Status:
TERMINATED
Conversion to Embeda With Rescue Trial
Lead Sponsor:
Pfizer
Conditions:
Chronic Disease
Pain
Eligibility:
All Genders
21+ years
Phase:
PHASE4
Brief Summary
The purpose of the research study is to find out if opioid dependent chronic pain patients who are judged by their physician to be eligible to change their current opioid medicine and to participate i...
Detailed Description
The decision to terminate the trial was based on a lack of study drug supply. The decision was not based on any safety concerns. The termination letter was sent on 11March2011.
Eligibility Criteria
Inclusion
- Be able to read, speak and understand English
- Have chronic moderate to severe pain for at least 3 months
- Require around the clock opioid medication for the relief of pain
- Have been taking a daily opioid for at least 30 days prior to starting the study
- Be able to be safely switched to a different pain medication
- Be practicing acceptable birth control methods for female patients of childbearing potential
- Be willing to participate in the study and able to comply with study procedures
Exclusion
- Be currently diagnosed with or participating in and/or seeking treatment for opioid and/or alcohol abuse
- Be allergic or intolerant to morphine, morphine salts, naltrexone or other opioids
- Be currently taking tramadol and/or extended release morphine products
- Have respiratory depression
- Have acute or severe bronchial asthma or severe chronic obstructive pulmonary disease
- Have migraines as your main source of pain
- Have any form of bowel obstruction
- Be pregnant or breast feeding
- Have had 2 or more surgeries for low back pain
- Be planning a major surgery during the study
- Be staying in a hospital or nursing home
- Be planning to have steroid injections for your chronic pain during the study
- Have a life expectancy of less than 2 months
Key Trial Info
Start Date :
August 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2011
Estimated Enrollment :
684 Patients enrolled
Trial Details
Trial ID
NCT01179191
Start Date
August 1 2010
End Date
April 1 2011
Last Update
October 11 2012
Active Locations (166)
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1
Adamsville Family Medicine
Adamsville, Alabama, United States, 35005
2
Office of David McLain
Birmingham, Alabama, United States, 35209
3
Monte Sano Clinical Research, LLC
Huntsville, Alabama, United States, 35801
4
Tennessee Valley Pain Consultants Properties, LLC
Huntsville, Alabama, United States, 35801