|
|
Home
Search
Study Topics
Glossary
|
 |
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||||||||||||||||||||||||
| Sponsor: | Alpharma Inc. |
|---|---|
| Information provided by: | Alpharma Inc. |
| ClinicalTrials.gov Identifier: | NCT00420992 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Osteoarthritis Chronic Pain |
Drug: ALO-01 (Morphine Sulfate Plus Naltrexone Hydrochloride ER) Drug: Placebo |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study |
| 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 |
| Enrollment: | 547 |
| Study Start Date: | December 2006 |
| Study Completion Date: | November 2007 |
| Primary Completion Date: | November 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| ALO-01: Experimental |
Drug: ALO-01 (Morphine Sulfate Plus Naltrexone Hydrochloride ER)
capsules, 20-160 mg total daily dose, given either once daily or twice daily
|
| Placebo: Placebo Comparator |
Drug: Placebo
capsules
|
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 BPI score of average pain (daily scores of average pain averaged over 7 days) from randomization to 12 weeks following randomization.
Eligibility| Ages Eligible for Study: | 21 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
Hide Study Locations| United States, Alabama | |
| The Birmingham Pain Center | |
| Birmingham, Alabama, United States, 35244 | |
| Horizon Research Group | |
| Mobile, Alabama, United States, 36608 | |
| United States, Arizona | |
| Arizona Research Center, Inc | |
| Phoenix, Arizona, United States, 85023 | |
| Arizona Center for Clinical Research | |
| Peoria, Arizona, United States, 85383 | |
| Premiere Pharmaceutical Research, LLC | |
| Tempe, Arizona, United States, 85282 | |
| United States, California | |
| Med Investigators Inc | |
| Fair Oaks, California, United States, 95628 | |
| STAT-CARE / Crest Clinical Trials | |
| Anaheim, California, United States, 92804 | |
| NervePro Research | |
| Irvine, California, United States, 92618 | |
| Private Practice | |
| Pico Rivera, California, United States, 90660 | |
| Boling Clinical Trials | |
| Upland, California, United States, 91786 | |
| Southbay Pharma Research | |
| Buena Park, California, United States, 90620 | |
| Advanced Clinical Research Institute | |
| Anaheim, California, United States, 92801 | |
| Quality of Life Medical Center, LLC | |
| Hawaiian Gardens, California, United States, 90716 | |
| Orange County Clinical Trials | |
| Anaheim, California, United States, 92801 | |
| Providence Clinical Res. (C-trials) | |
| Burbank, California, United States, 91505 | |
| UCSD Pain and Palliative Care | |
| La Jolla, California, United States, 92093 | |
| USCD Pain and Palliative Care | |
| La Jolla, California, United States, 92093 | |
| Pain Institute of Santa Monica | |
| Santa Monica, California, United States, 90404 | |
| United States, Colorado | |
| Mountain View Clinical Research, Inc | |
| Denver, Colorado, United States, 80209 | |
| United States, Connecticut | |
| New England Research Associates, LLC | |
| Trumbull, Connecticut, United States, 06611 | |
| Stamford Therapeutics Consortium | |
| Stamford, Connecticut, United States, 06905 | |
| United States, Florida | |
| Florida Institute of Medical Research | |
| Jacksonville, Florida, United States, 32257 | |
| University Clinical Research, Inc | |
| Pembroke Pines, Florida, United States, 33024 | |
| Gold Coast Research LLC | |
| Weston, Florida, United States, 33331 | |
| FPA Clinical Research | |
| Kissimmee, Florida, United States, 34741 | |
| Innovative Research of West Florida | |
| Largo, Florida, United States, 33770 | |
| Drug Study Institiute | |
| Jupiter, Florida, United States, 33458 | |
| Ormond Medical Arts - Pharmaceutical Research Center | |
| Ormond Beach, Florida, United States, 32174 | |
| Stedman Clinical Trials | |
| Tampa, Florida, United States, 33613 | |
| Eastern Research | |
| Hialeah, Florida, United States, 33013 | |
| Pharmaceutical Research Associates Inc | |
| Merritt Island, Florida, United States, 32953 | |
| Coastal Medical Research | |
| Port Orange, Florida, United States, 32127 | |
| MD Clinical | |
| Hallandale Beach, Florida, United States, 33009 | |
| United States, Georgia | |
| Best Clinical Research | |
| Decatur, Georgia, United States, 30034 | |
| Drug Studies America | |
| Marietta, Georgia, United States, 30066 | |
| River Birch Research Alliance | |
| Blue Ridge, Georgia, United States, 30513 | |
| Non-Surgical Orthopaedic and Spine Center | |
| Marietta, Georgia, United States, 30060 | |
| United States, Idaho | |
| Northwest Clinical Trials | |
| Boise, Idaho, United States, 83704 | |
| United States, Illinois | |
| Research Associates of Central Illinois | |
| Peoria, Illinois, United States, 61614 | |
| United States, Indiana | |
| MediSphere Medical Research Center, LLC | |
| Evansville, Indiana, United States, 47714 | |
