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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00640042
First received: March 13, 2008
Last updated: June 6, 2012
Last verified: June 2012
  Purpose

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.


Condition Intervention Phase
Pain
Drug: morphine sulfate extended release capsules
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Difference From Baseline (Week 0) in the Average Pain Score at Visit 3 (Week 6) [ Time Frame: Baseline (Week 0) to Visit 3 (Week 6) ] [ Designated as safety issue: No ]
    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

  • Difference From Baseline (Week 0) in the Average Pain Score at Visit 4 (Week 10) [ Time Frame: Baseline (Week 0) to Visit 4 (Week 10) ] [ Designated as safety issue: No ]
    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

  • Difference From Baseline (Week 0) in the Average Pain Score at Visit 5 (Week 14 / End of Study) [ Time Frame: Baseline (Week 0) to Visit 5 (Week 14 / End of Study) ] [ Designated as safety issue: No ]
    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

  • Number of Subjects With Treatment Emergent Adverse Events [ Time Frame: Up to 4 months ] [ Designated as safety issue: Yes ]
    Adverse events that occur or worsen after the first dose of Avinza

  • Number of Subjects at Each Level of Risk for Opioid Misuse or Abuse at Visit 3 (Week 6) [ Time Frame: Visit 3 (Week 6) ] [ Designated as safety issue: No ]
    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.

  • Number of Subjects at Each Level of Risk for Opioid Misuse or Abuse at Visit 4 (Week 10) [ Time Frame: Visit 4 (Week 10) ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Number of Cases in Which Investigators Were Satisfied or Very Satisfied With the Utility of the Risk Minimization Program in This Study. [ Time Frame: Up to 4 months ] [ Designated as safety issue: No ]
    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.

  • Number of Investigators Who Reported Continued Use of One or More Risk Minimization Tools Within 3 Months Post Study Completion. [ Time Frame: 3 months post study ] [ Designated as safety issue: No ]
    The risk minimization tools include SOAPP-R, treatment agreement, urine drug test, pill counts, PPAFT, Investigator Assessment and Plan and prescription card information.

  • Number of Investigators Who Reported Continued Use of One or More Risk Minimization Tools Within 3 to 6 Months Post Study Completion. [ Time Frame: 6 months post study ] [ Designated as safety issue: No ]
    The risk minimization tools include SOAPP-R, treatment agreement, urine drug test, pill counts, PPAFT, Investigator Assessment and Plan and prescription card information.


Enrollment: 1570
Study Start Date: March 2008
Study Completion Date: December 2008
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: AVINZA

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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00640042

