Urinary Bladder, Overactive Clinical Trial
Official title:
A Phase III Study to Evaluate the Efficacy and Safety of GSK1358820 (Botulinum Toxin Type A) in Patients With Urinary Incontinence Due to Neurogenic Detrusor Overactivity
This study will evaluate the efficacy and safety of GSK1358820 in Japanese patients with neurogenic detrusor overactivity (NDO) with urinary incontinence, whose symptoms have not been adequately managed with medications for urinary incontinence due to NDO. This study consists of a screening phase up to 28 days followed by a double-blind Treatment phase 1 of 12 to 48 weeks wherein subjects will receive a single treatment of either GSK1358820 200 Units (U) injection or placebo injection. After the first treatment, subjects who meet the re-treatment criteria between 12 to 36 weeks can enter an open-label Treatment phase 2 to receive a second treatment with GSK1358820 200 U. Subjects will be permitted to receive re-treatment up to 2 times, and there should be a gap of minimum of 12 weeks since the previous treatment. The duration of overall treatment phases is 48 weeks. The total duration of participation for any subject will not exceed 52 weeks, including screening.
n/a
| 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 |
NCT00613327 -
An Efficacy and Safety Study of Oxybutynin Chloride Oral Osmotic Therapeutic System (OROS) in Korean Overactive Bladder Participants
|
Phase 4 | |
| Completed |
NCT00527033 -
A Study of YM178 in Patients With Symptomatic Overactive Bladder
|
Phase 2 | |
| 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 |
NCT01194999 -
Evaluating the Change of Overactive Bladder Symptoms in Women Post Pubovaginal Sling Procedure for Stress Incontinence
|
Phase 4 | |
| 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 |
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 | |
| Recruiting |
NCT05968885 -
Evaluation the Efficacy Between Botox Injection and Combination Pharmacotherapy in Patients With Detrusor Overactivity
|
Phase 4 |