Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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TERMINATED
PHASE4
684 participants
INTERVENTIONAL
2010-08-31
2011-04-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Study Groups
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morphine sulfate and naltrexone hydrochloride (EMBEDA)
morphine sulfate and naltrexone hydrochloride (EMBEDA)
Capsules in dose strengths ranging from 20 to 100 mg morphine sulfate with 0.8 to 4 mg of naltrexone hydrochloride taken either once or twice daily with a starting dose calculated using the total daily dose of the current opioid being converted from until a stable dose is achieved or six weeks which ever comes first.
Interventions
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morphine sulfate and naltrexone hydrochloride (EMBEDA)
Capsules in dose strengths ranging from 20 to 100 mg morphine sulfate with 0.8 to 4 mg of naltrexone hydrochloride taken either once or twice daily with a starting dose calculated using the total daily dose of the current opioid being converted from until a stable dose is achieved or six weeks which ever comes first.
Eligibility Criteria
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Inclusion Criteria
* 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 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
21 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Adamsville Family Medicine
Adamsville, Alabama, United States
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
Bayview Research Group, LLC
Paramount, California, United States
Pasadena Rehabilitation Institute
Pasadena, California, United States
Quality Control Research, Inc.
Roseville, California, United States
Northern California Research
Sacramento, California, United States
Quality Control Research, Inc.
Sacramento, California, United States
Rancho Santa Fe Medical Group, Inc.
San Marcos, California, United States
Probe Clinical Research Corporation
Santa Ana, California, United States
Trinity Clinical Trials
Santa Ana, California, United States
Facility Medical Center
Upland, California, United States
Bayview Research Group, LLC
Valley Village, California, United States
Rocky Mountain Internal Medicine, PC
Aurora, Colorado, United States
Clinicos, LLC
Colorado Springs, Colorado, United States
Saint Luke's Medical Clinic, LLC
Fort Collins, Colorado, United States
ProHealth Physicians PC
Manchester, Connecticut, United States
Milford Physician Services, PC
Milford, Connecticut, United States
Orthopedic Research Institute, LLC
Boynton Beach, Florida, United States
Florida Research & Testing, LLC
Clearwater, Florida, United States
Omega Research Consultants, LLC
DeBary, 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
FPA Clinical Research, LLC
Kissimmee, Florida, United States
Clinical Research of Central Florida, Inc.
Lakeland, Florida, United States
Community Research Foundation, Inc.
Miami, Florida, United States
New Horizon Research Center, Inc.
Miami, Florida, United States
NextPhase Clinical Trials, Inc.
Miami Beach, 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
Office of Richard E. Promin, MD, PA
Ocala, Florida, United States
Advent Clinical Research Centers, Inc.
Pinellas Park, Florida, United States
Pain Management Strategies, Inc.
Pompano Beach, Florida, United States
Sarasota Pain Medicine Research, LLC
Sarasota, Florida, United States
Stedman Clinical Trials, LLC
Tampa, Florida, United States
Clinical Research Center, LLC
Wellington, Florida, United States
Perimeter Institute for Clinical Research, Inc.
Atlanta, Georgia, United States
Medical Research and Health Education Foundation, Inc.
Columbus, Georgia, United States
Ialum Clinical Research, LLC
Decatur, Georgia, United States
Ialum Clinical Research, LLC
Stone Mountain, Georgia, United States
Herman Clinical Research, LLC
Suwanee, Georgia, United States
Centers for Pain Management
Tifton, Georgia, United States
Chicago Clinical Research Institute Inc.
Chicago, Illinois, United States
Creve Coeur Family Practice
Creve Coeur, Illinois, United States
Office of Rebecca Knight, MD
Peoria, Illinois, United States
Josephson Wallack Munshower Neurology P.C.
Indianapolis, Indiana, United States
Laporte County Institute for Clinical Research Inc.
Michigan City, Indiana, United States
McKinley Research, LLC
Mishawaka, Indiana, United States
Accelovance, Inc.
South Bend, Indiana, United States
Des Moines Orthopaedic Surgeons, PC
West Des Moines, Iowa, United States
The Pain Treatment Center of the Bluegrass
Lexington, Kentucky, United States
Healing Options
Louisville, Kentucky, United States
Four Rivers Clinical Research, Inc.
Paducah, Kentucky, United States
Lakewood Family Practice
Russell Springs, Kentucky, United States
Diseasebusters, LLC
College Park, Maryland, United States
Office of Steven C. Miller, MD
Pikesville, Maryland, United States
Beacon Clinical Research, LLC
Brockton, Massachusetts, United States
Ronald J. Rapoport, MD, PC
Fall River, Massachusetts, United States
Boston Paincare Center, Inc.
Waltham, Massachusetts, United States
Clarkston Medical Group, PC
Clarkston, Michigan, United States
Apex Medical Research, AMR, Inc.
Flint, Michigan, United States
East Michigan Medical Associates
Flint, Michigan, United States
PCM Medical Services, PC
Lansing, Michigan, United States
Remedica LLC
Rochester, Michigan, United States
Michigan Lifestyle Change and Health Center, PC
Sterling, Michigan, United States
MAPS Applied Research Center, Inc.
Edina, Minnesota, United States
MAPS Applied Research Center, Inc.
Shakopee, Minnesota, 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
Primary Care Medicine, PC
Jefferson City, Missouri, United States
The Reiter Foundation, Inc.
Anaconda, Montana, United States
Medical Pain Relief Clinic
Omaha, Nebraska, United States
Omaha Clinical Research, PC
Omaha, Nebraska, United States
Atco Medical Associates, PC
Atco, New Jersey, United States
Office of John V. Bernard, MD
Belvidere, New Jersey, United States
Central Jersey Medical Research Center, Inc.
Elizabeth, New Jersey, United States
Center for Pain Management
Hackensack, New Jersey, United States
Advocare Heights Primary Care
Haddon Heights, New Jersey, United States
NJ Heart, LLC
Linden, New Jersey, United States
Spine and Pain Centers, PA
Shrewsbury, New Jersey, United States
Premier Research, Inc.
Trenton, New Jersey, United States
Adirondack Medical Research Center
Glens Falls, New York, United States
Long Island Gastrointestinal Research Group LLP
Great Neck, New York, United States
Drug Trials America, Inc.
Hartsdale, New York, United States
Office of Roger Kasendorf, DO
Long Beach, New York, United States
Family Health Medical Services PLLC
Mayville, New York, United States
New York Spine & Wellness Center
North Syracuse, New York, United States
North American Partners in Pain Management, LLP
Valley Stream, New York, United States
Carolina Clinical Research and Consulting, LLC
Asheboro, North Carolina, United States
Carolina Clinical Research and Consulting, LLC
Asheboro, North Carolina, United States
Joint and Muscle Research Institute, Inc.
Charlotte, North Carolina, United States
Catawba Valley Internal Medicine
Hickory, North Carolina, United States
Profen Research Network at ECMA
Jacksonville, North Carolina, United States
The Center For Clinical Research, LLC
Winston-Salem, North Carolina, United States
Medical Frontiers, LLC
Carlisle, Ohio, United States
Valley Medical Research
Centerville, Ohio, United States
Hightop Medical Research Center
Cincinnati, Ohio, United States
Sentral Clinical Research Services
Cincinnati, Ohio, United States
Delaware Smith Clinic Research
Delaware, Ohio, United States
Medical Frontiers, LLC
Franklin, Ohio, United States
Jeffrey J. Haggenjos, DO, Inc.
New Lexington, Ohio, United States
Whole Family Medical Care LLC
Perrysburg, Ohio, United States
Office of Jocelyn F. Shimek, DO
Salem, Ohio, United States
Office of James Lassiter
Tiffin, Ohio, United States
Health Research Institute, LLC
Oklahoma City, Oklahoma, 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
Portland Rheumatology Clinic, LLC
Lake Oswego, Oregon, United States
Office of Joseph E. Yankee, DO, PC
Milwaukie, Oregon, United States
Pennsylvania Pain Specialists, PC
Allentown, Pennsylvania, United States
Ware Medical Associates, PC
Aston Mills, Pennsylvania, United States
Altoona Center for Clinical Research, PC
Duncansville, Pennsylvania, United States
Kandra, Fierer, Kuskin Associates, Ltd.
Harrisburg, Pennsylvania, United States
Onuorah Umeh, M.D. P.C
Philadelphia, Pennsylvania, United States
Founders Research Corporation
Philadelphia, Pennsylvania, United States
Progressive Pain Solutions, LLC
Wind Gap, Pennsylvania, United States
Hartwell Research Group, LLC
Anderson, South Carolina, United States
Low Country Rheumatology, PA
Charleston, South Carolina, United States
Pharmacorp Clinical Trials, Inc.
Charleston, South Carolina, United States
Internal Medicine of Greer Research LLC
Greer, South Carolina, United States
Clinical Research Authority, LLC
Murrells Inlet, South Carolina, United States
Trident Institute of Medical Research, LLC
North Charleston, South Carolina, United States
Low Country Pain Center, LLC
Orangeburg, South Carolina, United States
Brown Clinic, PLLP
Watertown, South Dakota, United States
Chattanooga Medical Research, LLC
Chattanooga, Tennessee, United States
Comprehensive Pain Specialists
Hendersonville, Tennessee, United States
Corsicana Medical Research, PLLC
Corsicana, Texas, United States
DCT - Genesis Neighborhood Research, LLC
Dallas, Texas, United States
Southwest Urgent Care Center
El Paso, Texas, United States
Westbury Medical Clinic
Houston, Texas, United States
Accurate Clinical Research, Inc.
Houston, Texas, United States
Medstar Clinical Research
Houston, Texas, United States
Texas Medical Research Associates, LLC
San Antonio, Texas, United States
Hillcrest Family Health Center, Division of Clinical Research
Waco, Texas, United States
Hillcrest Family Health Center
Waco, Texas, United States
Progressive Clinical Research, LLC
Bountiful, Utah, United States
Sentara Medical Group, NDC Medical Center
Norfolk, Virginia, United States
Washington Center for Pain Management PLLC
Edmonds, Washington, United States
Pain Care, PLLC
Huntington, West Virginia, United States
Countries
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References
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Setnik B, Roland CL, Pixton GC, Sommerville KW. Prescription opioid abuse and misuse: gap between primary-care investigator assessment and actual extent of these behaviors among patients with chronic pain. Postgrad Med. 2017 Jan;129(1):5-11. doi: 10.1080/00325481.2017.1245585. Epub 2016 Oct 26.
Setnik B, Roland CL, Sommerville KW, Pixton GC, Berke R, Calkins A, Goli V. A multicenter, primary-care-based, open-label study to assess the success of converting opioid-experienced patients with chronic moderate-to-severe pain to morphine sulfate and naltrexone hydrochloride extended-release capsules using a standardized conversion guide. J Pain Res. 2015 Jul 8;8:347-60. doi: 10.2147/JPR.S82395. eCollection 2015.
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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B4541001
Identifier Type: -
Identifier Source: secondary_id
ALO-01-10-4003
Identifier Type: -
Identifier Source: org_study_id