Urinary Bladder, Overactive Clinical Trial
Official title:
A Multicenter, Open-label, Single Ascending Dose Study to Evaluate Pharmacokinetics, Safety and Tolerability of Solifenacin Succinate Suspension in Pediatric Patients Aged 5 to 17 Years (Inclusive) With Overactive Bladder (OAB)
This single-dose study will investigate how well solifenacin suspension is taken up, how long it stays in the body and how well it will be tolerated in children and adolescents aged 5-17 years with symptoms of overactive bladder.
This is a multicenter, open-label, sequential, single ascending dose study. The study will
consist of three treatment groups in children and three treatment groups in adolescents,
targeting equivalent exposure to the 2.5, 5 and 10 mg doses o.d. in adults at steady state.
The study will be conducted in pediatric OAB patients to establish the single-dose PK and the
acute safety profile of solifenacin aqueous suspension. Each of the six groups will consist
of at least six patients.
The study will start with the lowest dose group in adolescent patients (12 to 17 years). When
this group has completed the study, their safety and concentration data will be reviewed by a
Safety Review Committee. If no safety concerns are evident according to pre-specified
criteria, enrollment of children (5 to 11 years) in the lowest dose group and adolescents in
the intermediate dose group will be started simultaneously. When these groups have completed
the study, their safety data and drug concentration data will also be reviewed. If no safety
concerns occurred, enrollment of children in the intermediate dose group and of adolescents
in the highest dose group will be started simultaneously. Finally, after these groups
completed the study and no safety concerns occurred during associated data review, enrollment
of children in the highest dose group will start. Interim review of plasma exposure at lower
doses will be used to adjust the next higher doses administered, if necessary.
;
| 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 |
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 |
NCT01381120 -
Therapeutic Merit of Solifenacin in the Mitigation of Ureteral Stent-induced Pain and Lower Urinary Tract Symptoms
|
Phase 4 | |
| 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 | |
| Recruiting |
NCT05968885 -
Evaluation the Efficacy Between Botox Injection and Combination Pharmacotherapy in Patients With Detrusor Overactivity
|
Phase 4 |