Pain, Cancer
Conditions
Brief summary
The purpose of the study is to determine the effect of Egalet® Morphine once daily compared to MST Continus twice daily on pain intensity and use of rescue medication for break through pain after 2 weeks of treatment in patients with pain due to cancer.
Interventions
Egalet® morphine, Controlled Release 30 mg Oral tablet once daily for 2 weeks and MST Continus® 15 mg twice daily for 2 weeks
Sponsors
Egalet Ltd
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* The patient has stable strong opioid use equipotent to 30-240 mg oral morphine sulphate daily for a minimum of 2 weeks prior to entering the run-in phase. * The patient has opioid-sensitive pain caused by active cancer. * The patient is aged minimum 18 years.
Exclusion criteria
* The patient has a life expectancy less than 2 months. * The patient has received chemotherapy or radiation therapy less than 4 weeks prior to entering run-in phase * Patients with medical conditions contraindicating morphine treatment * The patient has hepatic disease or impaired kidney function * The patient is taking monoamine oxidase inhibitors (MAOIs) or has taken a MAOI within two weeks prior to entering baseline. * The patient is taking other opioid agonists or antagonists, zidovudine or cimetidine.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Use of rescue medication | 2 weeks treatment |
Secondary
| Measure | Time frame |
|---|---|
| Pain intensity | 2 weeks treatment |
Countries
Lithuania, Poland
Outcome results
None listed