A randomized, double-blind, placebo-controlled phase II dose-finding study of the novel anti-muscarinic agent imidafenacin in Japanese patients with overactive bladder

Yukio Homma, Takuhiro Yamaguchi, Osamu Yamaguchi

Research output: Contribution to journalArticlepeer-review

39 Citations (Scopus)

Abstract

Objectives: To evaluate the efficacy, safety/tolerability, and dose-response relationship of imidafenacin in Japanese patients with overactive bladder. Methods: Men and women who had overactive bladder symptoms were randomized equally to double-blind treatment with 0.05, 0.1, or 0.25 mg of imidafenacin twice daily or a placebo for 12 weeks, and assessed for efficacy and safety. Results: Overall, 401 patients were enrolled and randomized for treatment with 0.1 mg of imidafenacin/day (99 patients), 0.2 mg of imidafenacin/day (100), 0.5 mg of imidafenacin/day (101), or a placebo (101). After 12 weeks of treatment, the number of incontinence episodes was reduced in a dose-dependent manner, and a significant difference between the imidafenacin treatment and the placebo was observed (P < 0.0001). Compared with the placebo, imidafenacin caused significant reductions in urgency incontinence, voiding frequency, and urinary urgency, and a significant increase in the urine volume voided per micturition. Imidafenacin was also well tolerated. The incidence of dry mouth in the imidafenacin groups increased dose-dependently. Even though the percentage of patients receiving 0.5 mg/day who discontinued treatment due to dry mouth was high (8.9%), the percentages in the 0.1 mg/day and 0.2 mg/day groups (1.0% and 0.0%, respectively) were comparable with that in the placebo group (0.0%). Conclusions: Considering the balance between efficacy and safety, 0.1 mg of imidafenacin twice daily appeared to be a clinically appropriate dose for treating overactive bladder. This dose was therefore selected for further evaluation in large-scale phase III studies.

Original languageEnglish
Pages (from-to)809-815
Number of pages7
JournalInternational Journal of Urology
Volume15
Issue number9
DOIs
Publication statusPublished - 2008 Sep
Externally publishedYes

Keywords

  • Anti-muscarinic
  • Efficacy
  • Imidafenacin
  • Overactive bladder
  • Safety

ASJC Scopus subject areas

  • Urology

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