Effect of Acotiamide on Gastric Motility and Satiation in Healthy Volunteers

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03402984
• Other study ID #: Acotiamide1
• Status: Completed
• Phase: N/A
• First received: January 10, 2018
• Last updated: January 10, 2018
• Start date: April 1, 2017
• Est. completion date: December 4, 2017

Study information

• Verified date: January 2018
• Source: Universitaire Ziekenhuizen Leuven
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 4, 2017
• Est. primary completion date: July 30, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• Acotiamide
Acotiamide treatment, 100 mg, t.i.d. for three week. Intake 10 minutes before meal.
• Placebo Oral Tablet
Placebo treatment, t.i.d. for three week. Intake 10 minutes before meal.

Locations

Country	Name	City	State
Belgium	Jan Tack	Leuven

Sponsors (1)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	Change in subjective gastrointestinal symptom scores measured by visual analogue scale of 100 mm		assessment by questionnaire (100 mm Visual Analogue Scale) every 5 minutes, up to 1 hour after administration of the liquid meal