drugset / Trial / NCT00771758
Tapentadol IR vs Oxycodone IR vs Placebo in Acute Pain From Vertebral Compression Fracture Associated With Osteoporosis
Phase 3
Completed
108 enrolled
Ortho-McNeil Janssen Scientific Affairs, LLC
Grünenthal GmbH · collab
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The purpose of this study is to determine the effectiveness and safety of tapentadol immediate release (IR) as compared with placebo and oxycodone IR in patients with acute pain caused by vertebral compression fractures (VCF) associated with assumed osteoporosis for whom treatment with oral opioid analgesics is appropriate.
Timeline
- Start
- 2008-09
- Primary completion
- 2009-12
- Completion
- 2009-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Oxycodone | Other / unclassified | 5 mg | — |
| Subject | Oxycodone | Other / unclassified | 10 mg | — |
| Subject | Tapentadol | Small molecule | 50 mg | — |
| Subject | Tapentadol | Small molecule | 75 mg | — |
Indications
No indication recorded.