Conversion to Embeda With Rescue Trial
- Conditions
- Chronic DiseasePain
- Interventions
- Registration Number
- NCT01179191
- Lead Sponsor
- Pfizer
- 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 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.
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 684
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description morphine sulfate and naltrexone hydrochloride (EMBEDA) morphine sulfate and naltrexone hydrochloride (EMBEDA) -
- Primary Outcome Measures
Name Time Method Percentage of Participants Achieving Stable Dose of EMBEDA Within 6 Weeks Titration Phase Baseline through Week 6 A dose was considered to be stable dose if it met all of the following criteria: dose was taken for at least 48 hours; investigator deemed the balance between an acceptable level of analgesia and/or function and tolerance of side effects had been achieved; and rescue medication use less than or equal to 2 doses per day.
Percentage of Participants Achieving Stable Dose of EMBEDA Within 6 Weeks Titration Phase Stratified by Prior Opioid Therapy Baseline through Week 6 A dose was considered to be stable dose if it met all of the following criteria: dose was taken for at least 48 hours; investigator deemed the balance between an acceptable level of analgesia and/or function and tolerance of side effects had been achieved; and rescue medication use less than or equal to 2 doses per day.
- Secondary Outcome Measures
Name Time Method Investigator's Level of Satisfaction With the EMBEDA Conversion Guide Week 6 The conversion assessment survey is a brief questionnaire using multiple choice options and numeric rating scale (NRS) with specified anchored responses ranging on a scale from 0-10 (0 = very dissatisfied, 5 = neutral, and 10=very satisfied) to assess the Investigator's level of satisfaction with the EMBEDA Conversion Guide.
Change From Baseline in Brief Pain Inventory (BPI) at Visit 3 (First Visit After Successful Titration) Baseline, Visit 3 (up to Week 6) BPI is an 11-item self-report questionnaire: consist of 4 questions that assess pain intensity (worst, least, average, relief) and 7 questions that assess impact of pain on daily functions (general activity, mood, walking ability, normal work, relations with other people, sleep, enjoyment of life). Each question answered on a scale range:0-10 (0%-100% for relief), '0=No pain/no relief/no interference and 10=Pain as bad as you can imagine/complete relief/ complete interference'.Measure can be scored by item, with lower scores being indicative of less pain or pain interference.
Number of Titration Steps to Achieve Stable Dose Baseline through Week 6 A dose was considered to be stable dose if it met all of the following criteria: dose was taken for at least 48 hours; investigator deemed the balance between an acceptable level of analgesia and/or function and tolerance of side effects had been achieved; and rescue medication use less than or equal to 2 doses per day.
Number of Titration Steps to Achieve Stable Dose Stratified by Prior Opioid Therapy Baseline through Week 6 A dose was considered to be stable dose if it met all of the following criteria: dose was taken for at least 48 hours; investigator deemed the balance between an acceptable level of analgesia and/or function and tolerance of side effects had been achieved; and rescue medication use less than or equal to 2 doses per day.
Percentage of Participants With Rescue Medications Usage During Titration Baseline through Week 6 Rescue pain medications were used for supplemental analgesia for breakthrough pain during titration phase. Morphine sulfate IR tablet (less than 20 percent of the total daily dose of EMBEDA per IR dose), ibuprofen (up to 400 milligram (mg)/dose; not to exceed 1200 mg/day), and acetaminophen (up to 1000 mg/dose, not to exceed 4000 mg/day) were used as rescue medications.
Duration to Titrate Participants to Stable Dose Stratified by Prior Opioid Therapy Baseline through Week 6 A dose was considered to be stable dose if it met all of the following criteria: dose was taken for at least 48 hours; investigator deemed the balance between an acceptable level of analgesia and/or function and tolerance of side effects had been achieved; and rescue medication use less than or equal to 2 doses per day.
Duration to Titrate Participants to Stable Dose Baseline through Week 6 A dose was considered to be stable dose if it met all of the following criteria: dose was taken for at least 48 hours; investigator deemed the balance between an acceptable level of analgesia and/or function and tolerance of side effects had been achieved; and rescue medication use less than or equal to 2 doses per day.
Trial Locations
- Locations (159)
Washington Center for Pain Management PLLC
🇺🇸Edmonds, Washington, United States
Pacific Coast Pain Management Center
🇺🇸Laguna Hills, California, United States
Long Island Gastrointestinal Research Group LLP
🇺🇸Great Neck, New York, United States
Trinity Clinical Trials
🇺🇸Santa Ana, California, United States
Accelovance, Inc.
🇺🇸South Bend, Indiana, United States
Four Rivers Clinical Research, Inc.
🇺🇸Paducah, Kentucky, United States
Premiere Phamaceutical Research, LLC
🇺🇸Tempe, Arizona, United States
DCT - Genesis Neighborhood Research, LLC
🇺🇸Dallas, Texas, United States
Perimeter Institute for Clinical Research, Inc.
🇺🇸Atlanta, Georgia, United States
Ronald J. Rapoport, MD, PC
🇺🇸Fall River, Massachusetts, United States
Apex Medical Research, AMR, Inc.
🇺🇸Flint, Michigan, United States
Profen Research Network at ECMA
🇺🇸Jacksonville, North Carolina, United States
Pennsylvania Pain Specialists, PC
🇺🇸Allentown, Pennsylvania, United States
Chattanooga Medical Research, LLC
🇺🇸Chattanooga, Tennessee, United States
Quality of Life Medical and Research Center, LLC
🇺🇸Tucson, Arizona, United States
Hollis Family Medical Clinic, PLC
🇺🇸Paragould, Arkansas, United States
Diseasebusters, LLC
🇺🇸College Park, Maryland, United States
Office of Steven C. Miller, MD
🇺🇸Pikesville, Maryland, United States
Newport Beach Clinical Research Associates, Inc.
🇺🇸Newport Beach, California, United States
Rancho Santa Fe Medical Group, Inc.
🇺🇸San Marcos, California, United States
NextPhase Clinical Trials, Inc.
🇺🇸Miami Beach, Florida, United States
Sarasota Pain Medicine Research, LLC
🇺🇸Sarasota, Florida, United States
Laporte County Institute for Clinical Research Inc.
🇺🇸Michigan City, Indiana, United States
East Michigan Medical Associates
🇺🇸Flint, Michigan, United States
Remedica LLC
🇺🇸Rochester, Michigan, United States
Accurate Clinical Research, Inc.
🇺🇸Houston, Texas, United States
Medstar Clinical Research
🇺🇸Houston, Texas, United States
Josephson Wallack Munshower Neurology P.C.
🇺🇸Indianapolis, Indiana, United States
Community Research Foundation, Inc.
🇺🇸Miami, Florida, United States
New Horizon Research Center, Inc.
🇺🇸Miami, Florida, United States
Hightop Medical Research Center
🇺🇸Cincinnati, Ohio, United States
Sentral Clinical Research Services
🇺🇸Cincinnati, Ohio, United States
Texas Medical Research Associates, LLC
🇺🇸San Antonio, Texas, United States
Dedicated Clinical Research, Inc
🇺🇸Phoenix, Arizona, United States
Redpoint Research
🇺🇸Phoenix, Arizona, United States
Office of David McLain
🇺🇸Birmingham, Alabama, United States
Omaha Clinical Research, PC
🇺🇸Omaha, Nebraska, United States
Rocky Mountain Internal Medicine, PC
🇺🇸Aurora, Colorado, United States
Adamsville Family Medicine
🇺🇸Adamsville, Alabama, United States
Sunbelt Research Group, LLC
🇺🇸Mobile, Alabama, United States
Tennessee Valley Pain Consultants Properties, LLC
🇺🇸Huntsville, Alabama, United States
Anasazi Internal Medicine, PC
🇺🇸Phoenix, Arizona, United States
Monte Sano Clinical Research, LLC
🇺🇸Huntsville, Alabama, United States
Cochise Clinical Research
🇺🇸Sierra Vista, Arizona, United States
Dedicated Clinical Research
🇺🇸Goodyear, Arizona, United States
Office of Vaughn H. Mancha, Jr., PC
🇺🇸Montgomery, Alabama, United States
NEA Baptist Clinic
🇺🇸Jonesboro, Arkansas, United States
Ouachita Regional Pain Management
🇺🇸Hot Springs, 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
LA Pain & Wellness Institute
🇺🇸Los Angeles, California, United States
Triwest Research Associates LLC
🇺🇸La Mesa, California, United States
Bayview Research Group, LLC
🇺🇸Valley Village, California, United States
Samaritan Center for Medical Research
🇺🇸Los Gatos, California, United States
Pasadena Rehabilitation Institute
🇺🇸Pasadena, California, United States
Probe Clinical Research Corporation
🇺🇸Santa Ana, California, United States
Facility Medical Center
🇺🇸Upland, California, United States
Clinicos, LLC
🇺🇸Colorado Springs, Colorado, United States
Quality Control Research, Inc.
