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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-08-31

Study Completion Date

2008-08-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Pain Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Egalet® morphine

Group Type EXPERIMENTAL

Morphine Sulphate

Intervention Type DRUG

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®

Group Type ACTIVE_COMPARATOR

Morphine Sulphate

Intervention Type DRUG

Egalet® morphine, Controlled Release 30 mg Oral tablet once daily for 2 weeks and MST Continus® 15 mg twice daily for 2 weeks

Interventions

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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

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No