drugset / Trial / NCT03254459
Study of Buprenorphine Sublingual Spray Versus Standard of Care Narcotic Therapy for the Treatment of Post-Operative Pain
RandomizedParallel-groupOpen-labelTreatment
Summary
This study will evaluate the safety and tolerability based on the incidence of adverse experiences of buprenorphine sublingual spray (0.5 milligrams \[mg\] three times daily \[TID\]) compared with standard post-operative narcotic therapy in participants with postoperative pain. Standard post-operative narcotic therapy is defined as morphine intravenous (IV) injection (4 mg TID) followed by oxycodone hydrochloride tablet (10 mg TID).
Timeline
- Start
- 2017-09-12
- Primary completion
- 2017-11-13
- Completion
- 2017-11-13
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Buprenorphine | Other / unclassified | 0.5 mg | Other |
| Comparator | Morphine | Other / unclassified | 4 mg | Intravenous |
| Comparator | Oxycodone | Other / unclassified | 10 mg | Oral |
| Background | Ondansetron | Other / unclassified | 4 mg | Oral |
Indications
No indication recorded.