A Efficacy and Safety Trial of Controlled Release (CR) Morphine in Cancer Patients

Egalet

Status and phase: Completed; Phase 2

Conditions: Cancer; Pain

Treatments: Drug: Morphine Sulphate

Study type: Interventional

Funder types: Industry

Identifiers

NCT00446069

MP-EG-002

EudraCT number: 2006-006579-19

Details and patient eligibility

About

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.

Enrollment: 36 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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36 participants in 2 patient groups

Egalet® morphine

Experimental group

Treatment:

Drug: Morphine Sulphate

MST Continus®

Active Comparator group

Treatment:

Drug: Morphine Sulphate