21
Participants
Start Date
October 11, 2016
Primary Completion Date
March 2, 2018
Study Completion Date
December 20, 2018
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.
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
GSK Investigational Site, Aomori
GSK Investigational Site, Fukuoka
GSK Investigational Site, Hokkaido
GSK Investigational Site, Hyōgo
GSK Investigational Site, Miyagi
GSK Investigational Site, Nagasaki
GSK Investigational Site, Okayama
GSK Investigational Site, Tochigi
GSK Investigational Site, Yamanashi
Lead Sponsor
GlaxoSmithKline
INDUSTRY