| January 10, 2007 |
| October 28, 2009 |
| December 2006 |
| November 2007 (final data collection date for primary outcome measure) |
| Mean Change in Diary Brief Pain Inventory Score of Average Pain (Daily Scores of Average Pain Averaged Over 7 Days) [ Time Frame: randomization to 12 weeks following randomization ] [ Designated as safety issue: No ] |
| Evaluate the efficacy of Kadian NT (BID) compared with placebo as measured by mean change in diary Brief Pain Index score of average pain (daily scores of average pain averaged over 7 days) from randomization to 12 weeks following randomization. |
| Complete list of historical versions of study NCT00420992 on ClinicalTrials.gov Archive Site |
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- Evaluate the efficacy of Kadian NT (BID) compared with placebo as measured by in-clinic BPI, daily diary BPI, WOMAC Osteoarthritis Index, MOS Sleep Scale, Beck Depression Inventory, and PGIC
- Evaluate the safety and tolerability of Kadian NT compared to placebo using AEs, clinical laboratory data, vital signs, and two measures of opioid withdrawal: SOWS and COWS
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| |
| 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 |
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. |
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. |
| Phase III |
| Interventional |
| Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study |
- Osteoarthritis
- Chronic Pain
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- Drug: ALO-01 (Morphine Sulfate Plus Naltrexone Hydrochloride ER)
- Drug: Placebo
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| |
| |
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| Completed |
| 547 |
| November 2007 |
| November 2007 (final data collection date for primary outcome measure) |
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 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 GERD
- Subject has a documented history of rheumatoid arthritis, uncontrolled inflammatory arthritis or NSAID-dependent inflammatory arthritis
|
| Both |
| 21 Years and older |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| United States |
| |
| NCT00420992 |
| Kenneth Sommerville, M.D., FAAN, Vice President, Clinical Development, King Pharmaceuticals Research and Development |
| ALO-KNT-301 |
| Alpharma Inc. |
|
| Study Director: |
James B. Jones, MD, PharmD |
Alpharma Pharmceuticals |
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| Alpharma Inc. |
| September 2009 |
