Clinical trial NCT01179191: Conversion to Embeda With Rescue Trial
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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Chronic Disease
Pain
Keywords: chronic pain
Embeda
opioid
moderate pain
severe pain
conversion
converting
switching
morphine
aberrant behavior
Pain (DT) + Chronic Disease (DT)
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2010-08-11
Enrollment: 684
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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 potential
* 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

Primary outcomes:
measure: Percentage of Participants Achieving Stable Dose of EMBEDA Within 6 Weeks Titration Phase
timeFrame: Baseline through Week 6
measure: Percentage of Participants Achieving Stable Dose of EMBEDA Within 6 Weeks Titration Phase Stratified by Prior Opioid Therapy
timeFrame: Baseline through Week 6
Secondary outcomes:
measure: Duration to Titrate Participants to Stable Dose
timeFrame: Baseline through Week 6
measure: Duration to Titrate Participants to Stable Dose Stratified by Prior Opioid Therapy
timeFrame: Baseline through Week 6
measure: Number of Titration Steps to Achieve Stable Dose
timeFrame: Baseline through Week 6
measure: Number of Titration Steps to Achieve Stable Dose Stratified by Prior Opioid Therapy
timeFrame: Baseline through Week 6
measure: Percentage of Participants With Rescue Medications Usage During Titration
timeFrame: Baseline through Week 6
measure: Change From Baseline in Brief Pain Inventory (BPI) at Visit 3 (First Visit After Successful Titration)
timeFrame: Baseline, Visit 3 (up to Week 6)
measure: Investigator's Level of Satisfaction With the EMBEDA Conversion Guide
timeFrame: Week 6
Other outcomes:
measure: Number of Participants With Aberrant Behaviors
timeFrame: Day 5
measure: Number of Participants With Abnormal Urine Drug Test Results
timeFrame: Baseline, Visit 3 (up to Week 6)
measure: Number of Participants With Urine Drug Test Results Positive for Unaccounted Opioids
timeFrame: Visit 3 (up to Week 6)
measure: Number of Participants With Urine Drug Test Results Positive for Illicit Substances
timeFrame: Baseline, Visit 3 (up to Week 6)
measure: Number of Participants With Greater Than or Equal to One Urine Drug Test Results Negative for Expected Opioid
timeFrame: Baseline, Visit 3 (up to Week 6)
Locations:
city: Adamsville
country: United States
facility: Adamsville Family Medicine
state: Alabama
city: Birmingham
country: United States
facility: Office of David McLain
state: Alabama
city: Huntsville
country: United States
facility: Monte Sano Clinical Research, LLC
state: Alabama
city: Huntsville
country: United States
facility: Tennessee Valley Pain Consultants Properties, LLC
state: Alabama
city: Mobile
country: United States
facility: Sunbelt Research Group, LLC
state: Alabama
city: Montgomery
country: United States
facility: Office of Vaughn H. Mancha, Jr., PC
state: Alabama
city: Goodyear
country: United States
facility: Dedicated Clinical Research
state: Arizona
city: Phoenix
country: United States
facility: Dedicated Clinical Research, Inc
state: Arizona
city: Phoenix
country: United States
facility: Redpoint Research
state: Arizona
city: Phoenix
country: United States
facility: Anasazi Internal Medicine, PC
state: Arizona
city: Sierra Vista
country: United States
facility: Cochise Clinical Research
state: Arizona
city: Tempe
country: United States
facility: Premiere Phamaceutical Research, LLC
state: Arizona
city: Tucson
country: United States
facility: Quality of Life Medical and Research Center, LLC
state: Arizona
city: Hot Springs
country: United States
facility: Ouachita Regional Pain Management
state: Arkansas
city: Jonesboro
country: United States
facility: NEA Baptist Clinic
state: Arkansas
city: Paragould
country: United States
facility: Hollis Family Medical Clinic, PLC
state: Arkansas
city: Costa Mesa
country: United States
facility: CSI Clinical Trials
state: California
city: Foothill Ranch
country: United States
facility: Global Wellness Medical Corporation
state: California
city: Inglewood
country: United States
facility: Chrishard Medical Group
state: California
city: La Mesa
country: United States
facility: Triwest Research Associates LLC
state: California
city: Laguna Hills
country: United States
facility: Pacific Coast Pain Management Center
state: California
city: Long Beach
country: United States
facility: Valerius Medical Group and Research Center of Greater Long Beach, Inc.
