Evaluation of Risk Minimization, Assessment and Outcomes in Patients With Chronic Pain Taking Avinza (ACCESS 2008)

AVINZA Control of Chronic Pain, Effectiveness and Safety Study (ACCESS 2008) A Multi-Center Study to Evaluate the Effectiveness and Tolerability of AVINZA for Chronic Moderate-Severe Pain: A Focus on Risk Minimization Assessment, Intervention and Outcomes

The purpose of this study is to provide information in a broad, "real world" population of chronic pain patients assessing both pain control with AVINZA as well as the potential risk for misuse and abuse.

Study Overview

• Status: Completed
• Conditions: Pain
• Intervention / Treatment: Drug: morphine sulfate extended release capsules

Detailed Description

Pain affects more Americans than diabetes, heart disease and cancer combined and although it is one of the earliest known ailments, pain is still without a universal cure. It is estimated that only about 25% of patients with chronic pain receive adequate analgesia.

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.

• Study Type: Interventional
• Enrollment (Actual): 1570
• Phase: Phase 4

Contacts and Locations

Study Locations

• Puerto Rico
  • Carolina, Puerto Rico, 00986
  • Cidra, Puerto Rico, 00739
  • Hato Rey, Puerto Rico, 00917
  • Juncos, Puerto Rico, 00777
  • Ponce, Puerto Rico, 00717
  • San Juan, Puerto Rico, 00926
• United States
  • Alabama
    • Adamsville, Alabama, United States, 35005
  • Arizona
    • Phoenix, Arizona, United States, 85044
    • Scottsdale, Arizona, United States, 85258
    • Sun City, Arizona, United States, 85351
    • Sun Lakes, Arizona, United States, 85248
    • Tucson, Arizona, United States, 85712
    • Tucson, Arizona, United States, 85705
  • California
    • Burlingame, California, United States, 94010
    • Castro Valley, California, United States, 94546
    • Fountain Valley, California, United States, 92708
    • Hemet, California, United States, 92543
    • Lakewood, California, United States, 90712
    • Livermore, California, United States, 94550
    • Los Gatos, California, United States, 95032
    • Murrieta, California, United States, 92562
    • Murrieta, California, United States, 92563
    • Nevada City, California, United States, 95959
    • Oakland, California, United States, 94609
    • Rocklin, California, United States, 95677
    • Sacramento, California, United States, 95821
    • San Diego, California, United States, 92108
    • San Fransisco, California, United States, 94115
    • West Hollywood, California, United States, 90046
    • Whittier, California, United States, 90602
    • Yuba City, California, United States, 95993
  • Colorado
    • Aurora, Colorado, United States, 80012
    • Colorado Springs, Colorado, United States, 80919
    • Denver, Colorado, United States, 80220
    • Denver, Colorado, United States, 80239
    • Fort Collins, Colorado, United States, 80524
    • Fort Collins, Colorado, United States, 80525
    • Northglenn, Colorado, United States, 80234
    • Thornton, Colorado, United States, 80229
    • Wheat Ridge, Colorado, United States, 80003
    • Wheatridge, Colorado, United States, 80033
  • Connecticut
    • Manchester, Connecticut, United States, 06040
    • Milford, Connecticut, United States, 06460
    • New Haven, Connecticut, United States, 06511
    • North Haven, Connecticut, United States, 06473
    • Norwich, Connecticut, United States, 06360
  • Delaware
    • Georgetown, Delaware, United States, 19947
    • Milton, Delaware, United States, 19968
    • Wilmington, Delaware, United States, 19806
    • Wilmington, Delaware, United States, 19808
    • Wilmington, Delaware, United States, 19810
  • Florida
    • Apopka, Florida, United States, 32703
    • Bradenton, Florida, United States, 34205
    • Brandon, Florida, United States, 33511
    • Cape Coral, Florida, United States, 33990
    • Daytona Beach, Florida, United States, 32117
    • Deland, Florida, United States, 32720
    • Delray Beach, Florida, United States, 33484
