<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04429802</url>
  </required_header>
  <id_info>
    <org_study_id>S55741</org_study_id>
    <nct_id>NCT04429802</nct_id>
  </id_info>
  <brief_title>The Effect of Prucalopride (Resolor®) on Gastric Motor Function and Gastric Sensitivity</brief_title>
  <official_title>The Effect of Prucalopride (Resolor®) on Gastric Motor Function and Gastric Sensitivity</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universitaire Ziekenhuizen KU Leuven</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universitaire Ziekenhuizen KU Leuven</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Functional Dyspepsia-Postprandial Distress Syndrome (FD-PDS), is characterized by&#xD;
      meal-related symptoms such as early satiation and postprandial fullness. Disturbances of&#xD;
      gastric motor function have been implicated the pathogenesis of PDS symptoms, and hence,&#xD;
      motility modifying agents are considered for the treatment of PDS. Prucalopride (Resolor®), a&#xD;
      highly selective 5-TH4 receptor agonist which stimulates gastrointestinal motility throughout&#xD;
      the GI tract, is currently approved for the treatment of chronic constipation. The objective&#xD;
      of this study was to evaluate the effect of prucalopride on gastric sensorimotor function in&#xD;
      healthy volunteers (HV). Methods A total of 17 HV (59% females, mean age 29.4±2.7 years)&#xD;
      underwent a barostat and intragastric pressure (IGP) measurements after treatment with&#xD;
      placebo or prucalopride (2 mg) in a single blinded cross-over fashion. Isobaric distentions&#xD;
      with stepwise increments of 2 mm Hg starting from minimal distending pressure (MDP) and&#xD;
      scoring of intensities of gastric sensations (0-6: pain) were used to determine gastric&#xD;
      compliance and sensitivity. Gastric accommodation (GA) was quantified as the difference&#xD;
      (delta) in intra-balloon volume 30 min before and 60 min after ingestion of 200 ml of a&#xD;
      nutrient drink (ND) (1.5 kcal mL(-1)). GA measured by IGP was quantified as the drop of IGP&#xD;
      from baseline during the intragastric infusion of ND until maximal satiation. During all&#xD;
      tests, epigastric symptoms were scored every 5 minutes.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 26, 2013</start_date>
  <completion_date type="Actual">October 3, 2016</completion_date>
  <primary_completion_date type="Actual">June 1, 2015</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The effect of prucalopride on gastric accommodation with gastric barostat technique</measure>
    <time_frame>90 minutes</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The effect of prucalopride on gastric accommodation with intragastric pressure measurement technique</measure>
    <time_frame>60 minutes</time_frame>
    <description>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.&#xD;
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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Visual Analog Score for sensitivity</measure>
    <time_frame>120 minutes</time_frame>
    <description>Gastric sensitivity will be done by means of step-wise distention of the gastric barostat with Visual Analog Score for sensitivity</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The effect of prucalopride on gastric compliance</measure>
    <time_frame>120 minutes</time_frame>
    <description>Gastric compliance of the gastric wall will be assessed with step-wise distention of the gastric balloon</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The effect of prucalopride on nutrient tolerance</measure>
    <time_frame>30 minutes</time_frame>
    <description>The amount of ingested calories will be assessed during intragastric infusion of a nutrient drink will be evaluated</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">17</enrollment>
  <condition>Gastrointestinal Motility Disorder</condition>
  <condition>Dyspepsia</condition>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Prucalopride</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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 &gt;90%. Concomitant intake of food does not influence the oral bioavailability of prucalopride.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Prucalopride</intervention_name>
    <description>Orally administered</description>
    <arm_group_label>Prucalopride</arm_group_label>
    <other_name>Resolor</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Orally administered</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy volunteers, male and females, between 18-60 years old&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Subjects that:&#xD;
&#xD;
          -  They are older than 60 years old.&#xD;
&#xD;
          -  Have severely decreased kidney function.&#xD;
&#xD;
          -  Have severely decreased liver function.&#xD;
&#xD;
          -  Have severe heart disease, for example a history of irregular heartbeats, angina or&#xD;
             heart attack.&#xD;
&#xD;
          -  Have severe lung disease.&#xD;
&#xD;
          -  Have severe psychiatric illness or neurological illness.&#xD;
&#xD;
          -  Have any gastrointestinal disease&#xD;
&#xD;
          -  Women that are pregnant or breastfeeding.&#xD;
&#xD;
          -  Have a rare hereditary problems of galactose intolerance, the Lapp lactase deficiency&#xD;
             or glucose-galactose malabsorption (Resolor tablets contain lactose).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jan Tack, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Universitaire Ziekenhuizen KU Leuven</affiliation>
  </overall_official>
  <verification_date>October 2021</verification_date>
  <study_first_submitted>August 24, 2018</study_first_submitted>
  <study_first_submitted_qc>June 11, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 12, 2020</study_first_posted>
  <last_update_submitted>October 25, 2021</last_update_submitted>
  <last_update_submitted_qc>October 25, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">October 26, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>gastric accommodation</keyword>
  <keyword>gastric sensitivity</keyword>
  <keyword>gastric compliance</keyword>
  <keyword>nutrient tolerance</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypersensitivity</mesh_term>
    <mesh_term>Dyspepsia</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Prucalopride</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04429802
org study id: S55741
nct id: NCT04429802
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
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.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: The effect of prucalopride on gastric accommodation with gastric barostat technique
time frame: 90 minutes
description: 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.
measure: The effect of prucalopride on gastric accommodation with intragastric pressure measurement technique
time frame: 60 minutes
description: 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.
measure: Visual Analog Score for sensitivity
time frame: 120 minutes
description: Gastric sensitivity will be done by means of step-wise distention of the gastric barostat with Visual Analog Score for sensitivity
measure: The effect of prucalopride on gastric compliance
time frame: 120 minutes
description: Gastric compliance of the gastric wall will be assessed with step-wise distention of the gastric balloon
measure: The effect of prucalopride on nutrient tolerance
time frame: 30 minutes
description: The amount of ingested calories will be assessed during intragastric infusion of a nutrient drink will be evaluated
arm group label: Placebo
arm group type: Placebo Comparator
description: 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.
arm group label: Prucalopride
arm group type: Experimental
description: 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.
intervention type: Drug
intervention name: Prucalopride
description: Orally administered
arm group label: Prucalopride
other name: Resolor
intervention type: Drug
intervention name: Placebo
description: Orally administered
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Jan Tack, MD
role: Principal Investigator
affiliation: Universitaire Ziekenhuizen KU Leuven
responsible party type: Sponsor
mesh term: Hypersensitivity
mesh term: Dyspepsia
mesh term: Prucalopride
sharing ipd: No