DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more

Conversion to Embeda With Rescue Trial

Information source: Pfizer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Chronic Disease; Pain

Intervention: morphine sulfate and naltrexone hydrochloride (EMBEDA) (Drug)

Phase: Phase 4

Status: Terminated

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer


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.

Clinical 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

Study design: Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Primary outcome:

Percentage of Participants Achieving Stable Dose of EMBEDA Within 6 Weeks Titration Phase

Percentage of Participants Achieving Stable Dose of EMBEDA Within 6 Weeks Titration Phase Stratified by Prior Opioid Therapy

Secondary outcome:

Duration to Titrate Participants to Stable Dose

Duration to Titrate Participants to Stable Dose Stratified by Prior Opioid Therapy

Number of Titration Steps to Achieve Stable Dose

Number of Titration Steps to Achieve Stable Dose Stratified by Prior Opioid Therapy

Percentage of Participants With Rescue Medications Usage During Titration

Change From Baseline in Brief Pain Inventory (BPI) at Visit 3 (First Visit After Successful Titration)

Investigator's Level of Satisfaction With the EMBEDA Conversion Guide

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.


Minimum age: 21 Years. Maximum age: N/A. Gender(s): Both.


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


- 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

Locations and Contacts

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

Anasazi Internal Medicine, PC, Phoenix, Arizona 85032, United States

Dedicated Clinical Research, Inc, Phoenix, Arizona 85020, United States

Redpoint Research, Phoenix, Arizona 85029, 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 32746, United States

Omega Research Consultants, LLC, Debary, Florida 32713, 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

NextPhase Clinical Trials, Inc., Miami Beach, Florida 33140, United States

Community Research Foundation, Inc., Miami, Florida 33155, United States

New Horizon Research Center, Inc., Miami, Florida 33175, 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, 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

Founders Research Corporation, Philadelphia, Pennsylvania 19152, United States

Onuorah Umeh, M.D. P.C, Philadelphia, Pennsylvania 19104, 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

Accurate Clinical Research, Inc., Houston, Texas 77034, United States

Medstar Clinical Research, Houston, Texas 77083, United States

Westbury Medical Clinic, Houston, Texas 77005, United States

Texas Medical Research Associates, LLC, San Antonio, Texas 78238, United States

Hillcrest Family Health Center, Waco, Texas 76710, United States

Hillcrest Family Health Center, Division of Clinical Research, 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

Additional Information

To obtain contact information for a study center near you, click here.

Starting date: August 2010
Last updated: October 9, 2012

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017