Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000733279
Ethics application status
Approved
Date submitted
22/08/2009
Date registered
25/08/2009
Date last updated
10/12/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Tropisetron versus metoclopramide for nausea and vomiting in the emergency department: a randomised, double blinded, clinical trial
Scientific title
A randomised double blind clinical trial to compare the efficacy of tropisetron and metoclopramide in decreasing nausea and vomiting in the emergency department
Secondary ID [1] 288126 0
nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
nausea and vomiting 243572 0
Condition category
Condition code
Oral and Gastrointestinal 239867 239867 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
An intravenous bolus of 5mg of tropisetron (over 30 seconds)
Intervention code [1] 241174 0
Treatment: Drugs
Comparator / control treatment
An intravenous bolus of 10mg of metoclopramide (over 30 seconds)
Control group
Active

Outcomes
Primary outcome [1] 240653 0
Nausea score (0-100) on a visual analogue scale
Timepoint [1] 240653 0
0, 30, 60, 90, 120, 180 and 240 minutes after drug injection
Primary outcome [2] 240654 0
Incidence of vomiting
Timepoint [2] 240654 0
0, 30, 60, 90, 120, 180 and 240 minutes after drug injection
Secondary outcome [1] 257294 0
requirement for rescue medication (additional drugs to control nausea and/or vomiting) as determined by the treating medical staff (not by nausea score)
Timepoint [1] 257294 0
0, 30, 60, 90, 120, 180 and 240 minutes after drug injection
Secondary outcome [2] 257295 0
Side effects including drowsiness (measured using a 5 point sedation scale), dystonic reactions (determined clinically by the treating the clinicians) and akathisia (measured using the Prince Henry Hospital Akathisia Rating Scale.
Timepoint [2] 257295 0
0, 30, 60, 90, 120, 180 and 240 minutes after drug injection

Eligibility
Key inclusion criteria
Patients who have presented to the emergency department for treatment; age 18 years or more; nausea and/or vomiting that requires drug treatment as determined by the treating physician
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Refusal to participate; Migraine (metoclopramide sedation confers an advantage); Inability to co-operate or consent due to debility, significant illness, language barriers, altered consciousness (as determined by the emergency department or study staff); Known allergy or hypersensitivity to tropisetron or metoclopramide; Intoxication (alcohol, substance abuse); Pregnancy; Previous administration of antiemetic within 24 hours

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
A note containing each patient's allocation will be inside a sealed envelope inside each study pack.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computer generated random numbers
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Emergency department staff will open the allocation envelope, draw up the allocated drug and inject itinto the patient. However, these staff will not disclose the nature of the drug administered and take not part in the patient management of data collection.
Phase
Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/10/2009
Actual
26/10/2009
Date of last participant enrolment
Anticipated
Actual
30/03/2010
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
100
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 2041 0
3084

Funding & Sponsors
Funding source category [1] 237534 0
University
Name [1] 237534 0
University of Melbourne
Country [1] 237534 0
Australia
Primary sponsor type
Hospital
Name
Austin Hospital
Address
Studley Rd
Heidelberg
Victoria 3084
Country
Australia
Secondary sponsor category [1] 237010 0
None
Name [1] 237010 0
Address [1] 237010 0
Country [1] 237010 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 243665 0
Austin Health
Ethics committee address [1] 243665 0
Ethics committee country [1] 243665 0
Australia
Date submitted for ethics approval [1] 243665 0
19/08/2009
Approval date [1] 243665 0
01/10/2009
Ethics approval number [1] 243665 0
H2009/03731

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

Contacts
Principal investigator
Name 30083 0
Prof David Taylor
Address 30083 0
Emergency Departmetn, Austin Hospital, PO Box 5555, Hedelberg Vic 3084
Country 30083 0
Australia
Phone 30083 0
+61 3 9496 4711
Fax 30083 0
Email 30083 0
[email protected]
Contact person for public queries
Name 13330 0
A/Prof David Taylor
Address 13330 0
Emergency Department
Austin Hospital
Studley Rd
Heidelberg
Victoria 3084
Country 13330 0
Australia
Phone 13330 0
+61 3 9496 4883
Fax 13330 0
+61 3 9496 3380
Email 13330 0
[email protected]
Contact person for scientific queries
Name 4258 0
A/Prof David Taylor
Address 4258 0
Emergency Department
Austin Hospital
Studley Rd
Heidelberg
Victoria 3084
Country 4258 0
Australia
Phone 4258 0
+61 3 9496 4883
Fax 4258 0
+61 3 9496 3380
Email 4258 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
SourceTitleYear of PublicationDOI
Dimensions AITropisetron versus metoclopramide for the treatment of nausea and vomiting in the emergency department: A randomized, double-blinded, clinical trial2011https://doi.org/10.1111/j.1742-6723.2011.01444.x
N.B. These documents automatically identified may not have been verified by the study sponsor.