Conversion to Embeda With Rescue Trial

Stopped early · Phase 4

Conditions studied: Chronic Disease, Pain

In brief

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.

Key facts

Study ID

NCT01179191

Run by

Pfizer

People needed

684

Starts

2010-08-01

Expected to finish

2011-04-01

Last updated by the study team

2012-10-11

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Office of David McLain — Birmingham, Alabama, United States
• Monte Sano Clinical Research, LLC — Huntsville, Alabama, United States
• Tennessee Valley Pain Consultants Properties, LLC — Huntsville, Alabama, United States
• Sunbelt Research Group, LLC — Mobile, Alabama, United States
• Office of Vaughn H. Mancha, Jr., PC — Montgomery, Alabama, United States
• Dedicated Clinical Research — Goodyear, Arizona, United States
• Dedicated Clinical Research, Inc — Phoenix, Arizona, United States
• Redpoint Research — Phoenix, Arizona, United States
• Anasazi Internal Medicine, PC — Phoenix, Arizona, United States
• Cochise Clinical Research — Sierra Vista, Arizona, United States
• Premiere Phamaceutical Research, LLC — Tempe, Arizona, United States
• Quality of Life Medical and Research Center, LLC — Tucson, Arizona, United States
• Ouachita Regional Pain Management — Hot Springs, Arkansas, United States
• NEA Baptist Clinic — Jonesboro, Arkansas, United States
• Hollis Family Medical Clinic, PLC — Paragould, Arkansas, United States
• CSI Clinical Trials — Costa Mesa, California, United States
• Global Wellness Medical Corporation — Foothill Ranch, California, United States
• Chrishard Medical Group — Inglewood, California, United States
• Triwest Research Associates LLC — La Mesa, California, United States
• Pacific Coast Pain Management Center — Laguna Hills, California, United States
• Valerius Medical Group and Research Center of Greater Long Beach, Inc. — Long Beach, California, United States
• LA Pain & Wellness Institute — Los Angeles, California, United States
• Samaritan Center for Medical Research — Los Gatos, California, United States
• Newport Beach Clinical Research Associates, Inc. — Newport Beach, California, United States
• Adamsville Family Medicine — Adamsville, Alabama, United States

Full record on ClinicalTrials.gov

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