A Efficacy and Safety Trial of Controlled Release (CR) Morphine in Cancer Patients
Information source: Egalet a/s
Information obtained from ClinicalTrials.gov on August 08, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pain; Cancer
Intervention: Morphine Sulphate (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: Egalet a/s Official(s) and/or principal investigator(s):
Christine Andersen, MSc Pharm, Study Director, Affiliation: Egalet a/s
Overall contact:
Lillian Jespersen, MSc, Phone: +4544478080, Email: lj@egalet.com
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 weeks of treatment in patients with pain due to cancer.
Clinical Details
Official title: 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
Study design: Supportive Care, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Active Control, Crossover Assignment, Safety/Efficacy Study
Primary outcome: Use of rescue medication
Secondary outcome: Pain intensity
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Lillian Jespersen, MSc, Phone: +4544478080, Email: lj@egalet.com
Site 50, Vilnius, Lithuania; Recruiting
Site 51, Kaunas, Lithuania; Active, not recruiting
Site 60, Bydgoszcz, Poland; Recruiting
Site 61, Warszawa, Poland; Recruiting
Site 62, Poznań, Poland; Recruiting
Site 63, Bielsko-Biaia, Poland; Recruiting
Site 64, Wrocław, Poland; Recruiting
Site 65, Włocławek, Poland; Recruiting
Additional Information
Starting date: August 2007
Ending date: August 2008
Last updated: May 13, 2008
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