cancer patients MedDRA version: 8.1 Level: LLT Classification code 10058019 Term: Cancer pain
Conditions
Interventions
Product Name: Morphine Egalet® Formulation 30 mg
Pharmaceutical Form: Capsule*
INN or Proposed INN: morphine sulphate
CAS Number: 6211-15-0
Other descriptive name: MORPHINE SULPHATE
Concentration unit
Sponsors
Egalet a/s
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. 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. 2. The patient has opioid-sensitive pain caused by active cancer. 3. The patient is aged minimum 18 years. 4. The patient has the ability to comprehend and communicate effectively with the Investigator and staff. 5. The patient has provided written informed consent. 6. The patient has the ability to comply with all trial requirements. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. The patient has a life expectancy less than 2 months. 2. The patient has received chemotherapy less than 4 weeks prior to entering run-in phase 3. The patient has received radiation therapy less than 4 weeks prior to entering run-in phase 4. The patient plans to undergo radiation or chemotherapy or other non-pharmacological treatments with potential analgesic effect during the study. 5. Patients with medical conditions contraindicating morphine treatment: known hypersensitivity to morphine or any other component of the study drug, severe broncial asthma or obstructive airway disease, respiratory depression, increased intracranial pressure, paralytic ileus or gastrointestinal obstruction. 6. The patient has untreated psychiatric disease. 7. The patient has hepatic disease defined as a Child-Pugh score > 9 (i.e., Class C). 8. The patient has impaired kidney function (creatinine clearance less than 60 mL/min reported by the central laboratory). 9. The patient has a hematocrit less than 0.30. 10. The patient has a condition severely affecting gastrointestinal absorption. 11. The patient is taking monoamine oxidase inhibitors (MAOIs) or has taken a MAOI within two weeks prior to entering baseline. 12. The patient is taking other opiod agonists or antagonists, zidovudine or cimetidine. 13. Patients taking benzodiazepines, barbiturates, phenothiazines, chloralhydrat or tricyclic antidepressants can only be included if the dose has been stable for 2 weeks pritor to the randomization visit and if the dose is expected to remain stable throughout the study. 14. The patient has a current alcohol or drug abuse or a history of alcohol or drug abuse within the past 24 months. 15. Pregnant or lactating women. Female subjects of childbearing potential must use an adequate form of contraception (i.e., oral contraceptive pill, hormonal implant, IUD or double barrier method) and have a negative urine pregnancy test at screening.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this trial is to evaluate the efficacy of Morphine Egalet® formulation 30-240 mg once daily compared to MST Continus 15-120 mg twice daily after 2 weeks of treatment.;Secondary Objective: The secondary objective of this trial is to evaluate the safety and tolerability of Morphine Egalet® formulation compared to MST Continus after 2 weeks of treatment.;Primary end point(s): Use of rescue medication. The patient will record each dose (number of capsules and time of dosing) in the patient diary during the run-in phase and each treatment phase. Use of rescue medication on the last 7 days of each treatment period (exclusive the visit day) will be used for the efficacy analysis. Use of rescue medication during the last 3 days of the run-in phase will serve as statistical baseline for both treatment periods. | — |
Countries
Lithuania
Outcome results
None listed