Back to resultsA Study of Embeda (Kadian NT, ALO-01) in Subjects With Pain Due to Osteoarthritis of the Hip or Knee
Primary Purpose
Osteoarthritis, Chronic Pain
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
ALO-01 (Morphine Sulfate Plus Naltrexone Hydrochloride Extended Release)
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis focused on measuring hip, knee, pain, osteoarthritis, OA, Kadian, Alpharma, naltrexone, Opioid, morphine, Embeda, ALO-01
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- The Birmingham Pain Center
- Horizon Research Group
- Arizona Center for Clinical Research
- Arizona Research Center, Inc
- Premiere Pharmaceutical Research, LLC
- Advanced Clinical Research Institute
- Orange County Clinical Trials
- STAT-CARE / Crest Clinical Trials
- Southbay Pharma Research
- Providence Clinical Res. (C-trials)
- Med Investigators Inc
- Quality of Life Medical Center, LLC
- NervePro Research
- UCSD Pain and Palliative Care
- USCD Pain and Palliative Care
- Private Practice
- Pain Institute of Santa Monica
- Boling Clinical Trials
- Mountain View Clinical Research, Inc
- Stamford Therapeutics Consortium
- New England Research Associates, LLC
- MD Clinical
- Eastern Research
- Florida Institute of Medical Research
- Drug Study Institiute
- FPA Clinical Research
- Innovative Research of West Florida
- Pharmaceutical Research Associates Inc
- Ormond Medical Arts - Pharmaceutical Research Center
- University Clinical Research, Inc
- Coastal Medical Research
- Stedman Clinical Trials
- Gold Coast Research LLC
- River Birch Research Alliance
- Best Clinical Research
- Non-Surgical Orthopaedic and Spine Center
- Drug Studies America
- Northwest Clinical Trials
- Research Associates of Central Illinois
- MediSphere Medical Research Center, LLC
- Welborn Clinic
- International Clinical Research Institute, Inc
- Clinical Trials Management, LLC
- Lousiana Research Associates Inc.
- Internal Research Center
- Phase III Clinical Research
- Northeast Medical Research Associates, Inc
- FutureCare Studies
- Synergy Medical Education Alliance
- Medex Healthcare Research Inc
- Lovelace Scientific
- Advanced Biomedical Research of America
- Partners in Primary Care
- Elkind Headache Center
- The Arthritis Clinic and Carolina Bone and Joint
- The Center for Clinical Research, LLC
- Community Research
- Community Research
- Clinical Research Source, Inc
- COR Clinical Research
- Health Research Institute
- Cutting Edge Research
- Tulsa Clinical Research
- LVH Neurosciences and Pain Research
- Pennsylvania Research Institute
- Altoona Center for Clinical Research
- Commonwealth Primary Care / Fleetwood Clinical Research
- Pivotal Clinical Research, LLC
- Tipton Medical and Diagnostic Center
- Premier Medical Group
- SCRI
- Comprehensive Pain Specialists
- SCRI
- Integrity Clinical Research, LLC
- Walter F. Chase, MD, PA
- InSite Clinical Research
- Team Research of Central Texas
- Radiant Research, San Antonio Northeast
- North San Antonio Healthcare Associates
- Progressive Clinical Research
- HypotheTest, LLC
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
ALO-01
Placebo
Arm Description
Up to 80 mg twice a day (bid)
Twice a day (bid)
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00420992
Brief Title
A Study of Embeda (Kadian NT, ALO-01) in Subjects With Pain Due to Osteoarthritis of the Hip or Knee
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2013
Overall Recruitment Status
Completed
Study Start Date
December 2006 (undefined)
Primary Completion Date
November 2007 (Actual)
Study Completion Date
November 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer
4. Oversight
5. Study Description
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.
Detailed Description
The primary objective of this study is to evaluate the efficacy of ALO-01 compared with placebo for the treatment of chronic moderate to severe pain (focusing on osteoarthritis of the hip or knee) as measured by mean change in diary Brief Pain Inventory (BPI) score of average pain (daily scores of average pain averaged over 7 days) from randomization to 12 weeks following randomization.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Chronic Pain
Keywords
hip, knee, pain, osteoarthritis, OA, Kadian, Alpharma, naltrexone, Opioid, morphine, Embeda, ALO-01
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
547 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ALO-01
Arm Type
Experimental
Arm Description
Up to 80 mg twice a day (bid)
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Twice a day (bid)
Intervention Type
Drug
Intervention Name(s)
ALO-01 (Morphine Sulfate Plus Naltrexone Hydrochloride Extended Release)
Other Intervention Name(s)
Embeda
Intervention Description
capsules, up to 80 mg bid
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
capsules, bid
Primary Outcome Measure Information:
Title
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)
Description
Change in pain intensity scale. Average pain intensity over last 24 hours rated daily from 0=no pain to 10=worst pain.
