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

NCT ID: NCT04429802

Last Updated: 2021-10-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-26

Study Completion Date

2016-10-03

Brief Summary

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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.

Detailed Description

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Conditions

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Gastrointestinal Motility Disorder Dyspepsia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Placebo

Placebo is an opaque empty gel capsule obtained from the UZ Gasthuisberg pharmacy. These capsules are composed of 100% gelatine that will rapidly dissolve (disintegration time is 15 minutes) in the stomach without affecting the gastric motor function.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Orally administered

Prucalopride

2 mg, Resolor®, Shire, Belgium Prucalopride (2 mg) is rapidly absorbed; after a single oral dose of 2 mg Cmax was attained in 2-3 hours. The absolute oral bioavailability is \>90%. Concomitant intake of food does not influence the oral bioavailability of prucalopride.

Group Type EXPERIMENTAL

Prucalopride

Intervention Type DRUG

Orally administered

Interventions

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Prucalopride

Orally administered

Intervention Type DRUG

Placebo

Orally administered

Intervention Type DRUG

Other Intervention Names

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Resolor

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jan Tack, MD

Role: PRINCIPAL_INVESTIGATOR

Universitaire Ziekenhuizen KU Leuven

References

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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.

Reference Type DERIVED
PMID: 33615630 (View on PubMed)

Other Identifiers

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S55741

Identifier Type: -

Identifier Source: org_study_id