Clinical trial NCT00420992: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Osteoarthritis
Chronic Pain
Keywords: hip
knee
pain
osteoarthritis
OA
Kadian
Alpharma
naltrexone
Opioid
morphine
Embeda
ALO-01
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2007-01-11
Enrollment: 547
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: 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)
timeFrame: randomization to 12 weeks following randomization
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: The Birmingham Pain Center
state: Alabama
city: Mobile
country: United States
facility: Horizon Research Group
state: Alabama
city: Peoria
country: United States
facility: Arizona Center for Clinical Research
state: Arizona
city: Phoenix
country: United States
facility: Arizona Research Center, Inc
state: Arizona
city: Tempe
country: United States
facility: Premiere Pharmaceutical Research, LLC
state: Arizona
city: Anaheim
country: United States
facility: Advanced Clinical Research Institute
state: California
city: Anaheim
country: United States
facility: Orange County Clinical Trials
state: California
city: Anaheim
country: United States
facility: STAT-CARE / Crest Clinical Trials
state: California
city: Buena Park
country: United States
facility: Southbay Pharma Research
state: California
city: Burbank
country: United States
facility: Providence Clinical Res. (C-trials)
state: California
city: Fair Oaks
country: United States
facility: Med Investigators Inc
state: California
city: Hawaiian Gardens
country: United States
facility: Quality of Life Medical Center, LLC
state: California
city: Irvine
country: United States
facility: NervePro Research
state: California
city: La Jolla
country: United States
facility: UCSD Pain and Palliative Care
state: California
city: La Jolla
country: United States
facility: USCD Pain and Palliative Care
state: California
city: Pico Rivera
country: United States
facility: Private Practice
state: California
city: Santa Monica
country: United States
facility: Pain Institute of Santa Monica
state: California
city: Upland
country: United States
facility: Boling Clinical Trials
state: California
city: Denver
country: United States
facility: Mountain View Clinical Research, Inc
state: Colorado
city: Stamford
country: United States
facility: Stamford Therapeutics Consortium
state: Connecticut
city: Trumbull
country: United States
facility: New England Research Associates, LLC
state: Connecticut
city: Hallandale Beach
country: United States
facility: MD Clinical
state: Florida
city: Hialeah
country: United States
facility: Eastern Research
state: Florida
city: Jacksonville
country: United States
facility: Florida Institute of Medical Research
state: Florida
city: Jupiter
country: United States
facility: Drug Study Institiute
state: Florida
city: Kissimmee
country: United States
facility: FPA Clinical Research
state: Florida
city: Largo
country: United States
facility: Innovative Research of West Florida
state: Florida
city: Merritt Island
country: United States
facility: Pharmaceutical Research Associates Inc
state: Florida
city: Ormond Beach
country: United States
facility: Ormond Medical Arts - Pharmaceutical Research Center
state: Florida
city: Pembroke Pines
country: United States
facility: University Clinical Research, Inc
state: Florida
city: Port Orange
country: United States
facility: Coastal Medical Research
state: Florida
city: Tampa
country: United States
facility: Stedman Clinical Trials
state: Florida
city: Weston
country: United States
facility: Gold Coast Research LLC
state: Florida
city: Blue Ridge
country: United States
facility: River Birch Research Alliance
state: Georgia
city: Decatur
country: United States
facility: Best Clinical Research
state: Georgia
city: Marietta
country: United States
facility: Non-Surgical Orthopaedic and Spine Center
state: Georgia
city: Marietta
country: United States
facility: Drug Studies America
state: Georgia
city: Boise
country: United States
facility: Northwest Clinical Trials
state: Idaho
city: Peoria
country: United States
facility: Research Associates of Central Illinois
state: Illinois
city: Evansville
country: United States
facility: MediSphere Medical Research Center, LLC
state: Indiana
city: Newburgh
country: United States
facility: Welborn Clinic
state: Indiana
city: Overland Park
country: United States
facility: International Clinical Research Institute, Inc
state: Kansas
city: Mandeville
country: United States
facility: Clinical Trials Management, LLC
state: Louisiana
city: New Orleans
country: United States
facility: Lousiana Research Associates Inc.
state: Louisiana
city: Towson
country: United States
facility: Internal Research Center
state: Maryland
city: Fall River
country: United States
facility: Phase III Clinical Research
state: Massachusetts
city: No Dartmouth
country: United States
facility: Northeast Medical Research Associates, Inc
state: Massachusetts
city: Springfield
country: United States
facility: FutureCare Studies
state: Massachusetts
city: Saginaw
country: United States
facility: Synergy Medical Education Alliance
state: Michigan
city: St. Louis
country: United States
facility: Medex Healthcare Research Inc
state: Missouri
city: Henderson
country: United States
facility: Lovelace Scientific
state: Nevada
city: Las Vegas
country: United States
facility: Advanced Biomedical Research of America
state: Nevada
city: Voorhees
country: United States
facility: Partners in Primary Care
state: New Jersey
city: Mount Vernon
country: United States
facility: Elkind Headache Center
state: New York
city: Charlotte
country: United States
facility: The Arthritis Clinic and Carolina Bone and Joint
state: North Carolina
city: Winston-Salem
country: United States
facility: The Center for Clinical Research, LLC
state: North Carolina
city: Cincinnati
country: United States
facility: Community Research
state: Ohio
city: Cincinnati
country: United States
facility: Community Research
state: Ohio
city: Toledo
country: United States
facility: Clinical Research Source, Inc
state: Ohio
city: Oklahoma City
country: United States
facility: COR Clinical Research
state: Oklahoma
city: Oklahoma City
country: United States
facility: Health Research Institute
state: Oklahoma
city: Oklahoma City
country: United States
facility: Cutting Edge Research
state: Oklahoma
city: Tulsa
country: United States
facility: Tulsa Clinical Research
state: Oklahoma
city: Allentown
country: United States
facility: LVH Neurosciences and Pain Research
state: Pennsylvania
city: Bensalem
country: United States
facility: Pennsylvania Research Institute
state: Pennsylvania
city: Duncansville
country: United States
facility: Altoona Center for Clinical Research
state: Pennsylvania
city: Fleetwood
country: United States
facility: Commonwealth Primary Care / Fleetwood Clinical Research
state: Pennsylvania
city: Souderton
country: United States
facility: Pivotal Clinical Research, LLC
state: Pennsylvania
city: Tipton
country: United States
facility: Tipton Medical and Diagnostic Center
state: Pennsylvania
city: Clarksville
country: United States
facility: Premier Medical Group
state: Tennessee
city: Cordova
country: United States
facility: SCRI
state: Tennessee
city: Hendersonville
country: United States
facility: Comprehensive Pain Specialists
state: Tennessee
city: Memphis
country: United States
facility: SCRI
state: Tennessee
city: Milan
country: United States
facility: Integrity Clinical Research, LLC
state: Tennessee
city: Austin
country: United States
facility: Walter F. Chase, MD, PA
state: Texas
city: DeSoto
country: United States
facility: InSite Clinical Research
state: Texas
city: Killeen
country: United States
facility: Team Research of Central Texas
state: Texas
city: San Antonio
country: United States
facility: Radiant Research, San Antonio Northeast
state: Texas
city: San Antonio
country: United States
facility: North San Antonio Healthcare Associates
state: Texas
city: San Antonio
country: United States
facility: Progressive Clinical Research
state: Texas
city: Roanoke
country: United States
facility: HypotheTest, LLC
state: Virginia
Study officials:
affiliation: Alpharma Pharmceuticals
name: James B. Jones, MD, PharmD
role: STUDY_DIRECTOR
References:
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.