search
Back to results

Conversion to Embeda With Rescue Trial (ConvERT)

Primary Purpose

Chronic Disease, Pain

Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
morphine sulfate and naltrexone hydrochloride (EMBEDA)
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Chronic Disease focused on measuring chronic pain, Embeda, opioid, moderate pain, severe pain, conversion, converting, switching, morphine, aberrant behavior, Pain (DT) + Chronic Disease (DT)

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Adamsville Family Medicine
  • Office of David McLain
  • Monte Sano Clinical Research, LLC
  • Tennessee Valley Pain Consultants Properties, LLC
  • Sunbelt Research Group, LLC
  • Office of Vaughn H. Mancha, Jr., PC
  • Dedicated Clinical Research
  • Dedicated Clinical Research, Inc
  • Redpoint Research
  • Anasazi Internal Medicine, PC
  • Cochise Clinical Research
  • Premiere Phamaceutical Research, LLC
  • Quality of Life Medical and Research Center, LLC
  • Ouachita Regional Pain Management
  • NEA Baptist Clinic
  • Hollis Family Medical Clinic, PLC
  • CSI Clinical Trials
  • Global Wellness Medical Corporation
  • Chrishard Medical Group
  • Triwest Research Associates LLC
  • Pacific Coast Pain Management Center
  • Valerius Medical Group and Research Center of Greater Long Beach, Inc.
  • LA Pain & Wellness Institute
  • Samaritan Center for Medical Research
  • Newport Beach Clinical Research Associates, Inc.
  • Bayview Research Group, LLC
  • Pasadena Rehabilitation Institute
  • Quality Control Research, Inc.
  • Northern California Research
  • Quality Control Research, Inc.
  • Rancho Santa Fe Medical Group, Inc.
  • Probe Clinical Research Corporation
  • Trinity Clinical Trials
  • Facility Medical Center
  • Bayview Research Group, LLC
  • Rocky Mountain Internal Medicine, PC
  • Clinicos, LLC
  • Saint Luke's Medical Clinic, LLC
  • ProHealth Physicians PC
  • Milford Physician Services, PC
  • Orthopedic Research Institute, LLC
  • Florida Research & Testing, LLC
  • Omega Research Consultants, LLC
  • Omega Research Consultants, LLC
  • West Florida Medical Associate, PA
  • International Research Associates, LLC
  • Palm Springs Research Institute, Inc
  • FPA Clinical Research, LLC
  • Clinical Research of Central Florida, Inc.
  • NextPhase Clinical Trials, Inc.
  • Community Research Foundation, Inc.
  • New Horizon Research Center, Inc.
  • Harmony Clinical Research, Inc.
  • Office of Laszlo J. Mate, MD, PA
  • Office of Richard E. Promin, MD, PA
  • Advent Clinical Research Centers, Inc.
  • Pain Management Strategies, Inc.
  • Sarasota Pain Medicine Research, LLC
  • Stedman Clinical Trials, LLC
  • Clinical Research Center, LLC
  • Perimeter Institute for Clinical Research, Inc.
  • Medical Research and Health Education Foundation, Inc.
  • Ialum Clinical Research, LLC
  • Ialum Clinical Research, LLC
  • Herman Clinical Research, LLC
  • Centers for Pain Management
  • Chicago Clinical Research Institute Inc.
  • Creve Coeur Family Practice
  • Office of Rebecca Knight, MD
  • Josephson Wallack Munshower Neurology P.C.
  • Laporte County Institute for Clinical Research Inc.
  • McKinley Research, LLC
  • Accelovance, Inc.
  • Des Moines Orthopaedic Surgeons, PC
  • The Pain Treatment Center of the Bluegrass
