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Efficacy and Safety of DA-8010, a Novel M3 Antagonist, in Patients With Overactive Bladder: A Randomized, Double-Blind Phase 2 Study
- Title
- Efficacy and Safety of DA-8010, a Novel M3 Antagonist, in Patients With Overactive Bladder: A Randomized, Double-Blind Phase 2 Study
- Authors
- Son, Hee Seo; Oh, Cheol Young; Choo, Myung-Soo; Kim, Hyeong Gon; Kim, Joon Chul; Lee, Kyu-Sung; Shin, Dong Gil; Cho, Sung Yong; Jeong, Seong Jin; Seo, Ju Tae; Yoon, Hana; Moon, Hong Sang; Kim, Jang Hwan
- Ewha Authors
- 윤하나
- SCOPUS Author ID
- 윤하나
- Issue Date
- 2022
- Journal Title
- INTERNATIONAL NEUROUROLOGY JOURNAL
- ISSN
- 2093-4777
2093-6931
- Citation
- INTERNATIONAL NEUROUROLOGY JOURNAL vol. 26, no. 2, pp. 119 - 128
- Keywords
- DA-8010; Muscarinic antagonists; Receptor; Muscarinic M3; Urinary bladder; Overactive
- Publisher
- KOREAN CONTINENCE SOC
- Indexed
- SCIE; SCOPUS
- Document Type
- Article
- Abstract
- Purpose: DA-8010 is a novel muscarinic M3 receptor antagonist with significant selectivity for bladder over salivary gland in preclinical studies. We evaluated the clinical efficacy and safety of DA-8010 in overactive bladder (OAB) patients. Methods: This phase 2, randomized, double-blind, parallel-group, active reference-and placebo-controlled trial was conducted at 12 centers in South Korea (NCT03566134). Patients aged >_19 years with OAB symptoms for >_3 months were enrolled. Three hundred six patients (30.07% male) were randomized to 12 weeks of treatment among 4 groups; 2 experimental groups (DA-8010 2.5 or 5 mg), an active reference group (solifenacin 5 mg), and a placebo group. The change from the baseline of (= ???) 24-hour frequency at 12 weeks (primary endpoint), episodes of urgency, overall/urgency urinary incontinence, average/ maximum voided volume, nocturia, and patients' subjective responses were analyzed. Results: In the full analysis set, the mean (standard deviation) [median] values for ??? 24-hour frequency at 12 weeks were-1.01 (2.44) [-1.33] for placebo,-1.22 (2.05) [-1.33] for DA-8010 2.5 mg, and-1.67 (2.25) [-1.67] for DA-8010 5 mg; DA-8010 5 mg showed a significant decrease compared with placebo (P = 0.0413). At 4 and 8 weeks, both DA-8010 2.5 mg (P = 0.0391 at 4 weeks, P = 0.0335 at 8 weeks) and DA-8010 5 mg (P = 0.0001 at 4 weeks, P = 0.0210 at 8 weeks) showed significant decrease in ??? 24-hour frequency compared with placebo. DA-8010 5 mg achieved a significant decrease in ??? number of urgency episodes, compared with placebo at 4 (P = 0.0278) and 8 (P = 0.0092) weeks. Adverse drug reactions (ADRs) were observed in 3.95% of placebo, 6.67% of DA-8010 2.5 mg, 18.42% of DA-8010 5 mg, and 17.33% of solifenacin 5 mg groups. No serious ADRs were observed in any patient. Conclusions: Both DA-8010 2.5 mg and 5 mg showed therapeutic efficacy for OAB without serious ADRs. Therefore, both dosages of DA-8010 can advance to a subsequent large-scale phase 3 trial.
- DOI
- 10.5213/inj.2142382.191
- Appears in Collections:
- 의과대학 > 의학과 > Journal papers
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