Ignite Creation Date:
2025-12-24 @ 3:06 PM
Ignite Modification Date:
2026-01-28 @ 11:47 AM
Study NCT ID:
NCT03254459
Status:
COMPLETED
Last Update Posted:
2018-10-29
First Post:
2017-08-16
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study of Buprenorphine Sublingual Spray Versus Standard of Care Narcotic Therapy for the Treatment of Post-Operative Pain
Sponsor:
INSYS Therapeutics Inc
Organization:
Study Overview
Official Title:
A Phase 2, Randomized, Open Label, Multiple-Dose, Comparator, Parallel-Group, Safety and Tolerance Study of Buprenorphine Sublingual Spray (0.5 mg TID) Versus Standard of Care Post-Operative Narcotic Therapy for the Treatment of Post-Operative Pain
Status:
COMPLETED
Status Verified Date:
2018-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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).
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: