Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

Tracking Information
First Submitted Date  ICMJE March 9, 2007
First Posted Date  ICMJE March 12, 2007
Last Update Posted Date August 29, 2016
Study Start Date  ICMJE August 2007
Actual Primary Completion Date June 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 4, 2008)
Use of rescue medication [ Time Frame: 2 weeks treatment ]
Original Primary Outcome Measures  ICMJE
 (submitted: March 9, 2007)
Use of rescue medication
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 4, 2008)
Pain intensity [ Time Frame: 2 weeks treatment ]
Original Secondary Outcome Measures  ICMJE
 (submitted: March 9, 2007)
Pain intensity
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Efficacy and Safety Trial of Controlled Release (CR) Morphine in Cancer Patients
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Pain
  • Cancer
Intervention  ICMJE 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
Study Arms  ICMJE
  • Experimental: Egalet® morphine
    Intervention: Drug: Morphine Sulphate
  • Active Comparator: MST Continus®
    Intervention: Drug: Morphine Sulphate
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 9, 2007)
36
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2008
Actual Primary Completion Date June 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Lithuania,   Poland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00446069
Other Study ID Numbers  ICMJE MP-EG-002
EudraCT number: 2006-006579-19
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Egalet Ltd
Study Sponsor  ICMJE Egalet Ltd
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Christine Andersen, MSc Pharm Egalet A/S
PRS Account Egalet Ltd
Verification Date August 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP