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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acotiamide | Experimental | Acotiamide 100 mg t.i.d. for 3 weeks. Intake of medication 10 minutes before meal. |
|
| Placebo | Placebo Comparator | Placebo tablets, t.i.d. for 3 weeks. Intake of placebo 10 minutes before meal. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acotiamide | Drug | Acotiamide treatment, 100 mg, t.i.d. for three week. Intake 10 minutes before meal. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Gastric accommodation | Relaxation of the stomach upon food intake | Gastric pressure was measured until 1 hour after the start of the liquid meal. Liquid meal started 10 minutes after medication/placebo intake |
| Measure | Description | Time Frame |
|---|---|---|
| Gastric emptying | Gastric emptying was assess by a 13C-octanoid acid breath test | 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 |
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Inclusion Criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jan Tack, PhD, MD | UZ Leuven / KU Leuven | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jan Tack | Leuven | 3000 | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30663175 | Derived | Masuy I, Tack J, Verbeke K, Carbone F. Acotiamide affects antral motility, but has no effect on fundic motility, gastric emptying or symptom perception in healthy participants. Neurogastroenterol Motil. 2019 Apr;31(4):e13540. doi: 10.1111/nmo.13540. Epub 2019 Jan 20. |
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| ID | Term |
|---|---|
| C410959 | Z 338 |
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| Placebo Oral Tablet | Drug | Placebo treatment, t.i.d. for three week. Intake 10 minutes before meal. |
|
| assessment by questionnaire (100 mm Visual Analogue Scale) every 5 minutes, up to 1 hour after administration of the liquid meal |