drugset / Trial / NCT02401750
A Study to Evaluate Safety and Efficacy Following Dosing of Oxycodone/Naltrexone for Treatment of Adults With Pain Following Bunionectomy Surgery
RandomizedParallel-groupTriple-blindTreatment
Summary
This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group, Phase 3 study to evaluate the efficacy and safety of the administration of multiple doses of Oxycodone Hydrochloride plus Naltrexone Hydrochloride (a) or Oxycodone Hydrochloride plus Naltrexone Hydrochloride (b) in patients who have undergone primary, unilateral, distal first metatarsal bunionectomy with osteotomy and internal fixation.
Timeline
- Start
- 2015-06
- Primary completion
- 2015-07
- Completion
- 2015-09
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Naltrexone | Small molecule | — | Oral |
| Subject | Oxycodone | Other / unclassified | — | Oral |
Indications
No indication recorded.