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| Sponsored by: |
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 compared with placebo for treating moderate to severe chronic pain over a 12 week period.
| Condition | Intervention | Phase |
|---|---|---|
|
Osteoarthritis Chronic Pain |
Drug: Kadian NT (Morphine Plus Naltrexone Hydrochloride ER) Caps. |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study |
| Official Title: | A Multicenter, Randomized, Double Blind, Placebo-Controlled, Phase 3 Efficacy Study of Kadian NT (Morphine Plus Naltrexone Hydrochloride ER) Capsules in Subjects With Moderate to Severe Chronic Pain Due to Osteoarthritis of the Hip or Knee |
| Estimated Enrollment: | 400 |
| Study Start Date: | December 2006 |
| Study Completion Date: | January 2008 |
| Primary Completion Date: | January 2008 (Final data collection date for primary outcome measure) |
The primary objective of this study is to evaluate the efficacy of Kadian NT 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 af 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
Show 81 Study Locations| Study Director: | James B. Jones, MD, PharmD | Alpharma Pharmceuticals |
More Information
| Study ID Numbers: | ALO-KNT-301 |
| Study First Received: | January 10, 2007 |
| Last Updated: | January 16, 2008 |
| 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 |
|
Morphine Osteoarthritis Joint Diseases Narcotic Antagonists Central Nervous System Depressants Pain Narcotics Osteoarthritis, Hip |
Rheumatic Diseases Musculoskeletal Diseases Arthritis Naltrexone Analgesics Peripheral Nervous System Agents Analgesics, Opioid |
|
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 |