Study Stopped
See termination reason in detailed description.
Conversion to Embeda With Rescue Trial
ConvERT
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
2 other identifiers
interventional
684
1 country
166
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Aug 2010
Shorter than P25 for phase_4
166 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 30, 2010
CompletedStudy Start
First participant enrolled
August 1, 2010
CompletedFirst Posted
Study publicly available on registry
August 11, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2011
CompletedResults Posted
Study results publicly available
September 5, 2012
CompletedOctober 11, 2012
October 1, 2012
8 months
July 30, 2010
July 30, 2012
October 9, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Percentage of Participants Achieving Stable Dose of EMBEDA Within 6 Weeks Titration Phase
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.
Baseline through Week 6
Percentage of Participants Achieving Stable Dose of EMBEDA Within 6 Weeks Titration Phase Stratified by Prior Opioid Therapy
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.
Baseline through Week 6
Secondary Outcomes (7)
Duration to Titrate Participants to Stable Dose
Baseline through Week 6
Duration to Titrate Participants to Stable Dose Stratified by Prior Opioid Therapy
Baseline through Week 6
Number of Titration Steps to Achieve Stable Dose
Baseline through Week 6
Number of Titration Steps to Achieve Stable Dose Stratified by Prior Opioid Therapy
Baseline through Week 6
Percentage of Participants With Rescue Medications Usage During Titration
Baseline through Week 6
- +2 more secondary outcomes
Other Outcomes (5)
Number of Participants With Aberrant Behaviors
Day 5
Number of Participants With Abnormal Urine Drug Test Results
Baseline, Visit 3 (up to Week 6)
Number of Participants With Urine Drug Test Results Positive for Unaccounted Opioids
Visit 3 (up to Week 6)
- +2 more other outcomes
Study Arms (1)
morphine sulfate and naltrexone hydrochloride (EMBEDA)
EXPERIMENTALInterventions
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
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (166)
Adamsville Family Medicine
Adamsville, Alabama, 35005, United States
Office of David McLain
Birmingham, Alabama, 35209, United States
Monte Sano Clinical Research, LLC
Huntsville, Alabama, 35801, United States
Tennessee Valley Pain Consultants Properties, LLC
Huntsville, Alabama, 35801, United States
Sunbelt Research Group, LLC
Mobile, Alabama, 36693, United States
Office of Vaughn H. Mancha, Jr., PC
Montgomery, Alabama, 36117, United States
Dedicated Clinical Research
Goodyear, Arizona, 85395, United States
Dedicated Clinical Research, Inc
Phoenix, Arizona, 85020, United States
Redpoint Research
Phoenix, Arizona, 85029, United States
Anasazi Internal Medicine, PC
Phoenix, Arizona, 85032, United States
Cochise Clinical Research
Sierra Vista, Arizona, 85635, United States
Premiere Phamaceutical Research, LLC
Tempe, Arizona, 85282, United States
Quality of Life Medical and Research Center, LLC
Tucson, Arizona, 85712, United States
Ouachita Regional Pain Management
Hot Springs, Arkansas, 71913, United States
NEA Baptist Clinic
Jonesboro, Arkansas, 72401, United States
Hollis Family Medical Clinic, PLC
Paragould, Arkansas, 72450, United States
CSI Clinical Trials
Costa Mesa, California, 92626, United States
Global Wellness Medical Corporation
Foothill Ranch, California, 92610, United States
Chrishard Medical Group
Inglewood, California, 90301, United States
Triwest Research Associates LLC
La Mesa, California, 91942, United States
Pacific Coast Pain Management Center
Laguna Hills, California, 92637, United States
Valerius Medical Group and Research Center of Greater Long Beach, Inc.
Long Beach, California, 90806, United States
LA Pain & Wellness Institute
Los Angeles, California, 90017, United States
Samaritan Center for Medical Research
Los Gatos, California, 95032, United States
Newport Beach Clinical Research Associates, Inc.
Newport Beach, California, 92663, United States
Bayview Research Group, LLC
Paramount, California, 90723, United States
Pasadena Rehabilitation Institute
Pasadena, California, 91105, United States
Quality Control Research, Inc.
