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

Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00446069
• Other study ID #: MP-EG-002
• Secondary ID: EudraCT number:
• Status: Completed
• Phase: Phase 2
• First received: March 9, 2007
• Last updated: August 26, 2016
• Start date: August 2007
• Est. completion date: August 2008

Study information

• Verified date: August 2016
• Source: Egalet Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: Lithuania: State Medicine Control Agency - Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: August 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Cancer
• Pain

Intervention

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

Locations

Country	Name	City	State
Lithuania	Site 51	Kaunas
Lithuania	Site 50	Vilnius
Poland	Site 63	Bielsko-Biaia
Poland	Site 60	Bydgoszcz
Poland	Site 62	Poznan
Poland	Site 61	Warszawa
Poland	Site 65	Wloclawek
Poland	Site 64	Wroclaw

Sponsors (1)

Lead Sponsor	Collaborator
Egalet Ltd

Countries where clinical trial is conducted

Lithuania,  Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Use of rescue medication		2 weeks treatment	No
Secondary	Pain intensity		2 weeks treatment	No