Conversion to Embeda With Rescue Trial
TerminatedPhase 4NCT01179191
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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 in this study can be successfully adjusted to a stable dose of EMBEDA (morphine sulfate and naltrexone hydrochloride). The study will also assess each patient's risk for prescription opioid abuse, misuse and diversion.
Study details
- Official title
- A Multi-Center, Primary Care-Based, Open-Label Study to Assess the Success of Converting Opioid-Experienced Patients, With Chronic, Moderate to Severe Pain, to EMBEDA Using a Standardized Conversion Guide, and to Identify Behaviors Related to Prescription Opioid Abuse, Misuse, and Diversion
- Conditions
- Interventions
- Drug: morphine sulfate and naltrexone hydrochloride (EMBEDA)
- Sponsor
- Pfizer
- Start date
- 2010-08
- Primary completion
- 2011-04
- Sex
- All
- Age range
- from 21 Years
- Results posted
- Yes, on ClinicalTrials.gov
- Countries
- United States
- Total sites listed
- 166
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * 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 Criteria: * 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
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT01179191