    • Deltona, Florida, United States, 32725
    • Dunnellon, Florida, United States, 34432
    • Estero, Florida, United States, 33928
    • Eustis, Florida, United States, 32726
    • Loxahatchee, Florida, United States, 33470
    • Maitland, Florida, United States, 32751
    • Margate, Florida, United States, 33063
    • Miami, Florida, United States, 33176
    • Mount Dora, Florida, United States, 32757
    • N. Miami Beach, Florida, United States, 33179
    • New Smyrna Beach, Florida, United States, 32168
    • Oakland Park, Florida, United States, 33308
    • Oldsmar, Florida, United States, 34677
    • Orlando, Florida, United States, 32804
    • Ormond Beach, Florida, United States, 32174
    • Oviedo, Florida, United States, 32765
    • Pembroke Pines, Florida, United States, 33024
    • Port Richey, Florida, United States, 34668
    • Royal Palm Beach, Florida, United States, 33411
    • South Miami, Florida, United States, 33143
    • Tampa, Florida, United States, 33619
    • Tampa, Florida, United States, 33614
    • Tampa, Florida, United States, 33626
    • West Palm Beach, Florida, United States, 33411
  • Georgia
    • Augusta, Georgia, United States, 30909
    • Augusta, Georgia, United States, 30906
    • Cave Spring, Georgia, United States, 30124
    • Conyers, Georgia, United States, 30013
    • Covington, Georgia, United States, 30016
    • Decatur, Georgia, United States, 30034
    • Rome, Georgia, United States, 30165
    • Statesboro, Georgia, United States, 30458
    • Sugar Hill, Georgia, United States, 30518
  • Idaho
    • Rexburg, Idaho, United States, 83440
  • Illinois
    • Clinton, Illinois, United States, 61727
    • Crestwood, Illinois, United States, 60445
    • Creve Coeur, Illinois, United States, 61610
    • Danville, Illinois, United States, 61832
    • Dekalb, Illinois, United States, 60115
    • Elmwood Park, Illinois, United States, 60707
    • Flossmoor, Illinois, United States, 60422
    • Gurnee, Illinois, United States, 60031
    • Lockport, Illinois, United States, 60491
    • Maryville, Illinois, United States, 62062
    • Morton, Illinois, United States, 61550
    • Naperville, Illinois, United States, 60540
    • Oak Park, Illinois, United States, 60304
    • Oak Park, Illinois, United States, 60707
    • Pekin, Illinois, United States, 61554
    • Peoria, Illinois, United States, 61614
    • Peoria, Illinois, United States, 61605
    • St Charles, Illinois, United States, 60175
    • Washington, Illinois, United States, 61521
    • Washington, Illinois, United States, 61571
    • Zion, Illinois, United States, 60099
  • Indiana
    • Anderson, Indiana, United States, 46011
    • Anderson, Indiana, United States, 46012
    • Anderson, Indiana, United States, 46016
    • Evansville, Indiana, United States, 47712
    • Franklin, Indiana, United States, 46131
    • Highland, Indiana, United States, 46322
    • Indianapolis, Indiana, United States, 46237
    • Laporte, Indiana, United States, 46350
    • Lawrenceburg, Indiana, United States, 47025
    • Newburgh, Indiana, United States, 47630
    • Rushville, Indiana, United States, 46173
    • Seymour, Indiana, United States, 47274
    • Whiteland, Indiana, United States, 46184
  • Iowa
    • Des Moines, Iowa, United States, 50309
    • Le Claire, Iowa, United States, 52753
    • Newton, Iowa, United States, 50208
  • Kansas
    • Kansas City, Kansas, United States, 66106
    • Kansas City, Kansas, United States, 66112
    • Kansas City, Kansas, United States, 66172
    • Lansing, Kansas, United States, 66043
    • Shawnee, Kansas, United States, 66216
  • Kentucky
    • Florence, Kentucky, United States, 41042
    • London, Kentucky, United States, 40741
    • Louisville, Kentucky, United States, 40258
    • Monticello, Kentucky, United States, 42633
    • Russell Springs, Kentucky, United States, 42642
    • Somerset, Kentucky, United States, 42503
  • Maryland
    • Baltimore, Maryland, United States, 21208
    • Chester, Maryland, United States, 21619
    • Havre De Grace, Maryland, United States, 21078
    • Ocean City, Maryland, United States, 21842
  • Massachusetts
    • Brockton, Massachusetts, United States, 02301
    • Springfield, Massachusetts, United States, 11044
  • Michigan
    • Bloomfield Hills, Michigan, United States, 48302
    • Clarkston, Michigan, United States, 48346
    • Clinton, Michigan, United States, 49236
    • Dearborn, Michigan, United States, 48126
    • Dearborn Heights, Michigan, United States, 48127
    • Farmington Hills, Michigan, United States, 48375
    • Grand Rapids, Michigan, United States, 49546
    • Lansing, Michigan, United States, 48910
    • Lansing, Michigan, United States, 48917
    • Lansing, Michigan, United States, 48906
    • Lansing, Michigan, United States, 48911
    • Leslie, Michigan, United States, 49251
    • Livonia, Michigan, United States, 48152
    • Mason, Michigan, United States, 48854
    • Muskegon, Michigan, United States, 49444
    • Muskegon, Michigan, United States, 49441
    • Northville, Michigan, United States, 48167
    • Okemos, Michigan, United States, 48664
    • Okemos, Michigan, United States, 48864
    • Owosso, Michigan, United States, 48867
    • Pigeon, Michigan, United States, 48755
    • Rochester Hills, Michigan, United States, 48306
    • Southgate, Michigan, United States, 48195
    • Sterling Heights, Michigan, United States, 48314
    • Troy, Michigan, United States, 48085
    • Waterford, Michigan, United States, 48328
  • Minnesota
    • Cold Spring, Minnesota, United States, 56320
  • Missouri
    • Ballwin, Missouri, United States, 63011
    • Cape Girardeau, Missouri, United States, 63701
    • Chesterfield, Missouri, United States, 63017
    • Clinton, Missouri, United States, 64735
    • Florissant, Missouri, United States, 63031
    • Hazelwood, Missouri, United States, 63043
    • Jefferson City, Missouri, United States, 65109
    • Kansas City, Missouri, United States, 64112
    • Kansas City, Missouri, United States, 64133
    • Kansas City, Missouri, United States, 64151
    • Kansas City, Missouri, United States, 64158
    • Mexico, Missouri, United States, 65265
    • Mt Vernon, Missouri, United States, 65712
    • Platte City, Missouri, United States, 64079
    • Raymore, Missouri, United States, 64083
    • St Joseph, Missouri, United States, 64506
    • St Louis, Missouri, United States, 63117
    • St Louis, Missouri, United States, 63141
    • St Louis, Missouri, United States, 63112
    • St. Charles, Missouri, United States, 63301
    • St. Louis, Missouri, United States, 63112
    • Warrenton, Missouri, United States, 63383
    • Washington, Missouri, United States, 63090
    • Weston, Missouri, United States, 64098
  • Nevada
    • Henderson, Nevada, United States, 89074
    • Henderson, Nevada, United States, 89015
    • Las Vegas, Nevada, United States, 89128
    • Las Vegas, Nevada, United States, 89106
  • New Jersey
    • Atco, New Jersey, United States, 08004
    • Blackwood, New Jersey, United States, 08012
    • Bloomfield, New Jersey, United States, 07003
    • Brigantine, New Jersey, United States, 08203
    • East Orange, New Jersey, United States, 07018
    • Green Brook, New Jersey, United States, 08812
    • Irvington, New Jersey, United States, 07101
    • Irvington, New Jersey, United States, 07111
    • Iselin, New Jersey, United States, 08830
    • Jersey City, New Jersey, United States, 07306
    • Jersey City, New Jersey, United States, 07304
    • Kenilworth, New Jersey, United States, 07033
    • Lakewood, New Jersey, United States, 08701
    • Mays Landing, New Jersey, United States, 08330
    • Millburn, New Jersey, United States, 07041
    • Millburn, New Jersey, United States, 07083
    • Nutley, New Jersey, United States, 07110
    • Scotch Plains, New Jersey, United States, 08826
    • South Bound Brook, New Jersey, United States, 08880
    • Totowa, New Jersey, United States, 07512
    • Union, New Jersey, United States, 07083
    • Wenonah, New Jersey, United States, 08090
    • Westville, New Jersey, United States, 08093
