Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.
Trial record 20 of 185 for:    ERYTHROMYCIN

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE August 6, 2019
First Posted Date  ICMJE August 26, 2019
Last Update Posted Date September 10, 2019
Actual Study Start Date  ICMJE September 7, 2019
Estimated Primary Completion Date January 13, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 7, 2019)
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: August 20, 2019)
  • MIMTbaseline [ Time Frame: t = 0-120 min ]
    MIMT (Motility Index Medium Term) is measured with the VIPUN GMS. MIMT is a value between 0 and 1.
  • MIMT121-180 [ Time Frame: t = 121 - 180 min ]
    Motility during and shortly after erythromycin administration. MIMT (Motility Index Medium Term) is measured with the VIPUN GMS. MIMT is a value between 0 and 1.
Change History Complete list of historical versions of study NCT04066231 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 7, 2019)
  • 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.
  • 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.
  • Incidence of adverse events [ Time Frame: t = 0 - 240 minutes ]
    Incidence of adverse events
  • Severity of adverse (device) events/effects [ Time Frame: t = 0 - 240 minutes ]
    Severity of adverse (device) events/effects
  • Seriousness of adverse (device) events/effects [ Time Frame: t = 0 - 240 minutes ]
    Seriousness of adverse (device) events/effects
  • Relatedness of adverse (device) events/effects [ Time Frame: t = 0 - 240 minutes ]
    Relatedness of adverse (device) events/effects
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: August 20, 2019)
  • MIMT181-240 [ Time Frame: t = 181 - 240 min ]
    Motility in the period 181 - 240 minutes. MIMT (Motility Index Medium Term) is measured with the VIPUN GMS. MIMT is a value between 0 and 1.
  • Symptoms [ Time Frame: t = 0 - 240 min ]
    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.
  • Incidence of adverse events [ Time Frame: t = 0 - 240 min ]
    Incidence of adverse events
  • Severity of adverse (device) events/effects [ Time Frame: t = 0 - 240 min ]
    Severity of adverse (device) events/effects
  • Seriousness of adverse (device) events/effects [ Time Frame: t = 0 - 240 min ]
    Seriousness of adverse (device) events/effects
  • Relatedness of adverse (device) events/effects [ Time Frame: t = 0 - 240 min ]
    Relatedness of adverse (device) events/effects
  • Incidence of device deficiencies of the investigational medical device [ Time Frame: t = 0 - 240 min ]
    Qualitative description of the event, onset, duration, origin, action taken and outcome of the event
  • Incidence of protocol deviations related to the investigational medical device [ Time Frame: t = 0 - 240 min ]
    Qualitative description of the event, onset, duration, origin, action taken and outcome of the event
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE ANTERO-4: VIPUN Gastric Monitoring System in an Erythromycin Model
Official Title  ICMJE ANTERO-4: A Clinical Investigation of the Effects of Erythromycin on Gastric Motility, Assessed With the VIPUN Gastric Monitoring System in Healthy Adults
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE Gastric Motility
Intervention  ICMJE
  • 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.

Study Arms  ICMJE Experimental: VIPUN GMS
Single arm study.
Interventions:
  • Device: VIPUN GMS
  • Drug: Erythromycin Lactobionate
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 20, 2019)
6
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 13, 2020
Estimated Primary Completion Date January 13, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Nick Goelen, MSc +32 16 37 23 42 nick.goelen@kuleuven.be
Listed Location Countries  ICMJE Belgium
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04066231
Other Study ID Numbers  ICMJE S62862
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Prof Dr Jan Tack, Universitaire Ziekenhuizen Leuven
Study Sponsor  ICMJE Prof Dr Jan Tack
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Universitaire Ziekenhuizen Leuven
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP