Conversion to Embeda With Rescue Trial

Pain Clinical Trial

— 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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01179191
• Other study ID #: ALO-01-10-4003
• Secondary ID: B4541001
• Status: Terminated
• Phase: Phase 4
• First received: July 30, 2010
• Last updated: October 9, 2012
• Start date: August 2010
• Est. completion date: April 2011

Study information

• Verified date: October 2012
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 684
• Est. completion date: April 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Disease
• Pain

Intervention

Drug:
• morphine sulfate and naltrexone hydrochloride (EMBEDA)
Capsules in dose strengths ranging from 20 to 100 mg morphine sulfate with 0.8 to 4 mg of naltrexone hydrochloride taken either once or twice daily with a starting dose calculated using the total daily dose of the current opioid being converted from until a stable dose is achieved or six weeks which ever comes first.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of Participants With Aberrant Behaviors	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.	Day 5
Other	Number of Participants With Abnormal Urine Drug Test Results	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.	Baseline, Visit 3 (up to Week 6)
Other	Number of Participants With Urine Drug Test Results Positive for Unaccounted Opioids	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.	Visit 3 (up to Week 6)
Other	Number of Participants With Urine Drug Test Results Positive for Illicit Substances	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.	Baseline, Visit 3 (up to Week 6)
Other	Number of Participants With Greater Than or Equal to One Urine Drug Test Results Negative for Expected Opioid	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.	Baseline, Visit 3 (up to Week 6)
Primary	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
Primary	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	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.	Baseline through Week 6
Secondary	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.	Baseline through Week 6
Secondary	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.	Baseline through Week 6
Secondary	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.	Baseline through Week 6
Secondary	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.	Baseline through Week 6
Secondary	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.	Baseline, Visit 3 (up to Week 6)
Secondary	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.	Week 6

External Links

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