  • New York
    • Brooklyn, New York, United States, 11232
    • Glendale, New York, United States, 11385
    • Kenmore, New York, United States, 14217
    • Mayville, New York, United States, 14757
    • New York, New York, United States, 10021
    • New York, New York, United States, 10019
    • Orchard Park, New York, United States, 14127
    • Port Jefferson Station, New York, United States, 11776
    • Rochester, New York, United States, 14615
    • Staten Island, New York, United States, 10306
    • Staten Island, New York, United States, 10308
    • Suffern, New York, United States, 10901
  • North Carolina
    • Asheboro, North Carolina, United States, 27203
    • Jacksonville, North Carolina, United States, 28546
    • Raleigh, North Carolina, United States, 27607
    • Raleigh, North Carolina, United States, 27612
  • Ohio
    • Akron, Ohio, United States, 44304
    • Akron, Ohio, United States, 44310
    • Ashtabula, Ohio, United States, 44004
    • Bowling Green, Ohio, United States, 43402
    • Canal Winchester, Ohio, United States, 43110
    • Cincinnati, Ohio, United States, 45242
    • Cincinnati, Ohio, United States, 45236
    • Cuyahoga Falls, Ohio, United States, 44223
    • Dayton, Ohio, United States, 45410
    • Defiance, Ohio, United States, 43512
    • Fairfield, Ohio, United States, 45014
    • Fremont, Ohio, United States, 43420
    • Gahanna, Ohio, United States, 43230
    • Genoa, Ohio, United States, 43430
    • Hamilton, Ohio, United States, 45015
    • Hamilton, Ohio, United States, 45013
    • Kent, Ohio, United States, 44240
    • Kingston, Ohio, United States, 45644
    • Lancaster, Ohio, United States, 43130
    • Maumee, Ohio, United States, 43537
    • New Lexington, Ohio, United States, 43764
    • Perrysburg, Ohio, United States, 43551
    • Pickerington, Ohio, United States, 43147
    • Springboro, Ohio, United States, 45066
    • Stow, Ohio, United States, 44224
    • Toledo, Ohio, United States, 43606
    • Toledo, Ohio, United States, 43623
    • Toledo, Ohio, United States, 43614
    • Toledo, Ohio, United States, 43615
    • Toledo, Ohio, United States, 43617
    • Warren, Ohio, United States, 44483
    • Youngstown, Ohio, United States, 44514
    • Youngstown, Ohio, United States, 44510
  • Oklahoma
    • Stillwater, Oklahoma, United States, 74074
  • Oregon
    • Estacada, Oregon, United States, 97023
    • Eugene, Oregon, United States, 97401
    • Lake Oswego, Oregon, United States, 97035
    • Milwaukie, Oregon, United States, 97222
    • Oregon City, Oregon, United States, 97045
    • Portland, Oregon, United States, 97213
    • Portland, Oregon, United States, 97220
    • Portland, Oregon, United States, 97202
    • Salem, Oregon, United States, 97301
    • Tualatin, Oregon, United States, 97062
  • Pennsylvania
    • Aliquippa, Pennsylvania, United States, 15001
    • Archbald, Pennsylvania, United States, 18403
    • Aston, Pennsylvania, United States, 19014
    • Avoca, Pennsylvania, United States, 18641
    • Bala Cynwyd, Pennsylvania, United States, 19004
    • Bensalem, Pennsylvania, United States, 19020
    • Carbondale, Pennsylvania, United States, 18407
    • Chicora, Pennsylvania, United States, 16025
    • Clarks Summit, Pennsylvania, United States, 18411
    • Collegeville, Pennsylvania, United States, 19426
    • Conneaut Lake, Pennsylvania, United States, 16316
    • Cowansville, Pennsylvania, United States, 16218
    • Downingtown, Pennsylvania, United States, 19335
    • Doylestown, Pennsylvania, United States, 18901
    • Drexel Hill, Pennsylvania, United States, 19026
    • Drums, Pennsylvania, United States, 18222
    • Dublin, Pennsylvania, United States, 18917
    • Elizabeth, Pennsylvania, United States, 15037
    • Elkins Park, Pennsylvania, United States, 19027
    • Ford City, Pennsylvania, United States, 16226
    • Greensburg, Pennsylvania, United States, 15601
    • Honesdale, Pennsylvania, United States, 18431
    • King Of Prussia, Pennsylvania, United States, 19406
