Full metadata record
DC Field | Value | Language |
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dc.contributor.author | 윤하나 | * |
dc.date.accessioned | 2022-08-02T16:30:37Z | - |
dc.date.available | 2022-08-02T16:30:37Z | - |
dc.date.issued | 2022 | * |
dc.identifier.issn | 2093-4777 | * |
dc.identifier.issn | 2093-6931 | * |
dc.identifier.other | OAK-31842 | * |
dc.identifier.uri | https://dspace.ewha.ac.kr/handle/2015.oak/261630 | - |
dc.description.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. | * |
dc.language | English | * |
dc.publisher | KOREAN CONTINENCE SOC | * |
dc.subject | DA-8010 | * |
dc.subject | Muscarinic antagonists | * |
dc.subject | Receptor | * |
dc.subject | Muscarinic M3 | * |
dc.subject | Urinary bladder | * |
dc.subject | Overactive | * |
dc.title | Efficacy and Safety of DA-8010, a Novel M3 Antagonist, in Patients With Overactive Bladder: A Randomized, Double-Blind Phase 2 Study | * |
dc.type | Article | * |
dc.relation.issue | 2 | * |
dc.relation.volume | 26 | * |
dc.relation.index | SCIE | * |
dc.relation.index | SCOPUS | * |
dc.relation.startpage | 119 | * |
dc.relation.lastpage | 128 | * |
dc.relation.journaltitle | INTERNATIONAL NEUROUROLOGY JOURNAL | * |
dc.identifier.doi | 10.5213/inj.2142382.191 | * |
dc.identifier.wosid | WOS:000823540600006 | * |
dc.identifier.scopusid | 2-s2.0-85134613360 | * |
dc.author.google | Son, Hee Seo | * |
dc.author.google | Oh, Cheol Young | * |
dc.author.google | Choo, Myung-Soo | * |
dc.author.google | Kim, Hyeong Gon | * |
dc.author.google | Kim, Joon Chul | * |
dc.author.google | Lee, Kyu-Sung | * |
dc.author.google | Shin, Dong Gil | * |
dc.author.google | Cho, Sung Yong | * |
dc.author.google | Jeong, Seong Jin | * |
dc.author.google | Seo, Ju Tae | * |
dc.author.google | Yoon, Hana | * |
dc.author.google | Moon, Hong Sang | * |
dc.author.google | Kim, Jang Hwan | * |
dc.contributor.scopusid | 윤하나(8723844200) | * |
dc.date.modifydate | 20240118161124 | * |