state: California
city: Los Angeles
country: United States
facility: LA Pain & Wellness Institute
state: California
city: Los Gatos
country: United States
facility: Samaritan Center for Medical Research
state: California
city: Newport Beach
country: United States
facility: Newport Beach Clinical Research Associates, Inc.
state: California
city: Paramount
country: United States
facility: Bayview Research Group, LLC
state: California
city: Pasadena
country: United States
facility: Pasadena Rehabilitation Institute
state: California
city: Roseville
country: United States
facility: Quality Control Research, Inc.
state: California
city: Sacramento
country: United States
facility: Northern California Research
state: California
city: Sacramento
country: United States
facility: Quality Control Research, Inc.
state: California
city: San Marcos
country: United States
facility: Rancho Santa Fe Medical Group, Inc.
state: California
city: Santa Ana
country: United States
facility: Probe Clinical Research Corporation
state: California
city: Santa Ana
country: United States
facility: Trinity Clinical Trials
state: California
city: Upland
country: United States
facility: Facility Medical Center
state: California
city: Valley Village
country: United States
facility: Bayview Research Group, LLC
state: California
city: Aurora
country: United States
facility: Rocky Mountain Internal Medicine, PC
state: Colorado
city: Colorado Springs
country: United States
facility: Clinicos, LLC
state: Colorado
city: Fort Collins
country: United States
facility: Saint Luke's Medical Clinic, LLC
state: Colorado
city: Manchester
country: United States
facility: ProHealth Physicians PC
state: Connecticut
city: Milford
country: United States
facility: Milford Physician Services, PC
state: Connecticut
city: Boynton Beach
country: United States
facility: Orthopedic Research Institute, LLC
state: Florida
city: Clearwater
country: United States
facility: Florida Research & Testing, LLC
state: Florida
city: Debary
country: United States
facility: Omega Research Consultants, LLC
state: Florida
city: DeBary
country: United States
facility: Omega Research Consultants, LLC
state: Florida
city: Dunnellon
country: United States
facility: West Florida Medical Associate, PA
state: Florida
city: Hialeah
country: United States
facility: International Research Associates, LLC
state: Florida
city: Hialeah
country: United States
facility: Palm Springs Research Institute, Inc
state: Florida
city: Kissimmee
country: United States
facility: FPA Clinical Research, LLC
state: Florida
city: Lakeland
country: United States
facility: Clinical Research of Central Florida, Inc.
state: Florida
city: Miami Beach
country: United States
facility: NextPhase Clinical Trials, Inc.
state: Florida
city: Miami
country: United States
facility: Community Research Foundation, Inc.
state: Florida
city: Miami
country: United States
facility: New Horizon Research Center, Inc.
state: Florida
city: North Miami Beach
country: United States
facility: Harmony Clinical Research, Inc.
state: Florida
city: North Palm Beach
country: United States
facility: Office of Laszlo J. Mate, MD, PA
state: Florida
city: Ocala
country: United States
facility: Office of Richard E. Promin, MD, PA
state: Florida
city: Pinellas Park
country: United States
facility: Advent Clinical Research Centers, Inc.
state: Florida
city: Pompano Beach
country: United States
facility: Pain Management Strategies, Inc.
state: Florida
city: Sarasota
country: United States
facility: Sarasota Pain Medicine Research, LLC
state: Florida
city: Tampa
country: United States
facility: Stedman Clinical Trials, LLC
state: Florida
city: Wellington
country: United States
facility: Clinical Research Center, LLC
state: Florida
city: Atlanta
country: United States
facility: Perimeter Institute for Clinical Research, Inc.
state: Georgia
city: Columbus
country: United States
facility: Medical Research and Health Education Foundation, Inc.
state: Georgia
city: Decatur
country: United States
facility: Ialum Clinical Research, LLC
state: Georgia
city: Stone Mountain
country: United States
facility: Ialum Clinical Research, LLC
state: Georgia
city: Suwanee
country: United States
facility: Herman Clinical Research, LLC
state: Georgia
city: Tifton
country: United States
facility: Centers for Pain Management
state: Georgia
city: Chicago
country: United States
facility: Chicago Clinical Research Institute Inc.
state: Illinois
city: Creve Coeur
country: United States
facility: Creve Coeur Family Practice
state: Illinois
city: Peoria
country: United States
facility: Office of Rebecca Knight, MD
state: Illinois
city: Indianapolis
country: United States
facility: Josephson Wallack Munshower Neurology P.C.
state: Indiana
city: Michigan City
country: United States
facility: Laporte County Institute for Clinical Research Inc.
state: Indiana
city: Mishawaka
country: United States
facility: McKinley Research, LLC
state: Indiana
city: South Bend
country: United States
facility: Accelovance, Inc.