  • Healing Options
  • Four Rivers Clinical Research, Inc.
  • Lakewood Family Practice
  • Diseasebusters, LLC
  • Office of Steven C. Miller, MD
  • Beacon Clinical Research, LLC
  • Ronald J. Rapoport, MD, PC
  • Boston Paincare Center, Inc.
  • Clarkston Medical Group, PC
  • Apex Medical Research, AMR, Inc.
  • East Michigan Medical Associates
  • PCM Medical Services, PC
  • Remedica LLC
  • Michigan Lifestyle Change and Health Center, PC
  • MAPS Applied Research Center, Inc.
  • MAPS Applied Research Center, Inc.
  • Anesthesia and Pain Control Services
  • CRC of Jackson, LLC
  • Midsouth Anesthesia Consultants, PLLC
  • Patterson Medical Clinic, Inc.
  • Quality Clinical Research Inc.
  • Primary Care Medicine, PC
  • The Reiter Foundation, Inc.
  • Medical Pain Relief Clinic
  • Omaha Clinical Research, PC
  • Atco Medical Associates, PC
  • Office of John V. Bernard, MD
  • Central Jersey Medical Research Center, Inc.
  • Center for Pain Management
  • Advocare Heights Primary Care
  • NJ Heart, LLC
  • Spine and Pain Centers, PA
  • Premier Research, Inc.
  • Adirondack Medical Research Center
  • Long Island Gastrointestinal Research Group LLP
  • Drug Trials America, Inc.
  • Office of Roger Kasendorf, DO
  • Family Health Medical Services PLLC
  • New York Spine & Wellness Center
  • North American Partners in Pain Management, LLP
  • Carolina Clinical Research and Consulting, LLC
  • Carolina Clinical Research and Consulting, LLC
  • Joint and Muscle Research Institute, Inc.
  • Catawba Valley Internal Medicine
  • Profen Research Network at ECMA
  • The Center For Clinical Research, LLC
  • Medical Frontiers, LLC
  • Valley Medical Research
  • Hightop Medical Research Center
  • Sentral Clinical Research Services
  • Delaware Smith Clinic Research
  • Medical Frontiers, LLC
  • Jeffrey J. Haggenjos, DO, Inc.
  • Whole Family Medical Care LLC
  • Office of Jocelyn F. Shimek, DO
  • Office of James Lassiter
  • Health Research Institute, LLC
  • Office of Siavash Nael, MD, Inc.
  • Associates of Medicine/John D. Williams, MD, PLLC
  • Portland Rheumatology Clinic, LLC
  • Office of Joseph E. Yankee, DO, PC
  • Pennsylvania Pain Specialists, PC
  • Ware Medical Associates, PC
  • Altoona Center for Clinical Research, PC
  • Kandra, Fierer, Kuskin Associates, Ltd.
  • Onuorah Umeh, M.D. P.C
  • Founders Research Corporation
  • Progressive Pain Solutions, LLC
  • Hartwell Research Group, LLC
  • Low Country Rheumatology, PA
  • Pharmacorp Clinical Trials, Inc.
  • Internal Medicine of Greer Research LLC
  • Clinical Research Authority, LLC
  • Trident Institute of Medical Research, LLC
  • Low Country Pain Center, LLC
  • Brown Clinic, PLLP
  • Chattanooga Medical Research, LLC
  • Comprehensive Pain Specialists
  • Corsicana Medical Research, PLLC
  • DCT - Genesis Neighborhood Research, LLC
  • Southwest Urgent Care Center
  • Westbury Medical Clinic
  • Accurate Clinical Research, Inc.
  • Medstar Clinical Research
  • Texas Medical Research Associates, LLC
  • Hillcrest Family Health Center, Division of Clinical Research
  • Hillcrest Family Health Center
  • Progressive Clinical Research, LLC
  • Sentara Medical Group, NDC Medical Center
  • Washington Center for Pain Management PLLC
  • Pain Care, PLLC

