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Trial registered on ANZCTR


Registration number
ACTRN12607000075482
Ethics application status
Approved
Date submitted
16/01/2007
Date registered
23/01/2007
Date last updated
30/09/2009
Type of registration
Retrospectively registered

Titles & IDs
Public title
A prospective, randomized, placebo-controlled, double-blind, cross-over study of the usefulness of sustained-release opioids in the subjective sensation of dyspnoea secondary to advanced disease with no reversible components in opioid naive patients.
Scientific title
A prospective, randomized, placebo-controlled, double-blind, cross-over study of the usefulness of sustained-release opioids in the subjective sensation of dyspnoea secondary to advanced disease with no reversible components in opioid naive patients.
Universal Trial Number (UTN)
Trial acronym
Opioids in Dyspnoea study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Opioids in Refractory dyspnoea 1567 0
Condition category
Condition code
Respiratory 1668 1668 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients will be randomized in a double-blind fashion by the pharmacy’s central randomization service at The Repatriation General Hospital.
Each patient will be randomized to receive either a once-daily single 20mg KapanolTM capsule for 4 days followed 4 days of a once-daily single placebo capsule or vice versa. Patients will also receive 1-2 coloxyl with sennaTM tablets daily as prophylactic measure against constipation. Patients will be instructed that they can adjust the quantity and type of laxative according to response and preference. Medications will be dispensed from the central pharmacy according to the blinded randomization scheme.
Patients may continue any other ongoing dyspnoea management program that has been prescribed for them prior to entering the study, including oxygen, physical therapy, and non-opioid medications.
Since the steady state of five-times Tmax will be reached at 45-60 hours, the maintenance of the study drug for four days will allow sufficient washout time. Analysis will be on days 4 and 8 of the study.
Patients will be reviewed by the study investigators at randomisation, at the cross-over point, and at completion of the study (i.e. Days 0, 4, and 8). In addition, patients will be contacted by phone every 2 days when they are not seen by study investigators (i.e. Days 2 and 6) to follow their progress on the study and to monitor for adverse reactions.
At the completion of the study or if the patient withdraws early, the patient will revert to their previously prescribed dyspnoea management program as they were receiving prior to beginning of the study.
Intervention code [1] 1560 0
Treatment: Drugs
Comparator / control treatment
4 days of a once-daily single placebo capsule
Control group
Placebo

Outcomes
Primary outcome [1] 2308 0
Sensation of dyspnoea as measured on a visual analogue scale
Timepoint [1] 2308 0
In the evening on the final day of the period (days 4 and 8).
Secondary outcome [1] 4028 0
The exercise tolerance using the modified scale and the Modified Medical Research Council of Great Britain
Timepoint [1] 4028 0
While our measurements and analysis will be based upon the data from days 4 and 8, patients are also asked to provide responses once or twice daily to make sure that they are comfortable with the pattern of participation prior to responding on days 4 and 8.
Secondary outcome [2] 4029 0
The degree of sedation using a modified Borg scale
Timepoint [2] 4029 0
While our measurements and analysis will be based upon the data from days 4 and 8, patients are also asked to provide responses once or twice daily to make sure that they are comfortable with the pattern of participation prior to responding on days 4 and 8.
Secondary outcome [3] 4030 0
The overall feeling of well being using a modified Borg scale
Timepoint [3] 4030 0
While our measurements and analysis will be based upon the data from days 4 and 8, patients are also asked to provide responses once or twice daily to make sure that they are comfortable with the pattern of participation prior to responding on days 4 and 8.
Secondary outcome [4] 4031 0
The quality of sleep using a modified Borg scale
Timepoint [4] 4031 0
While our measurements and analysis will be based upon the data from days 4 and 8, patients are also asked to provide responses once or twice daily to make sure that they are comfortable with the pattern of participation prior to responding on days 4 and 8.
Secondary outcome [5] 4032 0
The level of dyspnoea control
Timepoint [5] 4032 0
While our measurements and analysis will be based upon the data from days 4 and 8, patients are also asked to provide responses once or twice daily to make sure that they are comfortable with the pattern of participation prior to responding on days 4 and 8.
Secondary outcome [6] 4033 0
The overall level of dyspnoea using a modified scale from the chronic Respiratory Disease Questionaire
Timepoint [6] 4033 0
While our measurements and analysis will be based upon the data from days 4 and 8, patients are also asked to provide responses once or twice daily to make sure that they are comfortable with the pattern of participation prior to responding on days 4 and 8.

Eligibility
Key inclusion criteria
English speaking. Dyspnoea as a symptom for which no treatment is likely to modify course of disease.Renal function within 2 times of normal as measured by serum creatinine.Able to fill out diary cards.On stable oxygen needs.On stable medications.Willing and able to give informed consent.Both male and female are eligible.
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
On other opioid medications. Confusion and/or obtundation.Uncontrolled nausea or vomiting. True adverse reaction(s) to previous opioidsKnown hypersensitivity to morphine, morphine salts or any of the capsule components.Acute or severe bronchial asthma.Respiratory depression.Gastrointestinal obstruction or biliary colic .Concomitant use of Monoamine Oxidase Inhibitor(s) (MAOIs) in the last 2 weeks.Pregnancy or breast feeding mothers.Past history of substance abuse.

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)
The study will be explained verbally and in writing, and will require the written consent of the involved individual. This will happen within 72 hours of identifying a potentially eligible patient. If, after the study has been explained, the patient later decides not to participate, they can withdraw with no detriment to his/her care. Once enrolled, patient Id number will be supplied to the central pharmacy for treatment allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised generation of allocation sequence in random permuted blocks and blinded disbursement of medicaiton. The placebo medication was identical in appearance and taste to the active medication, the bottle indicated which medication to take each day.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Study participants and investigators/study staff are blinded to the allocation. Central pharmacy will hold the allocation code.
Phase
Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/04/2001
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
48
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1813 0
Hospital
Name [1] 1813 0
Repatriation General Hospital, Southern Adelaide Palliative Services, general research funds
Country [1] 1813 0
Australia
Primary sponsor type
Hospital
Name
Repatriation General Hospital
Address
Country
Australia
Secondary sponsor category [1] 1635 0
None
Name [1] 1635 0
None
Address [1] 1635 0
Country [1] 1635 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3400 0
Repatriation General Hospital
Ethics committee address [1] 3400 0
Ethics committee country [1] 3400 0
Australia
Date submitted for ethics approval [1] 3400 0
Approval date [1] 3400 0
Ethics approval number [1] 3400 0
Ethics committee name [2] 3401 0
Nepean Hospital, Wentworth Area Health Service
Ethics committee address [2] 3401 0
Ethics committee country [2] 3401 0
Australia
Date submitted for ethics approval [2] 3401 0
Approval date [2] 3401 0
Ethics approval number [2] 3401 0

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

Contacts
Principal investigator
Name 27494 0
Address 27494 0
Country 27494 0
Phone 27494 0
Fax 27494 0
Email 27494 0
Contact person for public queries
Name 10749 0
David Currow
Address 10749 0
Southern Adelaide Palliative Services
Repatriation General Hospital
Daw Park SA 5041
Country 10749 0
Australia
Phone 10749 0
+61 8 82751732
Fax 10749 0
+61 8 83744018
Email 10749 0
[email protected]
Contact person for scientific queries
Name 1677 0
David Currow
Address 1677 0
Southern Adelaide Palliative Services
Repatriation General Hospital
Daw Park SA 5041
Country 1677 0
Australia
Phone 1677 0
+61 8 82751732
Fax 1677 0
+61 8 83744018
Email 1677 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

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