Evaluation of Risk Minimization, Assessment and Outcomes in Patients With Chronic Pain Taking Avinza
NCT ID: NCT00640042
Last Updated: 2012-06-11
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
1570 participants
INTERVENTIONAL
2008-03-31
2008-12-31
Brief Summary
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Detailed Description
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Long-term treatment of chronic pain with opioids is recognized as an important treatment option for patients with moderate-severe pain related to cancer and other chronic serious illnesses. AVINZA (morphine sulfate extended-release capsules) was approved for marketing by the Food and Drug Administration (FDA) in 2002 as a once daily treatment for the relief of moderate to severe pain requiring continuous opioid therapy for an extended period of time. While opioids, such as AVINZA, are beneficial in the management of chronic pain, they are sometimes associated with illicit activities. Misuse, abuse and diversion of controlled prescription drugs, particularly opioids, are problems that have increased dramatically in the United States (U.S.) since the 1990s.
This study will follow the Federation of State Medical Boards Model Policy for the Use of Controlled Substances for the Treatment of Pain. Patients will be counseled on the proper storage and destruction of unused AVINZA in accordance with federal and applicable state laws. A universal precautions approach to chronic pain management (KAIR) will be utilized in this study. Although not validated as a risk assessment and management instrument, KAIR is designed to assist clinicians with responsibly managing chronic moderate-severe pain patients prescribed AVINZA. The KAIR tools will be used by the Investigator to determine the level of monitoring required based on the patient's potential risk for opioid misuse or abuse (KAIR level). Investigators and staff participating in this study will be required to participate in a training program on the counseling to be given, procedures to be followed and tools to be used in this study.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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1
morphine sulfate extended release capsules
30 mg, 60 mg, 90 mg, 120 mg morphine will be prescribed by the Investigator in accordance with the AVINZA prescribing information.
Interventions
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morphine sulfate extended release capsules
30 mg, 60 mg, 90 mg, 120 mg morphine will be prescribed by the Investigator in accordance with the AVINZA prescribing information.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patient has chronic (greater than or equal to 3 months) moderate-severe pain who, at the discretion of the Investigator, requires an around-the-clock opioid for optimal analgesia. Patients may be opioid naïve (not currently on an opioid) or opioid tolerant. Opioid naïve patients with a pain score of greater than or equal to 4 on an 11-point NRS (numerical rating scale. OR Opioid tolerant patients experiencing suboptimal response (i.e. pain score of greater than or equal to 4) or unacceptable side effects to sustained release opioids or short-acting opioids.
* Patient is able to read and understand English and comply with protocol requirements.
Exclusion Criteria
* Respiratory depression (slowed breathing)
* Acute or severe bronchial asthma or severe chronic obstructive pulmonary disease (COPD)
* Currently has or is suspected of having paralytic ileus
* Requires a daily dose of AVINZA greater than 1600mg/day
* Patient is abusing alcohol
* Pregnancy or breast feeding
* Currently taking AVINZA
* Patient unwilling to sign the Treatment Agreement
* Life expectancy is less than 2 months
* Migraine as the primary pain score
* Patient resides in a hospital or nursing home
* Patient has had more than 2 surgeries for low back pain
* Patient is anticipated to require major surgery or steroid injections for chronic pain over the next 12 weeks
21 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Sherry Siegel, MD
Role: STUDY_DIRECTOR
King Pharmaceuticals is now a wholly owned subsidiary of Pfizer
Locations
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Adamsville, Alabama, United States
Phoenix, Arizona, United States
Scottsdale, Arizona, United States
Sun City, Arizona, United States
Sun Lakes, Arizona, United States
Tucson, Arizona, United States
Tucson, Arizona, United States
Burlingame, California, United States
Castro Valley, California, United States
Fountain Valley, California, United States
Hemet, California, United States
Lakewood, California, United States
Livermore, California, United States
Los Gatos, California, United States
Murrieta, California, United States
Murrieta, California, United States
Nevada City, California, United States
Oakland, California, United States
Rocklin, California, United States
Sacramento, California, United States
San Diego, California, United States
San Francisco, California, United States
West Hollywood, California, United States
Whittier, California, United States
Yuba City, California, United States
Aurora, Colorado, United States
Colorado Springs, Colorado, United States
Denver, Colorado, United States
Denver, Colorado, United States
Fort Collins, Colorado, United States
Fort Collins, Colorado, United States
Northglenn, Colorado, United States
Thornton, Colorado, United States
Wheat Ridge, Colorado, United States
Wheat Ridge, Colorado, United States
Manchester, Connecticut, United States
Milford, Connecticut, United States
New Haven, Connecticut, United States
North Haven, Connecticut, United States
Norwich, Connecticut, United States
Georgetown, Delaware, United States
Milton, Delaware, United States
Wilmington, Delaware, United States
Wilmington, Delaware, United States
Wilmington, Delaware, United States
Apopka, Florida, United States
Bradenton, Florida, United States
Brandon, Florida, United States
Cape Coral, Florida, United States
Daytona Beach, Florida, United States
DeLand, Florida, United States
Delray Beach, Florida, United States
Deltona, Florida, United States
Dunnellon, Florida, United States
Estero, Florida, United States
Eustis, Florida, United States
Loxahatchee Groves, Florida, United States
Maitland, Florida, United States
Margate, Florida, United States
Miami, Florida, United States
Mt. Dora, Florida, United States
New Smyrna Beach, Florida, United States
North Miami Beach, Florida, United States
Oakland Park, Florida, United States
Oldsmar, Florida, United States
Orlando, Florida, United States
Ormond Beach, Florida, United States
Oviedo, Florida, United States
Pembroke Pines, Florida, United States
Port Richey, Florida, United States
Royal Palm Beach, Florida, United States
South Miami, Florida, United States
Tampa, Florida, United States
Tampa, Florida, United States
Tampa, Florida, United States
West Palm Beach, Florida, United States
Augusta, Georgia, United States
Augusta, Georgia, United States
Cave Spring, Georgia, United States
Conyers, Georgia, United States
Covington, Georgia, United States
Decatur, Georgia, United States
Rome, Georgia, United States
Statesboro, Georgia, United States
Sugar Hill, Georgia, United States
Rexburg, Idaho, United States
Clinton, Illinois, United States
Crestwood, Illinois, United States
Creve Coeur, Illinois, United States
Danville, Illinois, United States
DeKalb, Illinois, United States
Elmwood Park, Illinois, United States
Flossmoor, Illinois, United States
Gurnee, Illinois, United States
Lockport, Illinois, United States
Maryville, Illinois, United States
Morton, Illinois, United States
Naperville, Illinois, United States
Oak Park, Illinois, United States
Oak Park, Illinois, United States
Pekin, Illinois, United States
Peoria, Illinois, United States
Peoria, Illinois, United States
St. Charles, Illinois, United States
Washington, Illinois, United States
Washington, Illinois, United States
Zion, Illinois, United States
Anderson, Indiana, United States
Anderson, Indiana, United States
Anderson, Indiana, United States
Evansville, Indiana, United States
Franklin, Indiana, United States
Highland, Indiana, United States
Indianapolis, Indiana, United States
La Porte, Indiana, United States
Lawrenceburg, Indiana, United States
Newburgh, Indiana, United States
Rushville, Indiana, United States
Seymour, Indiana, United States
Whiteland, Indiana, United States
Des Moines, Iowa, United States
Le Claire, Iowa, United States
Newton, Iowa, United States
Kansas City, Kansas, United States
Kansas City, Kansas, United States
Kansas City, Kansas, United States
Lansing, Kansas, United States
Shawnee, Kansas, United States
Florence, Kentucky, United States
London, Kentucky, United States
Louisville, Kentucky, United States
Monticello, Kentucky, United States
Russell Springs, Kentucky, United States
Somerset, Kentucky, United States
Baltimore, Maryland, United States
Chester, Maryland, United States
Havre de Grace, Maryland, United States
Ocean City, Maryland, United States
Brockton, Massachusetts, United States
Springfield, Massachusetts, United States
Bloomfield Hills, Michigan, United States
Clarkston, Michigan, United States
Clinton, Michigan, United States
Dearborn, Michigan, United States
Dearborn Heights, Michigan, United States
Farmington Hills, Michigan, United States
Grand Rapids, Michigan, United States
Lansing, Michigan, United States
Lansing, Michigan, United States
Lansing, Michigan, United States
Lansing, Michigan, United States
Leslie, Michigan, United States
Livonia, Michigan, United States
Mason, Michigan, United States
Muskegon, Michigan, United States
Muskegon, Michigan, United States
Northville, Michigan, United States
Okemos, Michigan, United States
Okemos, Michigan, United States
Owosso, Michigan, United States
Pigeon, Michigan, United States
Rochester Hills, Michigan, United States
Southgate, Michigan, United States
Sterling Heights, Michigan, United States
Troy, Michigan, United States
Waterford, Michigan, United States
Cold Spring, Minnesota, United States
Ballwin, Missouri, United States
Cape Girardeau, Missouri, United States
Chesterfield, Missouri, United States
Clinton, Missouri, United States
Florissant, Missouri, United States
Hazelwood, Missouri, United States
Jefferson City, Missouri, United States
Kansas City, Missouri, United States
Kansas City, Missouri, United States
Kansas City, Missouri, United States
Kansas City, Missouri, United States
Mexico, Missouri, United States
Mount Vernon, Missouri, United States
Platte City, Missouri, United States
Raymore, Missouri, United States
Saint Charles, Missouri, United States
Saint Joseph, Missouri, United States
St Louis, Missouri, United States
St Louis, Missouri, United States
St Louis, Missouri, United States
Warrenton, Missouri, United States
Washington, Missouri, United States
Weston, Missouri, United States
Henderson, Nevada, United States
Henderson, Nevada, United States
Las Vegas, Nevada, United States
Las Vegas, Nevada, United States
Atco, New Jersey, United States
Blackwood, New Jersey, United States
Bloomfield, New Jersey, United States
Brigantine, New Jersey, United States
East Orange, New Jersey, United States
Green Brook, New Jersey, United States
Irvington, New Jersey, United States
Irvington, New Jersey, United States
Iselin, New Jersey, United States
Jersey City, New Jersey, United States
Jersey City, New Jersey, United States
Kenilworth, New Jersey, United States
Lakewood, New Jersey, United States
Mays Landing, New Jersey, United States
Millburn, New Jersey, United States
Millburn, New Jersey, United States
Nutley, New Jersey, United States
Scotch Plains, New Jersey, United States
South Bound Brook, New Jersey, United States
Totowa, New Jersey, United States
Union, New Jersey, United States
Wenonah, New Jersey, United States
Westville, New Jersey, United States
Brooklyn, New York, United States
Glendale, New York, United States
Kenmore, New York, United States
Mayville, New York, United States
New York, New York, United States
New York, New York, United States
Orchard Park, New York, United States
Port Jefferson Station, New York, United States
Rochester, New York, United States
Staten Island, New York, United States
Staten Island, New York, United States
Suffern, New York, United States
Asheboro, North Carolina, United States
Jacksonville, North Carolina, United States
Raleigh, North Carolina, United States
Raleigh, North Carolina, United States
Akron, Ohio, United States
Akron, Ohio, United States
Ashtabula, Ohio, United States
Bowling Green, Ohio, United States
Canal Winchester, Ohio, United States
Cincinnati, Ohio, United States
Cincinnati, Ohio, United States
Cuyahoga Falls, Ohio, United States
Dayton, Ohio, United States
Defiance, Ohio, United States
Fairfield, Ohio, United States
Fremont, Ohio, United States
Gahanna, Ohio, United States
Genoa, Ohio, United States
Hamilton, Ohio, United States
Hamilton, Ohio, United States
Kent, Ohio, United States
Kingston, Ohio, United States
Lancaster, Ohio, United States
Maumee, Ohio, United States
New Lexington, Ohio, United States
Perrysburg, Ohio, United States
Pickerington, Ohio, United States
Springboro, Ohio, United States
Stow, Ohio, United States
Toledo, Ohio, United States
