- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00446069
A Efficacy and Safety Trial of Controlled Release (CR) Morphine in Cancer Patients
August 26, 2016 updated by: Egalet Ltd
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
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
36
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Egalet® morphine
|
Egalet® morphine, Controlled Release 30 mg Oral tablet once daily for 2 weeks and MST Continus® 15 mg twice daily for 2 weeks
|
Active Comparator: MST Continus®
|
Egalet® morphine, Controlled Release 30 mg Oral tablet once daily for 2 weeks and MST Continus® 15 mg twice daily for 2 weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Use of rescue medication
Time Frame: 2 weeks treatment
|
2 weeks treatment
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Pain intensity
Time Frame: 2 weeks treatment
|
2 weeks treatment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Christine Andersen, MSc Pharm, Egalet A/S
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2007
Primary Completion (Actual)
June 1, 2008
Study Completion (Actual)
August 1, 2008
Study Registration Dates
First Submitted
March 9, 2007
First Submitted That Met QC Criteria
March 9, 2007
First Posted (Estimate)
March 12, 2007
Study Record Updates
Last Update Posted (Estimate)
August 29, 2016
Last Update Submitted That Met QC Criteria
August 26, 2016
Last Verified
August 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MP-EG-002
- EudraCT number: 2006-006579-19
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Pain
-
Flowonix MedicalApproved for marketingBack Pain | Leg Pain | Trunk Pain | Intractable Pain | Arm Pain
-
University Hospital Schleswig-HolsteinZealand University Hospital; European Regional Development Fund; Design School...CompletedPain, Acute | Pain, Chronic | Pain Measurement | Pain, CancerGermany
-
Dow University of Health SciencesRecruitingLow Back Pain | Chronic Low-back Pain | Low Back Pain, Mechanical | Mechanical Low Back Pain | Pain, Chronic | Pain, Back | Lower Back Pain Chronic | CLBP - Chronic Low Back PainPakistan
-
Universitat Jaume ICompletedPain, Acute | Pain, Chronic | OncologySpain
-
Dr. Negrin University HospitalCompletedPostoperative Pain, Acute | Postoperative Pain, ChronicSpain
-
George Washington UniversityRecruitingCervical Fusion | Pain, Back | Pain, Neck | Myofacial PainUnited States
-
University of Campinas, BrazilCompletedPREGNANCY | LUMBAR BACK PAIN | PELVIC PAIN
-
Atatürk Chest Diseases and Chest Surgery Training...RecruitingPostoperative Pain | Postoperative Pain, Acute | Postoperative Pain, Chronic | VATSTurkey
-
Janssen Research & Development, LLCCompletedPain, Radiating | Pain, Burning | Pain, Crushing | Pain, Migratory | Pain, SplittingUnited States, France, Spain, Poland, Portugal
-
susanne beckerSNSFCompletedLow Back Pain | Pain, Acute | Pain, ChronicSwitzerland
Clinical Trials on Morphine Sulphate
-
Mundipharma Research LimitedCompleted
-
Papworth Hospital NHS Foundation TrustTerminated
-
Assiut UniversityUnknownMajor Abdominal SurgeriesEgypt
-
Istanbul UniversityCompleted
-
Cukurova UniversityCompleted
-
Nova Scotia Health AuthorityCanadian Institutes of Health Research (CIHR); Nova Scotia Health Research... and other collaboratorsCompletedChronic Obstructive Pulmonary Disease (COPD)Canada
-
Mundipharma Korea LtdCompleted
-
Assiut UniversityCompletedChronic Pain | Acute PainEgypt
-
St Vincent's University Hospital, IrelandUnknownPain | Liver DysfunctionIreland
-
University Health Network, TorontoCanadian Society of Hospital PharmacistsWithdrawn