state: Indiana
city: West Des Moines
country: United States
facility: Des Moines Orthopaedic Surgeons, PC
state: Iowa
city: Lexington
country: United States
facility: The Pain Treatment Center of the Bluegrass
state: Kentucky
city: Louisville
country: United States
facility: Healing Options
state: Kentucky
city: Paducah
country: United States
facility: Four Rivers Clinical Research, Inc.
state: Kentucky
city: Russell Springs
country: United States
facility: Lakewood Family Practice
state: Kentucky
city: College Park
country: United States
facility: Diseasebusters, LLC
state: Maryland
city: Pikesville
country: United States
facility: Office of Steven C. Miller, MD
state: Maryland
city: Brockton
country: United States
facility: Beacon Clinical Research, LLC
state: Massachusetts
city: Fall River
country: United States
facility: Ronald J. Rapoport, MD, PC
state: Massachusetts
city: Waltham
country: United States
facility: Boston Paincare Center, Inc.
state: Massachusetts
city: Clarkston
country: United States
facility: Clarkston Medical Group, PC
state: Michigan
city: Flint
country: United States
facility: Apex Medical Research, AMR, Inc.
state: Michigan
city: Flint
country: United States
facility: East Michigan Medical Associates
state: Michigan
city: Lansing
country: United States
facility: PCM Medical Services, PC
state: Michigan
city: Rochester
country: United States
facility: Remedica LLC
state: Michigan
city: Sterling
country: United States
facility: Michigan Lifestyle Change and Health Center, PC
state: Michigan
city: Edina
country: United States
facility: MAPS Applied Research Center, Inc.
state: Minnesota
city: Shakopee
country: United States
facility: MAPS Applied Research Center, Inc.
state: Minnesota
city: Biloxi
country: United States
facility: Anesthesia and Pain Control Services
state: Mississippi
city: Jackson
country: United States
facility: CRC of Jackson, LLC
state: Mississippi
city: Southhaven
country: United States
facility: Midsouth Anesthesia Consultants, PLLC
state: Mississippi
city: Florissant
country: United States
facility: Patterson Medical Clinic, Inc.
state: Missouri
city: Florissant
country: United States
facility: Quality Clinical Research Inc.
state: Missouri
city: Jefferson City
country: United States
facility: Primary Care Medicine, PC
state: Missouri
city: Anaconda
country: United States
facility: The Reiter Foundation, Inc.
state: Montana
city: Omaha
country: United States
facility: Medical Pain Relief Clinic
state: Nebraska
city: Omaha
country: United States
facility: Omaha Clinical Research, PC
state: Nebraska
city: Atco
country: United States
facility: Atco Medical Associates, PC
state: New Jersey
city: Belvidere
country: United States
facility: Office of John V. Bernard, MD
state: New Jersey
city: Elizabeth
country: United States
facility: Central Jersey Medical Research Center, Inc.
state: New Jersey
city: Hackensack
country: United States
facility: Center for Pain Management
state: New Jersey
city: Haddon Heights
country: United States
facility: Advocare Heights Primary Care
state: New Jersey
city: Linden
country: United States
facility: NJ Heart, LLC
state: New Jersey
city: Shrewsbury
country: United States
facility: Spine and Pain Centers, PA
state: New Jersey
city: Trenton
country: United States
facility: Premier Research, Inc.
state: New Jersey
city: Glens Falls
country: United States
facility: Adirondack Medical Research Center
state: New York
city: Great Neck
country: United States
facility: Long Island Gastrointestinal Research Group LLP
state: New York
city: Hartsdale
country: United States
facility: Drug Trials America, Inc.
state: New York
city: Long Beach
country: United States
facility: Office of Roger Kasendorf, DO
state: New York
city: Mayville
country: United States
facility: Family Health Medical Services PLLC
state: New York
city: North Syracuse
country: United States
facility: New York Spine & Wellness Center
state: New York
city: Valley Stream
country: United States
facility: North American Partners in Pain Management, LLP
state: New York
city: Asheboro
country: United States
facility: Carolina Clinical Research and Consulting, LLC
state: North Carolina
city: Asheboro
country: United States
facility: Carolina Clinical Research and Consulting, LLC
state: North Carolina
city: Charlotte
country: United States
facility: Joint and Muscle Research Institute, Inc.
