NCT00259220

Brief Summary

Gastric lavage is usually used for gastric preparation before endoscopy in patients with upper gastrointestinal bleeding. However, the benefit-risk balance of putting a nasogastric tube in these patients is not clearly defined. This randomized trial is aimed to determine if the use of erythromycin IV before endoscopy could avoid to put a gastric tube for the management of upper gastrointestinal bleeding.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
270

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Dec 2005

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 28, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 29, 2005

Completed
2 days until next milestone

Study Start

First participant enrolled

December 1, 2005

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2008

Completed
Last Updated

October 1, 2008

Status Verified

March 1, 2007

Enrollment Period

2.7 years

First QC Date

November 28, 2005

Last Update Submit

September 30, 2008

Conditions

Upper Gastrointestinal Bleeding

Keywords

BleedingEndoscopyGastric tubeErythromycinRandomized

Outcome Measures

Primary Outcomes (1)

  • Endoscopic yield

    at the beggining of the study

Secondary Outcomes (1)

  • Rebleeding until D 30, transfusion, gastric tube or erythromycin complications

    until 30 days

Study Arms (3)

drug

EXPERIMENTAL

erythromycine

Drug: erythomycin

2

OTHER

gastric lavage alone

Procedure: gastric lavage alone

3

ACTIVE COMPARATOR

erythromycine and gastric lavage

Procedure: erythromycine and gastric lavage

Interventions

erythomycinDRUG

erythomycin

drug
gastric lavage alonePROCEDURE

gastric lavage alone

2
erythromycine and gastric lavagePROCEDURE

erythromycine and gastric lavage

3

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Hematemesis or melaena
  • No QT enlargement

You may not qualify if:

  • Refusing endoscopy
  • Glasgow \< 15

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Jean VERDIER

Bondy, 93140, France

Location

MeSH Terms

Conditions

Gastrointestinal HemorrhageHemorrhage

Interventions

eryF protein, Saccharopolyspora erythraeaGastric Lavage

Condition Hierarchy (Ancestors)

Gastrointestinal DiseasesDigestive System DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutic IrrigationInvestigative Techniques

Study Officials

  • Dominique PATERON, MD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 28, 2005

First Posted

November 29, 2005

Study Start

December 1, 2005

Primary Completion

August 1, 2008

Study Completion

August 1, 2008

Last Updated

October 1, 2008

Record last verified: 2007-03

Locations

FR(1)