    • Levittown, Pennsylvania, United States, 19055
    • McKeesport, Pennsylvania, United States, 15131
    • Montrose, Pennsylvania, United States, 18801
    • Moon Township, Pennsylvania, United States, 15108
    • Morrisville, Pennsylvania, United States, 19067
    • Mt. Pleasant, Pennsylvania, United States, 15666
    • New Castle, Pennsylvania, United States, 16101
    • New Wilmington, Pennsylvania, United States, 16142
    • Norristown, Pennsylvania, United States, 19401
    • Philadelphia, Pennsylvania, United States, 19152
    • Philadelphia, Pennsylvania, United States, 19148
    • Philadelphia, Pennsylvania, United States, 19124
    • Philadelphia, Pennsylvania, United States, 19134
    • Philadelphia, Pennsylvania, United States, 19128
    • Philadelphia, Pennsylvania, United States, 19145
    • Philadelphia, Pennsylvania, United States, 19147
    • Phoenixville, Pennsylvania, United States, 19460
    • Pittsburgh, Pennsylvania, United States, 15206
    • Pittsburgh, Pennsylvania, United States, 15236
    • Pittsburgh, Pennsylvania, United States, 15226
    • Pittsburgh, Pennsylvania, United States, 15239
    • Royersford, Pennsylvania, United States, 19468
    • Scranton, Pennsylvania, United States, 18510
    • Scranton, Pennsylvania, United States, 18508
    • Shippensburg, Pennsylvania, United States, 17257
    • Southampton, Pennsylvania, United States, 18966
    • Springfield, Pennsylvania, United States, 19064
    • Stoneboro, Pennsylvania, United States, 16193
    • Union City, Pennsylvania, United States, 16438
    • Warminster, Pennsylvania, United States, 18974
    • Wilkes-Barre, Pennsylvania, United States, 18702
    • Yardley, Pennsylvania, United States, 19067
  • South Carolina
    • Camden, South Carolina, United States, 29020
    • Charleston, South Carolina, United States, 29414
    • Charleston, South Carolina, United States, 29464
    • Columbia, South Carolina, United States, 29219
    • Greer, South Carolina, United States, 29651
    • Marion, South Carolina, United States, 28571
    • Marion, South Carolina, United States, 29571
    • West Columbia, South Carolina, United States, 29169
  • Tennessee
    • Ashland City, Tennessee, United States, 37015
    • Collierville, Tennessee, United States, 38017
    • Dyersburg, Tennessee, United States, 38024
    • Hendersonville, Tennessee, United States, 37075
    • Hermitage, Tennessee, United States, 37076
    • Lebanon, Tennessee, United States, 37087
    • McKenzie, Tennessee, United States, 38201
    • Memphis, Tennessee, United States, 38122
    • Nashville, Tennessee, United States, 37203
    • Nashville, Tennessee, United States, 37220
    • Newport, Tennessee, United States, 37821
    • Springfield, Tennessee, United States, 37172
    • Sweetwater, Tennessee, United States, 37874
    • Woodbury, Tennessee, United States, 37190
  • Texas
    • Arlington, Texas, United States, 76012
    • Ft Worth, Texas, United States, 76104
    • Irving, Texas, United States, 75061
    • Rusk, Texas, United States, 75785
    • Southlake, Texas, United States, 76092
  • Utah
    • Layton, Utah, United States, 84041
    • Layton, Utah, United States, 94041
    • South Jordan, Utah, United States, 84095
    • West Jordan, Utah, United States, 84088
    • West Valley City, Utah, United States, 84120
  • Virginia
    • Annandale, Virginia, United States, 22003
    • Ashburn, Virginia, United States, 20147
    • Fairfax, Virginia, United States, 22030
    • Fairfax, Virginia, United States, 22033
    • Falls Church, Virginia, United States, 22046
    • Lynchburg, Virginia, United States, 24501
    • Reston, Virginia, United States, 20190
  • Washington
    • Edmonds, Washington, United States, 98020
    • Marysville, Washington, United States, 98270
    • Olympia, Washington, United States, 98506
    • Seattle, Washington, United States, 98107
  • West Virginia
    • Huntington, West Virginia, United States, 25705
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53208
    • Milwaukee, Wisconsin, United States, 53216

