Clinical trial NCT04429802: The Effect of Prucalopride (Resolor®) on Gastric Motor Function and Gastric Sensitivity
Official title: The Effect of Prucalopride (Resolor®) on Gastric Motor Function and Gastric Sensitivity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastrointestinal Motility Disorder
Dyspepsia
Keywords: gastric accommodation
gastric sensitivity
gastric compliance
nutrient tolerance
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2020-06-12
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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).

Primary outcomes:
measure: The effect of prucalopride on gastric accommodation with gastric barostat technique
timeFrame: 90 minutes
measure: The effect of prucalopride on gastric accommodation with intragastric pressure measurement technique
timeFrame: 60 minutes
Secondary outcomes:
measure: Visual Analog Score for sensitivity
timeFrame: 120 minutes
measure: The effect of prucalopride on gastric compliance
timeFrame: 120 minutes
measure: The effect of prucalopride on nutrient tolerance
timeFrame: 30 minutes
Other outcomes:
Locations:
Study officials:
affiliation: Universitaire Ziekenhuizen KU Leuven
name: Jan Tack, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Carbone F, Vanuytsel T, Tack J. The effect of prucalopride on gastric sensorimotor function and satiation in healthy volunteers. Neurogastroenterol Motil. 2021 Aug;33(8):e14083. doi: 10.1111/nmo.14083. Epub 2021 Feb 2.