state: North Carolina
city: Hickory
country: United States
facility: Catawba Valley Internal Medicine
state: North Carolina
city: Jacksonville
country: United States
facility: Profen Research Network at ECMA
state: North Carolina
city: Winston-Salem
country: United States
facility: The Center For Clinical Research, LLC
state: North Carolina
city: Carlisle
country: United States
facility: Medical Frontiers, LLC
state: Ohio
city: Centerville
country: United States
facility: Valley Medical Research
state: Ohio
city: Cincinnati
country: United States
facility: Hightop Medical Research Center
state: Ohio
city: Cincinnati
country: United States
facility: Sentral Clinical Research Services
state: Ohio
city: Delaware
country: United States
facility: Delaware Smith Clinic Research
state: Ohio
city: Franklin
country: United States
facility: Medical Frontiers, LLC
state: Ohio
city: New Lexington
country: United States
facility: Jeffrey J. Haggenjos, DO, Inc.
state: Ohio
city: Perrysburg
country: United States
facility: Whole Family Medical Care LLC
state: Ohio
city: Salem
country: United States
facility: Office of Jocelyn F. Shimek, DO
state: Ohio
city: Tiffin
country: United States
facility: Office of James Lassiter
state: Ohio
city: Oklahoma City
country: United States
facility: Health Research Institute, LLC
state: Oklahoma
city: Oklahoma City
country: United States
facility: Office of Siavash Nael, MD, Inc.
state: Oklahoma
city: Stillwater
country: United States
facility: Associates of Medicine/John D. Williams, MD, PLLC
state: Oklahoma
city: Lake Oswego
country: United States
facility: Portland Rheumatology Clinic, LLC
state: Oregon
city: Milwaukie
country: United States
facility: Office of Joseph E. Yankee, DO, PC
state: Oregon
city: Allentown
country: United States
facility: Pennsylvania Pain Specialists, PC
state: Pennsylvania
city: Aston
country: United States
facility: Ware Medical Associates, PC
state: Pennsylvania
city: Duncansville
country: United States
facility: Altoona Center for Clinical Research, PC
state: Pennsylvania
city: Harrisburg
country: United States
facility: Kandra, Fierer, Kuskin Associates, Ltd.
state: Pennsylvania
city: Philadelphia
country: United States
facility: Onuorah Umeh, M.D. P.C
state: Pennsylvania
city: Philadelphia
country: United States
facility: Founders Research Corporation
state: Pennsylvania
city: Wind Gap
country: United States
facility: Progressive Pain Solutions, LLC
state: Pennsylvania
city: Anderson
country: United States
facility: Hartwell Research Group, LLC
state: South Carolina
city: Charleston
country: United States
facility: Low Country Rheumatology, PA
state: South Carolina
city: Charleston
country: United States
facility: Pharmacorp Clinical Trials, Inc.
state: South Carolina
city: Greer
country: United States
facility: Internal Medicine of Greer Research LLC
state: South Carolina
city: Murrells Inlet
country: United States
facility: Clinical Research Authority, LLC
state: South Carolina
city: North Charleston
country: United States
facility: Trident Institute of Medical Research, LLC
state: South Carolina
city: Orangeburg
country: United States
facility: Low Country Pain Center, LLC
state: South Carolina
city: Watertown
country: United States
facility: Brown Clinic, PLLP
state: South Dakota
city: Chattanooga
country: United States
facility: Chattanooga Medical Research, LLC
state: Tennessee
city: Hendersonville
country: United States
facility: Comprehensive Pain Specialists
state: Tennessee
city: Corsicana
country: United States
facility: Corsicana Medical Research, PLLC
state: Texas
city: Dallas
country: United States
facility: DCT - Genesis Neighborhood Research, LLC
state: Texas
city: El Paso
country: United States
facility: Southwest Urgent Care Center
state: Texas
city: Houston
country: United States
facility: Westbury Medical Clinic
state: Texas
city: Houston
country: United States
facility: Accurate Clinical Research, Inc.
state: Texas
city: Houston
country: United States
facility: Medstar Clinical Research
state: Texas
city: San Antonio
country: United States
facility: Texas Medical Research Associates, LLC
state: Texas
city: Waco
country: United States
facility: Hillcrest Family Health Center, Division of Clinical Research
state: Texas
city: Waco
country: United States
facility: Hillcrest Family Health Center
state: Texas
city: Bountiful
country: United States
facility: Progressive Clinical Research, LLC
state: Utah
city: Norfolk
country: United States
facility: Sentara Medical Group, NDC Medical Center
state: Virginia
city: Edmonds
country: United States
facility: Washington Center for Pain Management PLLC
state: Washington
city: Huntington
country: United States
facility: Pain Care, PLLC
state: West Virginia
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.