🇺🇸Sacramento, California, United States
Northern California Research
🇺🇸Sacramento, California, United States
Saint Luke's Medical Clinic, LLC
🇺🇸Fort Collins, Colorado, United States
ProHealth Physicians PC
🇺🇸Manchester, Connecticut, United States
Orthopedic Research Institute, LLC
🇺🇸Boynton Beach, Florida, United States
Milford Physician Services, PC
🇺🇸Milford, Connecticut, United States
Florida Research & Testing, LLC
🇺🇸Clearwater, Florida, United States
Omega Research Consultants, LLC
🇺🇸DeBary, Florida, United States
West Florida Medical Associate, PA
🇺🇸Dunnellon, Florida, United States
International Research Associates, LLC
🇺🇸Hialeah, Florida, United States
Palm Springs Research Institute, Inc
🇺🇸Hialeah, Florida, United States
Clinical Research of Central Florida, Inc.
🇺🇸Lakeland, Florida, United States
FPA Clinical Research, LLC
🇺🇸Kissimmee, Florida, United States
Harmony Clinical Research, Inc.
🇺🇸North Miami Beach, Florida, United States
Office of Laszlo J. Mate, MD, PA
🇺🇸North Palm Beach, Florida, United States
Advent Clinical Research Centers, Inc.
🇺🇸Pinellas Park, Florida, United States
Office of Richard E. Promin, MD, PA
🇺🇸Ocala, Florida, United States
Pain Management Strategies, Inc.
🇺🇸Pompano Beach, Florida, United States
Clinical Research Center, LLC
🇺🇸Wellington, Florida, United States
Medical Research and Health Education Foundation, Inc.
🇺🇸Columbus, Georgia, United States
Herman Clinical Research, LLC
🇺🇸Suwanee, Georgia, United States
Ialum Clinical Research, LLC
🇺🇸Stone Mountain, Georgia, United States
Chicago Clinical Research Institute Inc.
🇺🇸Chicago, Illinois, United States
Centers for Pain Management
🇺🇸Tifton, Georgia, United States
Creve Coeur Family Practice
🇺🇸Creve Coeur, Illinois, United States
Office of Rebecca Knight, MD
🇺🇸Peoria, Illinois, United States
McKinley Research, LLC
🇺🇸Mishawaka, Indiana, United States
Des Moines Orthopaedic Surgeons, PC
🇺🇸West Des Moines, Iowa, United States
Stedman Clinical Trials, LLC
🇺🇸Tampa, Florida, United States
Healing Options
🇺🇸Louisville, Kentucky, United States
Lakewood Family Practice
🇺🇸Russell Springs, Kentucky, United States
Boston Paincare Center, Inc.
🇺🇸Waltham, Massachusetts, United States
Clarkston Medical Group, PC
🇺🇸Clarkston, Michigan, United States
Beacon Clinical Research, LLC
🇺🇸Brockton, Massachusetts, United States
PCM Medical Services, PC
🇺🇸Lansing, Michigan, United States
MAPS Applied Research Center, Inc.
🇺🇸Shakopee, Minnesota, United States
Michigan Lifestyle Change and Health Center, PC
🇺🇸Sterling, Michigan, United States
Anesthesia and Pain Control Services
🇺🇸Biloxi, Mississippi, United States
CRC of Jackson, LLC
🇺🇸Jackson, Mississippi, United States
Midsouth Anesthesia Consultants, PLLC
🇺🇸Southhaven, Mississippi, United States
Patterson Medical Clinic, Inc.
🇺🇸Florissant, Missouri, United States
Quality Clinical Research Inc.
🇺🇸Florissant, Missouri, United States
Office of John V. Bernard, MD
🇺🇸Belvidere, New Jersey, United States
The Reiter Foundation, Inc.
🇺🇸Anaconda, Montana, United States
Medical Pain Relief Clinic
🇺🇸Omaha, Nebraska, United States
Primary Care Medicine, PC
🇺🇸Jefferson City, Missouri, United States
Advocare Heights Primary Care
🇺🇸Haddon Heights, New Jersey, United States
Atco Medical Associates, PC
🇺🇸Atco, New Jersey, United States
Central Jersey Medical Research Center, Inc.
