Safety, efficacy, and tolerability of Trazpiroben for idiopathic or diabetic gastroparesis

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Created On: 05/12/2023

To study the safety, efficacy and tolerability of Trazpiroben (dopamine antagonist drug) in people with idiopathic and diabetic gastroparesis compared to placebo over the course of 12 weeks.

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Key take away

The use of Trazpiroben (TAK-906 or ATC-1906M) proved to be safe for patients with moderate-to-severe idiopathic and diabetic gastroparesis without serious side effects.

Background

To study the safety, efficacy and tolerability of Trazpiroben (dopamine antagonist drug) in people with idiopathic and diabetic gastroparesis compared to placebo over the course of 12 weeks.

Method

This phase 2b controlled study registered adults with symptomatic idiopathic or diabetic gastroparesis in the age group of 18 to 85 years. They were randomized to receive either a placebo orally or Trazpiroben dosed at 5, 25, or 50 mg allocated two times every day till 12 weeks. They were asked to fill in the Daily Diary for Gastroparesis Symptoms by the American Neurogastroenterology and Motility Society.

The variation in the composite score per week from the treatment initiation to week 12 (primary outcome measure) was noted. Also, the adverse events were carefully recorded. The data were described in a summary format.

Result

In total, 242 participants were part of the study (average age of 55.7 years, 75.6% females). Of these, 193 completed the study. When comparing the change from the starting point in the weekly average of the daily diary composite score at week 12, there were no substantial differences between the placebo group and the different doses of Trazpiroben.

In terms of adverse events, 41.4% of participants in the Trazpiroben group reported experiencing them, while the placebo group had a slightly lower rate (39.7%). Importantly, the adverse events in the Trazpiroben group were not considered as serious or fatal.

Conclusion

The primary analysis revealed no profound difference in how effectively Trazpiroben treated gastroparesis compared to a placebo. Trazpiroben also showed good tolerance and did not reveal any new safety issues, which further backens its favorable safety profile.