Effect of Erythromycin Before Endoscopy of Patients With... | NCT01659619

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

NCT01659619

Sponsor

The Catholic University of Korea

Status

Completed

Last Update Posted

Feb 21, 2013Estimated

Enrollment

114Actual

Phase

Phase 2

Conditions

Subtotal Gastrectomy
Stomach Cancer

Interventions

Erythromycin

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2012

Primary Completion Date

Oct 2012Actual

Completion Date

Oct 2012Actual

First Submitted Date

Apr 10, 2012

First Submission Date that Met QC Criteria

Aug 3, 2012

First Posted Date

Aug 8, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 20, 2013

Last Update Posted Date

Feb 21, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

114Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
erythromycin	Experimental		Drug: Erythromycin
saline	No Intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Erythromycin	Drug	125mg in normal saline single use infusion for 5 min.	erythromycin

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

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

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Seoul St. Mary hospital		Seoul			South Korea

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
1955115	Background	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. doi: 10.1016/0016-5085(91)90383-v.
1537520	Background	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. doi: 10.1016/0016-5085(92)90164-t.

ID	Term
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

ID	Term
D018942	Macrolides
D061065	Polyketides
D007783	Lactones
D009930	Organic Chemicals