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| ID | Type | Description | Link |
|---|---|---|---|
| B4541001 |
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See termination reason in detailed description.
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| morphine sulfate and naltrexone hydrochloride (EMBEDA) | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| morphine sulfate and naltrexone hydrochloride (EMBEDA) | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving Stable Dose of EMBEDA Within 6 Weeks Titration Phase | A dose was considered to be stable dose if it met all of the following criteria: dose was taken for at least 48 hours; investigator deemed the balance between an acceptable level of analgesia and/or function and tolerance of side effects had been achieved; and rescue medication use less than or equal to 2 doses per day. | Baseline through Week 6 |
| Percentage of Participants Achieving Stable Dose of EMBEDA Within 6 Weeks Titration Phase Stratified by Prior Opioid Therapy | A dose was considered to be stable dose if it met all of the following criteria: dose was taken for at least 48 hours; investigator deemed the balance between an acceptable level of analgesia and/or function and tolerance of side effects had been achieved; and rescue medication use less than or equal to 2 doses per day. | Baseline through Week 6 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Adamsville Family Medicine | Adamsville | Alabama | 35005 | United States | ||
| Office of David McLain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27782769 | Derived | 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. | |
| 26185466 | Derived |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | EMBEDA | EMBEDA (morphine sulfate/naltrexone hydrochloride) extended-release capsules orally prescribed according to usual clinical practice using a standardized conversion guide. Treatment included titration phase (up to 6 weeks) followed by maintenance phase (8 weeks). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Titration Phase (up to 6 Weeks) |
|
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| 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 |
| 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 |
| 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 |
| 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 |
| 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) |
| 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 |
| 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) |
| 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) |
| 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) |
| 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) |
| Birmingham |
| Alabama |
| 35209 |
| United States |
| Monte Sano Clinical Research, LLC | Huntsville | Alabama | 35801 | United States |
| Tennessee Valley Pain Consultants Properties, LLC | Huntsville | Alabama | 35801 | United States |
| Sunbelt Research Group, LLC | Mobile | Alabama | 36693 | United States |
| Office of Vaughn H. Mancha, Jr., PC | Montgomery | Alabama | 36117 | United States |
| Dedicated Clinical Research | Goodyear | Arizona | 85395 | United States |
| Dedicated Clinical Research, Inc | Phoenix | Arizona | 85020 | United States |
| Redpoint Research | Phoenix | Arizona | 85029 | United States |
| Anasazi Internal Medicine, PC | Phoenix | Arizona | 85032 | United States |
| Cochise Clinical Research | Sierra Vista | Arizona | 85635 | United States |
| Premiere Phamaceutical Research, LLC | Tempe | Arizona | 85282 | United States |
| Quality of Life Medical and Research Center, LLC | Tucson | Arizona | 85712 | United States |
| Ouachita Regional Pain Management | Hot Springs | Arkansas | 71913 | United States |
| NEA Baptist Clinic | Jonesboro | Arkansas | 72401 | United States |
| Hollis Family Medical Clinic, PLC | Paragould | Arkansas | 72450 | United States |
| CSI Clinical Trials | Costa Mesa | California | 92626 | United States |
| Global Wellness Medical Corporation | Foothill Ranch | California | 92610 | United States |
| Chrishard Medical Group | Inglewood | California | 90301 | United States |
| Triwest Research Associates LLC | La Mesa | California | 91942 | United States |
| Pacific Coast Pain Management Center | Laguna Hills | California | 92637 | United States |
| Valerius Medical Group and Research Center of Greater Long Beach, Inc. | Long Beach | California | 90806 | United States |
| LA Pain & Wellness Institute | Los Angeles | California | 90017 | United States |
| Samaritan Center for Medical Research | Los Gatos | California | 95032 | United States |
| Newport Beach Clinical Research Associates, Inc. | Newport Beach | California | 92663 | United States |
| Bayview Research Group, LLC | Paramount | California | 90723 | United States |
| Pasadena Rehabilitation Institute | Pasadena | California | 91105 | United States |
| Quality Control Research, Inc. | Roseville | California | 95661 | United States |
| Northern California Research | Sacramento | California | 95821 | United States |
| Quality Control Research, Inc. | Sacramento | California | 95842 | United States |
| Rancho Santa Fe Medical Group, Inc. | San Marcos | California | 92078 | United States |
| Probe Clinical Research Corporation | Santa Ana | California | 92701 | United States |
| Trinity Clinical Trials | Santa Ana | California | 92701 | United States |
| Facility Medical Center | Upland | California | 91786 | United States |
| Bayview Research Group, LLC | Valley Village | California | 91607 | United States |
| Rocky Mountain Internal Medicine, PC | Aurora | Colorado | 80012 | United States |
| Clinicos, LLC | Colorado Springs | Colorado | 80904 | United States |
| Saint Luke's Medical Clinic, LLC | Fort Collins | Colorado | 80525 | United States |
| ProHealth Physicians PC | Manchester | Connecticut | 06040 | United States |
| Milford Physician Services, PC | Milford | Connecticut | 06460 | United States |
| Orthopedic Research Institute, LLC | Boynton Beach | Florida | 33472 | United States |
| Florida Research & Testing, LLC | Clearwater | Florida | 33755 | United States |
| Omega Research Consultants, LLC | DeBary | Florida | 32713 | United States |
| Omega Research Consultants, LLC | DeBary | Florida | 32746 | United States |
| West Florida Medical Associate, PA | Dunnellon | Florida | 34432 | United States |
| International Research Associates, LLC | Hialeah | Florida | 33012 | United States |
| Palm Springs Research Institute, Inc | Hialeah | Florida | 33012 | United States |
| FPA Clinical Research, LLC | Kissimmee | Florida | 34741 | United States |
| Clinical Research of Central Florida, Inc. | Lakeland | Florida | 33810 | United States |
| Community Research Foundation, Inc. | Miami | Florida | 33155 | United States |
| New Horizon Research Center, Inc. | Miami | Florida | 33175 | United States |
| NextPhase Clinical Trials, Inc. | Miami Beach | Florida | 33140 | United States |
| Harmony Clinical Research, Inc. | North Miami Beach | Florida | 33162 | United States |
| Office of Laszlo J. Mate, MD, PA | North Palm Beach | Florida | 33408 | United States |
| Office of Richard E. Promin, MD, PA | Ocala | Florida | 34474 | United States |
| Advent Clinical Research Centers, Inc. | Pinellas Park | Florida | 33781 | United States |
| Pain Management Strategies, Inc. | Pompano Beach | Florida | 33064 | United States |
| Sarasota Pain Medicine Research, LLC | Sarasota | Florida | 34238 | United States |
| Stedman Clinical Trials, LLC | Tampa | Florida | 33613 | United States |
| Clinical Research Center, LLC | Wellington | Florida | 33414 | United States |
| Perimeter Institute for Clinical Research, Inc. | Atlanta | Georgia | 30338 | United States |
| Medical Research and Health Education Foundation, Inc. | Columbus | Georgia | 31909 | United States |
| Ialum Clinical Research, LLC | Decatur | Georgia | 30032 | United States |
| Ialum Clinical Research, LLC | Stone Mountain | Georgia | 30088 | United States |
| Herman Clinical Research, LLC | Suwanee | Georgia | 30024 | United States |
| Centers for Pain Management | Tifton | Georgia | 31794 | United States |
| Chicago Clinical Research Institute Inc. | Chicago | Illinois | 60616 | United States |
| Creve Coeur Family Practice | Creve Coeur | Illinois | 61610 | United States |
| Office of Rebecca Knight, MD | Peoria | Illinois | 61614 | United States |
| Josephson Wallack Munshower Neurology P.C. | Indianapolis | Indiana | 46237 | United States |
| Laporte County Institute for Clinical Research Inc. | Michigan City | Indiana | 46360 | United States |
| McKinley Research, LLC | Mishawaka | Indiana | 46545 | United States |
| Accelovance, Inc. | South Bend | Indiana | 46601 | United States |
| Des Moines Orthopaedic Surgeons, PC | West Des Moines | Iowa | 50266 | United States |
| The Pain Treatment Center of the Bluegrass | Lexington | Kentucky | 40503 | United States |
| Healing Options | Louisville | Kentucky | 40223 | United States |
| Four Rivers Clinical Research, Inc. | Paducah | Kentucky | 42003 | United States |
| Lakewood Family Practice | Russell Springs | Kentucky | 42642 | United States |
| Diseasebusters, LLC | College Park | Maryland | 20740 | United States |
| Office of Steven C. Miller, MD | Pikesville | Maryland | 21208 | United States |
| Beacon Clinical Research, LLC | Brockton | Massachusetts | 02301 | United States |
| Ronald J. Rapoport, MD, PC | Fall River | Massachusetts | 02720 | United States |
| Boston Paincare Center, Inc. | Waltham | Massachusetts | 02154 | United States |
| Clarkston Medical Group, PC | Clarkston | Michigan | 48346 | United States |
| Apex Medical Research, AMR, Inc. | Flint | Michigan | 48504 | United States |
| East Michigan Medical Associates | Flint | Michigan | 48507 | United States |
| PCM Medical Services, PC | Lansing | Michigan | 48910 | United States |
| Remedica LLC | Rochester | Michigan | 48307 | United States |
| Michigan Lifestyle Change and Health Center, PC | Sterling | Michigan | 48314 | United States |
| MAPS Applied Research Center, Inc. | Edina | Minnesota | 55435 | United States |
| MAPS Applied Research Center, Inc. | Shakopee | Minnesota | 55379 | United States |
| Anesthesia and Pain Control Services | Biloxi | Mississippi | 39531 | United States |
| CRC of Jackson, LLC | Jackson | Mississippi | 39202 | United States |
| Midsouth Anesthesia Consultants, PLLC | Southhaven | Mississippi | 38671 | United States |
| Patterson Medical Clinic, Inc. | Florissant | Missouri | 63031 | United States |
| Quality Clinical Research Inc. | Florissant | Missouri | 63033 | United States |
| Primary Care Medicine, PC | Jefferson City | Missouri | 65109 | United States |
| The Reiter Foundation, Inc. | Anaconda | Montana | 59711 | United States |
| Medical Pain Relief Clinic | Omaha | Nebraska | 68114 | United States |
| Omaha Clinical Research, PC | Omaha | Nebraska | 68116 | United States |
