Acotiamide Affects Antral Motility, But Has no Effect on Fundic Motility, Gastric Emptying or Symptom Perception in Healthy Participants
| Registry | NCT03402984 |
|---|---|
| Status | Completed |
| Phase | Not applicable |
| Study type | Interventional; randomized, crossover, masking: single, other |
| Enrollment | 20 (Actual) |
| Sponsor | Universitaire Ziekenhuizen KU Leuven (Other) |
| Conditions | Healthy |
| Interventions | Acotiamide, Placebo Oral Tablet (Drug) |
| Dates | start 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 in Belgium |
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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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Acotiamide | Experimental | Drug: Acotiamide | Acotiamide 100 mg t.i.d. for 3 weeks. Intake of medication 10 minutes before meal. |
| Placebo | Placebo comparator | Drug: Placebo Oral Tablet | Placebo tablets, t.i.d. for 3 weeks. Intake of placebo 10 minutes before meal. |
Sex: All, ages: 18 Years to 60 Years, accepts healthy volunteers
Inclusion Criteria: * age: 18-60 years old. * Participant must provide witnessed written informed consent prior to any study procedures being performed. Exclusion criteria: * Age > 60 years old. * severely decreased kidney function. * severely decreased liver function. * severe heart disease, for example a history of irregular heartbeats, angina or heart attack. * severe lung disease. * severe psychiatric illness or neurological illness. * any gastrointestinal disease. * any dyspeptic symptoms. * pregnant or breastfeeding.
| Facility | City | Country | Status |
|---|---|---|---|
| Jan Tack | Leuven | Belgium |