The Effect of Prucalopride (Resolor®) on Gastric Motor Function and Gastric Sensitivity

Dyspepsia Clinical Trial

Official title:

The Effect of Prucalopride (Resolor®) on Gastric Motor Function and Gastric Sensitivity

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04429802
• Other study ID #: S55741
• Status: Completed
• Phase: N/A
• Start date: September 26, 2013
• Est. completion date: October 3, 2016

Study information

• Verified date: October 2021
• Source: Universitaire Ziekenhuizen Leuven
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Functional Dyspepsia-Postprandial Distress Syndrome (FD-PDS), is characterized by meal-related symptoms such as early satiation and postprandial fullness. Disturbances of gastric motor function have been implicated the pathogenesis of PDS symptoms, and hence, motility modifying agents are considered for the treatment of PDS. Prucalopride (Resolor®), a highly selective 5-TH4 receptor agonist which stimulates gastrointestinal motility throughout the GI tract, is currently approved for the treatment of chronic constipation. The objective of this study was to evaluate the effect of prucalopride on gastric sensorimotor function in healthy volunteers (HV). Methods A total of 17 HV (59% females, mean age 29.4±2.7 years) underwent a barostat and intragastric pressure (IGP) measurements after treatment with placebo or prucalopride (2 mg) in a single blinded cross-over fashion. Isobaric distentions with stepwise increments of 2 mm Hg starting from minimal distending pressure (MDP) and scoring of intensities of gastric sensations (0-6: pain) were used to determine gastric compliance and sensitivity. Gastric accommodation (GA) was quantified as the difference (delta) in intra-balloon volume 30 min before and 60 min after ingestion of 200 ml of a nutrient drink (ND) (1.5 kcal mL(-1)). GA measured by IGP was quantified as the drop of IGP from baseline during the intragastric infusion of ND until maximal satiation. During all tests, epigastric symptoms were scored every 5 minutes.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: October 3, 2016
• Est. primary completion date: June 1, 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Healthy volunteers, male and females, between 18-60 years old Exclusion Criteria:

Subjects that:

• They are older than 60 years old.
• Have severely decreased kidney function.
• Have severely decreased liver function.
• Have severe heart disease, for example a history of irregular heartbeats, angina or heart attack.
• Have severe lung disease.
• Have severe psychiatric illness or neurological illness.
• Have any gastrointestinal disease
• Women that are pregnant or breastfeeding.
• Have a rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption (Resolor tablets contain lactose).

Related Conditions & MeSH terms

• Dyspepsia
• Gastrointestinal Motility Disorder
• Hypersensitivity

Intervention

Drug:
• Prucalopride
Orally administered
• Placebo
Orally administered

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen Leuven

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The effect of prucalopride on gastric accommodation with gastric barostat technique	Gastric barostat: The gastric balloon will be distended at the minimal distending pressure plus 2 mmHg for 90 minutes. During this time, the subject will score their gastric satiation (0-5) every 5 minutes. After the first 30 minutes, the subject will be asked to drink a liquid meal (20 ml Nutridrink, Nutricia; 630 KJ, 6 g proteins, 18.4 g carbohydrates, and 5.8 g lipids per 100 mL) to induce gastric accommodation.	90 minutes
Primary	The effect of prucalopride on gastric accommodation with intragastric pressure measurement technique	Intragastric pressure measurement with high resolution manometry. A manometry probe, a small, flexible tube, will be passed through the nose into the stomach of the subject. The probe contains 36 channels that measure pressure. The manometry probe will be positioned in the fundus and the position will be then verified by fluoroscopy.; To infuse the nutrient drink directly into the stomach, a second infusion catheter will be positioned through the mouth of the subject. nutrient drink (Nutridrink, Nutricia) will be infused directly into the stomach at a constant speed of 60 millilitres per minute. Infusion is stopped when the subject reports maximal satiation.	60 minutes
Secondary	Visual Analog Score for sensitivity	Gastric sensitivity will be done by means of step-wise distention of the gastric barostat with Visual Analog Score for sensitivity	120 minutes
Secondary	The effect of prucalopride on gastric compliance	Gastric compliance of the gastric wall will be assessed with step-wise distention of the gastric balloon	120 minutes
Secondary	The effect of prucalopride on nutrient tolerance	The amount of ingested calories will be assessed during intragastric infusion of a nutrient drink will be evaluated	30 minutes