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• W4385514227 abstract "Abstract Background Previous clinical studies of trazpiroben, a dopamine D 2 /D 3 receptor antagonist for long‐term treatment of moderate‐to‐severe idiopathic and diabetic gastroparesis, have shown improved symptoms of fullness. This study assessed trazpiroben efficacy, safety, and tolerability in adults with idiopathic and diabetic gastroparesis versus placebo. Methods This global, multicenter, double‐blind, parallel‐group, phase 2b study (NCT03544229) enrolled eligible adults aged 18–85 years with symptomatic idiopathic or diabetic gastroparesis. Randomized participants received either oral placebo or trazpiroben 5, 25, or 50 mg, administered twice daily over 12 weeks, and completed the American Neurogastroenterology and Motility Society Gastroparesis Cardinal Symptom Index‐Daily Diary. Change in weekly composite score from baseline to week 12 (primary endpoint) and treatment‐emergent adverse events were assessed. Data were summarized descriptively. Key Results Overall, 242 participants were enrolled (mean [standard deviation] age 55.7 [14.2] years; 75.6% female); 193 completed the study. No significant differences in change from baseline in weekly average of the daily diary composite score occurred at week 12 between placebo (least‐squares mean [standard error] −1.19 [0.12]) and trazpiroben (5, 25, and 50 mg: −1.11 [0.22], −1.17 [0.12], and −1.21 [0.12], respectively). Overall, 41.4% of participants receiving trazpiroben reported treatment‐emergent adverse events (placebo, 39.7%). No serious events were considered trazpiroben‐related; no life‐threatening or fatal events were reported. Conclusions & Inferences There was no clinically meaningful difference in efficacy between trazpiroben and placebo in treating gastroparesis, based on the primary endpoint analysis. Trazpiroben was well tolerated with no new safety concerns identified, strengthening evidence supporting its favorable safety profile. NCT number: NCT03544229." @default.
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• W4385514227 date "2023-08-03" @default.
• W4385514227 modified "2023-10-17" @default.
• W4385514227 title "Randomized clinical trial: A phase 2b controlled study of the efficacy and safety of trazpiroben (TAK‐906) for idiopathic or diabetic gastroparesis" @default.
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• W4385514227 doi "https://doi.org/10.1111/nmo.14652" @default.
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