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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.

Phase 3
Completed
Conditions
Opioids in Refractory dyspnoea
Respiratory - Other respiratory disorders / diseases
Registration Number
ACTRN12607000075482
Lead Sponsor
Repatriation General Hospital
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
All
Target Recruitment
48
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.

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

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Sensation of dyspnoea as measured on a visual analogue scale[In the evening on the final day of the period (days 4 and 8).]
Secondary Outcome Measures
NameTimeMethod
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