| December 21, 2006 |
| October 28, 2009 |
| December 2006 |
| March 2008 (final data collection date for primary outcome measure) |
| Subjects With Treatment Emergent Adverse Events [ Time Frame: up to 12 months ] [ Designated as safety issue: Yes ] |
| To evaluate the long-term safety of Kadian NT administered for up to 12 months. |
| Complete list of historical versions of study NCT00415597 on ClinicalTrials.gov Archive Site |
- Mean Percent Change From Baseline in Brief Pain Inventory Score (BPI) of Average Pain [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- Mean Percent Change From Baseline in Brief Pain Inventory Score (BPI) of Average Pain [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
|
- Evaluate the long-term efficacy of Kadian NT during a 12-month period by assessing pain intensity (PI)
- in the past 24 hours using the Brief Pain Inventory (BPI) Short Form, and the Global Assessment of Study Drug
- Evaluate opioid withdrawal symptoms in subjects who receive Kadian NT upon completion of 12-months exposure
- or early termination from the study using the Clinical Opiate Withdrawal Scale (COWS)
- Evaluate plasma naltrexone, 6-B-naltrexol, and morphine concentrations at Visits 2 through 15 in selected male
- and female subjects for pharmacokinetic study.
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| |
| Study of Embeda (Kadian NT, ALO-01) in Subjects With Chronic Moderate to Severe Nonmalignant Pain |
| A Long-Term, Open-Label Safety Study of ALO-01 (Morphine Sulfate Plus Naltrexone Hydrochloride Extended-Release) Capsules in Subjects With Chronic Moderate to Severe Nonmalignant Pain |
Open-Label, Safety Study to evaluate the long-term safety of Kadian NT (ALO-01) administered for up to 12 months. |
| |
| Phase III |
| Interventional |
| Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study |
| Pain |
| Drug: ALO-01 (Morphine Sulfate Plus Naltrexone Hydrochloride ER) |
| |
| |
| |
| Completed |
| 467 |
| March 2008 |
| March 2008 (final data collection date for primary outcome measure) |
Inclusion Criteria:
- Subject 18-70 years of age
- Subject agrees to refrain from taking any opioid medications other than study medication during study period.
- History of chronic moderate to severe pain caused by a nonmalignant condition for at least 3 months prior to baseline
Exclusion Criteria:
- Subject has a documented history of allergic reaction or clinically significant intolerance to morphine or other opioids, such that treatment with morphine is contraindicated.
- Subject is pregnant or breast-feeding.
- Subject is receiving chemotherapy, or has an active malignancy of any type or has been diagnosed with cancer within the past three years (excluding squamous or basal cell carcinoma of the skin).
- Subject has a documented history of drug abuse/dependence/misuse or narcotic analgesic abuse/dependence/misuse within five years prior to the Baseline Visit.
- Subject has a Body Mass Index (BMI)>45kg/m2.
|
| Both |
| 18 Years to 70 Years |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| United States |
| |
| NCT00415597 |
| Kenneth Sommerville, M.D., FAAN, Vice President, Clinical Development, King Pharmaceuticals Research and Development, Inc. |
| ALO-KNT-302 |
| Alpharma Inc. |
|
| Study Director: |
James B. Jones, MD, PharmD |
Alpharma Pharmaceuticals |
|
|
| Alpharma Inc. |
| September 2009 |