drugset / Trial / NCT00986180
NUCYNTA (Tapentadol Immediate Release) Versus Oxycodone Immediate Release in the Treatment of Acute Low Back Pain
Phase 3
Completed
667 enrolled
Ortho-McNeil Janssen Scientific Affairs, LLC
Grünenthal GmbH · collab
RandomizedParallel-groupQuadruple-blindTreatment
Summary
Evaluate how NUCYNTA (tapentadol) immediate release (IR) compares with oxycodone IR in the treatment of acute low back pain.
Timeline
- Start
- 2009-09
- Primary completion
- 2010-12
- Completion
- 2010-12
Outcome
Met primary endpoint
paper The 95% CI for the LSM difference was -32.1 to 30.9; therefore, tapentadol IR was non-inferior to oxycodone IR for relief of LBP. PMID 23703422 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Oxycodone | Other / unclassified | 5 mg | — |
| Comparator | Oxycodone | Other / unclassified | 10 mg | — |
| Comparator | Oxycodone | Other / unclassified | 15 mg | — |
| Subject | Tapentadol | Small molecule | 50 mg | — |
| Subject | Tapentadol | Small molecule | 75 mg | — |
| Subject | Tapentadol | Small molecule | 100 mg | — |
Indications
No indication recorded.