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Gastrointestinal Motility DisorderNCT04429802

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

A study testing Prucalopride in people with Gastrointestinal Motility Disorder and Dyspepsia, run by Universitaire Ziekenhuizen KU Leuven.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for
Gastrointestinal Motility Disorder, Dyspepsia
What is being tested?
Prucalopride
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
17 participants
Where
No sites listed yet
Study dates
26 Sep 2013to 3 Oct 2016
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

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

Who cannot join

  • 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.
Show all 10Show fewer
  • 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).

About this study

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.

Being tested
Prucalopride, Placebo
Keywords
gastric accommodation, gastric sensitivity, gastric compliance, nutrient tolerance
Medical subject headings
Dyspepsia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PrucaloprideDrug

    Also called Resolor

    Orally administered

  • PlaceboDrug

    Orally administered

Study groups in NCT04429802
Study groupRoleWhat they receive
PlaceboPlacebo comparatorPlacebo 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.
Receives: Drug: Placebo
PrucaloprideExperimental2 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.
Receives: Drug: Prucalopride

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 90 minutes

  2. 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.

    Measured: 60 minutes

Secondary outcomes (3)

  1. 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

    Measured: 120 minutes

  2. The effect of prucalopride on gastric compliance

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

    Measured: 120 minutes

  3. 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

    Measured: 30 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jun 2020
  2. Study start26 Sep 2013
  3. Primary completion1 Jun 2015
  4. Study completion3 Oct 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Single blind
Who is masked
Participant
Enrolment
17 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04429802
Sponsor's protocol ID
S55741
Status last verified
Oct 2021
First submitted
24 Aug 2018
Last updated
26 Oct 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 33615630

Questions about this trial

What is this clinical trial studying?

A study testing Prucalopride in people with Gastrointestinal Motility Disorder and Dyspepsia, run by Universitaire Ziekenhuizen KU Leuven.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The effect of prucalopride on gastric accommodation with gastric barostat technique (time frame: 90 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04429802, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2021.

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