| Atco Medical Associates, PC | Atco | New Jersey | 08004 | United States |
| Office of John V. Bernard, MD | Belvidere | New Jersey | 07823 | United States |
| Central Jersey Medical Research Center, Inc. | Elizabeth | New Jersey | 07202 | United States |
| Center for Pain Management | Hackensack | New Jersey | 07601 | United States |
| Advocare Heights Primary Care | Haddon Heights | New Jersey | 08035 | United States |
| NJ Heart, LLC | Linden | New Jersey | 07036 | United States |
| Spine and Pain Centers, PA | Shrewsbury | New Jersey | 07702 | United States |
| Premier Research, Inc. | Trenton | New Jersey | 08611 | United States |
| Adirondack Medical Research Center | Glens Falls | New York | 12801 | United States |
| Long Island Gastrointestinal Research Group LLP | Great Neck | New York | 11023 | United States |
| Drug Trials America, Inc. | Hartsdale | New York | 10530 | United States |
| Office of Roger Kasendorf, DO | Long Beach | New York | 11561 | United States |
| Family Health Medical Services PLLC | Mayville | New York | 14757 | United States |
| New York Spine & Wellness Center | North Syracuse | New York | 13212 | United States |
| North American Partners in Pain Management, LLP | Valley Stream | New York | 11580 | United States |
| Carolina Clinical Research and Consulting, LLC | Asheboro | North Carolina | 27203 | United States |
| Carolina Clinical Research and Consulting, LLC | Asheboro | North Carolina | 27205 | United States |
| Joint and Muscle Research Institute, Inc. | Charlotte | North Carolina | 28204 | United States |
| Catawba Valley Internal Medicine | Hickory | North Carolina | 28602 | United States |
| Profen Research Network at ECMA | Jacksonville | North Carolina | 28546 | United States |
| The Center For Clinical Research, LLC | Winston-Salem | North Carolina | 27103 | United States |
| Medical Frontiers, LLC | Carlisle | Ohio | 45005 | United States |
| Valley Medical Research | Centerville | Ohio | 45459 | United States |
| Hightop Medical Research Center | Cincinnati | Ohio | 45224 | United States |
| Sentral Clinical Research Services | Cincinnati | Ohio | 45236 | United States |
| Delaware Smith Clinic Research | Delaware | Ohio | 43015 | United States |
| Medical Frontiers, LLC | Franklin | Ohio | 45005 | United States |
| Jeffrey J. Haggenjos, DO, Inc. | New Lexington | Ohio | 43764 | United States |
| Whole Family Medical Care LLC | Perrysburg | Ohio | 43551 | United States |
| Office of Jocelyn F. Shimek, DO | Salem | Ohio | 44460 | United States |
| Office of James Lassiter | Tiffin | Ohio | 44883 | United States |
| Health Research Institute, LLC | Oklahoma City | Oklahoma | 73109 | United States |
| Office of Siavash Nael, MD, Inc. | Oklahoma City | Oklahoma | 73109 | United States |
| Associates of Medicine/John D. Williams, MD, PLLC | Stillwater | Oklahoma | 74074 | United States |
| Portland Rheumatology Clinic, LLC | Lake Oswego | Oregon | 97035 | United States |
| Office of Joseph E. Yankee, DO, PC | Milwaukie | Oregon | 97222 | United States |
| Pennsylvania Pain Specialists, PC | Allentown | Pennsylvania | 18102 | United States |
| Ware Medical Associates, PC | Aston Mills | Pennsylvania | 19014 | United States |
| Altoona Center for Clinical Research, PC | Duncansville | Pennsylvania | 16635 | United States |
| Kandra, Fierer, Kuskin Associates, Ltd. | Harrisburg | Pennsylvania | 17112 | United States |
| Onuorah Umeh, M.D. P.C | Philadelphia | Pennsylvania | 19104 | United States |
| Founders Research Corporation | Philadelphia | Pennsylvania | 19152 | United States |
| Progressive Pain Solutions, LLC | Wind Gap | Pennsylvania | 18091 | United States |
| Hartwell Research Group, LLC | Anderson | South Carolina | 29621 | United States |
| Low Country Rheumatology, PA | Charleston | South Carolina | 29406 | United States |
| Pharmacorp Clinical Trials, Inc. | Charleston | South Carolina | 29412 | United States |
| Internal Medicine of Greer Research LLC | Greer | South Carolina | 29650 | United States |
| Clinical Research Authority, LLC | Murrells Inlet | South Carolina | 29576 | United States |
| Trident Institute of Medical Research, LLC | North Charleston | South Carolina | 29406 | United States |
| Low Country Pain Center, LLC | Orangeburg | South Carolina | 29118 | United States |
| Brown Clinic, PLLP | Watertown | South Dakota | 57201 | United States |
| Chattanooga Medical Research, LLC | Chattanooga | Tennessee | 37404 | United States |
| Comprehensive Pain Specialists | Hendersonville | Tennessee | 37075 | United States |
| Corsicana Medical Research, PLLC | Corsicana | Texas | 75110 | United States |
| DCT - Genesis Neighborhood Research, LLC | Dallas | Texas | 75254 | United States |
| Southwest Urgent Care Center | El Paso | Texas | 79902 | United States |
| Westbury Medical Clinic | Houston | Texas | 77005 | United States |
| Accurate Clinical Research, Inc. | Houston | Texas | 77034 | United States |
| Medstar Clinical Research | Houston | Texas | 77083 | United States |
| Texas Medical Research Associates, LLC | San Antonio | Texas | 78238 | United States |
| Hillcrest Family Health Center, Division of Clinical Research | Waco | Texas | 76710 | United States |
| Hillcrest Family Health Center | Waco | Texas | 76710 | United States |
| Progressive Clinical Research, LLC | Bountiful | Utah | 84010 | United States |
| Sentara Medical Group, NDC Medical Center | Norfolk | Virginia | 23502 | United States |
| Washington Center for Pain Management PLLC | Edmonds | Washington | 98026 | United States |
| Pain Care, PLLC | Huntington | West Virginia | 25701 | United States |
| 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. |
| COMPLETED |
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| NOT COMPLETED |
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| Maintenance Phase (8 Weeks) |
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| ID | Title | Description |
|---|---|---|
| BG000 | EMBEDA | EMBEDA (morphine sulfate/naltrexone hydrochloride) extended-release capsules orally prescribed according to usual clinical practice using a standardized conversion guide. Treatment included titration phase (up to 6 weeks) followed by maintenance phase (8 weeks). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean | Standard Deviation | Years |
| ||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||||
| Brief Pain Inventory (BPI) | BPI:11-item questionnaire,4 questions:pain intensity(worst,least,average,relief),7questions:pain impact on daily functions(general activity,mood,walking ability,normal work,relations with others,sleep,life enjoyment).Each question range=0-10(0%-100% for relief),higher score=more pain/relief/interference.'n'=participants evaluated for each subscale. | Mean | Standard Deviation | Units on a scale |
| |||||||||||||||||||
| Investigator(Ir) Compared to Participant(Pa)-Derived Risk Level Assessment of Misuse,Abuse,Diversion | Number of participants at Ir-assessed risk level compared to Pa-derived risk level (low,moderate[mod] or high) for opioid misuse,abuse,diversion. An exploratory scoring algorithm applied to results of Participant's Experience and Concerns Questionnaire to get Pa-derived risk levels. Pa evaluable=683. 'n'=Pa evaluated for each assessed risk level. | Number | Participants |
| ||||||||||||||||||||
| Number of Participants Reporting Concerns With Prescription Opioid (Op) Misuse, Abuse or Diversion | Participant experience and concerns with prescription opioids questionnaire consisted of multiple choice questions and numeric rating scale(NRS);range=0(not at all) to 10 (extremely worried);used to assess current concerns, past behaviors related to opioid misuse, abuse, diversion.n=Pa evaluable for given question. Pa may choose more than 1 reason. | Number | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Safety population included all participants who completed the first study visit and filled a prescription for EMBEDA. | Posted | Number | 95% Confidence Interval | Percentage of participants | Baseline through Week 6 |
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| 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. | Safety population included all participants who completed the first study visit and filled a prescription for EMBEDA. Participants were stratified based on prior opioid therapy. The 'n' is signifying those participants who were evaluated for this measure for each of the prior medication received. | Posted | Number | 95% Confidence Interval | Percentage of participants | Baseline through Week 6 |
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| 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. | Safety population included all participants who completed the first study visit and filled a prescription for EMBEDA. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. | Posted | Mean | Standard Deviation | Days | Baseline through Week 6 |
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| 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. | Safety population. Participants were stratified based on prior opioid therapy. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluated for this measure for each of the prior medication received. | Posted | Mean | Standard Deviation | Days | Baseline through Week 6 |
|
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| 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. | Safety population included all participants who completed the first study visit and filled a prescription for EMBEDA. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. | Posted | Mean | Standard Deviation | titration steps | Baseline through Week 6 |
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| 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. | Safety population. Participants were stratified based on prior opioid therapy. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluated for this measure for each of the prior medication received. | Posted | Mean | Standard Deviation | titration steps | 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. | Safety population included all participants who completed the first study visit and filled a prescription for EMBEDA. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. | Posted | Number | Percentage of participants | 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. | Safety population included all participants who completed the first study visit and filled a prescription for EMBEDA. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. The 'n' is signifying those participants who were evaluated for the respective subscale. | Posted | Mean | Standard Deviation | Units on a scale | 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. | Safety population included all participants who completed the first study visit and filled a prescription for EMBEDA. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. | Posted | Mean | Standard Deviation | Units on a Scale | Week 6 |