Roseville, California, 95661, United States
Northern California Research
Sacramento, California, 95821, United States
Quality Control Research, Inc.
Sacramento, California, 95842, United States
Rancho Santa Fe Medical Group, Inc.
San Marcos, California, 92078, United States
Probe Clinical Research Corporation
Santa Ana, California, 92701, United States
Trinity Clinical Trials
Santa Ana, California, 92701, United States
Facility Medical Center
Upland, California, 91786, United States
Bayview Research Group, LLC
Valley Village, California, 91607, United States
Rocky Mountain Internal Medicine, PC
Aurora, Colorado, 80012, United States
Clinicos, LLC
Colorado Springs, Colorado, 80904, United States
Saint Luke's Medical Clinic, LLC
Fort Collins, Colorado, 80525, United States
ProHealth Physicians PC
Manchester, Connecticut, 06040, United States
Milford Physician Services, PC
Milford, Connecticut, 06460, United States
Orthopedic Research Institute, LLC
Boynton Beach, Florida, 33472, United States
Florida Research & Testing, LLC
Clearwater, Florida, 33755, United States
Omega Research Consultants, LLC
DeBary, Florida, 32713, United States
Omega Research Consultants, LLC
DeBary, Florida, 32746, United States
West Florida Medical Associate, PA
Dunnellon, Florida, 34432, United States
International Research Associates, LLC
Hialeah, Florida, 33012, United States
Palm Springs Research Institute, Inc
Hialeah, Florida, 33012, United States
FPA Clinical Research, LLC
Kissimmee, Florida, 34741, United States
Clinical Research of Central Florida, Inc.
Lakeland, Florida, 33810, United States
Community Research Foundation, Inc.
Miami, Florida, 33155, United States
New Horizon Research Center, Inc.
Miami, Florida, 33175, United States
NextPhase Clinical Trials, Inc.
Miami Beach, Florida, 33140, United States
Harmony Clinical Research, Inc.
North Miami Beach, Florida, 33162, United States
Office of Laszlo J. Mate, MD, PA
North Palm Beach, Florida, 33408, United States
Office of Richard E. Promin, MD, PA
Ocala, Florida, 34474, United States
Advent Clinical Research Centers, Inc.
Pinellas Park, Florida, 33781, United States
Pain Management Strategies, Inc.
Pompano Beach, Florida, 33064, United States
Sarasota Pain Medicine Research, LLC
Sarasota, Florida, 34238, United States
Stedman Clinical Trials, LLC
Tampa, Florida, 33613, United States
Clinical Research Center, LLC
Wellington, Florida, 33414, United States
Perimeter Institute for Clinical Research, Inc.
Atlanta, Georgia, 30338, United States
Medical Research and Health Education Foundation, Inc.
Columbus, Georgia, 31909, United States
Ialum Clinical Research, LLC
Decatur, Georgia, 30032, United States
Ialum Clinical Research, LLC
Stone Mountain, Georgia, 30088, United States
Herman Clinical Research, LLC
Suwanee, Georgia, 30024, United States
Centers for Pain Management
Tifton, Georgia, 31794, United States
Chicago Clinical Research Institute Inc.
Chicago, Illinois, 60616, United States
Creve Coeur Family Practice
Creve Coeur, Illinois, 61610, United States
Office of Rebecca Knight, MD
Peoria, Illinois, 61614, United States
Josephson Wallack Munshower Neurology P.C.
Indianapolis, Indiana, 46237, United States
Laporte County Institute for Clinical Research Inc.
Michigan City, Indiana, 46360, United States
McKinley Research, LLC
Mishawaka, Indiana, 46545, United States
Accelovance, Inc.
South Bend, Indiana, 46601, United States
Des Moines Orthopaedic Surgeons, PC
West Des Moines, Iowa, 50266, United States
The Pain Treatment Center of the Bluegrass
Lexington, Kentucky, 40503, United States
Healing Options
Louisville, Kentucky, 40223, United States
Four Rivers Clinical Research, Inc.
