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A Study of Embeda (Kadian NT, ALO-01) in Subjects With Pain Due to Osteoarthritis of the Hip or Knee

Information source: Pfizer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Osteoarthritis; Chronic Pain

Intervention: ALO-01 (Morphine Sulfate Plus Naltrexone Hydrochloride Extended Release) (Drug); Placebo (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
James B. Jones, MD, PharmD, Study Director, Affiliation: Alpharma Pharmceuticals


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.

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: 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)

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.


Minimum age: 21 Years. Maximum age: N/A. Gender(s): Both.


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

Locations and Contacts

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 Beach, 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

Drug Studies America, Marietta, Georgia 30066, United States

Non-Surgical Orthopaedic and Spine Center, Marietta, Georgia 30060, 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, 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

Cutting Edge Research, Oklahoma City, Oklahoma 73116, United States

Health Research Institute, Oklahoma City, Oklahoma 73109, 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

North San Antonio Healthcare Associates, San Antonio, Texas 78218, United States

Progressive Clinical Research, San Antonio, Texas 78229, United States

Radiant Research, San Antonio Northeast, San Antonio, Texas 78217, United States

HypotheTest, LLC, Roanoke, Virginia 24018, United States

Additional Information

Starting date: December 2006
Last updated: September 13, 2013

Page last updated: August 23, 2015

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