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

Phase 2

Completed

• Conditions: Pain; Cancer
• Interventions: Drug: Morphine Sulphate

• Registration Number: NCT00446069
• Lead Sponsor: Egalet Ltd

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 available

Study Timeline

• Study First Submitted: 2007-03-09
• Study First Submitted QC: 2007-03-09
• Study First Posted: 2007-03-12
• Study Start: 2007-08
• Primary Completion: 2008-06
• Study Completion: 2008-08
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-26
• Last Update Posted: 2016-08-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
MST Continus®	Morphine Sulphate	-
Egalet® morphine	Morphine Sulphate	-

Primary Outcome Measures

Name	Time	Method
Use of rescue medication	2 weeks treatment

Secondary Outcome Measures

Name	Time	Method
Pain intensity	2 weeks treatment

Trial Locations

Locations (8)

Site 51; 🇱🇹 Kaunas, Lithuania

Site 62; 🇵🇱 Poznań, Poland

Site 64; 🇵🇱 Wrocław, Poland

Site 65; 🇵🇱 Włocławek, Poland

Site 63; 🇵🇱 Bielsko-Biaia, Poland

Site 60; 🇵🇱 Bydgoszcz, Poland

Site 50; 🇱🇹 Vilnius, Lithuania

Site 61; 🇵🇱 Warszawa, Poland