Trial record 15 of 182 for: ERYTHROMYCIN

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Effect of Erythromycin Before Endoscopy of Patients With Subtotal Gastrectomy (STG), High Risk of Gastric Stasis

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ClinicalTrials.gov Identifier: NCT01659619

Recruitment Status : Completed

First Posted : August 8, 2012

Last Update Posted : February 21, 2013

Sponsor:

Information provided by (Responsible Party):

Myung-gui Choi, The Catholic University of Korea

Study Description

Brief Summary:

Erythromycin has a prokinetic effect through Motilin receptor. It evokes migrating motor complex with longer and stronger contraction.

In patients with upper gastrointestinal bleeding, It has been shown that erythromycin could clear the stomach of blood, so visual examination could be improved.

Frequent food stasis is encounted when we examine patients with subtotal gastrectomy. It is postulated that erythromycin reduce food stasis and help to improve endoscopy in these cases.

Condition or disease	Intervention/treatment	Phase
Subtotal Gastrectomy Stomach Cancer	Drug: Erythromycin	Phase 2

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	114 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Double (Participant, Investigator)
Primary Purpose:	Prevention
Official Title:	Effect of Erythromycin Before Endoscopy of Patients With Subtotal Gastrectomy (STG), High Risk of Gastric Stasis : Randomized and Prospective Study
Study Start Date :	April 2012
Actual Primary Completion Date :	October 2012
Actual Study Completion Date :	October 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy

Drug Information available for: Erythromycin Erythromycin stearate Erythromycin ethylsuccinate Erythromycin phosphate

Genetic and Rare Diseases Information Center resources: Stomach Cancer Gastroparesis

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Experimental: erythromycin	Drug: Erythromycin 125mg in normal saline single use infusion for 5 min.
No Intervention: saline

Outcome Measures

Primary Outcome Measures :

degree of food stasis [ Time Frame: when endoscopy is performed. ]
ref> Gastric Cancer (2002) 5: 83-89

Eligibility Criteria

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Ages Eligible for Study:	Child, Adult, Older Adult
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients who undergone STG (billroth I, billroth II, R-Y STG) within 5 years to treat gastric cancer
Stage of T1-2N0M0

Exclusion Criteria:

concomitant therapy with astemizole, cisapride, dihydroergotamine, ergotamine, pimozide, or terfenadine, narcotics, alpha-2-adrenergic agonist, TCA, CCB, dopamine agonist, muscarinic cholinergic antagonists, octreotide, exenatide and GLP-1 agonist, phenothiazines
chemotherapy Hx.
hypersensitivity to erythromycin or any component of the product
pregnancy or lactation
comobidity : DM, AIDS, neurologic disease(parkinsonism, multiple sclerosis, brainstem stroke or tumor, diabetic or amyloid neuropathy, or primary dysautonomias) scleroderma and other connective tissue disease, recent viral enteritis history
recurrence

Contacts and Locations

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): NCT01659619

Locations

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Korea, Republic of
Seoul St. Mary hospital
Seoul, Korea, Republic of

Sponsors and Collaborators

The Catholic University of Korea

Investigators

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Principal Investigator:	Myung-Gyu Choi, M.D.	Department of Internal Medicine, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea

More Information

Publications:

Sarna SK, Soergel KH, Koch TR, Stone JE, Wood CM, Ryan RP, Arndorfer RC, Cavanaugh JH, Nellans HN, Lee MB. Gastrointestinal motor effects of erythromycin in humans. Gastroenterology. 1991 Dec;101(6):1488-96.

Annese V, Janssens J, Vantrappen G, Tack J, Peeters TL, Willemse P, Van Cutsem E. Erythromycin accelerates gastric emptying by inducing antral contractions and improved gastroduodenal coordination. Gastroenterology. 1992 Mar;102(3):823-8.

Bruley des Varannes S, Parys V, Ropert A, Chayvialle JA, Rozé C, Galmiche JP. Erythromycin enhances fasting and postprandial proximal gastric tone in humans. Gastroenterology. 1995 Jul;109(1):32-9.

Ramirez B, Eaker EY, Drane WE, Hocking MP, Sninsky CA. Erythromycin enhances gastric emptying in patients with gastroparesis after vagotomy and antrectomy. Dig Dis Sci. 1994 Nov;39(11):2295-300.

Kendall BJ, Chakravarti A, Kendall E, Soykan I, McCallum RW. The effect of intravenous erythromycin on solid meal gastric emptying in patients with chronic symptomatic post-vagotomy-antrectomy gastroparesis. Aliment Pharmacol Ther. 1997 Apr;11(2):381-5.

Frossard JL, Spahr L, Queneau PE, Giostra E, Burckhardt B, Ory G, De Saussure P, Armenian B, De Peyer R, Hadengue A. Erythromycin intravenous bolus infusion in acute upper gastrointestinal bleeding: a randomized, controlled, double-blind trial. Gastroenterology. 2002 Jul;123(1):17-23. Erratum in: Gastroenterology 2002 Dec;123(6):2162.

Altraif I, Handoo FA, Aljumah A, Alalwan A, Dafalla M, Saeed AM, Alkhormi A, Albekairy AK, Tamim H. Effect of erythromycin before endoscopy in patients presenting with variceal bleeding: a prospective, randomized, double-blind, placebo-controlled trial. Gastrointest Endosc. 2011 Feb;73(2):245-50. doi: 10.1016/j.gie.2010.09.043. Epub 2010 Dec 8.

Kubo M, Sasako M, Gotoda T, Ono H, Fujishiro M, Saito D, Sano T, Katai H. Endoscopic evaluation of the remnant stomach after gastrectomy: proposal for a new classification. Gastric Cancer. 2002;5(2):83-9.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Jun BY, Choi MG, Lee JY, Baeg MK, Moon SJ, Lim CH, Kim JS, Cho YK, Lee IS, Kim SW, Choi KY. Premedication with erythromycin improves endoscopic visualization of the gastric mucosa in patients with subtotal gastrectomy: a prospective, randomized, controlled trial. Surg Endosc. 2014 May;28(5):1641-7. doi: 10.1007/s00464-013-3364-y. Epub 2014 Jan 1.

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Responsible Party:	Myung-gui Choi, Professor, The Catholic University of Korea
ClinicalTrials.gov Identifier:	NCT01659619 History of Changes
Other Study ID Numbers:	KC12MISI0164
First Posted:	August 8, 2012 Key Record Dates
Last Update Posted:	February 21, 2013
Last Verified:	February 2013

Additional relevant MeSH terms:

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Erythromycin Erythromycin Estolate Erythromycin Ethylsuccinate Erythromycin stearate Stomach Neoplasms Gastroparesis Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases	Gastrointestinal Diseases Stomach Diseases Paralysis Neurologic Manifestations Signs and Symptoms Anti-Bacterial Agents Anti-Infective Agents Gastrointestinal Agents Protein Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action

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