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

morphine sulfate and naltrexone hydrochloride (EMBEDA)

Arm Description

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Duration to Titrate Participants to Stable Dose
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 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.
Number of Titration Steps to Achieve Stable Dose
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
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
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.
Change From Baseline in Brief Pain Inventory (BPI) at Visit 3 (First Visit After Successful Titration)
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.
Investigator's Level of Satisfaction With the EMBEDA Conversion Guide
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.

Full Information

First Posted
July 30, 2010
Last Updated
October 9, 2012
Sponsor
Pfizer
search

1. Study Identification

Unique Protocol Identification Number
NCT01179191
Brief Title
Conversion to Embeda With Rescue Trial
Acronym
ConvERT
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

2. Study Status

Record Verification Date
October 2012
Overall Recruitment Status
Terminated
Why Stopped
See termination reason in detailed description.
Study Start Date
August 2010 (undefined)
Primary Completion Date
April 2011 (Actual)
Study Completion Date
April 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Disease, Pain
Keywords
chronic pain, Embeda, opioid, moderate pain, severe pain, conversion, converting, switching, morphine, aberrant behavior, Pain (DT) + Chronic Disease (DT)

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
684 (Actual)

8. Arms, Groups, and Interventions

Arm Title
morphine sulfate and naltrexone hydrochloride (EMBEDA)
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
morphine sulfate and naltrexone hydrochloride (EMBEDA)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Percentage of Participants Achieving Stable Dose of EMBEDA Within 6 Weeks Titration Phase
Description
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.
Time Frame
Baseline through Week 6
Title
Percentage of Participants Achieving Stable Dose of EMBEDA Within 6 Weeks Titration Phase Stratified by Prior Opioid Therapy
Description
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.
Time Frame
Baseline through Week 6
Secondary Outcome Measure Information:
Title
Duration to Titrate Participants to Stable Dose
Description
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.
Time Frame
Baseline through Week 6
Title
Duration to Titrate Participants to Stable Dose Stratified by Prior Opioid Therapy
Description
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.
Time Frame
Baseline through Week 6
Title
Number of Titration Steps to Achieve Stable Dose
Description
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.
Time Frame
Baseline through Week 6
Title
Number of Titration Steps to Achieve Stable Dose Stratified by Prior Opioid Therapy
Description
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.
Time Frame
Baseline through Week 6
Title
Percentage of Participants With Rescue Medications Usage During Titration
Description
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.
Time Frame
Baseline through Week 6
Title
Change From Baseline in Brief Pain Inventory (BPI) at Visit 3 (First Visit After Successful Titration)
Description
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.
Time Frame
Baseline, Visit 3 (up to Week 6)
Title
Investigator's Level of Satisfaction With the EMBEDA Conversion Guide
Description
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.
Time Frame
Week 6
Other Pre-specified Outcome Measures:
Title
Number of Participants With Aberrant Behaviors
Description
Current Opioid Misuse Measure (COMM) is a 17-item self-administered test used to monitor aberrant behavior in participants on opioid therapy. Aberrant behaviors assessed using a 5-point scale [0 = 'never' and 4 = 'very often']. Score range 0-68. Scores greater than or equal to 9 indicated the presence of aberrant behaviors.
Time Frame
Day 5
Title
Number of Participants With Abnormal Urine Drug Test Results
Description
Urine samples collected were screened using immunoassay techniques for the following types of drugs: opioids, barbiturates, benzodiazepines, amphetamines, ecstasy [3, 4-methylenedioxyamphetamine (MDMA)], cocaine, phencyclidine (PCP) and marijuana [tetrahydrocannabinol (THC)]. Quantitative, confirmatory urine drug testing was performed for positive results using gas chromatography or high-pressure liquid chromatography, for the following analytes: morphine, oxycodone, oxymorphone, hydrocodone, hydromorphone, fentanyl, methadone, benzodiazepines, amphetamines, cocaine, THC, PCP, and MDMA.
