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Completed

NCT Number: NCT00446069

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

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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Key information

Conditions

Pain Cancer Neoplasms Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Site 51, Kaunas, Lithuania

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Morphine sulphate

Drug

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

Primary outcomes

  1. Use of rescue medication

    Time frame: 2 weeks treatment

Secondary outcomes

  1. Pain intensity

    Time frame: 2 weeks treatment

Sponsors and collaborators

Lead sponsor

Egalet Ltd

Industry

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Mar 12, 2007
Registry last updated
Aug 29, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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