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Trial record 20 of 182 for:    ERYTHROMYCIN

ANTERO-4: VIPUN Gastric Monitoring System in an Erythromycin Model (ANTERO-4)

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ClinicalTrials.gov Identifier: NCT04066231
Recruitment Status : Recruiting
First Posted : August 26, 2019
Last Update Posted : September 10, 2019
Sponsor:
Information provided by (Responsible Party):
Prof Dr Jan Tack, Universitaire Ziekenhuizen Leuven

Brief Summary:

It has been demonstrated that the VIPUN Gastric Monitoring System (GMS) can discriminate healthy physiological and pharmacologically-inhibited gastric motility, using a codeine-model in healthy adults (S60320 / AFMPS80M0687).

Erythromycin is a gastroprokinetic agent, known to stimulate gastric contractility. A single dose of 200 mg erythromycin has been shown to induce a prolonged period of enhanced phasic contractile activity.

The primary aim of this investigation is to validate the ability of the VIPUN GMS to discriminate between normal and pharmacologically-enhanced fasting gastric motility in healthy adults.

The performance of the VIPUN GMS can be enhanced by data-driven optimization of the VIPUN Motility Algorithm, used to quantify gastric motility.


Condition or disease Intervention/treatment Phase
Gastric Motility Device: VIPUN GMS Drug: Erythromycin Lactobionate Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 6 participants
Intervention Model: Single Group Assignment
Intervention Model Description: A gastroprokinetic agent is administered to stimulate gastric motility.
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: ANTERO-4: A Clinical Investigation of the Effects of Erythromycin on Gastric Motility, Assessed With the VIPUN Gastric Monitoring System in Healthy Adults
Actual Study Start Date : September 7, 2019
Estimated Primary Completion Date : January 13, 2020
Estimated Study Completion Date : January 13, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: VIPUN GMS
Single arm study.
Device: VIPUN GMS
Motility is measured for 4 hours with the VIPUN Gastric Monitoring System (GMS).

Drug: Erythromycin Lactobionate

Test model: Erythromycin has gastroprokinetic properties. The primary aim of this investigation is to validate the ability of the VIPUN GMS to discriminate between normal and pharmacologically-enhanced fasting gastric motility in healthy adults.

Erythromycin Lactobionate infusion: 200 mg i.v. infusion over a period of 20 minutes. Note: Erythromycin is not labeled as a gastroprokinetic agent in Belgium.





Primary Outcome Measures :
  1. MIMTbaseline [ Time Frame: t = 0-120 minutes ]
    MIMT (Motility Index Medium Term) is measured with the VIPUN Gastric Monitoring System. MIMT is a value between 0 and 1.

  2. MIMT121-180 [ Time Frame: t = 121 - 180 minutes ]
    Motility during and shortly after erythromycin administration. MIMT (Motility Index Medium Term) is measured with the VIPUN Gastric Monitoring System. MIMT is a value between 0 and 1.


Secondary Outcome Measures :
  1. MIMT181-240 [ Time Frame: t = 181 - 240 minutes ]
    Motility in the period 181 - 240 minutes. MIMT (Motility Index Medium Term) is measured with the VIPUN Gastric Monitoring System. MIMT is a value between 0 and 1.

  2. Symptoms [ Time Frame: t = 0 - 240 minutes ]
    Epigastric symptoms (nausea, bloating, pain) are surveyed with Visual Analogue Scales for severity of each individual symptom (100 mm, 0 = Absent to 100 mm = worst possible sensation) at a 15 minute interval.

  3. Incidence of adverse events [ Time Frame: t = 0 - 240 minutes ]
    Incidence of adverse events

  4. Severity of adverse (device) events/effects [ Time Frame: t = 0 - 240 minutes ]
    Severity of adverse (device) events/effects

  5. Seriousness of adverse (device) events/effects [ Time Frame: t = 0 - 240 minutes ]
    Seriousness of adverse (device) events/effects

  6. Relatedness of adverse (device) events/effects [ Time Frame: t = 0 - 240 minutes ]
    Relatedness of adverse (device) events/effects

  7. Incidence of device deficiencies of the investigational medical device [ Time Frame: t = 0 - 240 minutes ]
    Qualitative description of the event, onset, duration, origin, action taken and outcome of the event

  8. Incidence of protocol deviations related to the investigational medical device [ Time Frame: t = 0 - 240 minutes ]
    Qualitative description of the event, onset, duration, origin, action taken and outcome of the event



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Signed Informed Consent
  • Aged between and including 18 and 65 years
  • BMI between and including 18 and 30
  • Understand and able to read Dutch
  • In good health on the basis of medical history
  • Refrains from herbal, vitamin and other dietary supplements on the day of the visits

Exclusion Criteria:

  • Dyspeptic symptoms (assessed with PAGI-SYM questionnaire)
  • Using any medication that might affect gastric function or visceral sensitivity
  • Known / suspected current use of illicit drugs
  • Known psychiatric or neurological illness
  • Any gastrointestinal surgery that could influence normal gastric function in the opinion of the investigator
  • History of heart or vascular diseases like irregular heartbeats, angina or heart attack
  • Nasopharyngeal surgery in the last 30 days
  • Suspected basal skull fracture or severe maxillofacial trauma
  • History of thermal or chemical injury to upper respiratory tract or esophagus
  • Current esophageal or nasopharyngeal obstruction
  • Known coagulopathy
  • Known esophageal varices
  • Pregnant or breastfeeding women
  • Have known side-effects/allergic reactions when taking erythromycin or other macrolide antibiotics (such as azithromycin, clarithromycin)
  • Kidney disease
  • Liver disease
  • Myasthenia gravis
  • QT prolongation (QT ≥400 ms) at the screening
  • Cardiac arrhythmia or heart failure
  • History of C. difficile infection
  • Family history of QT prolongation, sudden cardiac death or other heart problems
  • Recent vaccinations with live bacterial vaccines (such as typhoid vaccine)
  • Concomitant medication use

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04066231


Contacts
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Contact: Nick Goelen, MSc +32 16 37 23 42 nick.goelen@kuleuven.be

Locations
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Belgium
UZ Leuven Recruiting
Leuven, Belgium, 3000
Contact: Nick Goelen, MSc    003216372342    nick.goelen@kuleuven.be   
Principal Investigator: Jan Tack         
Sponsors and Collaborators
Prof Dr Jan Tack

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Responsible Party: Prof Dr Jan Tack, Head of Clinic - Gastroenterology / Professor of Medicine / Principal Investigator, Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT04066231     History of Changes
Other Study ID Numbers: S62862
First Posted: August 26, 2019    Key Record Dates
Last Update Posted: September 10, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Erythromycin
Erythromycin Estolate
Erythromycin Ethylsuccinate
Erythromycin stearate
Erythromycin lactobionate
Anti-Bacterial Agents
Anti-Infective Agents
Gastrointestinal Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action