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

Phase 2

Completed

• Conditions: Pain, Postoperative
• Interventions: Drug: Buprenorphine Sublingual Spray; Drug: Morphine; Drug: Zofran; Drug: Oxycodone Hydrochloride

• Registration Number: NCT03254459
• Lead Sponsor: INSYS Therapeutics Inc

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

Not available

Study Timeline

• Study First Submitted: 2017-08-16
• Study First Submitted QC: 2017-08-16
• Study First Posted: 2017-08-18
• Study Start: 2017-09-12
• Primary Completion: 2017-11-13
• Study Completion: 2017-11-13
• Status Verified: 2018-09
• Results First Submitted: 2018-09-25
• Results First Submitted QC: 2018-09-25
• Last Update Submitted: 2018-09-25
• Results First Posted: 2018-10-29
• Last Update Posted: 2018-10-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Buprenorphine Sublingual Spray 0.5 mg	Buprenorphine Sublingual Spray	Buprenorphine Sublingual Spray 0.5 milligrams (mg) three times a day (TID) for 7 days.
Buprenorphine Sublingual Spray 0.5 mg	Zofran	Buprenorphine Sublingual Spray 0.5 milligrams (mg) three times a day (TID) for 7 days.
Standard of Care Narcotic Therapy	Oxycodone Hydrochloride	Morphine intravenous (IV), 4 mg TID for 24 hours, followed by oxycodone hydrochloride tablet, 10 mg TID for 6 days.
Standard of Care Narcotic Therapy	Morphine	Morphine intravenous (IV), 4 mg TID for 24 hours, followed by oxycodone hydrochloride tablet, 10 mg TID for 6 days.
Standard of Care Narcotic Therapy	Zofran	Morphine intravenous (IV), 4 mg TID for 24 hours, followed by oxycodone hydrochloride tablet, 10 mg TID for 6 days.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Treatment Emergent Adverse Events (TEAEs)	Days 1 to 8	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.

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants Provided Rescue Medication for Nausea	Days 1 to7	Zofran was used at the clinician's discretion as rescue medication for nausea.
Time to First Use of Rescue Medication for Nausea Following Each Dose of the Investigational Product (IP)	Days 1 to 7	Zofran was used at the clinician's discretion as rescue medication for nausea. Time "0" is defined as the time of the administration of study drug.
Total Use of Rescue Medication for Nausea Over 0 to 24 Hours, Over 0 to 48 Hours, Over 0-72 Hours and 0-7 Days	0 to 24 hours, 0 to 48 hours, 0 to 72 hours and 0 to 7 days	Zofran was used at the clinician's discretion as rescue medication for nausea. The total use of rescue medication was calculated for the following 4 time-frames: 0 to 24 hours, 0 to 48 hours, 0 to 72 hours and 0 to 7 days.
Pulse Oximetry Levels at 90 Minutes,12, 24, 48 and 72 Hours	90 Minutes,12, 24, 48 and 72 Hours	Pulse oximetry is a non-invasive method to measure a person's oxygen saturation.
Number of Participants With Abnormal Oral Cavity Examinations	Pre-dose and 90 minutes, 12, 24, 48 and 72 hours after first dose on Days 1 to 4 and End of Study Day 8	Study staff will perform a sublingual (under the tongue) assessment, noting the color of mucosa and whether inflammation is present.
Number of Participants With Abnormal Electrocardiograms (ECGs) Findings at 90 Minutes,12, 24, 48 and 72 Hours	Pre-dose and 90 minutes, 12, 24, 48 and 72 hours after first dose	A standard 12-lead ECG will be performed after the participant is in the supine (lying face up) position for 5 minutes.

Trial Locations

Locations (2)

Lotus Clinical Research, LLC; 🇺🇸 Pasadena, California, United States

Epic Medical Research; 🇺🇸 Murray, Utah, United States