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Trial record 24 of 180 for:    ERYTHROMYCIN

Effect of the Motilin Receptor Agonist, Erythromycin, on Hunger and Food Intake; Study of Role of Cholinergic Pathways

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ClinicalTrials.gov Identifier: NCT02633579
Recruitment Status : Completed
First Posted : December 17, 2015
Last Update Posted : December 17, 2015
Sponsor:
Information provided by (Responsible Party):
Universitaire Ziekenhuizen Leuven

Brief Summary:
In this study, the investigators will evaluate if the food intake associated with the infusion of erythromycin is caused by the phase 3 contractions or by another yet unknown effect of erythromycin. To obtain this the investigators will use atropine, a muscarinic receptor antagonist, to inhibit the formation of contractions induced by a low dose of erythromycin

Condition or disease Intervention/treatment Phase
Healthy Drug: erythromycin lactobionate Drug: Atropine Drug: Erythromycin with atropine Drug: Saline Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Official Title: The Role of Induced Phase 3 Contractions in the Control of Hunger and Food Intake
Study Start Date : October 2012
Actual Primary Completion Date : August 2014
Actual Study Completion Date : August 2014


Arm Intervention/treatment
Active Comparator: Erythromycin lactobionate
40 mg erythromycin lactobionate was administered over a 20 min period in a volume of 100 ml sodium chloride 0.9 %
Drug: erythromycin lactobionate
intravenous administration of erythromycin
Other Name: Erythromycin

Active Comparator: Erythromycin lactobionate with atropine
40 mg erythromycin lactobionate was administered over a 20 min period in a volume of 100 ml sodium chloride 0.9 %; Atropine sulfate was given as an i.v. bolus (15 µg/kg) followed by a continuous infusion of 15 µg/kg/h over 30 min
Drug: Erythromycin with atropine
intravenous administration of erythromycin with saline

Placebo Comparator: Atropine

Atropine sulfate was given as an i.v. bolus (15 µg/kg) followed by a continuous infusion of 15 µg/kg/h over 30 min.

Infusion of saline as a placebo for erythromycin was administered over a 20 min period in a volume of 100 ml sodium chloride 0.9 %

Drug: Atropine
intravenous administration of atropine

Placebo Comparator: Placebo
Infusion of saline was administered over a 20 min period in a volume of 100 ml sodium chloride 0.9 %; also placebo for atropine was given as an i.v. bolus of saline followed by a continuous infusion over 30 min
Drug: Saline
intravenous administration of saline
Other Name: Control




Primary Outcome Measures :
  1. Change in hunger ratings from time of administration over 6 hours [ Time Frame: 6 hours after intervention, assessment every 5 minutes ]
    visual analog scale


Secondary Outcome Measures :
  1. Timing of food intake [ Time Frame: 6 hours after intervention; up to 2 moments of food intake allowed ]
    decision to take a soup meal



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

Inclusion criteria:

  • Female or male subjects aged 18 to 60
  • Subject is capable and willing to give informed consent
  • Female volunteers of child bearing potential must use oral, injected or implanted hormonal methods of contraception

Exclusion criteria:

  • Female volunteer is pregnant or breastfeeding
  • Gastrointestinal diseases, major abdominal surgery
  • Major psychiatric illnesses
  • Volunteers that use drugs affecting the gastrointestinal tract or the central nervous system
  • Allergy for macrolide antibiotics
  • Allergy for atropine
  • Severe heartburn
  • Enlarged prostate
  • Blockage of urinary tract
  • Acute closed-angle glaucoma
  • Myasthenia gravies
  • Severe heart disease
  • Thyrotoxicosis
  • Fever
  • Liver problems
  • High blood pressure or fast heart rate
  • Lung disease

Publications:
Itoh Z. AI, Takeuchi S., Couch E. F., editor. Hunger contractions and motilin. 5th International Symposium on Gastrointestinal Motility; 1975; Herentals, Belgium.
Scarpellini E. HN, D. Ang, P. Vanden Berghe, I. Depoortere, J. Tack. Role of upper gastrointestinal motility stimulation in the occurence of hunger peaks. Gastroenterology. 2009;136:A330

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT02633579     History of Changes
Other Study ID Numbers: ErythromycinHungerFoodIntake
First Posted: December 17, 2015    Key Record Dates
Last Update Posted: December 17, 2015
Last Verified: October 2015
Keywords provided by Universitaire Ziekenhuizen Leuven:
Healthy volunteers
Additional relevant MeSH terms:
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Erythromycin
Erythromycin Estolate
Erythromycin Ethylsuccinate
Erythromycin stearate
Erythromycin lactobionate
Atropine
Adjuvants, Anesthesia
Anti-Arrhythmia Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Mydriatics
Parasympatholytics
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Bacterial Agents
Anti-Infective Agents
Gastrointestinal Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors