Efficacy and Safety of GSK1358820 in Subjects With Overactive Bladder

Summary

GSK1358820 is a botulinum neurotoxin A complex that has been approved for the treatment of overactive bladder (OAB) in several countries, however, it has not been approved for OAB treatment in Japan. This study has been planned to evaluate the efficacy and safety of GSK1358820 in Japanese OAB patients with urinary incontinence whose symptoms have not been adequately managed with other medications for OAB. The primary objective of this study is to evaluate the superiority of a single dose treatment of GSK1358820 100 units (U) compared with placebo. The study comprises a screening phase up to 28 days, followed by a double-blind treatment phase of 12 to 48 weeks wherein subjects will receive a single treatment of either GSK1358820 100 U injection or Placebo injection, in a ratio of 1:1, with further stratification within the treatment arms according to the number of urinary urge incontinence episodes during screening. Subjects meeting the criteria for re-treatment will receive a second and third treatment. Each re-treatment will be with open-label GSK1358820 100 U injection, and will be spaced at least 12 weeks from the previous treatment. The total duration of participation for any subject will not exceed 52 weeks, including screening and the 48-week treatment period.

Timeline

Start

2016-08-10

Primary completion

2018-03-06

Completion

2018-11-12

Outcome

Met primary endpoint

registry analysis (other test); Treatment Cycle 1: Placebo vs Treatment Cycle 1: GSK1358820 100 U; p <0.001; Mean Difference (Net) -2.16 (95% CI -3.14 to -1.18) NCT02820844 ↗

Publications

• Background Yokoyama O, Honda M, Yamanishi T, Sekiguchi Y, Fujii K, Nakayama T, Mogi T. OnabotulinumtoxinA (botulinum toxin type A) for the treatment of Japanese patients with overactive bladder and urinary incontinence: Results of single-dose treatment from a phase III, randomized, double-blind, placebo-controlled trial (interim analysis). Int J Urol. 2020 Mar;27(3):227-234. doi: 10.1111/iju.14176. Epub 2020 Jan 20.
• Yokoyama O, Honda M, Yamanishi T, Sekiguchi Y, Fujii K, Kinoshita K, Nakayama T, Ueno A, Mogi T. Efficacy and safety of onabotulinumtoxinA in patients with overactive bladder: subgroup analyses by sex and by serum prostate-specific antigen levels in men from a randomized controlled trial. Int Urol Nephrol. 2021 Nov;53(11):2243-2250. doi: 10.1007/s11255-021-02962-z. Epub 2021 Jul 22.

Drugs

Indications