ArticleInternational neurourology journal2022
Efficacy and Safety of DA-8010, a Novel M3 Antagonist, in Patients With Overactive Bladder: A Randomized, Double-Blind Phase 2 Study.
Article in International neurourology journal, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03566134 (A Therapeutic Exploratory Clinical Study to Evaluate the Efficacy and Safety of DA-8010 in Patients With Overactive Bladder), which is not on this map. Cited by 7 papers.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Therapeutic Exploratory Clinical Study to Evaluate the Efficacy and Safety of DA-8010 in Patients With Overactive Bladder
Who cites it
7 citing papers in PubMed, 9 citations in OpenAlex.
- Pharmacokinetic Drug-Drug Interactions of DA-8010 with Clarithromycin or Rifampicin: Influence of CYP2D6 Phenotype on the Extent of These Interactions.Drug design, development and therapy · 2026Trial
- Biomechanical regulation of bladder injury and repair.Nature reviews. Urology · 2026Review
- Muscarinic control of cardiovascular function in humans: a review of current clinical evidence.Clinical autonomic research : official journal of the Clinical Autonomic Research Society · 2024Review
- Oral anticholinergic drugs versus placebo or no treatment for managing overactive bladder syndrome in adults.The Cochrane database of systematic reviews · 2023Review
- Mixed urinary incontinence: Are there effective treatments?Neurourology and urodynamics · 2023Article
- Novel botulinum neurotoxin-A tibial nerve perineural injection to alleviate overactive bladder symptoms in male rats.Animal cells and systems · 2022Article
- Pharmacological Management of Urinary Incontinence: Current and Emerging Treatment.Clinical pharmacology : advances and applications · 2021Review
Corrections and comments
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Authors and funding
13 authors at 11 institutions in 1 country.
Funding
Abstract
purposeDA-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.
methodsThis 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.
resultsIn 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.
conclusionBoth 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.
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Registered trials
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