drugset / Trial / NCT03544229
A Study to Evaluate the Efficacy and Safety of TAK-906 in Adult Participants With Symptomatic Idiopathic or Diabetic Gastroparesis
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The purpose of this study is to assess the efficacy and safety of treatment with 2 dose levels of TAK-906 in adult participants with gastroparesis compared with placebo during 12 weeks of treatment.
Timeline
- Start
- 2018-10-14
- Primary completion
- 2021-06-14
- Completion
- 2021-07-15
Outcome
Missed primary endpoint
registry analysis (superiority test); Placebo vs TAK-906 Maleate 50 mg; p =0.447; Least Square Mean Difference -0.02 (90% CI -0.30 to 0.25) NCT03544229 ↗
paper There was no clinically meaningful difference in efficacy between trazpiroben and placebo in treating gastroparesis, based on the primary endpoint analysis. PMID 37533380 ↗
Publications
- Tack J, McCallum R, Kuo B, Huh SY, Zhang Y, Chen YJ, Mehrotra S, Parkman HP. Randomized clinical trial: A phase 2b controlled study of the efficacy and safety of trazpiroben (TAK-906) for idiopathic or diabetic gastroparesis. Neurogastroenterol Motil. 2023 Oct;35(10):e14652. doi: 10.1111/nmo.14652. Epub 2023 Aug 3.
- Yamaguchi T, Kudou K, Okamoto H, Chen C, Whiting R, Sekino H. Evaluating the Safety, Tolerability, and Disposition of Trazpiroben, a D2 /D3 Receptor Antagonist: Phase I Single- and Multiple-Ascending Dose Studies in Healthy Japanese Participants. Clin Pharmacol Drug Dev. 2022 Jun;11(6):695-706. doi: 10.1002/cpdd.1057. Epub 2021 Dec 29.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Trazpiroben | Small molecule | 5 mg | Oral |
| Subject | Trazpiroben | Small molecule | 25 mg | Oral |
| Subject | Trazpiroben | Small molecule | 50 mg | Oral |