drugset / Trial / NCT00415597
Study of Embeda (Kadian NT, ALO-01) in Subjects With Chronic Moderate to Severe Nonmalignant Pain
Non-randomizedSingle-groupOpen-labelTreatment
Summary
Open-Label, Safety Study to evaluate the long-term safety of Kadian NT (ALO-01) administered for up to 12 months.
Timeline
- Start
- 2006-12
- Primary completion
- 2008-03
- Completion
- 2008-03
Publications
- Setnik B, Pixton GC, Webster LR. Safety profile of extended-release morphine sulfate with sequestered naltrexone hydrochloride in older patients: pooled analysis of three clinical trials. Curr Med Res Opin. 2016;32(3):563-72. doi: 10.1185/03007995.2015.1131153. Epub 2016 Jan 26.
- Webster LR, Brewer R, Morris D, Cleveland JM, Setnik B. Opioid titration and conversion in patients receiving morphine sulfate and naltrexone hydrochloride extended release capsules. Postgrad Med. 2011 Sep;123(5):155-64. doi: 10.3810/pgm.2011.09.2471.
- Webster LR, Brewer R, Wang C, Sekora D, Johnson FK, Morris D, Stauffer J. Long-term safety and efficacy of morphine sulfate and naltrexone hydrochloride extended release capsules, a novel formulation containing morphine and sequestered naltrexone, in patients with chronic, moderate to severe pain. J Pain Symptom Manage. 2010 Nov;40(5):734-46. doi: 10.1016/j.jpainsymman.2010.05.004.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Morphine | Other / unclassified | 20 mg | — |
| Subject | Morphine | Other / unclassified | 30 mg | — |
| Subject | Morphine | Other / unclassified | 40 mg | — |
| Subject | Morphine | Other / unclassified | 50 mg | — |
| Subject | Morphine | Other / unclassified | 60 mg | — |
| Subject | Morphine | Other / unclassified | 80 mg | — |
| Subject | Morphine | Other / unclassified | 100 mg | — |
| Background | Naltrexone | Small molecule | 4 % | — |
Indications
No indication recorded.