Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000745640
Ethics application status
Approved
Date submitted
15/10/2005
Date registered
16/11/2005
Date last updated
16/11/2005
Type of registration
Prospectively registered

Titles & IDs
Public title
Does metoclopramide improve quality of endoscopy in acute upper gastrointestinal bleeding?.
Scientific title
Does metoclopramide improve quality of endoscopy in acute upper gastrointestinal bleeding?.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Upper Gastrointestinal Bleeding 897 0
Condition category
Condition code
Oral and Gastrointestinal 965 965 0 0
Normal oral and gastrointestinal development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study aims to investigate whether the administration of intravenous 10mg metoclopramide, 30-60minutes prior to endoscopy will improve the quality of endoscopic examination, will reduce the duration of endoscopic procedure and will decrease the need for repeat endoscopy
Intervention code [1] 718 0
Diagnosis / Prognosis
Comparator / control treatment
Control group
Placebo

Outcomes
Primary outcome [1] 1280 0
The primary outcome for this study is quality of endoscopic examination reported as:
a) % empty stomach using objective scores of 0 to 2.
Timepoint [1] 1280 0
Measured at time of endoscopic procedure by the gastroenterologist
Primary outcome [2] 1281 0
The primary outcome for this study is quality of endoscopic examination to be reported as:
b) Ease of visibility of bleeding source, using a 7 point scale from no blood (7) to large amount of blood completely obscuring the view (1).
Timepoint [2] 1281 0
Measured at time of endoscopic procedure by the gastroenterologist
Secondary outcome [1] 2309 0
The secondary outcomes will be based on analysis of results measured at time of endoscopic procedure and recorded on the case report form by the edoscopist after the procedure. This secondary outcome will be reported as: 1) % of patients with re-scope (due to problems with visualization) 2) Mean Duration of endoscopy (minutes).
Timepoint [1] 2309 0

Eligibility
Key inclusion criteria
Upper GI bleeding defined as either fresh and bright red or coffee ground haematemesis, Admission within 12 hours of initial clinical signs of bleeding and Written informed consent from patient.
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Previous allergy to metoclopramide, use of Nasogastric tube or gastric lavage, Prior gastrectomy, Pregnancy or lactation, Unable to give informed consent for any reason, Parkinsons disease and other contraindication to use of metoclopramide, Severe renal impairment and Advanced liver disease .

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
treatment allocation will be concealed and they will be packaged in sequentially numbered sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random numbers will be generated using Geigy scientific tables and these numbers will be used to assign the treatment allocation (using metoclopramide = 1 and placebo =2).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Safety
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/05/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
70
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1063 0
Government body
Name [1] 1063 0
Pharmacy department , Southerm Health
Country [1] 1063 0
Australia
Primary sponsor type
Government body
Name
Pharmacy department , Southerm Health.
Address
Country
Australia
Secondary sponsor category [1] 925 0
Individual
Name [1] 925 0
Bunmi Adebayo
Address [1] 925 0
Country [1] 925 0
Australia

Ethics approval
Ethics application status
Approved

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 36160 0
Address 36160 0
Country 36160 0
Phone 36160 0
Fax 36160 0
Email 36160 0
Contact person for public queries
Name 9907 0
Bunmi Adebayo
Address 9907 0
Pharmacy Department
Dandenong Hospital
Southern Health
Dandenong Melbourne VIC 3175
Country 9907 0
Australia
Phone 9907 0
+61 3 95548303 or +61 3 95548302
Fax 9907 0
+61 3 97692073
Email 9907 0
[email protected]
Contact person for scientific queries
Name 835 0
Bunmi Adebayo
Address 835 0
Pharmacy Department
Dandenong Hospital
Southern Health
Dandenong Melbourne VIC 3175
Country 835 0
Australia
Phone 835 0
+61 3 95548303 or +61 3 95548302
Fax 835 0
+61 3 97692073
Email 835 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.