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

Active, not recruiting

• Conditions: cancer patients; MedDRA version: 8.1Level: LLTClassification code 10058019Term: Cancer pain

• Registration Number: EUCTR2006-006579-19-LT
• Lead Sponsor: Egalet a/s

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-01-30
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: All
• Target Recruitment: 60

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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified