Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12609000573257
Ethics application status
Not yet submitted
Date submitted
6/07/2009
Date registered
14/07/2009
Date last updated
14/07/2009
Type of registration
Prospectively registered

Titles & IDs
Public title
Investigation into the efficacy of Chlorpromazine as a second line therapy for Cannabis Hyperemesis.
Scientific title
Prospective randomised single-blind trial to determine whether standard antiemetic treatment plus chlorpromazine is more effective in reducing episodes of vomiting in patients who present acutely with cannabinoid hyperemesis than standard antiemetic treatment alone.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cannabinoid Hyperemesis Syndrome 237166 0
Condition category
Condition code
Other 237490 237490 0 0
Conditions of unknown or disputed aetiology (such as chronic fatigue syndrome/myalgic encephalomyelitis)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A single dose of metaclopramide 10mg intravenous (iv) and tropisetron 2mg Intravenous (iv) given to all patients in trail. A single dose of Chlorpromazine 25mg in normal saline 1L intravenous (iv) given to treatment group.
Intervention code [1] 236879 0
Treatment: Drugs
Comparator / control treatment
A single dose of metaclopramide 10mg intravenously (iv) and tropisetron 2mg intravenously (iv) given to all patients in trial. Control group to have normal saline 1L intravenously (iv)
Control group
Active

Outcomes
Primary outcome [1] 238298 0
Reduction of self-recorded episodes of vomiting in the chlorproamzine group
Timepoint [1] 238298 0
Over 5 hours observation, reported hourly
Secondary outcome [1] 244684 0
patient satisfaction
Timepoint [1] 244684 0
Visual Analogue scale (VAS) at baseline and after 5 hours
Secondary outcome [2] 244685 0
nausea
Timepoint [2] 244685 0
VAS at baseline and after 5 hours

Eligibility
Key inclusion criteria
Intractable vomiting in patients with known cannabis use and no other pathological cause identified.
Informed consent given.
Minimum age
16 Years
Maximum age
99 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Declined consent.
Previous participation
Grossly abnormal observations or signs of serious pathology.
Pregnancy
Allergy to chlorpromazine
Concurrent use of any drug which is contraindicated with chlorpromazine

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)
Patients will be identified by nursing staff or treating doctors on presentation to the Emergency department with symptoms of Cannabinoid Hyperemesis. They will all receive standard antiemetic therapy and fluids. They will be provided with an information sheet and the oppourtunity to ask questions. If they agree to participate they will sign a consent form. The nursing staff will open a pre-randomised study pack which will tell them to which group the patient belongs. The allocation is concealed from the medical and nursing staff until the point of entry into the trial by pre-randomisation and sealed opaque envelopes. A label in the pack bearing the study number will be the only identification on the fluid bag. The chlorpromazine will be charted in the notes as per standard practice.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/08/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
35
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 237268 0
Hospital
Name [1] 237268 0
Royal Darwin Hospital
Country [1] 237268 0
Australia
Primary sponsor type
Individual
Name
Charlotte Heldreich
Address
Emergency Department,
Royal Darwin Hospital,
Rocklands Drive,
Tiwi, Darwin
NT 0810
Country
Australia
Secondary sponsor category [1] 236753 0
Individual
Name [1] 236753 0
Dr Ian Norton
Address [1] 236753 0
Emergency Department,
Royal Darwin Hospital,
Rocklands Drive,
Tiwi, Darwin.
NT 0810
Country [1] 236753 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 239368 0
Human research Ethics Committee of Northern Territory Department of Health and Families and Menzies School of Health Research (EC 00153)
Ethics committee address [1] 239368 0
John Mathews Building,
Royal Darwin Hospital Campus,
Rocklands Drive,
Tiwi, Darwin.
NT 0810
Ethics committee country [1] 239368 0
Australia
Date submitted for ethics approval [1] 239368 0
21/06/2009
Approval date [1] 239368 0
Ethics approval number [1] 239368 0
09/33

Summary
Brief summary
This study aims to identify whether the use of chlorpromazine is more effective than standard therapy at treating vomiting associated with Cannabis Hyperemesis Syndrome. The cause of this condition is unknown but similar syndromes of Adult Cylclical vomiting are thought to be related to migraines. Chlorpromazine has been chosen because it is both an antiemetic and anti-migraine therapy.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29852 0
Address 29852 0
Country 29852 0
Phone 29852 0
Fax 29852 0
Email 29852 0
Contact person for public queries
Name 13099 0
Charlotte Heldreich
Address 13099 0
Emergency Department,
Royal Darwin Hospital,
Rocklands Drive,
Tiwi, Darwin
NT0810
Country 13099 0
Australia
Phone 13099 0
+61 8 89228888
Fax 13099 0
Email 13099 0
[email protected]
Contact person for scientific queries
Name 4027 0
Charlotte Heldreich
Address 4027 0
Emergency Department,
Royal Darwin Hospital,
Rocklands Drive,
Tiwi, Darwin.
NT 0810
Country 4027 0
Australia
Phone 4027 0
+61 8 89228888
Fax 4027 0
Email 4027 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.