available for: Succinic acid Solifenacin Solifenacin succinate

U.S. FDA Resources

Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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 ]

Enrollment:	768
Study Start Date:	August 2007
Study Completion Date:	July 2008
Primary Completion Date:	July 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: Solifenacin succinate Oral Administration
2: Placebo Comparator	Drug: Placebo Oral Administration

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00573508

Hide Study Locations

Locations

United States, Alabama

Montgomery, Alabama, United States, 36067
United States, Arizona

Phoenix, Arizona, United States, 85051

Tucson, Arizona, United States, 85741
United States, California

Buena Park, California, United States, 90620

Fresno, California, United States, 93720

San Bernardino, California, United States, 92404

San Diego, California, United States, 92108

Carmichael, California, United States, 95608

Sacramento, California, United States, 95825
United States, Colorado

Aurora, Colorado, United States, 80012

Denver, Colorado, United States, 80220

Englewood, Colorado, United States, 32308

Denver, Colorado, United States, 80211
United States, Connecticut

Waterbury, Connecticut, United States, 67080
United States, Florida

Tampa, Florida, United States, 33613

Clearwater, Florida, United States, 33761

Wellington, Florida, United States, 33414

Tallahassee, Florida, United States, 32308

Plantation, Florida, United States, 33324

Tampa, Florida, United States, 33607
United States, Georgia

Roswell, Georgia, United States, 30076
United States, Idaho

Idaho Falls, Idaho, United States, 83404
United States, Illinois

Melrose Park, Illinois, United States, 60160
United States, Indiana

Jeffersonville, Indiana, United States, 47130
United States, Louisiana

Shreveport, Louisiana, United States, 71106
United States, Massachusetts

Watertown, Massachusetts, United States, 02472
United States, Montana

Billings, Montana, United States, 59102
United States, Nebraska

Omaha, Nebraska, United States, 68114
United States, New Jersey

Englewood, New Jersey, United States, 07631

Lawrenceville, New Jersey, United States, 08648
United States, New York

New York, New York, United States, 10029

Garden City, New York, United States, 11530

Poughkeepsie, New York, United States, 12601

Kingston, New York, United States, 12401

Orchard Park, New York, United States, 14127

New York, New York, United States, 10016

Endwell, New York, United States, 13760
United States, North Carolina

Winston Salem, North Carolina, United States, 27103

Concord, North Carolina, United States, 28025

Raleigh, North Carolina, United States, 27612
United States, North Dakota

Fargo, North Dakota, United States, 58104
United States, Ohio

Cincinnati, Ohio, United States, 45212

Lyndhurst, Ohio, United States, 44124
United States, Oklahoma

Edmond, Oklahoma, United States, 73034
United States, Oregon

Central Point, Oregon, United States, 97502
United States, Pennsylvania

Uniontown, Pennsylvania, United States, 15401

West Reading, Pennsylvania, United States, 19611

Philadelphia, Pennsylvania, United States, 19114
United States, South Carolina

Simpsonville, South Carolina, United States, 29681

Greer, South Carolina, United States, 29650
United States, Texas

Houston, Texas, United States, 77024

Arlington, Texas, United States, 76017

Austin, Texas, United States, 78759

Corpus Christi, Texas, United States, 78414

Bedford, Texas, United States, 76021
United States, Washington

Mount Lake, Washington, United States, 98043

Spokane, Washington, United States, 99202

Tacoma, Washington, United States, 98405
United States, Wisconsin

Madison, Wisconsin, United States, 53703

Sponsors and Collaborators

Astellas Pharma Inc

Investigators

Study Director:

Central Contact

Astellas Pharma US, Inc.

More Information

No publications provided

Responsible Party:	Astellas Pharma US, Inc ( Sr. Manager Clinical Trials Registry )
Study ID Numbers:	905-UC-010
Study First Received:	December 12, 2007
Last Updated:	September 11, 2008
ClinicalTrials.gov Identifier:	NCT00573508 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Astellas Pharma Inc:

Overactive Bladder

Additional relevant MeSH terms:

Urinary Bladder, Overactive
Neurotransmitter Agents
Cholinergic Antagonists
Molecular Mechanisms of Pharmacological Action
Urinary Bladder Diseases
Physiological Effects of Drugs
Cholinergic Agents

Pharmacologic Actions
Muscarinic Antagonists
Urological Manifestations
Signs and Symptoms
Urologic Diseases
Quinuclidin-3'-yl-1-phenyl-1,2,3,4-tetrahydroisoquinoline-2-carboxylate monosuccinate

ClinicalTrials.gov processed this record on November 30, 2009