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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00446069
Recruitment Status : Completed
First Posted : March 12, 2007
Last Update Posted : August 29, 2016
Sponsor:
Information provided by (Responsible Party):
Egalet Ltd

Brief 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.

Condition or disease Intervention/treatment Phase
Pain Cancer Drug: Morphine Sulphate Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
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 Start Date : August 2007
Actual Primary Completion Date : June 2008
Actual Study Completion Date : August 2008

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Egalet® morphine 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

Active Comparator: MST Continus® 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




Primary Outcome Measures :
  1. Use of rescue medication [ Time Frame: 2 weeks treatment ]

Secondary Outcome Measures :
  1. Pain intensity [ Time Frame: 2 weeks treatment ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00446069


Locations
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Lithuania
Site 51
Kaunas, Lithuania
Site 50
Vilnius, Lithuania
Poland
Site 63
Bielsko-Biaia, Poland
Site 60
Bydgoszcz, Poland
Site 62
Poznań, Poland
Site 61
Warszawa, Poland
Site 64
Wrocław, Poland
Site 65
Włocławek, Poland
Sponsors and Collaborators
Egalet Ltd
Investigators
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Study Director: Christine Andersen, MSc Pharm Egalet A/S

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Responsible Party: Egalet Ltd
ClinicalTrials.gov Identifier: NCT00446069    
Other Study ID Numbers: MP-EG-002
EudraCT number: 2006-006579-19
First Posted: March 12, 2007    Key Record Dates
Last Update Posted: August 29, 2016
Last Verified: August 2016
Additional relevant MeSH terms:
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Morphine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents