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NCT03254459 · ClinicalTrials.gov registry record · Phase 2
Study of Buprenorphine Sublingual Spray Versus Standard of Care Narcotic Therapy for the Treatment of Post-Operative Pain
A Phase 2 study, sponsored by INSYS Therapeutics.
- Completed
- Registry status
- Phase 2
- Development phase
- 100
- Enrollment target
NCT03254459 is a Phase 2 study that has completed, run by INSYS Therapeutics. The registered enrollment target is 100 participants.
The verdict
NCT03254459, a Phase 2 study, has completed, sponsored by INSYS Therapeutics.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 100 participants
- Enrollment target
Study 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).
Interventions
- DRUG Morphine
- DRUG Oxycodone Hydrochloride
- DRUG Zofran
- DRUG Buprenorphine Sublingual Spray
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2017-09-12 |
| Est. Completion | 2017-11-13 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03254459
The ClinicalTrials.gov registry entry for NCT03254459 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 100 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is INSYS Therapeutics, which has 35 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Morphine is the first listed.
NCT03254459 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03254459 about?
NCT03254459 is a clinical study titled "Study of Buprenorphine Sublingual Spray Versus Standard of Care Narcotic Therapy for the Treatment of Post-Operative Pain". 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-operati...
What is the current status of trial NCT03254459?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 100 participants. The study started on 2017-09-12. Estimated completion is 2017-11-13.
What interventions are being tested in trial NCT03254459?
The interventions under investigation include: Morphine (DRUG), Oxycodone Hydrochloride (DRUG), Zofran (DRUG), Buprenorphine Sublingual Spray (DRUG).
Who is sponsoring clinical trial NCT03254459?
This trial is sponsored by INSYS Therapeutics, which has 35 total clinical trials registered on ClinicalTrials.gov.
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