Time Frame
randomization to 12 weeks following randomization
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James B. Jones, MD, PharmD
Organizational Affiliation
Alpharma Pharmceuticals
Official's Role
Study Director
Facility Information:
Facility Name
The Birmingham Pain Center
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35244
Country
United States
Facility Name
Horizon Research Group
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36608
Country
United States
Facility Name
Arizona Center for Clinical Research
City
Peoria
State/Province
Arizona
ZIP/Postal Code
85383
Country
United States
Facility Name
Arizona Research Center, Inc
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85023
Country
United States
Facility Name
Premiere Pharmaceutical Research, LLC
City
Tempe
State/Province
Arizona
ZIP/Postal Code
85282
Country
United States
Facility Name
Advanced Clinical Research Institute
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
Facility Name
Orange County Clinical Trials
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
Facility Name
STAT-CARE / Crest Clinical Trials
City
Anaheim
State/Province
California
ZIP/Postal Code
92804
Country
United States
Facility Name
Southbay Pharma Research
City
Buena Park
State/Province
California
ZIP/Postal Code
90620
Country
United States
Facility Name
Providence Clinical Res. (C-trials)
City
Burbank
State/Province
California
ZIP/Postal Code
91505
Country
United States
Facility Name
Med Investigators Inc
City
Fair Oaks
State/Province
California
ZIP/Postal Code
95628
Country
United States
Facility Name
Quality of Life Medical Center, LLC
City
Hawaiian Gardens
State/Province
California
ZIP/Postal Code
90716
Country
United States
Facility Name
NervePro Research
City
Irvine
State/Province
California
ZIP/Postal Code
92618
Country
United States
Facility Name
UCSD Pain and Palliative Care
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
Facility Name
USCD Pain and Palliative Care
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
Facility Name
Private Practice
City
Pico Rivera
State/Province
California
ZIP/Postal Code
90660
Country
United States
Facility Name
Pain Institute of Santa Monica
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
Boling Clinical Trials
City
Upland
State/Province
California
ZIP/Postal Code
91786
Country
United States
Facility Name
Mountain View Clinical Research, Inc
City
Denver
State/Province
Colorado
ZIP/Postal Code
80209
Country
United States
Facility Name
Stamford Therapeutics Consortium
City
Stamford
State/Province
Connecticut
ZIP/Postal Code
06905
Country
United States
Facility Name
New England Research Associates, LLC
City
Trumbull
State/Province
Connecticut
ZIP/Postal Code
06611
Country
United States
Facility Name
MD Clinical
City
Hallandale Beach
State/Province
Florida
ZIP/Postal Code
33009
Country
United States
Facility Name
Eastern Research
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33013
Country
United States
Facility Name
Florida Institute of Medical Research
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32257
Country
United States
Facility Name
Drug Study Institiute
City
Jupiter
State/Province
Florida
ZIP/Postal Code
33458
Country
United States
Facility Name
FPA Clinical Research
City
Kissimmee
State/Province
Florida
ZIP/Postal Code
34741
Country
United States
Facility Name
Innovative Research of West Florida
City
Largo
State/Province
Florida
ZIP/Postal Code
33770
Country
United States
Facility Name
Pharmaceutical Research Associates Inc
City
Merritt Island
State/Province
Florida
ZIP/Postal Code
32953
Country
United States
Facility Name
Ormond Medical Arts - Pharmaceutical Research Center
City
Ormond Beach
State/Province
Florida
ZIP/Postal Code
32174
Country
United States
Facility Name
University Clinical Research, Inc
City
Pembroke Pines
State/Province
Florida
ZIP/Postal Code
33024
Country
United States
Facility Name
Coastal Medical Research
City
Port Orange
State/Province
Florida
ZIP/Postal Code
32127
Country
United States
Facility Name
Stedman Clinical Trials
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
Facility Name
Gold Coast Research LLC
City
Weston
State/Province
Florida
ZIP/Postal Code
33331
Country
United States
Facility Name
River Birch Research Alliance
City
Blue Ridge
State/Province
Georgia
ZIP/Postal Code
30513
Country
United States
Facility Name
Best Clinical Research
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30034
Country
United States
Facility Name
Non-Surgical Orthopaedic and Spine Center
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
Drug Studies America
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30066
Country
United States
Facility Name
Northwest Clinical Trials
City
Boise
State/Province
Idaho
ZIP/Postal Code
83704
Country
United States
Facility Name
Research Associates of Central Illinois
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61614
Country
United States
Facility Name
MediSphere Medical Research Center, LLC
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47714
Country
United States
Facility Name
Welborn Clinic
City
Newburgh
State/Province
Indiana
ZIP/Postal Code
47630
Country
United States
Facility Name
International Clinical Research Institute, Inc
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66211
Country
United States
Facility Name
Clinical Trials Management, LLC
City
Mandeville
State/Province
Louisiana
ZIP/Postal Code
70471
Country
United States
Facility Name
Lousiana Research Associates Inc.
