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OpenTrials
Completed

NCT Number: NCT04429802

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

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

prucalopride

Drug

Orally administered

Other names: Resolor

Placebo

Drug

Orally administered

Primary outcomes

  1. The effect of prucalopride on gastric accommodation with gastric barostat technique

    Time frame: 90 minutes

    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.

  2. The effect of prucalopride on gastric accommodation with intragastric pressure measurement technique

    Time frame: 60 minutes

    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.

Secondary outcomes

  1. Visual Analog Score for sensitivity

    Time frame: 120 minutes

    Gastric sensitivity will be done by means of step-wise distention of the gastric barostat with Visual Analog Score for sensitivity

  2. The effect of prucalopride on gastric compliance

    Time frame: 120 minutes

    Gastric compliance of the gastric wall will be assessed with step-wise distention of the gastric balloon

  3. The effect of prucalopride on nutrient tolerance

    Time frame: 30 minutes

    The amount of ingested calories will be assessed during intragastric infusion of a nutrient drink will be evaluated

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Registry information

Important dates

Study start
2013
Primary completion
2015
Study completion
2016
First posted
Jun 12, 2020
Registry last updated
Oct 26, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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