An interventional study of Acotiamide and Placebo Oral Tablet in Healthy, sponsored by Universitaire Ziekenhuizen KU Leuven. Completed at 1 site in Belgium. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-01-18.
Sponsored by Universitaire Ziekenhuizen KU Leuven · Not applicable, Interventional, and Other
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.
Exclusion criteria:
Acotiamide 100 mg t.i.d. for 3 weeks. Intake of medication 10 minutes before meal.
Drug: Acotiamide
Placebo tablets, t.i.d. for 3 weeks. Intake of placebo 10 minutes before meal.
Drug: Placebo Oral Tablet
Acotiamide treatment, 100 mg, t.i.d. for three week. Intake 10 minutes before meal.
Placebo treatment, t.i.d. for three week. Intake 10 minutes before meal.
Gastric accommodation
Relaxation of the stomach upon food intake
Time frame: Gastric pressure was measured until 1 hour after the start of the liquid meal. Liquid meal started 10 minutes after medication/placebo intake
Gastric emptying
Gastric emptying was assess by a 13C-octanoid acid breath test
Time frame: Breath samples were collected before intake of medication/placebo and every 15 minutes until 4h after intake of 13C-octanoid acid
Change in subjective gastrointestinal symptom scores measured by visual analogue scale of 100 mm
Time frame: assessment by questionnaire (100 mm Visual Analogue Scale) every 5 minutes, up to 1 hour after administration of the liquid meal
Plan to share: No
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Universitaire Ziekenhuizen KU Leuven