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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.

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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

FieldValue
Enrollment Target 100 participants
Start Date 2017-09-12
Est. Completion 2017-11-13
Phase Phase 2

Sponsor

INSYS Therapeutics

35 total trials

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.