Clinical Trials Directory

Trials / Completed

CompletedNCT00446069

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

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

Status
Completed
Phase
Phase 2
Study type
Interventional
Enrollment
36 (actual)
Sponsor
Egalet Ltd · Industry
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

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

Timeline

Start date
2007-08-01
Primary completion
2008-06-01
Completion
2008-08-01
First posted
2007-03-12
Last updated
2016-08-29

Locations

8 sites across 2 countries: Lithuania, Poland

Source: ClinicalTrials.gov record NCT00446069. Inclusion in this directory is not an endorsement.