Time Frame
Baseline, Visit 3 (up to Week 6)
Title
Number of Participants With Urine Drug Test Results Positive for Unaccounted Opioids
Description
Urine samples collected were screened using immunoassay techniques for the following types of drugs: opioids, barbiturates, benzodiazepines, amphetamines, ecstasy (3, 4-MDMA), cocaine, PCP and marijuana (THC). Quantitative, confirmatory urine drug testing was performed for positive results using gas chromatography or high-pressure liquid chromatography, for the following analytes: morphine, oxycodone, oxymorphone, hydrocodone, hydromorphone, fentanyl, methadone, benzodiazepines, amphetamines, cocaine, THC, PCP, and MDMA.
Time Frame
Visit 3 (up to Week 6)
Title
Number of Participants With Urine Drug Test Results Positive for Illicit Substances
Description
Urine samples collected were screened using immunoassay techniques for following types of drugs:opioids,barbiturates,benzodiazepines,amphetamines,ecstasy(3,4MDMA),cocaine,PCP,marijuana (THC).Quantitative, confirmatory urine drug testing performed for positive results using gas chromatography or high-pressure liquid chromatography for following analytes: morphine,oxycodone,oxymorphone,hydrocodone,hydromorphone,fentanyl,methadone,benzodiazepines,amphetamines,cocaine,THC,PCP,MDMA. Illicit substances were drugs of categories:marijuana (THC) metabolite,cocaine metabolite,PCP,amphetamine.
Time Frame
Baseline, Visit 3 (up to Week 6)
Title
Number of Participants With Greater Than or Equal to One Urine Drug Test Results Negative for Expected Opioid
Description
Urine samples collected were screened using immunoassay techniques for the following types of drugs: opioids, barbiturates, benzodiazepines, amphetamines, ecstasy (3, 4-MDMA), cocaine, PCP and marijuana (THC). Quantitative, confirmatory urine drug testing was performed for positive results using gas chromatography or high-pressure liquid chromatography, for the following analytes: morphine, oxycodone, oxymorphone, hydrocodone, hydromorphone, fentanyl, methadone, benzodiazepines, amphetamines, cocaine, THC, PCP, and MDMA.
Time Frame
Baseline, Visit 3 (up to Week 6)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Adamsville Family Medicine
City
Adamsville
State/Province
Alabama
ZIP/Postal Code
35005
Country
United States
Facility Name
Office of David McLain
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35209
Country
United States
Facility Name
Monte Sano Clinical Research, LLC
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States
Facility Name
Tennessee Valley Pain Consultants Properties, LLC
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States
Facility Name
Sunbelt Research Group, LLC
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36693
Country
United States
Facility Name
Office of Vaughn H. Mancha, Jr., PC
City
Montgomery
State/Province
Alabama
ZIP/Postal Code
36117
Country
United States
Facility Name
Dedicated Clinical Research
City
Goodyear
State/Province
Arizona
ZIP/Postal Code
85395
Country
United States
Facility Name
Dedicated Clinical Research, Inc
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85020
Country
United States
Facility Name
Redpoint Research
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85029
Country
United States
Facility Name
Anasazi Internal Medicine, PC
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85032
Country
United States
Facility Name
Cochise Clinical Research
City
Sierra Vista
State/Province
Arizona
ZIP/Postal Code
85635
Country
United States
Facility Name
Premiere Phamaceutical Research, LLC
City
Tempe
State/Province
Arizona
ZIP/Postal Code
85282
Country
United States
Facility Name
Quality of Life Medical and Research Center, LLC
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
Facility Name
Ouachita Regional Pain Management
City
Hot Springs
State/Province
Arkansas
ZIP/Postal Code
71913
Country
United States
Facility Name
NEA Baptist Clinic
City
Jonesboro
State/Province
Arkansas
ZIP/Postal Code
72401
Country
United States
Facility Name
Hollis Family Medical Clinic, PLC
City
Paragould
State/Province
Arkansas
ZIP/Postal Code
72450
Country
United States
Facility Name
CSI Clinical Trials
City
Costa Mesa
State/Province
California
ZIP/Postal Code
92626
Country
United States
Facility Name
Global Wellness Medical Corporation
City
Foothill Ranch
State/Province
California
ZIP/Postal Code
92610
Country
United States
Facility Name
Chrishard Medical Group
City
Inglewood
State/Province
California
ZIP/Postal Code
90301
Country
United States
Facility Name
Triwest Research Associates LLC
City
La Mesa
State/Province
California
ZIP/Postal Code
91942
Country
United States
Facility Name
Pacific Coast Pain Management Center
City
Laguna Hills
State/Province
California
ZIP/Postal Code
92637
Country
United States
