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
ACTRN12614000622606
Ethics application status
Not yet submitted
Date submitted
30/05/2014
Date registered
11/06/2014
Date last updated
11/06/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Pilot Trial Proposal looking at the use of Cannabinoids for analgesia in chronic myocardial ischaemic chest pain, using Sativex Oromucosal Spray
Scientific title
In a patient with chronic ischaemic chest pain, will Sativex Oromucosal Spray reduce their pain
Secondary ID [1] 284692 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Ischaemic Chest Pain 292046 0
Condition category
Condition code
Cardiovascular 292382 292382 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
In this initial trial the treatment group will be patients admitted to Waikato Hospital Emergency Department or Cardiology department, who are known to suffer from intractable coronary disease.
They will score their pain from 1-10 on a Numeric Rating Scale (NRS) and be given a single oromucosal spray dose of Sativex up to every 4 hours for a max of 5 days their NRS pain score will then be recorded one hour after receiving the dose.

Each 100 microlitre Sativex spray contains:

2.7 mg delta-9-tetrahydrocannabinol (THC) and 2.5 mg cannabidiol (CBD).

Each ml contains:

38-44 mg and 35-42 mg of two extracts (as soft extracts) from Cannabis sativa L., folium cum flore (Cannabis leaf and flower) corresponding to 27 mg delta-9-tetrahydrocannabinol and 25 mg cannabidiol.

Extraction solvent: Liquid carbon dioxide.

Excipient(s) with known effect: each 100 microlitre spray also contains up to 0.04 g ethanol.
Intervention code [1] 289482 0
Treatment: Drugs
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 292242 0
Chest pain. using a 10 point Numeric Rating Scale NRS. The patients will be asked to give a score proir to administation of the spray and 1 hour afterwards.
Timepoint [1] 292242 0
Outcome is assessed one hour after administration of every spray received over the 5 day intervention period or until pain is relieved completely.
Secondary outcome [1] 308522 0
Nil
Timepoint [1] 308522 0
Nil

Eligibility
Key inclusion criteria
In this initial trial the treatment group will be patients admitted to Waikato Hospital Emergency Department or Cardiology department, who are known to suffer from intractable coronary disease
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
– Hypersensitivity to cannabinoids
– History of Schizophrenia
– Pregnant or breast feeding mothers

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1 / Phase 2
Type of endpoint/s
Pharmacodynamics
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/07/2014
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment outside Australia
Country [1] 6079 0
New Zealand
State/province [1] 6079 0
Waikato

Funding & Sponsors
Funding source category [1] 289314 0
Self funded/Unfunded
Name [1] 289314 0
Country [1] 289314 0
Primary sponsor type
Individual
Name
Dr Adrian Owen
Address
Waikato Hospital
Pembroke Street
Private Bag 3200
Hamilton 3240
NEW ZEALAND
Country
New Zealand
Secondary sponsor category [1] 287985 0
None
Name [1] 287985 0
Address [1] 287985 0
Country [1] 287985 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 291088 0
HDEC
Ethics committee address [1] 291088 0
Health and Disability Ethics Committees
C/- MEDSAFE, Level 6, Deloitte House
10 Brandon Street
PO Box 5013
Wellington
6145
Ethics committee country [1] 291088 0
New Zealand
Date submitted for ethics approval [1] 291088 0
17/06/2014
Approval date [1] 291088 0
Ethics approval number [1] 291088 0
NZ/1/E69504

Summary
Brief summary
Currently treatment for patients with longstanding chest pain caused by blockage of the blood supply to the heart is often ineffective.

This trial will be to see if a spray under the tongue of a cannabis extract will help to relieve their pain. It is already used for chronic pain associated with cancer.
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 62 62 0 0
/AnzctrAttachments/366438-Ethics form.pdf
Attachments [2] 69 69 0 0
/AnzctrAttachments/366438-Trial_proposal_2[1].doc

Contacts
Principal investigator
Name 48810 0
Dr Adrian Owen
Address 48810 0
Waikato Hospital
Pembroke Street
Private Bag 3200
Hamilton 3240
NEW ZEALAND
Country 48810 0
New Zealand
Phone 48810 0
+6421803229
Fax 48810 0
Email 48810 0
[email protected]
Contact person for public queries
Name 48811 0
Dr Adrian Owen
Address 48811 0
Waikato Hospital
Pembroke Street
Private Bag 3200
Hamilton 3240
NEW ZEALAND
Country 48811 0
New Zealand
Phone 48811 0
6421803229
Fax 48811 0
Email 48811 0
[email protected]
Contact person for scientific queries
Name 48812 0
Dr Adrian Owen
Address 48812 0
Waikato Hospital
Pembroke Street
Private Bag 3200
Hamilton 3240
NEW ZEALAND
Country 48812 0
New Zealand
Phone 48812 0
6421803229
Fax 48812 0
Email 48812 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.