| Welborn Clinic | |
| Newburgh, Indiana, United States, 47630 | |
| United States, Kansas | |
| International Clinical Research Institute, Inc | |
| Overland Park, Kansas, United States, 66211 | |
| United States, Louisiana | |
| Lousiana Research Associates Inc. | |
| New Orleans, Louisiana, United States, 70114 | |
| Clinical Trials Management, LLC | |
| Mandeville, Louisiana, United States, 70471 | |
| United States, Maryland | |
| Internal Research Center | |
| Towson, Maryland, United States, 21286 | |
| United States, Massachusetts | |
| FutureCare Studies | |
| Springfield, Massachusetts, United States, 01107 | |
| Northeast Medical Research Associates, Inc | |
| No Dartmouth, Massachusetts, United States, 02747 | |
| Phase III Clinical Research | |
| Fall River, Massachusetts, United States, 02720 | |
| United States, Michigan | |
| Synergy Medical Education Alliance | |
| Saginaw, Michigan, United States, 48602 | |
| United States, Missouri | |
| Medex Healthcare Research Inc | |
| St. Louis, Missouri, United States, 63117 | |
| United States, Nevada | |
| Advanced Biomedical Research of America | |
| Las Vegas, Nevada, United States, 89123 | |
| Lovelace Scientific | |
| Henderson, Nevada, United States, 89014 | |
| United States, New Jersey | |
| Partners in Primary Care | |
| Voorhees, New Jersey, United States, 08043 | |
| United States, New York | |
| Elkind Headache Center | |
| Mount Vernon, New York, United States, 10550 | |
| United States, North Carolina | |
| The Arthritis Clinic and Carolina Bone and Joint | |
| Charlotte, North Carolina, United States, 28210 | |
| The Center for Clinical Research, LLC | |
| Winston-Salem, North Carolina, United States, 27103 | |
| United States, Ohio | |
| Community Research | |
| Cincinnati, Ohio, United States, 45227 | |
| Clinical Research Source, Inc | |
| Toledo, Ohio, United States, 43551 | |
| Community Research | |
| Cincinnati, Ohio, United States, 45245 | |
| United States, Oklahoma | |
| COR Clinical Research | |
| Oklahoma City, Oklahoma, United States, 73103 | |
| Health Research Institute | |
| Oklahoma City, Oklahoma, United States, 73109 | |
| Tulsa Clinical Research | |
| Tulsa, Oklahoma, United States, 74101 | |
| Cutting Edge Research | |
| Oklahoma City, Oklahoma, United States, 73116 | |
| United States, Pennsylvania | |
| Commonwealth Primary Care / Fleetwood Clinical Research | |
| Fleetwood, Pennsylvania, United States, 19522 | |
| Pivotal Clinical Research, LLC | |
| Souderton, Pennsylvania, United States, 18964 | |
| Tipton Medical and Diagnostic Center | |
| Tipton, Pennsylvania, United States, 16684 | |
| Altoona Center for Clinical Research | |
| Duncansville, Pennsylvania, United States, 16635 | |
| Pennsylvania Research Institute | |
| Bensalem, Pennsylvania, United States, 19020 | |
| LVH Neurosciences and Pain Research | |
| Allentown, Pennsylvania, United States, 18103 | |
| United States, Tennessee | |
| Integrity Clinical Research, LLC | |
| Milan, Tennessee, United States, 38358 | |
| Premier Medical Group | |
| Clarksville, Tennessee, United States, 37043 | |
| Comprehensive Pain Specialists | |
| Hendersonville, Tennessee, United States, 37075 | |
| SCRI | |
| Cordova, Tennessee, United States, 38018 | |
| SCRI | |
| Memphis, Tennessee, United States, 38119 | |
| United States, Texas | |
| Radiant Research, San Antonio Northeast | |
| San Antonio, Texas, United States, 78217 | |
| Walter F. Chase, MD, PA | |
| Austin, Texas, United States, 78705 | |
| Progressive Clinical Research | |
| San Antonio, Texas, United States, 78229 | |
| InSite Clinical Research | |
| DeSoto, Texas, United States, 75115 | |
| Team Research of Central Texas | |
| Killeen, Texas, United States, 76543 | |
| North San Antonio Healthcare Associates | |
| San Antonio, Texas, United States, 78218 | |
| United States, Virginia | |
| HypotheTest, LLC | |
| Roanoke, Virginia, United States, 24018 | |
| Study Director: | James B. Jones, MD, PharmD | Alpharma Pharmceuticals |
More Information
| Responsible Party: | King Pharmaceuticals Research and Development ( Kenneth Sommerville, M.D., FAAN, Vice President, Clinical Development ) |
| Study ID Numbers: | ALO-KNT-301 |
| Study First Received: | January 10, 2007 |
| Results First Received: | September 11, 2009 |
| Last Updated: | October 28, 2009 |
| ClinicalTrials.gov Identifier: | NCT00420992 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
hip knee pain osteoarthritis OA Kadian |
Alpharma naltrexone Opioid morphine Embeda ALO-01 |
|
Morphine Osteoarthritis Joint Diseases Narcotic Antagonists Physiological Effects of Drugs Central Nervous System Depressants Narcotics Osteoarthritis, Hip Rheumatic Diseases Pharmacologic Actions |
Musculoskeletal Diseases Sensory System Agents Therapeutic Uses Arthritis Naltrexone Analgesics Peripheral Nervous System Agents Central Nervous System Agents Analgesics, Opioid |