Toledo, Ohio, United States
Toledo, Ohio, United States
Toledo, Ohio, United States
Toledo, Ohio, United States
Warren, Ohio, United States
Youngstown, Ohio, United States
Youngstown, Ohio, United States
Stillwater, Oklahoma, United States
Estacada, Oregon, United States
Eugene, Oregon, United States
Lake Oswego, Oregon, United States
Milwaukie, Oregon, United States
Oregon City, Oregon, United States
Portland, Oregon, United States
Portland, Oregon, United States
Portland, Oregon, United States
Salem, Oregon, United States
Tualatin, Oregon, United States
Aliquippa, Pennsylvania, United States
Archbald, Pennsylvania, United States
Aston Mills, Pennsylvania, United States
Avoca, Pennsylvania, United States
Bala-Cynwyd, Pennsylvania, United States
Bensalem, Pennsylvania, United States
Carbondale, Pennsylvania, United States
Chicora, Pennsylvania, United States
Clarks Summit, Pennsylvania, United States
Collegeville, Pennsylvania, United States
Conneaut Lake, Pennsylvania, United States
Cowansville, Pennsylvania, United States
Downingtown, Pennsylvania, United States
Doylestown, Pennsylvania, United States
Drexel Hill, Pennsylvania, United States
Drums, Pennsylvania, United States
Dublin, Pennsylvania, United States
Elizabeth, Pennsylvania, United States
Elkins Park, Pennsylvania, United States
Ford City, Pennsylvania, United States
Greensburg, Pennsylvania, United States
Honesdale, Pennsylvania, United States
King of Prussia, Pennsylvania, United States
Levittown, Pennsylvania, United States
McKeesport, Pennsylvania, United States
Montrose, Pennsylvania, United States
Moon Township, Pennsylvania, United States
Morrisville, Pennsylvania, United States
Mount Pleasant, Pennsylvania, United States
New Castle, Pennsylvania, United States
New Wilmington, Pennsylvania, United States
Norristown, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Phoenixville, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Royersford, Pennsylvania, United States
Scranton, Pennsylvania, United States
Scranton, Pennsylvania, United States
Shippensburg, Pennsylvania, United States
Southampton, Pennsylvania, United States
Springfield, Pennsylvania, United States
Stoneboro, Pennsylvania, United States
Union City, Pennsylvania, United States
Warminster, Pennsylvania, United States
Wilkes-Barre, Pennsylvania, United States
Yardley, Pennsylvania, United States
Camden, South Carolina, United States
Charleston, South Carolina, United States
Charleston, South Carolina, United States
Columbia, South Carolina, United States
Greer, South Carolina, United States
Marion, South Carolina, United States
Marion, South Carolina, United States
West Columbia, South Carolina, United States
Ashland City, Tennessee, United States
Collierville, Tennessee, United States
Dyersburg, Tennessee, United States
Hendersonville, Tennessee, United States
Hermitage, Tennessee, United States
Lebanon, Tennessee, United States
McKenzie, Tennessee, United States
Memphis, Tennessee, United States
Nashville, Tennessee, United States
Nashville, Tennessee, United States
Newport, Tennessee, United States
Springfield, Tennessee, United States
Sweetwater, Tennessee, United States
Woodbury, Tennessee, United States
Arlington, Texas, United States
Fort Worth, Texas, United States
Irving, Texas, United States
Rusk, Texas, United States
Southlake, Texas, United States
Layton, Utah, United States
Layton, Utah, United States
South Jordan, Utah, United States
West Jordan, Utah, United States
West Valley City, Utah, United States
Annandale, Virginia, United States
Ashburn, Virginia, United States
Fairfax, Virginia, United States
Fairfax, Virginia, United States
Falls Church, Virginia, United States
Lynchburg, Virginia, United States
Reston, Virginia, United States
Edmonds, Washington, United States
Marysville, Washington, United States
Olympia, Washington, United States
Seattle, Washington, United States
Huntington, West Virginia, United States
Milwaukee, Wisconsin, United States
Milwaukee, Wisconsin, United States
Carolina, , Puerto Rico
Cidra, , Puerto Rico
Hato Rey, , Puerto Rico
Juncos, , Puerto Rico
Ponce, , Puerto Rico
San Juan, , Puerto Rico
Countries
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References
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The American Pain Foundation. Pain Facts & Figures. January 2007. Available from http://www.painfoundation.org/print.asp?file=Newsroom/PainFacts.htm.
Weiner KA. The decade of pain control and research. The Pain Practitioner. 2003 Spring;13(1):3-4.
Joranson DE, Berger JW. Regulatory issues in pain management. J Am Pharm Assoc (Wash). 2000 Sep-Oct;40(5 Suppl 1):S60-1.
Caldwell JR, Rapoport RJ, Davis JC, Offenberg HL, Marker HW, Roth SH, Yuan W, Eliot L, Babul N, Lynch PM. Efficacy and safety of a once-daily morphine formulation in chronic, moderate-to-severe osteoarthritis pain: results from a randomized, placebo-controlled, double-blind trial and an open-label extension trial. J Pain Symptom Manage. 2002 Apr;23(4):278-91. doi: 10.1016/s0885-3924(02)00383-4.
Rauck RL, Bookbinder SA, Bunker TR, Alftine CD, Ghalie R, Negro-Vilar A, de Jong E, Gershon S. The ACTION study: a randomized, open-label, multicenter trial comparing once-a-day extended-release morphine sulfate capsules (AVINZA) to twice-a-day controlled-release oxycodone hydrochloride tablets (OxyContin) for the treatment of chronic, moderate to severe low back pain. J Opioid Manag. 2006 May-Jun;2(3):155-66. doi: 10.5055/jom.2006.0025.
Rauck RL, Bookbinder SA, Bunker TR, Alftine CD, Ghalie R, Negro-Vilar A, de Jong E, Gershon S. A randomized, open-label study of once-a-day AVINZA (morphine sulfate extended-release capsules) versus twice-a-day OxyContin (oxycodone hydrochloride controlled-release tablets) for chronic low back pain: the extension phase of the ACTION trial. J Opioid Manag. 2006 Nov-Dec;2(6):325-8, 331-3. doi: 10.5055/jom.2006.0048.
Rosenthal M, Moore P, Groves E, Iwan T, Schlosser LG, Dziewanowska Z, Negro-Vilar A. Sleep improves when patients with chronic OA pain are managed with morning dosing of once a day extended-release morphine sulfate (AVINZA): findings from a pilot study. J Opioid Manag. 2007 May-Jun;3(3):145-54. doi: 10.5055/jom.2007.0052.
Katz NP, Adams EH, Chilcoat H, Colucci RD, Comer SD, Goliber P, Grudzinskas C, Jasinski D, Lande SD, Passik SD, Schnoll SH, Sellers E, Travers D, Weiss R. Challenges in the development of prescription opioid abuse-deterrent formulations. Clin J Pain. 2007 Oct;23(8):648-60. doi: 10.1097/AJP.0b013e318125c5e8.
Ives TJ, Chelminski PR, Hammett-Stabler CA, Malone RM, Perhac JS, Potisek NM, Shilliday BB, DeWalt DA, Pignone MP. Predictors of opioid misuse in patients with chronic pain: a prospective cohort study. BMC Health Serv Res. 2006 Apr 4;6:46. doi: 10.1186/1472-6963-6-46.
Gourlay DL, Heit HA, Almahrezi A. Universal precautions in pain medicine: a rational approach to the treatment of chronic pain. Pain Med. 2005 Mar-Apr;6(2):107-12. doi: 10.1111/j.1526-4637.2005.05031.x.
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.
Other Identifiers
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K284-07-4001
Identifier Type: -
Identifier Source: org_study_id
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