Paducah, Kentucky, 42003, United States
Lakewood Family Practice
Russell Springs, Kentucky, 42642, United States
Diseasebusters, LLC
College Park, Maryland, 20740, United States
Office of Steven C. Miller, MD
Pikesville, Maryland, 21208, United States
Beacon Clinical Research, LLC
Brockton, Massachusetts, 02301, United States
Ronald J. Rapoport, MD, PC
Fall River, Massachusetts, 02720, United States
Boston Paincare Center, Inc.
Waltham, Massachusetts, 02154, United States
Clarkston Medical Group, PC
Clarkston, Michigan, 48346, United States
Apex Medical Research, AMR, Inc.
Flint, Michigan, 48504, United States
East Michigan Medical Associates
Flint, Michigan, 48507, United States
PCM Medical Services, PC
Lansing, Michigan, 48910, United States
Remedica LLC
Rochester, Michigan, 48307, United States
Michigan Lifestyle Change and Health Center, PC
Sterling, Michigan, 48314, United States
MAPS Applied Research Center, Inc.
Edina, Minnesota, 55435, United States
MAPS Applied Research Center, Inc.
Shakopee, Minnesota, 55379, United States
Anesthesia and Pain Control Services
Biloxi, Mississippi, 39531, United States
CRC of Jackson, LLC
Jackson, Mississippi, 39202, United States
Midsouth Anesthesia Consultants, PLLC
Southhaven, Mississippi, 38671, United States
Patterson Medical Clinic, Inc.
Florissant, Missouri, 63031, United States
Quality Clinical Research Inc.
Florissant, Missouri, 63033, United States
Primary Care Medicine, PC
Jefferson City, Missouri, 65109, United States
The Reiter Foundation, Inc.
Anaconda, Montana, 59711, United States
Medical Pain Relief Clinic
Omaha, Nebraska, 68114, United States
Omaha Clinical Research, PC
Omaha, Nebraska, 68116, United States
Atco Medical Associates, PC
Atco, New Jersey, 08004, United States
Office of John V. Bernard, MD
Belvidere, New Jersey, 07823, United States
Central Jersey Medical Research Center, Inc.
Elizabeth, New Jersey, 07202, United States
Center for Pain Management
Hackensack, New Jersey, 07601, United States
Advocare Heights Primary Care
Haddon Heights, New Jersey, 08035, United States
NJ Heart, LLC
Linden, New Jersey, 07036, United States
Spine and Pain Centers, PA
Shrewsbury, New Jersey, 07702, United States
Premier Research, Inc.
Trenton, New Jersey, 08611, United States
Adirondack Medical Research Center
Glens Falls, New York, 12801, United States
Long Island Gastrointestinal Research Group LLP
Great Neck, New York, 11023, United States
Drug Trials America, Inc.
Hartsdale, New York, 10530, United States
Office of Roger Kasendorf, DO
Long Beach, New York, 11561, United States
Family Health Medical Services PLLC
Mayville, New York, 14757, United States
New York Spine & Wellness Center
North Syracuse, New York, 13212, United States
North American Partners in Pain Management, LLP
Valley Stream, New York, 11580, United States
Carolina Clinical Research and Consulting, LLC
Asheboro, North Carolina, 27203, United States
Carolina Clinical Research and Consulting, LLC
Asheboro, North Carolina, 27205, United States
Joint and Muscle Research Institute, Inc.
Charlotte, North Carolina, 28204, United States
Catawba Valley Internal Medicine
Hickory, North Carolina, 28602, United States
Profen Research Network at ECMA
Jacksonville, North Carolina, 28546, United States
The Center For Clinical Research, LLC
Winston-Salem, North Carolina, 27103, United States
Medical Frontiers, LLC
Carlisle, Ohio, 45005, United States
Valley Medical Research
Centerville, Ohio, 45459, United States
Hightop Medical Research Center
Cincinnati, Ohio, 45224, United States
Sentral Clinical Research Services
Cincinnati, Ohio, 45236, United States
Delaware Smith Clinic Research
Delaware, Ohio, 43015, United States
Medical Frontiers, LLC
Franklin, Ohio, 45005, United States
Jeffrey J. Haggenjos, DO, Inc.
