drugset / Trial / NCT00955110
Study to Compare Oxymorphone Extended-Release (Opana ER) Versus Oxycodone Controlled-Release (Oxycontin)
Phase 4
Completed
78 enrolled
Endo USA Inc., a Keenova Therapeutics Company
Kendle Early Stage - Toronto · collab
RandomizedCrossoverQuadruple-blindBasic science
Summary
The purpose of this study is to compare the subjective and objective effects of Oxymorphone ER (Opana ER) versus Oxycodone CR (Oxycontin).
Timeline
- Start
- 2009-06
- Primary completion
- 2009-09
- Completion
- 2009-09
Outcome
Met primary endpoint
registry Oxymorphone ER 30 mg vs Oxycodone CR 60 mg; p <0.001; Least Square Means Difference -28.8 (95% CI -41.6 to -16.0) NCT00955110 ↗
registry Oxymorphone ER 15 mg vs Oxycodone CR 30 mg; p <0.001; Least Square Mean Difference -50.5 (95% CI -63.4 to -37.5) NCT00955110 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Oxycodone | Other / unclassified | 30 mg | Oral |
| Comparator | Oxycodone | Other / unclassified | 60 mg | Oral |
| Subject | Oxymorphone | Small molecule | 15 mg | Oral |
| Subject | Oxymorphone | Small molecule | 30 mg | Oral |
| Background | Hydromorphone | Other / unclassified | 8 mg | — |
Indications
No indication recorded.