|
| ||||||||||||||||||||||||||
| Other Pre-specified | 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. | Safety population included all participants who completed the first study visit and filled a prescription for EMBEDA. | Posted | Number | Participants | Day 5 |
|
| |||||||||||||||||||||||||||
| Other Pre-specified | 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. | Safety population included all participants who completed the first study visit and filled a prescription for EMBEDA. Here, the 'n' is signifying those participants who were evaluable for this measure at the specified time point for this arm group. | Posted | Number | Participants | Baseline, Visit 3 (up to Week 6) |
|
| |||||||||||||||||||||||||||
| Other Pre-specified | 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. | Safety population included all participants who completed the first study visit and filled a prescription for EMBEDA. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. | Posted | Number | Participants | Visit 3 (up to Week 6) |
|
| |||||||||||||||||||||||||||
| Other Pre-specified | 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. | Safety population included all participants who completed the first study visit and filled a prescription for EMBEDA. Here, the 'n' is signifying those participants who were evaluable for this measure at the specified time point for this arm group. | Posted | Number | Participants | Baseline, Visit 3 (up to Week 6) |
|
| |||||||||||||||||||||||||||
| Other Pre-specified | 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. | Safety population included all participants who completed the first study visit and filled a prescription for EMBEDA. Here, the 'n' is signifying those participants who were evaluable for this measure at the specified time point for this arm group. | Posted | Number | Participants | Baseline, Visit 3 (up to Week 6) |
|
|
Not provided
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | EMBEDA | EMBEDA (morphine sulfate/naltrexone hydrochloride) extended-release capsules orally prescribed according to usual clinical practice using a standardized conversion guide. Treatment included titration phase (up to 6 weeks) followed by maintenance phase (8 weeks). | 24 | 684 | 331 | 684 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina unstable | Cardiac disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Dyspnoea | Cardiac disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Right ventricular hypertrophy | Cardiac disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Hyperglycaemia | Endocrine disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Diverticulitis | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Gastroenteritis | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Sudden death | General disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Hepatitis acute | Hepatobiliary disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Skin infection | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
| |
| Radius fracture | Injury, poisoning and procedural complications | MedDRA 13.1 | Non-systematic Assessment |
| |
| Electrocardiogram t wave inversion | Investigations | MedDRA 13.1 | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Gout | Metabolism and nutrition disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Rhabdomyolysis | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Carotid artery disease | Nervous system disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Convulsion | Nervous system disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Dyskinesia | Nervous system disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Transient ishaemic attack | Nervous system disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Drug abuse | Psychiatric disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Pulmonary hypertension | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Dyspnoea | Cardiac disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Oedema peripheral | Cardiac disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Syncope | Cardiac disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Tinnitus | Ear and labyrinth disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Diabetes mellitus | Endocrine disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Blindness transient | Eye disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Diplopia | Eye disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Eye pain | Eye disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Metamorphopsia | Eye disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Scleral haemorrhage | Eye disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Breath odour | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Crohn's disease | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Dysgeusia | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Enteritis infectious | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Food poisoning | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Gastroenteritis viral | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Haematochezia | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Haemorrhoidal haemorrhage | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Painful defaecation | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Tooth disorder | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Tooth