New Lexington, Ohio, 43764, United States
Whole Family Medical Care LLC
Perrysburg, Ohio, 43551, United States
Office of Jocelyn F. Shimek, DO
Salem, Ohio, 44460, United States
Office of James Lassiter
Tiffin, Ohio, 44883, United States
Health Research Institute, LLC
Oklahoma City, Oklahoma, 73109, United States
Office of Siavash Nael, MD, Inc.
Oklahoma City, Oklahoma, 73109, United States
Associates of Medicine/John D. Williams, MD, PLLC
Stillwater, Oklahoma, 74074, United States
Portland Rheumatology Clinic, LLC
Lake Oswego, Oregon, 97035, United States
Office of Joseph E. Yankee, DO, PC
Milwaukie, Oregon, 97222, United States
Pennsylvania Pain Specialists, PC
Allentown, Pennsylvania, 18102, United States
Ware Medical Associates, PC
Aston Mills, Pennsylvania, 19014, United States
Altoona Center for Clinical Research, PC
Duncansville, Pennsylvania, 16635, United States
Kandra, Fierer, Kuskin Associates, Ltd.
Harrisburg, Pennsylvania, 17112, United States
Onuorah Umeh, M.D. P.C
Philadelphia, Pennsylvania, 19104, United States
Founders Research Corporation
Philadelphia, Pennsylvania, 19152, United States
Progressive Pain Solutions, LLC
Wind Gap, Pennsylvania, 18091, United States
Hartwell Research Group, LLC
Anderson, South Carolina, 29621, United States
Low Country Rheumatology, PA
Charleston, South Carolina, 29406, United States
Pharmacorp Clinical Trials, Inc.
Charleston, South Carolina, 29412, United States
Internal Medicine of Greer Research LLC
Greer, South Carolina, 29650, United States
Clinical Research Authority, LLC
Murrells Inlet, South Carolina, 29576, United States
Trident Institute of Medical Research, LLC
North Charleston, South Carolina, 29406, United States
Low Country Pain Center, LLC
Orangeburg, South Carolina, 29118, United States
Brown Clinic, PLLP
Watertown, South Dakota, 57201, United States
Chattanooga Medical Research, LLC
Chattanooga, Tennessee, 37404, United States
Comprehensive Pain Specialists
Hendersonville, Tennessee, 37075, United States
Corsicana Medical Research, PLLC
Corsicana, Texas, 75110, United States
DCT - Genesis Neighborhood Research, LLC
Dallas, Texas, 75254, United States
Southwest Urgent Care Center
El Paso, Texas, 79902, United States
Westbury Medical Clinic
Houston, Texas, 77005, United States
Accurate Clinical Research, Inc.
Houston, Texas, 77034, United States
Medstar Clinical Research
Houston, Texas, 77083, United States
Texas Medical Research Associates, LLC
San Antonio, Texas, 78238, United States
Hillcrest Family Health Center, Division of Clinical Research
Waco, Texas, 76710, United States
Hillcrest Family Health Center
Waco, Texas, 76710, United States
Progressive Clinical Research, LLC
Bountiful, Utah, 84010, United States
Sentara Medical Group, NDC Medical Center
Norfolk, Virginia, 23502, United States
Washington Center for Pain Management PLLC
Edmonds, Washington, 98026, United States
Pain Care, PLLC
Huntington, West Virginia, 25701, United States
Related Publications (2)
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.
PMID: 27782769DERIVEDSetnik 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.
PMID: 26185466DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
The study was prematurely terminated due to drug supply issues.
Results Point of Contact
- Title
- Pfizer ClinicalTrials.gov Call Center
- Organization
- Pfizer, Inc.
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 30, 2010
First Posted
August 11, 2010
Study Start
August 1, 2010
Primary Completion
April 1, 2011
Study Completion
April 1, 2011
Last Updated
October 11, 2012
Results First Posted
September 5, 2012
Record last verified: 2012-10