A Study of Embeda (Kadian NT, ALO-01) in Subjects With Pain Due to Osteoarthritis of the Hip or Knee
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Efficacy Study of Kadian NT (Morphine Sulfate Plus Naltrexone Hydrochloride Extended-Release) Capsules in Subjects With Moderate to Severe Chronic Pain Due to Osteoarthritis of the Hip or Knee
1 other identifier
interventional
547
1 country
81
Brief Summary
The purpose of this study is to evaluate the efficacy of Kadian NT (ALO-01) compared with placebo for treating moderate to severe chronic pain over a 12 week period.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Dec 2006
Shorter than P25 for phase_3
81 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2006
CompletedFirst Submitted
Initial submission to the registry
January 10, 2007
CompletedFirst Posted
Study publicly available on registry
January 11, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2007
CompletedResults Posted
Study results publicly available
October 30, 2009
CompletedSeptember 20, 2013
September 1, 2013
11 months
January 10, 2007
September 11, 2009
September 13, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Mean Change From Randomization to 12 Weeks Following Randomization in Diary Brief Pain Inventory Score of Average Pain (Daily Scores of Average Pain Averaged Over 7 Days)
Change in pain intensity scale. Average pain intensity over last 24 hours rated daily from 0=no pain to 10=worst pain.
randomization to 12 weeks following randomization
Study Arms (2)
ALO-01
EXPERIMENTALUp to 80 mg twice a day (bid)
Placebo
PLACEBO COMPARATORTwice a day (bid)
Interventions
capsules, up to 80 mg bid
Eligibility Criteria
You may qualify if:
- Subject is 21 years of age or older
- Subject is either not of childbearing potential OR subject must use an acceptable method of birth control if of childbearing potential
- Negative pregnancy test if female of childbearing potential
- Subject is in general good health
- Subject required treatment of joint pain within the last 90 days
- Subject has primary diagnosis of osteoarthritis (OA) of the hip or knee
You may not qualify if:
- Subject has a documented history of allergic reaction or intolerance to morphine or other opioids
- Subject is pregnant or breast-feeding
- Subject is receiving systemic chemotherapy
- Subject has a history of drug abuse/dependence/misuse or alcohol abuse/dependence
- Subject has history of major depressive disorder not controlled with medication
- Subject has any chronic pain syndrome (i.e., fibromyalgia) that may interfere with the symptoms of OA
- Subject has active gastrointestinal disease, with the exception of gastroesophageal reflux disease (GERD)
- Subject has a documented history of rheumatoid arthritis, uncontrolled inflammatory arthritis or non-steroidal anti-inflammatory drug (NSAID)-dependent inflammatory arthritis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (81)
The Birmingham Pain Center
Birmingham, Alabama, 35244, United States
Horizon Research Group
Mobile, Alabama, 36608, United States
Arizona Center for Clinical Research
Peoria, Arizona, 85383, United States
Arizona Research Center, Inc
Phoenix, Arizona, 85023, United States
Premiere Pharmaceutical Research, LLC
Tempe, Arizona, 85282, United States
Advanced Clinical Research Institute
Anaheim, California, 92801, United States
Orange County Clinical Trials
Anaheim, California, 92801, United States
STAT-CARE / Crest Clinical Trials
Anaheim, California, 92804, United States
Southbay Pharma Research
Buena Park, California, 90620, United States
Providence Clinical Res. (C-trials)
Burbank, California, 91505, United States
Med Investigators Inc
Fair Oaks, California, 95628, United States
Quality of Life Medical Center, LLC
Hawaiian Gardens, California, 90716, United States
NervePro Research
Irvine, California, 92618, United States
UCSD Pain and Palliative Care
La Jolla, California, 92093, United States
USCD Pain and Palliative Care
La Jolla, California, 92093, United States
Private Practice
Pico Rivera, California, 90660, United States
Pain Institute of Santa Monica
Santa Monica, California, 90404, United States
Boling Clinical Trials
Upland, California, 91786, United States
Mountain View Clinical Research, Inc
Denver, Colorado, 80209, United States
Stamford Therapeutics Consortium
Stamford, Connecticut, 06905, United States
New England Research Associates, LLC
Trumbull, Connecticut, 06611, United States
MD Clinical
Hallandale, Florida, 33009, United States
Eastern Research
Hialeah, Florida, 33013, United States
Florida Institute of Medical Research
Jacksonville, Florida, 32257, United States
Drug Study Institiute
Jupiter, Florida, 33458, United States
FPA Clinical Research
Kissimmee, Florida, 34741, United States
Innovative Research of West Florida
Largo, Florida, 33770, United States
Pharmaceutical Research Associates Inc
Merritt Island, Florida, 32953, United States
Ormond Medical Arts - Pharmaceutical Research Center
Ormond Beach, Florida, 32174, United States
University Clinical Research, Inc
Pembroke Pines, Florida, 33024, United States
Coastal Medical Research
Port Orange, Florida, 32127, United States
Stedman Clinical Trials
Tampa, Florida, 33613, United States
Gold Coast Research LLC
Weston, Florida, 33331, United States
River Birch Research Alliance
Blue Ridge, Georgia, 30513, United States
Best Clinical Research
Decatur, Georgia, 30034, United States
Non-Surgical Orthopaedic and Spine Center
Marietta, Georgia, 30060, United States
Drug Studies America
Marietta, Georgia, 30066, United States
Northwest Clinical Trials
Boise, Idaho, 83704, United States
Research Associates of Central Illinois
Peoria, Illinois, 61614, United States
MediSphere Medical Research Center, LLC
Evansville, Indiana, 47714, United States
Welborn Clinic
Newburgh, Indiana, 47630, United States
International Clinical Research Institute, Inc
Overland Park, Kansas, 66211, United States
Clinical Trials Management, LLC
Mandeville, Louisiana, 70471, United States
Lousiana Research Associates Inc.
New Orleans, Louisiana, 70114, United States
Internal Research Center
Towson, Maryland, 21286, United States
Phase III Clinical Research
Fall River, Massachusetts, 02720, United States
Northeast Medical Research Associates, Inc
No Dartmouth, Massachusetts, 02747, United States
FutureCare Studies
Springfield, Massachusetts, 01107, United States
Synergy Medical Education Alliance
Saginaw, Michigan, 48602, United States
Medex Healthcare Research Inc
St Louis, Missouri, 63117, United States
Lovelace Scientific
Henderson, Nevada, 89014, United States
Advanced Biomedical Research of America
Las Vegas, Nevada, 89123, United States
Partners in Primary Care
Voorhees Township, New Jersey, 08043, United States
Elkind Headache Center
Mount Vernon, New York, 10550, United States
The Arthritis Clinic and Carolina Bone and Joint
Charlotte, North Carolina, 28210, United States
The Center for Clinical Research, LLC
Winston-Salem, North Carolina, 27103, United States
Community Research
Cincinnati, Ohio, 45227, United States
Community Research
Cincinnati, Ohio, 45245, United States
Clinical Research Source, Inc
Toledo, Ohio, 43551, United States
COR Clinical Research
Oklahoma City, Oklahoma, 73103, United States
Health Research Institute
Oklahoma City, Oklahoma, 73109, United States
Cutting Edge Research
Oklahoma City, Oklahoma, 73116, United States
Tulsa Clinical Research
Tulsa, Oklahoma, 74101, United States
LVH Neurosciences and Pain Research
Allentown, Pennsylvania, 18103, United States
Pennsylvania Research Institute
Bensalem, Pennsylvania, 19020, United States
Altoona Center for Clinical Research
Duncansville, Pennsylvania, 16635, United States
Commonwealth Primary Care / Fleetwood Clinical Research
Fleetwood, Pennsylvania, 19522, United States
Pivotal Clinical Research, LLC
Souderton, Pennsylvania, 18964, United States
Tipton Medical and Diagnostic Center
Tipton, Pennsylvania, 16684, United States
Premier Medical Group
Clarksville, Tennessee, 37043, United States
SCRI
Cordova, Tennessee, 38018, United States
Comprehensive Pain Specialists
Hendersonville, Tennessee, 37075, United States
SCRI
Memphis, Tennessee, 38119, United States
Integrity Clinical Research, LLC
Milan, Tennessee, 38358, United States
Walter F. Chase, MD, PA
Austin, Texas, 78705, United States
InSite Clinical Research
DeSoto, Texas, 75115, United States
Team Research of Central Texas
Killeen, Texas, 76543, United States
Radiant Research, San Antonio Northeast
San Antonio, Texas, 78217, United States
North San Antonio Healthcare Associates
San Antonio, Texas, 78218, United States
Progressive Clinical Research
San Antonio, Texas, 78229, United States
HypotheTest, LLC
Roanoke, Virginia, 24018, United States
Related Publications (1)
Setnik B, Pixton GC, Webster LR. Safety profile of extended-release morphine sulfate with sequestered naltrexone hydrochloride in older patients: pooled analysis of three clinical trials. Curr Med Res Opin. 2016;32(3):563-72. doi: 10.1185/03007995.2015.1131153. Epub 2016 Jan 26.
PMID: 26695349DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Vice President, Clinical Development
- Organization
- King Pharmaceuticals Research and Development, Inc.
Study Officials
- STUDY DIRECTOR
James B. Jones, MD, PharmD
Alpharma Pharmceuticals
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 10, 2007
First Posted
January 11, 2007
Study Start
December 1, 2006
Primary Completion
November 1, 2007
Study Completion
November 1, 2007
Last Updated
September 20, 2013
Results First Posted
October 30, 2009
Record last verified: 2013-09