infection | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Adverse drug reaction | General disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Adverse event | General disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Burning sensation | General disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Chest discomfort | General disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Chills | General disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Drug intolerance | General disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Drug withdrawal syndrome | General disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Face oedema | General disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Feeling abnormal | General disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Feeling of body temperature change | General disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Flushing | General disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Gait disturbance | General disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Hot flush | General disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Hyperhidrosis | General disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Irritability | General disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Lethargy | General disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Oedema | General disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Pain | General disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Thirst | General disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Withdrawal syndrome | General disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Chronic hepatitis | Hepatobiliary disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Urticaria | Immune system disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
| |
| Candidiasis | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
| |
| Localised infection | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
| |
| Pharyngitis streptococcal | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
| |
| Staphylococcal infection | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
| |
| Tooth infection | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
| |
| Vulvovaginal mycotic infection | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
| |
| Accidental overdose | Injury, poisoning and procedural complications | MedDRA 13.1 | Non-systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA 13.1 | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 13.1 | Non-systematic Assessment |
| |
| Foot fracture | Injury, poisoning and procedural complications | MedDRA 13.1 | Non-systematic Assessment |
| |
| Foreign body | Injury, poisoning and procedural complications | MedDRA 13.1 | Non-systematic Assessment |
| |
| Hand fracture | Injury, poisoning and procedural complications | MedDRA 13.1 | Non-systematic Assessment |
| |
| Joint injury | Injury, poisoning and procedural complications | MedDRA 13.1 | Non-systematic Assessment |
| |
| Muscle strain | Injury, poisoning and procedural complications | MedDRA 13.1 | Non-systematic Assessment |
| |
| Rotator cuff syndrome | Injury, poisoning and procedural complications | MedDRA 13.1 | Non-systematic Assessment |
| |
| Skeletal injury | Injury, poisoning and procedural complications | MedDRA 13.1 | Non-systematic Assessment |
| |
| Skin laceration | Injury, poisoning and procedural complications | MedDRA 13.1 | Non-systematic Assessment |
| |
| Tendonitis | Injury, poisoning and procedural complications | MedDRA 13.1 | Non-systematic Assessment |
| |
| Thermal burn | Injury, poisoning and procedural complications | MedDRA 13.1 | Non-systematic Assessment |
| |
| Blood pressure increased | Investigations | MedDRA 13.1 | Non-systematic Assessment |
| |
| Intraocular pressure increased | Investigations | MedDRA 13.1 | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Gout | Metabolism and nutrition disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Obesity | Metabolism and nutrition disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Gout | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Mobility decreased | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Muscle twitching | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Restless legs syndrome | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Synovial cyst | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Abnormal dreams | Nervous system disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Agitation | Nervous system disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Balance disorder | Nervous system disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Carpal tunnel syndrome | Nervous system disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Cognitive disorder | Nervous system disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Confusional state | Nervous system disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Disorientation | Nervous system disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Disturbance in attention | Nervous system disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Dysaesthesia | Nervous system disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Dysarthria | Nervous system disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Dysphemia | Nervous system disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Dysphonia | Nervous system disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Insomnia | Nervous system disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Restless legs syndrome | Nervous system disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Restlessness | Nervous system disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Sciatica | Nervous system disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Sedation | Nervous system disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Sinus headache | Nervous system disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Tension headache | Nervous system disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Urinary incontinence | Nervous system disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Affective disorder | Psychiatric disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Aggression | Psychiatric disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Crying | Psychiatric disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Delirium | Psychiatric disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Dysphoria | Psychiatric disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Emotional disorder | Psychiatric disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Enuresis | Psychiatric disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Hallucination | Psychiatric disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Hallucinations, mixed | Psychiatric disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Hypersomnia | Psychiatric disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Mood swings | Psychiatric disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Nervousness | Psychiatric disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Nightmare | Psychiatric disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Throat tightness | Psychiatric disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Pollakiuria | Renal and urinary disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Urinary hesitation | Renal and urinary disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Ejaculation disorder | Reproductive system and breast disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Erectile dysfunction | Reproductive system and breast disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Hot flush | Reproductive system and breast disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Polymenorrhoea | Reproductive system and breast disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Sexual dysfunction | Reproductive system and breast disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Pulmonary congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Sinus congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Sleep apnoea syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Sneezing | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Acne | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Night sweats | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Pruritus generalised | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Rash generalised | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Swelling face | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 13.1 | Non-systematic Assessment |
|
The study was prematurely terminated due to drug supply issues.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| ID | Term |
|---|---|
| D002908 | Chronic Disease |
| D010146 | Pain |
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D009020 | Morphine |
| D009271 | Naltrexone |
| C550436 | morphine, naltrexone combination |
| ID | Term |
|---|---|
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D009270 | Naloxone |
Not provided
Not provided
| Withdrawal by Subject |
|
| Other |
|
|
| Least Pain (n = 642) |
|
| Relief (n = 639) |
|
| General Activity (n = 643) |
|
| Mood (n = 642) |
|
| Walking Ability (n = 641) |
|
| Normal Work (n = 637) |
|
| Relationships with Others (n = 644) |
|
| Sleep (n = 642) |
|
| Enjoyment of Life (n = 640) |
|
|
| Abuse: Low(Ir)/ High(Pa) (n= 6) |
|
| Abuse: Mod(Ir)/ Low(Pa) (n= 1) |
|
| Abuse: Mod(Ir)/ Mod(Pa) (n= 1) |
|
| Abuse: Mod(Ir)/ High(Pa) (n= 1) |
|
| Abuse: High(Ir)/ Low(Pa) (n= 1) |
|
| Abuse: High(Ir)/ Mod(Pa) (n= 1) |
|
| Abuse: High(Ir)/ High(Pa) (n= 1) |
|
| Misuse General: Low(Ir)/ Low(Pa) (n= 127) |
|
| Misuse General: Low(Ir)/ Mod(Pa) (n= 127) |
|
| Misuse General: Low(Ir)/ High(Pa) (n= 127) |
|
| Misuse General: Mod(Ir)/ Low(Pa) (n= 24) |
|
| Misuse General: Mod(Ir)/ Mod(Pa) (n= 24) |
|
| Misuse General: Mod(Ir)/ High(Pa) (n= 24) |
|
| Misuse General: High(Ir)/ Low(Pa) (n= 3) |
|
| Misuse General: High(Ir)/ Mod(Pa) (n= 3) |
|
| Misuse General: High(Ir)/ High(Pa) (n= 3) |
|
| Misuse Pseudoaddiction: Low(Ir)/ Low(Pa) (n= 227) |
|
| Misuse Pseudoaddiction: Low(Ir)/ Mod(Pa) (n= 227) |
|
| Misuse Pseudoaddiction: Low(Ir)/ High(Pa) (n= 227) |
|
| Misuse Pseudoaddiction: Mod(Ir)/ Low(Pa) (n= 42) |
|
| Misuse Pseudoaddiction: Mod(Ir)/ Mod(Pa) (n= 42) |
|
| Misuse Pseudoaddiction: Mod(Ir)/ High(Pa) (n= 42) |
|
| Misuse Pseudoaddiction: High(Ir)/ Low(Pa) (n= 5) |
|
| Misuse Pseudoaddiction: High(Ir)/ Mod(Pa) (n= 5) |
|
| Misuse Pseudoaddiction: High(Ir)/ High(Pa) (n= 5) |
|
| Misuse Total: Low(Ir)/ Low(Pa) (n= 295) |
|
| Misuse Total: Low(Ir)/ Mod(Pa) (n= 295) |
|
| Misuse Total: Low(Ir)/ High(Pa) (n= 295) |
|
| Misuse Total: Mod(Ir)/ Low(Pa) (n= 56) |
|
| Misuse Total: Mod(Ir)/ Mod(Pa) (n= 56) |
|
| Misuse Total: Mod(Ir)/ High(Pa) (n= 56) |
|
