A Efficacy and Safety Trial of Controlled Release (CR) Morphine in Cancer Patients - Full Text View

Sponsored by:	Egalet a/s
Information provided by:	Egalet a/s
ClinicalTrials.gov Identifier:	NCT00446069

Purpose

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.

Condition	Intervention	Phase
Pain Cancer	Drug: Morphine Sulphate	Phase II

MedlinePlus related topics: Cancer

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Supportive Care, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Active Control, Crossover Assignment, Safety/Efficacy Study
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

Further study details as provided by Egalet a/s:

Primary Outcome Measures:

Use of rescue medication [ Time Frame: 2 weeks treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Pain intensity [ Time Frame: 2 weeks treatment ] [ Designated as safety issue: No ]

Enrollment:	36
Study Start Date:	August 2007
Study Completion Date:	August 2008
Primary Completion Date:	June 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Egalet® morphine: Experimental	Drug: Morphine Sulphate Egalet® morphine, Controlled Release 30 mg Oral tablet once daily for 2 weeks and MST Continus® 15 mg twice daily for 2 weeks
MST Continus®: Active Comparator	Drug: Morphine Sulphate Egalet® morphine, Controlled Release 30 mg Oral tablet once daily for 2 weeks and MST Continus® 15 mg twice daily for 2 weeks

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00446069

Locations

Lithuania
Site 50
Vilnius, Lithuania
Site 51
Kaunas, Lithuania
Poland
Site 60
Bydgoszcz, Poland
Site 61
Warszawa, Poland
Site 65
Włocławek, Poland
Site 63
Bielsko-Biaia, Poland
Site 64
Wrocław, Poland
Site 62
Poznań, Poland

Sponsors and Collaborators

Egalet a/s

Investigators

Study Director:

Christine Andersen, MSc Pharm

Egalet a/s

More Information

Responsible Party:	Egalet ( Lillian Jespersen, CRA/Medical Writer )
Study ID Numbers:	MP-EG-002, EudraCT number: 2006-006579-19
Study First Received:	March 9, 2007
Last Updated:	September 3, 2008
ClinicalTrials.gov Identifier:	NCT00446069
Health Authority:	Lithuania: State Medicine Control Agency - Ministry of Health

Study placed in the following topic categories:

Morphine
Pain

Additional relevant MeSH terms:

Sensory System Agents
Therapeutic Uses
Physiological Effects of Drugs
Central Nervous System Depressants
Narcotics

Peripheral Nervous System Agents
Analgesics
Central Nervous System Agents
Pharmacologic Actions
Analgesics, Opioid

ClinicalTrials.gov processed this record on January 16, 2009