Urinary Bladder, Overactive Clinical Trial
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
Evaluate the effect of VESIcare® on symptom bother for subjects with OAB
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT06201013 -
Efficacy and Safety of Vitamin D in the Treatment of OAB-wet in Children
|
N/A | |
Recruiting |
NCT05880862 -
Comparative Effectiveness of Initial OAB Treatment Options Among Older Women at High Risk of Falls
|
Early Phase 1 | |
Recruiting |
NCT04807920 -
BOTOX® at the Time of Prolapse Surgery for OAB
|
Phase 4 | |
Terminated |
NCT02385500 -
Fesoterodine on Urgency Episodes in Parkinson's Disease Population
|
Phase 4 | |
Not yet recruiting |
NCT02477241 -
Brain Areas Involved in Bladder Filling and Contraction
|
N/A | |
Completed |
NCT01698138 -
Prevention of Bladder Dysfunction in Acute Spinal Cord Injury
|
Phase 4 | |
Completed |
NCT00527033 -
A Study of YM178 in Patients With Symptomatic Overactive Bladder
|
Phase 2 | |
Completed |
NCT00613327 -
An Efficacy and Safety Study of Oxybutynin Chloride Oral Osmotic Therapeutic System (OROS) in Korean Overactive Bladder Participants
|
Phase 4 | |
Completed |
NCT00368706 -
A Double-Blind, Paralleled Study Comparing Efficacy/Safety of Solifenacin to Tolterodine in Overactive Bladder Patients
|
Phase 3 | |
Recruiting |
NCT04305743 -
Post-procedural Pain Associated With 5 Versus 20 Intravesical Injections of Onabotulinumtoxin A
|
Phase 4 | |
Active, not recruiting |
NCT03681678 -
Laser Therapy for Treatment of Urogenital Symptoms in Women
|
||
Completed |
NCT01655069 -
A Study to Investigate How Safe and Effective Solifenacin Solution is in Treating Children/Adolescents With Symptoms of Overactive Bladder (OAB) Who Completed Study 905-CL-076
|
Phase 3 | |
Completed |
NCT01558856 -
Unilateral Versus Bilateral Neuromodulation Tests in the Treatment of Refractory Idiopathic Overactive Bladder
|
N/A | |
Completed |
NCT01521767 -
Pharmacokinetics and Relative Bioavailability Study
|
Phase 1 | |
Completed |
NCT01381120 -
Therapeutic Merit of Solifenacin in the Mitigation of Ureteral Stent-induced Pain and Lower Urinary Tract Symptoms
|
Phase 4 | |
Completed |
NCT01157377 -
Safety and Efficacy Study of AGN-214868 in Patients With Idiopathic Overactive Bladder and Urinary Incontinence
|
Phase 2 | |
Completed |
NCT01194999 -
Evaluating the Change of Overactive Bladder Symptoms in Women Post Pubovaginal Sling Procedure for Stress Incontinence
|
Phase 4 | |
Completed |
NCT01262391 -
Single-dose Study to Assess Pharmacokinetics of Solifenacin Succinate Suspension in Children and Adolescents
|
Phase 1 | |
Completed |
NCT04528784 -
Feasibility Study of Transcutaneous Tibial Nerve Stimulation for Urinary Symptoms in People With Multiple Sclerosis
|
N/A | |
Completed |
NCT02849418 -
Efficacy and Safety Study of GSK1358820 in Japanese Patients With Urinary Incontinence Due to Neurogenic Detrusor Overactivity
|
Phase 3 |