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patient is an adult (greater than or equal to 21 years old
• 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:

A patient who meets ANY of the following exclusion criteria will not be enrolled:

• Hypersensitivity to morphine, morphine salts, or any components of AVINZA
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 1	Drug: 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 Names: AVINZA

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference From Baseline (Week 0) in the Average Pain Score at Visit 3 (Week 6)	Average pain intensity over last 24 hours rated by the subject using an 11 point numeric rating scale (ranging from 0=no pain to 10=worst pain) at Visit 3	Baseline (Week 0) to Visit 3 (Week 6)
Difference From Baseline (Week 0) in the Average Pain Score at Visit 4 (Week 10)	Average pain intensity over last 24 hours rated by the subject using an 11 point numeric rating scale (ranging from 0=no pain to 10=worst pain) at Visit 4	Baseline (Week 0) to Visit 4 (Week 10)
Difference From Baseline (Week 0) in the Average Pain Score at Visit 5 (Week 14 / End of Study)	Average pain intensity over last 24 hours rated by the subject using an 11 point numeric rating scale (ranging from 0=no pain to 10=worst pain) at Visit 5 / End of Study	Baseline (Week 0) to Visit 5 (Week 14 / End of Study)
Number of Subjects With Treatment Emergent Adverse Events	Adverse events that occur or worsen after the first dose of Avinza	Up to 4 months
Number of Subjects at Each Level of Risk for Opioid Misuse or Abuse at Visit 3 (Week 6)	Risk level was determined by the investigator using the subject's SOAPP-R (Screener and Opioid Assessment for Patients with Pain® - Revised Questionnaire) score, reports/ evidence of aberrant behavior and clinical judgment. Low Risk: SOAPP-R score <= 9 and no signals of aberrant behavior; Moderate Risk: SOAPP-R score <= 9 with positive signals of aberrant behavior OR SOAPP-R score = 10-21 with or without positive signals of aberrant behavior OR SOAPP-R score >= 22; High Risk: SOAPP-R score >= 22 with positive signals of aberrant behavior.	Visit 3 (Week 6)
Number of Subjects at Each Level of Risk for Opioid Misuse or Abuse at Visit 4 (Week 10)	Risk level was determined by the investigator using the subject's SOAPP-R score, reports/ evidence of aberrant behavior and clinical judgment. Low Risk: SOAPP-R score <= 9 and no signals of aberrant behavior; Moderate Risk: SOAPP-R score <= 9 with positive signals of aberrant behavior OR SOAPP-R score = 10-21 with or without positive signals of aberrant behavior OR SOAPP-R score >= 22; High Risk: SOAPP-R score >= 22 with positive signals of aberrant behavior.	Visit 4 (Week 10)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Cases in Which Investigators Were Satisfied or Very Satisfied With the Utility of the Risk Minimization Program in This Study.	After each subject completed participation in the study, investigators reported satisfaction with the utility of the risk minimization program in handling each subject's particular case. The risk minimization program is a set of tools used to assist clinicians in responsibly managing pain patients prescribed Avinza. The tools include SOAPP-R, treatment agreement, urine drug test, pill counts, PPAFT (Pain Patient Follow-up Tool), Investigator Assessment and Plan and prescription card data. These tools were used at each visit to assess subject risk and to aid in the management of subject's pain.	Up to 4 months
Number of Investigators Who Reported Continued Use of One or More Risk Minimization Tools Within 3 Months Post Study Completion.	The risk minimization tools include SOAPP-R, treatment agreement, urine drug test, pill counts, PPAFT, Investigator Assessment and Plan and prescription card information.	3 months post study
Number of Investigators Who Reported Continued Use of One or More Risk Minimization Tools Within 3 to 6 Months Post Study Completion.	The risk minimization tools include SOAPP-R, treatment agreement, urine drug test, pill counts, PPAFT, Investigator Assessment and Plan and prescription card information.	6 months post study

Collaborators and Investigators

• Sponsor: Pfizer
• Investigators: Study Director: Sherry Siegel, MD, King Pharmaceuticals is now a wholly owned subsidiary of Pfizer

Publications and helpful links

General Publications

• 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.
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Study record dates

Study Major Dates

• Study Start: March 1, 2008
• Primary Completion (ACTUAL): November 1, 2008
• Study Completion (ACTUAL): December 1, 2008

Study Registration Dates

• First Submitted: March 13, 2008
• First Submitted That Met QC Criteria: March 19, 2008
• First Posted (ESTIMATE): March 20, 2008

Study Record Updates

• Last Update Posted (ESTIMATE): June 11, 2012
• Last Update Submitted That Met QC Criteria: June 6, 2012
• Last Verified: June 1, 2012

More Information

Terms related to this study

• Keywords: opioid; pain; abuse; moderate-severe pain requiring continuous, around-the-clock opioid therapy for an extended period of time
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Opioid; Narcotics; Morphine
• Other Study ID Numbers: K284-07-4001