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

Summary

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.

Timeline

Start

2016-10-11

Primary completion

2018-03-02

Completion

2018-12-20

Outcome

Met primary endpoint

registry analysis (other test); Treatment Cycle 1: Placebo vs Treatment Cycle 1: GSK1358820 200U; Mean Difference (Net) -3.02 (95% CI -5.85 to -0.19) NCT02849418 ↗

Publications

• Background Honda M, Yokoyama O, Takahashi R, Matsuda T, Nakayama T, Mogi T. Botulinum toxin injections for Japanese patients with urinary incontinence caused by neurogenic detrusor overactivity: Clinical evaluation of onabotulinumtoxinA in a randomized, placebo-controlled, double-blind trial with an open-label extension. Int J Urol. 2021 Sep;28(9):906-912. doi: 10.1111/iju.14602. Epub 2021 Jun 1.

Drugs

Indications