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Trial registered on ANZCTR


Registration number
ACTRN12610000783022
Ethics application status
Approved
Date submitted
9/09/2010
Date registered
21/09/2010
Date last updated
21/09/2010
Type of registration
Prospectively registered

Titles & IDs
Public title
Cannabis-Based Medicine (Sativex) in the Treatment of Pain in Kidney Failure
Scientific title
The Efficacy and Tolerability of Cannabis-Based Medicine (Sativex) in the Treatment of Pain and Symptom Burden in End Stage Renal Disease: A double-blind, randomized, placebo-controlled study
Secondary ID [1] 969 0
CRG090800150 (Cochrane Renal Group)
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
End stage renal disease 243630 0
Chronic pain 258156 0
Condition category
Condition code
Renal and Urogenital 258335 258335 0 0
Kidney disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A battery of tests will be completed at the baseline assessment (following a 7 day run-in period), prior to the first dose of Sativex. This will include the modified Edmonton Symptom asse3ssment Scale that uses a 0-10 numerical rating scale (NRS) to assess 10 common symptoms, the Beck Depression inventory, the Brief Pain Inventory, the Pittsburgh Sleep Quality Index, and the Short Blessed Orientation-Memory-Concentration test. Vital signs will be recorded. Participants will then receive their first dose of Sativex and dosing instructions from the study nurse. The patients will then take the medication home with them for a 21 day treatment period. Sativex is a sublingual buccal spray. Dosing will start at 2 doses (sprays)/day and then be titrated by patients depending upon need. The study nurse will follow-up with the patient either while on dialysis or over the telephone at least every 2 days to review their doses, pain severity, and assess for any adverse effects of the drug. During the telephone follow-up, patients will be advised to optimize dosing when suboptimal benefit has been achieved (suboptimal being defined as = 4/10 on NRS or considered suboptimal by the patient). Patients will be asked to keep a daily log of pain scores, time and dose of study medication, time and use of any other analgesics.
Intervention code [1] 257177 0
Treatment: Drugs
Comparator / control treatment
As above but randomized to a matched placebo identical in appearance and taste but without active ingredients.
Control group
Placebo

Outcomes
Primary outcome [1] 240708 0
1. Change in mean numerical rating scale (NRS) pain score of 30% from baseline to end of study
Timepoint [1] 240708 0
21 days after start of intervention
Secondary outcome [1] 257364 0
Change in use of escape analgesia for those patients on opioids. This will be assessed by determining the average daily morphine equivalent in the last 3 days of intervention; i.e. days 19-21 inclusive after starting the intervention.
Timepoint [1] 257364 0
21 days after start of intervention
Secondary outcome [2] 265544 0
Brief pain inventory. This determines maximum, minimum and average pain intensity as well as the impact of pain on activities of daily living.
Timepoint [2] 265544 0
21 days after start of intervention
Secondary outcome [3] 265545 0
Nausea (0-10 NRS), Appetite (0-10 NRS), Pruritis (0-10 NRS),
and total symptom burden (using the Modified Edmonton Symptom Assessment System)
Timepoint [3] 265545 0
21 days after start of intervention
Secondary outcome [4] 265546 0
Sleep (0-10 NRS and the Pittsburgh Sleep Quality Index)
Timepoint [4] 265546 0
21 days after start of intervention
Secondary outcome [5] 265547 0
Depression (0-10 NRS and the Beck Depression Inventory)
Timepoint [5] 265547 0
21 days after start of intervention
Secondary outcome [6] 265548 0
Quality of life (Kidney Disease Quality of Life Questionnaire)
Timepoint [6] 265548 0
21 days after start of intervention
Secondary outcome [7] 265549 0
Cognition/Memory: Short Blessed Orientation-Memory-Concentration test
Timepoint [7] 265549 0
21 days after start of intervention
Secondary outcome [8] 265550 0
Adverse events via a questionnaire that assesses for complications such as nausea, vomiting, constipation, mood changes, euphoria, dizziness, mouth ulcers, and hallucinations
Timepoint [8] 265550 0
21 days after start of intervention

Eligibility
Key inclusion criteria
1. ESRD on chronic dialysis (greater than or equal to 3 months)

2. Moderate to severe daily pain (greater than or equal to 4 on 0-10 Numerical Rating Scale (NRS))

a. Receiving no opioids

b. Receiving opioids (for at least 14 days prior to the screening visit) but pain not adequately relieved

c. If receiving analgesics, no increase in analgesic dose for the past 14 days.

3. No cannabinoid use for at least 7 days before screening and during the course of the study

4. Stable dry weight for the past 2 weeks

5. Have given written, informed consent
Minimum age
18 Years
Maximum age
99 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. No history of myocardial infarction or stroke

2. > 3 of the last 6 post hemodialysis blood pressure readings greater than or equal to 160/100 mmHg (or mean arterial pressure (MAP) of 120 mmHg)

3. > 3 of the last 6 post hemodialysis blood pressure readings of greater than or equal to 100/55 mmHg (or MAP of 70)

4. History of psychosis or psychiatric disorder other than depression

5. History or suspicion of substance abuse

6. Cancer of the oral cavity

7. Scheduled procedures requiring general anesthesia during the study (4 weeks)

8. Taking levodopa or the immunosuppressives cyclosporine or tacrolimus

9. Known or suspected hypersensitivity to cannabinoids

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)
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
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/03/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment outside Australia
Country [1] 1983 0
Canada
State/province [1] 1983 0

Funding & Sponsors
Funding source category [1] 257626 0
Hospital
Name [1] 257626 0
Northern Alberta Renal program
Country [1] 257626 0
Canada
Primary sponsor type
Hospital
Name
Northern Alberta Renal Program
Address
11-107 Clinical Sciences Building
8440 112 st NW
Edmonton, Alberta T6G 2B7
Country
Canada
Secondary sponsor category [1] 256847 0
University
Name [1] 256847 0
University of Alberta
Address [1] 256847 0
8440 112 st NW
Edmonton, Alberta T6G 2B7
Country [1] 256847 0
Canada

Ethics approval
Ethics application status
Approved

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

Contacts
Principal investigator
Name 30118 0
Address 30118 0
Country 30118 0
Phone 30118 0
Fax 30118 0
Email 30118 0
Contact person for public queries
Name 13365 0
Dr, Sara Nicola, Davison
Address 13365 0
Associate Professor, Medicine, University of Alberta, 11-107 CSB Edmonton AB Cabada T6G 2G3
Country 13365 0
Canada
Phone 13365 0
1 780 407 8716
Fax 13365 0
Email 13365 0
sara.davison@ualberta.ca
Contact person for scientific queries
Name 4293 0
Jeannine Flores
Address 4293 0
11-107 Clinical Sciences Building
8440 112 St NW
Edmonton AB T6G 2B7
Country 4293 0
Canada
Phone 4293 0
1 780 407 8716
Fax 4293 0
Email 4293 0
jeannineflores@ualberta.ca

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.