🇺🇸Elizabeth, New Jersey, United States
NJ Heart, LLC
🇺🇸Linden, New Jersey, United States
Spine and Pain Centers, PA
🇺🇸Shrewsbury, New Jersey, United States
Center for Pain Management
🇺🇸Hackensack, New Jersey, United States
North American Partners in Pain Management, LLP
🇺🇸Valley Stream, New York, United States
Premier Research, Inc.
🇺🇸Trenton, New Jersey, United States
Office of Roger Kasendorf, DO
🇺🇸Long Beach, New York, United States
Adirondack Medical Research Center
🇺🇸Glens Falls, New York, United States
Family Health Medical Services PLLC
🇺🇸Mayville, New York, United States
Drug Trials America, Inc.
🇺🇸Hartsdale, New York, United States
New York Spine & Wellness Center
🇺🇸North Syracuse, New York, United States
Joint and Muscle Research Institute, Inc.
🇺🇸Charlotte, North Carolina, United States
Carolina Clinical Research and Consulting, LLC
🇺🇸Asheboro, North Carolina, United States
Catawba Valley Internal Medicine
🇺🇸Hickory, North Carolina, United States
Medical Frontiers, LLC
🇺🇸Franklin, Ohio, United States
Valley Medical Research
🇺🇸Centerville, Ohio, United States
Office of James Lassiter
🇺🇸Tiffin, Ohio, United States
Whole Family Medical Care LLC
🇺🇸Perrysburg, Ohio, United States
Jeffrey J. Haggenjos, DO, Inc.
🇺🇸New Lexington, Ohio, United States
Office of Siavash Nael, MD, Inc.
🇺🇸Oklahoma City, Oklahoma, United States
Associates of Medicine/John D. Williams, MD, PLLC
🇺🇸Stillwater, Oklahoma, United States
Delaware Smith Clinic Research
🇺🇸Delaware, Ohio, United States
Office of Jocelyn F. Shimek, DO
🇺🇸Salem, Ohio, United States
Health Research Institute, LLC
🇺🇸Oklahoma City, Oklahoma, United States
Portland Rheumatology Clinic, LLC
🇺🇸Lake Oswego, Oregon, United States
Office of Joseph E. Yankee, DO, PC
🇺🇸Milwaukie, Oregon, United States
Progressive Pain Solutions, LLC
🇺🇸Wind Gap, Pennsylvania, United States
Onuorah Umeh, M.D. P.C
🇺🇸Philadelphia, Pennsylvania, United States
Ware Medical Associates, PC
🇺🇸Aston, Pennsylvania, United States
Founders Research Corporation
🇺🇸Philadelphia, Pennsylvania, United States
Altoona Center for Clinical Research, PC
🇺🇸Duncansville, Pennsylvania, United States
Kandra, Fierer, Kuskin Associates, Ltd.
🇺🇸Harrisburg, Pennsylvania, United States
Clinical Research Authority, LLC
🇺🇸Murrells Inlet, South Carolina, United States
Low Country Pain Center, LLC
🇺🇸Orangeburg, South Carolina, United States
Internal Medicine of Greer Research LLC
🇺🇸Greer, South Carolina, United States
Hartwell Research Group, LLC
🇺🇸Anderson, South Carolina, United States
Brown Clinic, PLLP
🇺🇸Watertown, South Dakota, United States
Southwest Urgent Care Center
🇺🇸El Paso, Texas, United States
Trident Institute of Medical Research, LLC
🇺🇸North Charleston, South Carolina, United States
Comprehensive Pain Specialists
🇺🇸Hendersonville, Tennessee, United States
Corsicana Medical Research, PLLC
🇺🇸Corsicana, Texas, United States
Westbury Medical Clinic
🇺🇸Houston, Texas, United States
Hillcrest Family Health Center, Division of Clinical Research
🇺🇸Waco, Texas, United States
Sentara Medical Group, NDC Medical Center
🇺🇸Norfolk, Virginia, United States
Progressive Clinical Research, LLC
🇺🇸Bountiful, Utah, United States
Hillcrest Family Health Center
🇺🇸Waco, Texas, United States
Pain Care, PLLC
🇺🇸Huntington, West Virginia, United States
The Center For Clinical Research, LLC
🇺🇸Winston-Salem, North Carolina, United States
Valerius Medical Group and Research Center of Greater Long Beach, Inc.
🇺🇸Long Beach, California, United States
The Pain Treatment Center of the Bluegrass
🇺🇸Lexington, Kentucky, United States
Low Country Rheumatology, PA
🇺🇸Charleston, South Carolina, United States
Pharmacorp Clinical Trials, Inc.
🇺🇸Charleston, South Carolina, United States