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70114
Country
United States
Facility Name
Internal Research Center
City
Towson
State/Province
Maryland
ZIP/Postal Code
21286
Country
United States
Facility Name
Phase III Clinical Research
City
Fall River
State/Province
Massachusetts
ZIP/Postal Code
02720
Country
United States
Facility Name
Northeast Medical Research Associates, Inc
City
No Dartmouth
State/Province
Massachusetts
ZIP/Postal Code
02747
Country
United States
Facility Name
FutureCare Studies
City
Springfield
State/Province
Massachusetts
ZIP/Postal Code
01107
Country
United States
Facility Name
Synergy Medical Education Alliance
City
Saginaw
State/Province
Michigan
ZIP/Postal Code
48602
Country
United States
Facility Name
Medex Healthcare Research Inc
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63117
Country
United States
Facility Name
Lovelace Scientific
City
Henderson
State/Province
Nevada
ZIP/Postal Code
89014
Country
United States
Facility Name
Advanced Biomedical Research of America
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89123
Country
United States
Facility Name
Partners in Primary Care
City
Voorhees
State/Province
New Jersey
ZIP/Postal Code
08043
Country
United States
Facility Name
Elkind Headache Center
City
Mount Vernon
State/Province
New York
ZIP/Postal Code
10550
Country
United States
Facility Name
The Arthritis Clinic and Carolina Bone and Joint
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28210
Country
United States
Facility Name
The Center for Clinical Research, LLC
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Community Research
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45227
Country
United States
Facility Name
Community Research
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45245
Country
United States
Facility Name
Clinical Research Source, Inc
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43551
Country
United States
Facility Name
COR Clinical Research
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73103
Country
United States
Facility Name
Health Research Institute
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73109
Country
United States
Facility Name
Cutting Edge Research
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73116
Country
United States
Facility Name
Tulsa Clinical Research
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74101
Country
United States
Facility Name
LVH Neurosciences and Pain Research
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18103
Country
United States
Facility Name
Pennsylvania Research Institute
City
Bensalem
State/Province
Pennsylvania
ZIP/Postal Code
19020
Country
United States
Facility Name
Altoona Center for Clinical Research
City
Duncansville
State/Province
Pennsylvania
ZIP/Postal Code
16635
Country
United States
Facility Name
Commonwealth Primary Care / Fleetwood Clinical Research
City
Fleetwood
State/Province
Pennsylvania
ZIP/Postal Code
19522
Country
United States
Facility Name
Pivotal Clinical Research, LLC
City
Souderton
State/Province
Pennsylvania
ZIP/Postal Code
18964
Country
United States
Facility Name
Tipton Medical and Diagnostic Center
City
Tipton
State/Province
Pennsylvania
ZIP/Postal Code
16684
Country
United States
Facility Name
Premier Medical Group
City
Clarksville
State/Province
Tennessee
ZIP/Postal Code
37043
Country
United States
Facility Name
SCRI
City
Cordova
State/Province
Tennessee
ZIP/Postal Code
38018
Country
United States
Facility Name
Comprehensive Pain Specialists
City
Hendersonville
State/Province
Tennessee
ZIP/Postal Code
37075
Country
United States
Facility Name
SCRI
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Facility Name
Integrity Clinical Research, LLC
City
Milan
State/Province
Tennessee
ZIP/Postal Code
38358
Country
United States
Facility Name
Walter F. Chase, MD, PA
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
InSite Clinical Research
City
DeSoto
State/Province
Texas
ZIP/Postal Code
75115
Country
United States
Facility Name
Team Research of Central Texas
City
Killeen
State/Province
Texas
ZIP/Postal Code
76543
Country
United States
Facility Name
Radiant Research, San Antonio Northeast
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78217
Country
United States
Facility Name
North San Antonio Healthcare Associates
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78218
Country
United States
Facility Name
Progressive Clinical Research
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
HypotheTest, LLC
City
Roanoke
State/Province
Virginia
ZIP/Postal Code
24018
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
26695349
Citation
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.
Results Reference
derived
Learn more about this trial
A Study of Embeda (Kadian NT, ALO-01) in Subjects With Pain Due to Osteoarthritis of the Hip or Knee
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