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Locations
United States, Alabama
Adamsville, Alabama, United States, 35005
United States, 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
United States, 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
United States, 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, 80525
Fort Collins, Colorado, United States, 80524
Northglenn, Colorado, United States, 80234
Thornton, Colorado, United States, 80229
Wheat Ridge, Colorado, United States, 80003
Wheatridge, Colorado, United States, 80033
United States, 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
United States, Delaware
Georgetown, Delaware, United States, 19947
Milton, Delaware, United States, 19968
Wilmington, Delaware, United States, 19810
Wilmington, Delaware, United States, 19806
Wilmington, Delaware, United States, 19808
United States, 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, 33614
Tampa, Florida, United States, 33619
Tampa, Florida, United States, 33626
West Palm Beach, Florida, United States, 33411
United States, 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
United States, Idaho
Rexburg, Idaho, United States, 83440
United States, 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, 60707
Oak Park, Illinois, United States, 60304
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
United States, Indiana
Anderson, Indiana, United States, 46012
Anderson, Indiana, United States, 46011
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
United States, Iowa
Des Moines, Iowa, United States, 50309
Le Claire, Iowa, United States, 52753
Newton, Iowa, United States, 50208
United States, Kansas
Kansas City, Kansas, United States, 66172
Kansas City, Kansas, United States, 66106
Kansas City, Kansas, United States, 66112
Lansing, Kansas, United States, 66043
Shawnee, Kansas, United States, 66216
United States, 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
United States, Maryland
Baltimore, Maryland, United States, 21208
Chester, Maryland, United States, 21619
Havre De Grace, Maryland, United States, 21078
Ocean City, Maryland, United States, 21842
United States, Massachusetts
Brockton, Massachusetts, United States, 02301
Springfield, Massachusetts, United States, 11044
United States, 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, 48911
Lansing, Michigan, United States, 48917
Lansing, Michigan, United States, 48906
Leslie, Michigan, United States, 49251
Livonia, Michigan, United States, 48152
Mason, Michigan, United States, 48854
Muskegon, Michigan, United States, 49441
Muskegon, Michigan, United States, 49444
Northville, Michigan, United States, 48167
Okemos, Michigan, United States, 48864
Okemos, Michigan, United States, 48664
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
United States, Minnesota
Cold Spring, Minnesota, United States, 56320
United States, 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, 64158
Kansas City, Missouri, United States, 64151
Kansas City, Missouri, United States, 64133
Kansas City, Missouri, United States, 64112
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, 63141
St Louis, Missouri, United States, 63117
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
United States, Nevada
Henderson, Nevada, United States, 89015
Henderson, Nevada, United States, 89074
Las Vegas, Nevada, United States, 89128
Las Vegas, Nevada, United States, 89106
United States, 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
United States, 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
United States, North Carolina
Asheboro, North Carolina, United States, 27203
Jacksonville, North Carolina, United States, 28546
Raleigh, North Carolina, United States, 27612
Raleigh, North Carolina, United States, 27607
United States, Ohio
Akron, Ohio, United States, 44310
Akron, Ohio, United States, 44304
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, 45013
Hamilton, Ohio, United States, 45015
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, 43623
Toledo, Ohio, United States, 43615
Toledo, Ohio, United States, 43614
Toledo, Ohio, United States, 43606
Toledo, Ohio, United States, 43617
Warren, Ohio, United States, 44483
Youngstown, Ohio, United States, 44510
Youngstown, Ohio, United States, 44514
United States, Oklahoma
Stillwater, Oklahoma, United States, 74074
United States, 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, 97202
Portland, Oregon, United States, 97213
Portland, Oregon, United States, 97220
Salem, Oregon, United States, 97301
Tualatin, Oregon, United States, 97062
United States, 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, 19128
Philadelphia, Pennsylvania, United States, 19124
Philadelphia, Pennsylvania, United States, 19134
Philadelphia, Pennsylvania, United States, 19147
Philadelphia, Pennsylvania, United States, 19145
Phoenixville, Pennsylvania, United States, 19460
Pittsburgh, Pennsylvania, United States, 15236
Pittsburgh, Pennsylvania, United States, 15206
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
United States, 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
United States, 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, 37220
Nashville, Tennessee, United States, 37203
Newport, Tennessee, United States, 37821
Springfield, Tennessee, United States, 37172
Sweetwater, Tennessee, United States, 37874
Woodbury, Tennessee, United States, 37190
United States, 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
United States, Utah
Layton, Utah, United States, 94041
Layton, Utah, United States, 84041
South Jordan, Utah, United States, 84095
West Jordan, Utah, United States, 84088
West Valley City, Utah, United States, 84120
United States, 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
United States, Washington
Edmonds, Washington, United States, 98020
Marysville, Washington, United States, 98270
Olympia, Washington, United States, 98506
Seattle, Washington, United States, 98107
United States, West Virginia
Huntington, West Virginia, United States, 25705
United States, Wisconsin
Milwaukee, Wisconsin, United States, 53216
Milwaukee, Wisconsin, United States, 53208
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
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Sherry Siegel, MD King Pharmaceuticals is now a wholly owned subsidiary of Pfizer
  More Information

Publications:
Weiner KA. The decade of pain control and research. The Pain Practitioner. 2003 Spring;13(1):3-4.

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00640042     History of Changes
Other Study ID Numbers: K284-07-4001
Study First Received: March 13, 2008
Results First Received: November 30, 2009
Last Updated: June 6, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Pfizer:
pain
opioid
abuse
moderate-severe pain requiring continuous, around-the-clock opioid therapy for an extended period of time

Additional relevant MeSH terms:
Chronic Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Morphine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 28, 2014