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

Show 59 Study Locations

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