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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


Phase 2
18 Years
N/A
Not Enrolling
Both
Pain, Cancer

Thank you

Trial Information

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


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.

Type of Study:

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

Outcome Measure:

Use of rescue medication

Outcome Time Frame:

2 weeks treatment

Safety Issue:

No

Principal Investigator

Christine Andersen, MSc Pharm

Investigator Role:

Study Director

Investigator Affiliation:

Egalet a/s

Authority:

Lithuania: State Medicine Control Agency - Ministry of Health

Study ID:

MP-EG-002

NCT ID:

NCT00446069

Start Date:

August 2007

Completion Date:

August 2008

Related Keywords:

  • Pain
  • Cancer

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