Efficacy and Safety Study of GSK1358820 in Japanese Patients With Urinary Incontinence Due to Neurogenic Detrusor Overactivity

PHASE3CompletedINTERVENTIONAL
Enrollment

21

Participants

Timeline

Start Date

October 11, 2016

Primary Completion Date

March 2, 2018

Study Completion Date

December 20, 2018

Conditions
Urinary Bladder, Overactive
Interventions
DRUG

GSK1358820

GSK1358820 injection contains botulinum toxin type A (100 U), sodium chloride (0.9 milligrams \[mg\]), and human serum albumin (0.5 mg). The 30 mL of study drug will be administered as 30 injections each of 1.0 mL, evenly distributed at 30 sites in the detrusor muscle, spaced approximately 1 centimeter (cm) apart. The injection will be administered using cystoscopy and under local anesthesia. General anesthesia may be used excluding neuromuscular blocking agents.

DRUG

Placebo

Placebo injection contains sodium chloride (0.9 milligrams \[mg\]); 30 mL of the injection will be injected at 30 sites in the detrusor muscle, spaced approximately 1 centimeter (cm) apart. The injection will be administered using cystoscopy and under local anesthesia. General anesthesia may be used excluding neuromuscular blocking agents

Trial Locations (9)

036-8563

GSK Investigational Site, Aomori

820-8508

GSK Investigational Site, Fukuoka

060-8648

GSK Investigational Site, Hokkaido

651-2181

GSK Investigational Site, Hyōgo

981-8563

GSK Investigational Site, Miyagi

852-8501

GSK Investigational Site, Nagasaki

700-8558

GSK Investigational Site, Okayama

321-0293

GSK Investigational Site, Tochigi

409-3898

GSK Investigational Site, Yamanashi

Sponsors

Lead Sponsor

All Listed Sponsors
lead

GlaxoSmithKline

INDUSTRY

NCT02849418 - Efficacy and Safety Study of GSK1358820 in Japanese Patients With Urinary Incontinence Due to Neurogenic Detrusor Overactivity | Biotech Hunter | Biotech Hunter