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Study of Buprenorphine Sublingual Spray Versus Standard of Care Narcotic Therapy for the Treatment of Post-Operative Pain

NCT03254459 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2018-10-29

Study results available
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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).

Conditions

  • Pain, Postoperative

Interventions

DRUG

Buprenorphine Sublingual Spray

0.5 mg Sublingual Spray

DRUG

Morphine

4 mg Intravenous Injection

DRUG

Oxycodone Hydrochloride

10 mg tablet

DRUG

Zofran

4 mg oral disintegrating tablet (ODT) or IV injection given at the investigator's discretion for nausea

Sponsors & Collaborators

  • INSYS Therapeutics Inc

    lead INDUSTRY

Principal Investigators

  • Giovanni DeCastro · INSYS Therapeutics Inc

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-09-12
Primary Completion
2017-11-13
Completion
2017-11-13
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03254459 on ClinicalTrials.gov