Facility Name
Valerius Medical Group and Research Center of Greater Long Beach, Inc.
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
Country
United States
Facility Name
LA Pain & Wellness Institute
City
Los Angeles
State/Province
California
ZIP/Postal Code
90017
Country
United States
Facility Name
Samaritan Center for Medical Research
City
Los Gatos
State/Province
California
ZIP/Postal Code
95032
Country
United States
Facility Name
Newport Beach Clinical Research Associates, Inc.
City
Newport Beach
State/Province
California
ZIP/Postal Code
92663
Country
United States
Facility Name
Bayview Research Group, LLC
City
Paramount
State/Province
California
ZIP/Postal Code
90723
Country
United States
Facility Name
Pasadena Rehabilitation Institute
City
Pasadena
State/Province
California
ZIP/Postal Code
91105
Country
United States
Facility Name
Quality Control Research, Inc.
City
Roseville
State/Province
California
ZIP/Postal Code
95661
Country
United States
Facility Name
Northern California Research
City
Sacramento
State/Province
California
ZIP/Postal Code
95821
Country
United States
Facility Name
Quality Control Research, Inc.
City
Sacramento
State/Province
California
ZIP/Postal Code
95842
Country
United States
Facility Name
Rancho Santa Fe Medical Group, Inc.
City
San Marcos
State/Province
California
ZIP/Postal Code
92078
Country
United States
Facility Name
Probe Clinical Research Corporation
City
Santa Ana
State/Province
California
ZIP/Postal Code
92701
Country
United States
Facility Name
Trinity Clinical Trials
City
Santa Ana
State/Province
California
ZIP/Postal Code
92701
Country
United States
Facility Name
Facility Medical Center
City
Upland
State/Province
California
ZIP/Postal Code
91786
Country
United States
Facility Name
Bayview Research Group, LLC
City
Valley Village
State/Province
California
ZIP/Postal Code
91607
Country
United States
Facility Name
Rocky Mountain Internal Medicine, PC
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80012
Country
United States
Facility Name
Clinicos, LLC
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80904
Country
United States
Facility Name
Saint Luke's Medical Clinic, LLC
City
Fort Collins
State/Province
Colorado
ZIP/Postal Code
80525
Country
United States
Facility Name
ProHealth Physicians PC
City
Manchester
State/Province
Connecticut
ZIP/Postal Code
06040
Country
United States
Facility Name
Milford Physician Services, PC
City
Milford
State/Province
Connecticut
ZIP/Postal Code
06460
Country
United States
Facility Name
Orthopedic Research Institute, LLC
City
Boynton Beach
State/Province
Florida
ZIP/Postal Code
33472
Country
United States
Facility Name
Florida Research & Testing, LLC
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33755
Country
United States
Facility Name
Omega Research Consultants, LLC
City
Debary
State/Province
Florida
ZIP/Postal Code
32713
Country
United States
Facility Name
Omega Research Consultants, LLC
City
DeBary
State/Province
Florida
ZIP/Postal Code
32746
Country
United States
Facility Name
West Florida Medical Associate, PA
City
Dunnellon
State/Province
Florida
ZIP/Postal Code
34432
Country
United States
Facility Name
International Research Associates, LLC
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33012
Country
United States
Facility Name
Palm Springs Research Institute, Inc
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33012
Country
United States
Facility Name
FPA Clinical Research, LLC
City
Kissimmee
State/Province
Florida
ZIP/Postal Code
34741
Country
United States
Facility Name
Clinical Research of Central Florida, Inc.
City
Lakeland
State/Province
Florida
ZIP/Postal Code
33810
Country
United States
Facility Name
NextPhase Clinical Trials, Inc.
City
Miami Beach
State/Province
Florida
ZIP/Postal Code
33140
Country
United States
Facility Name
Community Research Foundation, Inc.
City
Miami
State/Province
Florida
ZIP/Postal Code
33155
Country
United States
Facility Name
New Horizon Research Center, Inc.
City
Miami
State/Province
Florida
ZIP/Postal Code
33175
Country
United States
Facility Name
Harmony Clinical Research, Inc.
City
North Miami Beach
State/Province
Florida
ZIP/Postal Code
33162
Country
United States
Facility Name
Office of Laszlo J. Mate, MD, PA
City
North Palm Beach
State/Province
Florida
ZIP/Postal Code
33408
Country
United States
Facility Name
Office of Richard E. Promin, MD, PA
City
Ocala
State/Province
Florida
ZIP/Postal Code
34474
Country
United States
Facility Name
Advent Clinical Research Centers, Inc.
City
Pinellas Park
State/Province
Florida
ZIP/Postal Code
33781
Country
United States
Facility Name
Pain Management Strategies, Inc.
City
Pompano Beach
State/Province
Florida
ZIP/Postal Code
33064
Country
United States
Facility Name
Sarasota Pain Medicine Research, LLC
