A Double-Blind, Randomized, 2-Way Cross-Over, Phase II, Efficacy Trial in Cancer Patients to Assess the Overall Efficacy, Patient Preference, Morphine Related Side Effect Profile and Safety of the Egalet® Controlled Release Morphine Formulation 30-240 mg Once Daily Compared to MST Continus® 15-120 mg Twice Daily After 2 Weeks of Treatment
- 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.
- 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.
Type of Study:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care
Use of rescue medication
Outcome Time Frame:
2 weeks treatment
Christine Andersen, MSc Pharm
Lithuania: State Medicine Control Agency - Ministry of Health