| Misuse Total: High(Ir)/ Low(Pa) (n= 6) |
|
| Misuse Total: High(Ir)/ Mod(Pa) (n= 6) |
|
| Misuse Total: High(Ir)/ High(Pa) (n= 6) |
|
| Diversion: Low (Ir)/ Low (Pa) (n= 487) |
|
| Diversion: Low (Ir)/ Mod (Pa) (n= 487) |
|
| Diversion: Low (Ir)/ High (Pa) (n= 487) |
|
| Diversion: Mod (Ir)/ Low (Pa) (n= 22) |
|
| Diversion: Mod (Ir)/ Mod (Pa) (n= 22) |
|
| Diversion: Mod (Ir)/ High (Pa) (n= 22) |
|
| Diversion: High (Ir)/ Low (Pa) (n= 5) |
|
| Diversion: High (Ir)/ Mod (Pa) (n= 5) |
|
| Diversion: High (Ir)/ High (Pa) (n= 5) |
|
|
| Worried getting addicted or hooked to Op:2(n=537) |
|
| Worried getting addicted or hooked to Op:3(n=537) |
|
| Worried getting addicted or hooked to Op:4(n=537) |
|
| Worried getting addicted or hooked to Op:5(n=537) |
|
| Worried getting addicted or hooked to Op:6(n=537) |
|
| Worried getting addicted or hooked to Op:7(n=537) |
|
| Worried getting addicted or hooked to Op:8(n=537) |
|
| Worried getting addicted or hooked to Op:9(n=537) |
|
| Worried getting addicted or hooked to Op:10(n=537) |
|
| Worried about hard time to stop Op:0(n=537) |
|
| Worried about hard time to stop Op:1(n=537) |
|
| Worried about hard time to stop Op:2(n=537) |
|
| Worried about hard time to stop Op:3(n=537) |
|
| Worried about hard time to stop Op:4(n=537) |
|
| Worried about hard time to stop Op:5(n=537) |
|
| Worried about hard time to stop Op:6(n=537) |
|
| Worried about hard time to stop Op:7(n=537) |
|
| Worried about hard time to stop Op:8(n=537) |
|
| Worried about hard time to stop Op:9(n=537) |
|
| Worried about hard time to stop Op:10(n=537) |
|
| Chewed/crushed Op:tried once/twice(n=534) |
|
| Chewed/crushed Op:few times a year(n=534) |
|
| Chewed/crushed Op:few times a month(n=534) |
|
| Chewed/crushed Op:few times a week(n=534) |
|
| Chewed/crushed Op:daily(n=534) |
|
| Chewed/crushed Op:never(n=534) |
|
| Reason(Rn)to chew/crush Op:treat pain better(n=71) |
|
| Rn to chew/crush Op:treat new pain(n=71) |
|
| Rn to chew/crush Op:sleep better/relax(n=71) |
|
| Rn to chew/crush Op:help swallow drug(n=71) |
|
| Rn to chew/crush Op:feel pleasant/high(n=71) |
|
| Rn to chew/crush Op:feel less depressed (n=71) |
|
| Rn to chew/crush Op:feel talkative/outgoing(n=71) |
|
| Rn to chew/crush Op:other(n=71) |
|
| More Op than prescribed:tried once/twice(n=530) |
|
| More Op than prescribed:few times a year(n=530) |
|
| More Op than prescribed:few times a month(n=530) |
|
| More Op than prescribed:few times a week(n=530) |
|
| More Op than prescribed:daily(n=530) |
|
| More Op than prescribed:never(n=530) |
|
| Rn for more Op use:treat pain better(n=315) |
|
| Rn for more Op use:treat new pain(n=315) |
|
| Rn for more Op use:sleep better/relax(n=315) |
|
| Rn for more Op use:feel pleasant/high(n=315) |
|
| Rn for more Op use:feel less depressed (n=315) |
|
| Rn for more Op use:feel talkative/outgoing(n=315) |
|
| Rn for more Op use: other(n=315) |
|
| Snort,smoke,inject(inj) Op:once/twice(n=533) |
|
| Snort,smoke,inj Op: few times a year(n=533) |
|
| Snort,smoke,inj Op:few times a month(n=533) |
|
| Snort,smoke,inj Op:few times a week(n=533) |
|
| Snort,smoke,inj Op:daily(n=533) |
|
| Snort,smoke,inj Op:never(n=533) |
|
| Rn-snort,smoke,inj:treat pain better(n=37) |
|
| Rn-snort,smoke,inj:treat new pain (n=37) |
|
| Rn-snort,smoke,inj:sleep better/relax(n=37) |
|
| Rn-snort,smoke,inj:feel pleasant/high(n=37) |
|
| Rn-snort,smoke,inj:feel less depressed (n=37) |
|
| Rn-snort,smoke,inj:feel talkative/outgoing(n=37) |
|
| Rn-snort,smoke,inj:other(n=37) |
|
| Alcohol(Alc)use when on Op:tried once/twice(n=534) |
|
| Alc use when on Op:few times a year(n=534) |
|
| Alc use when on Op:few times a month(n=534) |
|
| Alc use when on Op:few times a week(n=534) |
|
| Alc use when on Op:daily(n=534) |
|
| Alc use when on Op:never(n=534) |
|
| Rn-Alc when on Op:treat pain better(n=170) |
|
| Rn-Alc when on Op:treat new pain(n=170) |
|
| Rn-Alc when on Op:sleep better/relax(n=170) |
|
| Rn-Alc when on Op:enjoy occasional drink(n=170 |
|
| Rn-Alc when on Op:feel pleasant/high(n=170) |
|
| Rn-Alc when on Op:feel less depressed(n=170) |
|
| Rn-Alc when on Op:feel talkative/outgoing(n=170) |
|
| Rn-Alc when on Op:other(n=170) |
|
| More than 1 doctor (Dr) for Op:once/twice(n=529) |
|
| More than 1 Dr for Op:sometime(n=529) |
|
| More than 1 Dr for Op:often(n=529) |
|
| More than 1 Dr for Op:never(n=529) |
|
| Rn- more than 1 Dr:treat pain better(n=61) |
|
| Rn- more than 1 Dr: prevent withdrawal(n=61) |
|
| Rn- more than 1 Dr:afraid to ask for more(n=61) |
|
| Rn- more than 1 Dr:feel pleasant/high (n=61) |
|
| Rn- more than 1 Dr:Dr didn't prescribed more(n=61) |
|
| Rn- more than (>) 1 Dr:other(n=61) |
|
| Gave Op to sick/in pain:yes (n=526) |
|
| Gave Op to sick/in pain:yes,once(n=35) |
|
| Gave Op to sick/in pain:yes, 2-5times(n=35) |
|
| Gave Op to sick/in pain:yes,6-10times(n=35) |
|
| Gave Op to sick/in pain:yes, >10 times(n=35) |
|
| Gave Op to sick/in pain:no(n=526) |
|
| Got Op from someone other than a doctor:yes(n=537) |
|
| Got Op from someone other than a doctor:no(n=537) |
|
| Keeps Op hidden or locked:yes(n=535) |
|
| Keeps Op hidden or locked:no(n=535) |
|
| Suspected someone taking Op:yes(n=535) |
|
| Suspected someone taking Op:yes,once(n=70) |
|
| Suspected someone taking Op:yes,few times(n=70) |
|
| Suspected someone taking Op:yes,sometimes (n=70) |
|
| Suspected someone taking Op:yes,all times (n=70) |
|
| Suspected someone taking Op:no(n=535) |
|
|
|
|
|
|
|
| Participants |
|
|
|
|
|
|
|
|