drugset / Trial / NCT01369615
Long-Term Safety of Twice Daily Oxycodone Hydrochloride Controlled-release Tablets in Children Who Completed OTR3001
NaSingle-groupOpen-labelTreatment
Summary
The purpose of this study is to characterize the long-term safety of oxycodone hydrochloride (HCl) controlled-release (CR) tablets in opioid experienced pediatric patients aged 6 to 17 years, inclusive, with moderate to severe malignant and/or nonmalignant pain requiring opioid therapy who completed the 4 -week treatment period in OTR3001.
Timeline
- Start
- 2011-10
- Primary completion
- 2013-12
- Completion
- 2014-05
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Oxycodone | Other / unclassified | 10 mg | — |
| Subject | Oxycodone | Other / unclassified | 15 mg | — |
| Subject | Oxycodone | Other / unclassified | 20 mg | — |
| Subject | Oxycodone | Other / unclassified | 30 mg | — |
| Subject | Oxycodone | Other / unclassified | 40 mg | — |
Indications
No indication recorded.