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34238
Country
United States
Facility Name
Stedman Clinical Trials, LLC
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
Facility Name
Clinical Research Center, LLC
City
Wellington
State/Province
Florida
ZIP/Postal Code
33414
Country
United States
Facility Name
Perimeter Institute for Clinical Research, Inc.
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30338
Country
United States
Facility Name
Medical Research and Health Education Foundation, Inc.
City
Columbus
State/Province
Georgia
ZIP/Postal Code
31909
Country
United States
Facility Name
Ialum Clinical Research, LLC
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30032
Country
United States
Facility Name
Ialum Clinical Research, LLC
City
Stone Mountain
State/Province
Georgia
ZIP/Postal Code
30088
Country
United States
Facility Name
Herman Clinical Research, LLC
City
Suwanee
State/Province
Georgia
ZIP/Postal Code
30024
Country
United States
Facility Name
Centers for Pain Management
City
Tifton
State/Province
Georgia
ZIP/Postal Code
31794
Country
United States
Facility Name
Chicago Clinical Research Institute Inc.
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60616
Country
United States
Facility Name
Creve Coeur Family Practice
City
Creve Coeur
State/Province
Illinois
ZIP/Postal Code
61610
Country
United States
Facility Name
Office of Rebecca Knight, MD
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61614
Country
United States
Facility Name
Josephson Wallack Munshower Neurology P.C.
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46237
Country
United States
Facility Name
Laporte County Institute for Clinical Research Inc.
City
Michigan City
State/Province
Indiana
ZIP/Postal Code
46360
Country
United States
Facility Name
McKinley Research, LLC
City
Mishawaka
State/Province
Indiana
ZIP/Postal Code
46545
Country
United States
Facility Name
Accelovance, Inc.
City
South Bend
State/Province
Indiana
ZIP/Postal Code
46601
Country
United States
Facility Name
Des Moines Orthopaedic Surgeons, PC
City
West Des Moines
State/Province
Iowa
ZIP/Postal Code
50266
Country
United States
Facility Name
The Pain Treatment Center of the Bluegrass
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40503
Country
United States
Facility Name
Healing Options
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40223
Country
United States
Facility Name
Four Rivers Clinical Research, Inc.
City
Paducah
State/Province
Kentucky
ZIP/Postal Code
42003
Country
United States
Facility Name
Lakewood Family Practice
City
Russell Springs
State/Province
Kentucky
ZIP/Postal Code
42642
Country
United States
Facility Name
Diseasebusters, LLC
City
College Park
State/Province
Maryland
ZIP/Postal Code
20740
Country
United States
Facility Name
Office of Steven C. Miller, MD
City
Pikesville
State/Province
Maryland
ZIP/Postal Code
21208
Country
United States
Facility Name
Beacon Clinical Research, LLC
City
Brockton
State/Province
Massachusetts
ZIP/Postal Code
02301
Country
United States
Facility Name
Ronald J. Rapoport, MD, PC
City
Fall River
State/Province
Massachusetts
ZIP/Postal Code
02720
Country
United States
Facility Name
Boston Paincare Center, Inc.
City
Waltham
State/Province
Massachusetts
ZIP/Postal Code
02154
Country
United States
Facility Name
Clarkston Medical Group, PC
City
Clarkston
State/Province
Michigan
ZIP/Postal Code
48346
Country
United States
Facility Name
Apex Medical Research, AMR, Inc.
City
Flint
State/Province
Michigan
ZIP/Postal Code
48504
Country
United States
Facility Name
East Michigan Medical Associates
City
Flint
State/Province
Michigan
ZIP/Postal Code
48507
Country
United States
Facility Name
PCM Medical Services, PC
City
Lansing
State/Province
Michigan
ZIP/Postal Code
48910
Country
United States
Facility Name
Remedica LLC
City
Rochester
State/Province
Michigan
ZIP/Postal Code
48307
Country
United States
Facility Name
Michigan Lifestyle Change and Health Center, PC
City
Sterling
State/Province
Michigan
ZIP/Postal Code
48314
Country
United States
Facility Name
MAPS Applied Research Center, Inc.
City
Edina
State/Province
Minnesota
ZIP/Postal Code
55435
Country
United States
Facility Name
MAPS Applied Research Center, Inc.
City
Shakopee
State/Province
Minnesota
ZIP/Postal Code
55379
Country
United States
Facility Name
Anesthesia and Pain Control Services
City
Biloxi
State/Province
Mississippi
ZIP/Postal Code
39531
Country
United States
Facility Name
CRC of Jackson, LLC
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39202
Country
United States
Facility Name
Midsouth Anesthesia Consultants, PLLC
City
Southhaven
State/Province
Mississippi
ZIP/Postal Code
38671
Country
United States
Facility Name
Patterson Medical Clinic, Inc.
City
Florissant
State/Province
Missouri
ZIP/Postal Code
63031
Country
