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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: Completed Phase 2 study, sponsored by INSYS Therapeutics.
NCT03254459 is a Phase 2 study that has completed, run by INSYS Therapeutics. The registered enrollment target is 100 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (25% lower). According to ClinicalTrials.gov, the official US trial registry.
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).
Primary Outcome
An adverse event (AE) is defined as any untoward medical occurrence in a participant administered a pharmaceutical product during the course of a clinical investigation. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an investigational product, whether or not thought to be related to the investigational product. A TEAE is an AE with onset that occurs after receiving study drug.
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 |
What the finished NCT03254459 record still lists
NCT03254459 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (25% lower).
The record links to 0 conditions, and to 4 interventions - of which Morphine is the first listed.
NCT03254459 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03254459's enrollment target sits among peer trials
100 672nd of 2000 higher than 1,263 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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