A Efficacy and Safety Trial of Controlled Release (CR) Morphine in Cancer Patients
This study has been completed.
Sponsor:
Egalet a/s
Information provided by:
Egalet a/s
ClinicalTrials.gov Identifier:
NCT00446069
First received: March 9, 2007
Last updated: September 3, 2008
Last verified: September 2008
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Pain Cancer |
Drug: Morphine Sulphate |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Supportive Care |
| 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 |
Resource links provided by NLM:
MedlinePlus related topics:
Cancer
Drug Information available for:
Morphine sulfate
U.S. FDA Resources
Further study details as provided by Egalet a/s:
Primary Outcome Measures:
- Use of rescue medication [ Time Frame: 2 weeks treatment ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Pain intensity [ Time Frame: 2 weeks treatment ] [ Designated as safety issue: No ]
| Enrollment: | 36 |
| Study Start Date: | August 2007 |
| Study Completion Date: | August 2008 |
| Primary Completion Date: | June 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Egalet® morphine |
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
|
| Active Comparator: MST Continus® |
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
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00446069
Locations
| Lithuania | |
| Site 51 | |
| Kaunas, Lithuania | |
| Site 50 | |
| Vilnius, Lithuania | |
| Poland | |
| Site 63 | |
| Bielsko-Biaia, Poland | |
| Site 60 | |
| Bydgoszcz, Poland | |
| Site 62 | |
| Poznań, Poland | |
| Site 61 | |
| Warszawa, Poland | |
| Site 64 | |
| Wrocław, Poland | |
| Site 65 | |
| Włocławek, Poland | |
Sponsors and Collaborators
Egalet a/s
Investigators
| Study Director: | Christine Andersen, MSc Pharm | Egalet a/s |
More Information
No publications provided
| Responsible Party: | Lillian Jespersen, CRA/Medical Writer, Egalet |
| ClinicalTrials.gov Identifier: | NCT00446069 History of Changes |
| Other Study ID Numbers: | MP-EG-002, EudraCT number: 2006-006579-19 |
| Study First Received: | March 9, 2007 |
| Last Updated: | September 3, 2008 |
| Health Authority: | Lithuania: State Medicine Control Agency - Ministry of Health |
Additional relevant MeSH terms:
|
Morphine Analgesics, Opioid Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs |
Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Central Nervous System Depressants Narcotics |
ClinicalTrials.gov processed this record on May 23, 2013