United States
Facility Name
Quality Clinical Research Inc.
City
Florissant
State/Province
Missouri
ZIP/Postal Code
63033
Country
United States
Facility Name
Primary Care Medicine, PC
City
Jefferson City
State/Province
Missouri
ZIP/Postal Code
65109
Country
United States
Facility Name
The Reiter Foundation, Inc.
City
Anaconda
State/Province
Montana
ZIP/Postal Code
59711
Country
United States
Facility Name
Medical Pain Relief Clinic
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68114
Country
United States
Facility Name
Omaha Clinical Research, PC
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68116
Country
United States
Facility Name
Atco Medical Associates, PC
City
Atco
State/Province
New Jersey
ZIP/Postal Code
08004
Country
United States
Facility Name
Office of John V. Bernard, MD
City
Belvidere
State/Province
New Jersey
ZIP/Postal Code
07823
Country
United States
Facility Name
Central Jersey Medical Research Center, Inc.
City
Elizabeth
State/Province
New Jersey
ZIP/Postal Code
07202
Country
United States
Facility Name
Center for Pain Management
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
Advocare Heights Primary Care
City
Haddon Heights
State/Province
New Jersey
ZIP/Postal Code
08035
Country
United States
Facility Name
NJ Heart, LLC
City
Linden
State/Province
New Jersey
ZIP/Postal Code
07036
Country
United States
Facility Name
Spine and Pain Centers, PA
City
Shrewsbury
State/Province
New Jersey
ZIP/Postal Code
07702
Country
United States
Facility Name
Premier Research, Inc.
City
Trenton
State/Province
New Jersey
ZIP/Postal Code
08611
Country
United States
Facility Name
Adirondack Medical Research Center
City
Glens Falls
State/Province
New York
ZIP/Postal Code
12801
Country
United States
Facility Name
Long Island Gastrointestinal Research Group LLP
City
Great Neck
State/Province
New York
ZIP/Postal Code
11023
Country
United States
Facility Name
Drug Trials America, Inc.
City
Hartsdale
State/Province
New York
ZIP/Postal Code
10530
Country
United States
Facility Name
Office of Roger Kasendorf, DO
City
Long Beach
State/Province
New York
ZIP/Postal Code
11561
Country
United States
Facility Name
Family Health Medical Services PLLC
City
Mayville
State/Province
New York
ZIP/Postal Code
14757
Country
United States
Facility Name
New York Spine & Wellness Center
City
North Syracuse
State/Province
New York
ZIP/Postal Code
13212
Country
United States
Facility Name
North American Partners in Pain Management, LLP
City
Valley Stream
State/Province
New York
ZIP/Postal Code
11580
Country
United States
Facility Name
Carolina Clinical Research and Consulting, LLC
City
Asheboro
State/Province
North Carolina
ZIP/Postal Code
27203
Country
United States
Facility Name
Carolina Clinical Research and Consulting, LLC
City
Asheboro
State/Province
North Carolina
ZIP/Postal Code
27205
Country
United States
Facility Name
Joint and Muscle Research Institute, Inc.
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Facility Name
Catawba Valley Internal Medicine
City
Hickory
State/Province
North Carolina
ZIP/Postal Code
28602
Country
United States
Facility Name
Profen Research Network at ECMA
City
Jacksonville
State/Province
North Carolina
ZIP/Postal Code
28546
Country
United States
Facility Name
The Center For Clinical Research, LLC
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Medical Frontiers, LLC
City
Carlisle
State/Province
Ohio
ZIP/Postal Code
45005
Country
United States
Facility Name
Valley Medical Research
City
Centerville
State/Province
Ohio
ZIP/Postal Code
45459
Country
United States
Facility Name
Hightop Medical Research Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45224
Country
United States
Facility Name
Sentral Clinical Research Services
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45236
Country
United States
Facility Name
Delaware Smith Clinic Research
City
Delaware
State/Province
Ohio
ZIP/Postal Code
43015
Country
United States
Facility Name
Medical Frontiers, LLC
City
Franklin
State/Province
Ohio
ZIP/Postal Code
45005
Country
United States
Facility Name
Jeffrey J. Haggenjos, DO, Inc.
City
New Lexington
State/Province
Ohio
ZIP/Postal Code
43764
Country
United States
Facility Name
Whole Family Medical Care LLC
City
Perrysburg
State/Province
Ohio
ZIP/Postal Code
43551
Country
United States
Facility Name
Office of Jocelyn F. Shimek, DO
City
Salem
State/Province
Ohio
ZIP/Postal Code
44460
Country
United States
Facility Name
Office of James Lassiter
City
Tiffin
State/Province
Ohio
ZIP/Postal Code
44883
Country
United States
Facility Name
Health Research Institute, LLC
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73109
Country
United States
Facility Name
Office of Siavash Nael, MD, Inc.
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73109
Country
United States
Facility Name
