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

This study has been completed.
Sponsor:
Information provided by:
Egalet a/s
ClinicalTrials.gov Identifier:
NCT00446069
First received: March 9, 2007
Last updated: September 3, 2008
Last verified: September 2008
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


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
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

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
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 a/s
Investigators
Study Director: Christine Andersen, MSc Pharm Egalet a/s
  More Information

No publications provided

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

Additional relevant MeSH terms:
Morphine
Analgesics
Analgesics, Opioid
Central Nervous System Agents
Central Nervous System Depressants
Narcotics
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014