Status:
COMPLETED
A Efficacy and Safety Trial of Controlled Release (CR) Morphine in Cancer Patients
Lead Sponsor:
Egalet Ltd
Conditions:
Pain
Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 we...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2008
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT00446069
Start Date
August 1 2007
End Date
August 1 2008
Last Update
August 29 2016
Active Locations (8)
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1
Site 51
Kaunas, Lithuania
2
Site 50
Vilnius, Lithuania
3
Site 63
Bielsko-Biaia, Poland
4
Site 60
Bydgoszcz, Poland