Associates of Medicine/John D. Williams, MD, PLLC
City
Stillwater
State/Province
Oklahoma
ZIP/Postal Code
74074
Country
United States
Facility Name
Portland Rheumatology Clinic, LLC
City
Lake Oswego
State/Province
Oregon
ZIP/Postal Code
97035
Country
United States
Facility Name
Office of Joseph E. Yankee, DO, PC
City
Milwaukie
State/Province
Oregon
ZIP/Postal Code
97222
Country
United States
Facility Name
Pennsylvania Pain Specialists, PC
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18102
Country
United States
Facility Name
Ware Medical Associates, PC
City
Aston
State/Province
Pennsylvania
ZIP/Postal Code
19014
Country
United States
Facility Name
Altoona Center for Clinical Research, PC
City
Duncansville
State/Province
Pennsylvania
ZIP/Postal Code
16635
Country
United States
Facility Name
Kandra, Fierer, Kuskin Associates, Ltd.
City
Harrisburg
State/Province
Pennsylvania
ZIP/Postal Code
17112
Country
United States
Facility Name
Onuorah Umeh, M.D. P.C
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Founders Research Corporation
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19152
Country
United States
Facility Name
Progressive Pain Solutions, LLC
City
Wind Gap
State/Province
Pennsylvania
ZIP/Postal Code
18091
Country
United States
Facility Name
Hartwell Research Group, LLC
City
Anderson
State/Province
South Carolina
ZIP/Postal Code
29621
Country
United States
Facility Name
Low Country Rheumatology, PA
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29406
Country
United States
Facility Name
Pharmacorp Clinical Trials, Inc.
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29412
Country
United States
Facility Name
Internal Medicine of Greer Research LLC
City
Greer
State/Province
South Carolina
ZIP/Postal Code
29650
Country
United States
Facility Name
Clinical Research Authority, LLC
City
Murrells Inlet
State/Province
South Carolina
ZIP/Postal Code
29576
Country
United States
Facility Name
Trident Institute of Medical Research, LLC
City
North Charleston
State/Province
South Carolina
ZIP/Postal Code
29406
Country
United States
Facility Name
Low Country Pain Center, LLC
City
Orangeburg
State/Province
South Carolina
ZIP/Postal Code
29118
Country
United States
Facility Name
Brown Clinic, PLLP
City
Watertown
State/Province
South Dakota
ZIP/Postal Code
57201
Country
United States
Facility Name
Chattanooga Medical Research, LLC
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37404
Country
United States
Facility Name
Comprehensive Pain Specialists
City
Hendersonville
State/Province
Tennessee
ZIP/Postal Code
37075
Country
United States
Facility Name
Corsicana Medical Research, PLLC
City
Corsicana
State/Province
Texas
ZIP/Postal Code
75110
Country
United States
Facility Name
DCT - Genesis Neighborhood Research, LLC
City
Dallas
State/Province
Texas
ZIP/Postal Code
75254
Country
United States
Facility Name
Southwest Urgent Care Center
City
El Paso
State/Province
Texas
ZIP/Postal Code
79902
Country
United States
Facility Name
Westbury Medical Clinic
City
Houston
State/Province
Texas
ZIP/Postal Code
77005
Country
United States
Facility Name
Accurate Clinical Research, Inc.
City
Houston
State/Province
Texas
ZIP/Postal Code
77034
Country
United States
Facility Name
Medstar Clinical Research
City
Houston
State/Province
Texas
ZIP/Postal Code
77083
Country
United States
Facility Name
Texas Medical Research Associates, LLC
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78238
Country
United States
Facility Name
Hillcrest Family Health Center, Division of Clinical Research
City
Waco
State/Province
Texas
ZIP/Postal Code
76710
Country
United States
Facility Name
Hillcrest Family Health Center
City
Waco
State/Province
Texas
ZIP/Postal Code
76710
Country
United States
Facility Name
Progressive Clinical Research, LLC
City
Bountiful
State/Province
Utah
ZIP/Postal Code
84010
Country
United States
Facility Name
Sentara Medical Group, NDC Medical Center
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
Facility Name
Washington Center for Pain Management PLLC
City
Edmonds
State/Province
Washington
ZIP/Postal Code
98026
Country
United States
Facility Name
Pain Care, PLLC
City
Huntington
State/Province
West Virginia
ZIP/Postal Code
25701
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
27782769
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.
Results Reference
derived
PubMed Identifier
26185466
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.
Results Reference
derived
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=ALO-01-10-4003&StudyName=Conversion%20to%20Embeda%20With%20Rescue%20Trial
Description
To obtain contact information for a study center near you, click here.

Learn more about this trial

Conversion to Embeda With Rescue Trial

We'll reach out to this number within 24 hrs