NCT03402984

Effect of Acotiamide on Gastric Motility and Satiation in Healthy Volunteers

Acotiamide Affects Antral Motility, But Has no Effect on Fundic Motility, Gastric Emptying or Symptom Perception in Healthy Participants

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Universitaire Ziekenhuizen KU Leuven · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

Introduction. Functional dyspepsia (FD) is a common chronic gastrointestinal disorder with a high socio-economic impact. Acotiamide, a new prokinetic agent, was shown to be efficacious in the treatment of FD, especially in the postprandial distress syndrome subgroup. To date, the exact mechanism of action of acotiamide is incompletely elucidated. The aim of this study was to examine the effect of acotiamide on gastric motility, gastric emptying rate and gastrointestinal symptom perception in healthy participants in a randomized, placebo-controlled, cross-over study design. Participants were treated with acotiamide (100 mg t.i.d.) and placebo for 3 weeks, separated by a one-week wash-out period. At the end of each treatment period, gastric emptying and motility were assessed on two consecutive study days. During gastric motility assessment, epigastric symptom scores were collected at multiple time points.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Acotiamide	Acotiamide treatment, 100 mg, t.i.d. for three week. Intake 10 minutes before meal.
DRUG	Placebo Oral Tablet	Placebo treatment, t.i.d. for three week. Intake 10 minutes before meal.

Timeline

• Start date: 2017-04-01
• Primary completion: 2017-07-30
• Completion: 2017-12-04
• First posted: 2018-01-18
• Last updated: 2018-01-18

Locations

1 site across 1 country: Belgium