NCT03254459

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

Completed Phase 2 Results posted Last updated 29 October 2018

What this trial tests

Phase 2 trial testing Buprenorphine Sublingual Spray in Pain, Postoperative in 100 participants. Completed in 13 November 2017.

Timeline

12 September 2017

Primary endpoint
13 November 2017

13 November 2017

Quick facts

Lead sponsor	INSYS Therapeutics Inc
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	100
Start date	12 September 2017
Primary completion	13 November 2017
Estimated completion	13 November 2017
Sites	2 locations across United States

Drugs / interventions tested

• Buprenorphine Sublingual Spray — full drug profile →
• Morphine
• Oxycodone Hydrochloride — full drug profile →
• Zofran (ondansetron) — full drug profile →

Conditions studied

• Pain, Postoperative — all drugs for Pain, Postoperative →

Sponsor

INSYS Therapeutics Inc — full company profile →

Who can join

Adults 18 to 65, any sex, with Pain, Postoperative. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants With Treatment Emergent Adverse Events (TEAEs) Primary · 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.

Group	Value	95% CI
Standard of Care Narcotic Therapy	33
Buprenorphine Sublingual Spray 0.5 mg	47

Percentage of Participants Provided Rescue Medication for Nausea Secondary · Days 1 to7

Zofran was used at the clinician's discretion as rescue medication for nausea.

Group	Value	95% CI
Standard of Care Narcotic Therapy	12
Buprenorphine Sublingual Spray 0.5 mg	35

Time to First Use of Rescue Medication for Nausea Following Each Dose of the Investigational Product (IP) Secondary · 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.

Group	Value	95% CI
Standard of Care Narcotic Therapy	NA	NA – NA
Buprenorphine Sublingual Spray 0.5 mg	11.25	5.60 – 23.13

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 Secondary · 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.

0 to 24 hours

Group	Value	95% CI
Standard of Care Narcotic Therapy	9
Buprenorphine Sublingual Spray 0.5 mg	68

0 to 48 hours

Group	Value	95% CI
Standard of Care Narcotic Therapy	18
Buprenorphine Sublingual Spray 0.5 mg	92

0 to 72 hours

Group	Value	95% CI
Standard of Care Narcotic Therapy	22
Buprenorphine Sublingual Spray 0.5 mg	110

0 to 7 days

Group	Value	95% CI
Standard of Care Narcotic Therapy	42
Buprenorphine Sublingual Spray 0.5 mg	152

Pulse Oximetry Levels at 90 Minutes,12, 24, 48 and 72 Hours Secondary · 90 Minutes,12, 24, 48 and 72 Hours

Pulse oximetry is a non-invasive method to measure a person's oxygen saturation.

90 minutes

Group	Value	95% CI
Standard of Care Narcotic Therapy	96.3	± 1.99
Buprenorphine Sublingual Spray 0.5 mg	96.0	± 2.11

12 hours

Group	Value	95% CI
Standard of Care Narcotic Therapy	96.0	± 1.93
Buprenorphine Sublingual Spray 0.5 mg	95.8	± 2.06

24 hours

Group	Value	95% CI
Standard of Care Narcotic Therapy	96.9	± 1.63
Buprenorphine Sublingual Spray 0.5 mg	96.6	± 2.27

48 hours

Group	Value	95% CI
Standard of Care Narcotic Therapy	96.5	± 2.01
Buprenorphine Sublingual Spray 0.5 mg	96.0	± 2.15

72 hours

Group	Value	95% CI
Standard of Care Narcotic Therapy	97.3	± 1.36
Buprenorphine Sublingual Spray 0.5 mg	96.2	± 2.66

Number of Participants With Abnormal Electrocardiograms (ECGs) Findings at 90 Minutes,12, 24, 48 and 72 Hours Secondary · 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.

Pre-dose

Group	Value	95% CI
Standard of Care Narcotic Therapy	26
Buprenorphine Sublingual Spray 0.5 mg	32

90 minutes

Group	Value	95% CI
Standard of Care Narcotic Therapy	33
Buprenorphine Sublingual Spray 0.5 mg	30

12 hours

Group	Value	95% CI
Standard of Care Narcotic Therapy	31
Buprenorphine Sublingual Spray 0.5 mg	34

24 hours

Group	Value	95% CI
Standard of Care Narcotic Therapy	23
Buprenorphine Sublingual Spray 0.5 mg	29

48 hours

Group	Value	95% CI
Standard of Care Narcotic Therapy	18
Buprenorphine Sublingual Spray 0.5 mg	25

72 hours

Group	Value	95% CI
Standard of Care Narcotic Therapy	14
Buprenorphine Sublingual Spray 0.5 mg	18

Number of Participants With Abnormal Oral Cavity Examinations Secondary · 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.

Pre-dose

Group	Value	95% CI
Standard of Care Narcotic Therapy	0
Buprenorphine Sublingual Spray 0.5 mg	0

90 minutes

Group	Value	95% CI
Standard of Care Narcotic Therapy	0
Buprenorphine Sublingual Spray 0.5 mg	0

12 hours

Group	Value	95% CI
Standard of Care Narcotic Therapy	0
Buprenorphine Sublingual Spray 0.5 mg	0

24 hours

Group	Value	95% CI
Standard of Care Narcotic Therapy	0
Buprenorphine Sublingual Spray 0.5 mg	0

48 hours

Group	Value	95% CI
Standard of Care Narcotic Therapy	0
Buprenorphine Sublingual Spray 0.5 mg	1

72 hours

Group	Value	95% CI
Standard of Care Narcotic Therapy	0
Buprenorphine Sublingual Spray 0.5 mg	0

Adverse events — posted to ClinicalTrials.gov

Time frame: Screening to Day 8. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Standard of Care Narcotic Therapy

Serious: 0/50 (0%)

Deaths: 0/50

Buprenorphine Sublingual Spray 0.5 mg

Serious: 1/50 (2%)

Deaths: 0/50

Serious adverse events (1 terms)

Reaction	System	Standard of Care Narcotic …	Buprenorphine Sublingual S…
Hematoma	General disorders	—	—

Other adverse events (9 terms — click to expand)

Reaction	System	Standard of Care Narcotic …	Buprenorphine Sublingual S…
Nausea	Gastrointestinal disorders	—	—
Vomiting	Gastrointestinal disorders	—	—
Hypoxia	Respiratory, thoracic and mediastinal disorders	—	—
Dizziness	Nervous system disorders	—	—
Headache	Nervous system disorders	—	—
Pruritus	Skin and subcutaneous tissue disorders	—	—
Constipation	Gastrointestinal disorders	—	—
Dyspnea	Respiratory, thoracic and mediastinal disorders	—	—
Somnolence	Nervous system disorders	—	—

Most-reported serious reactions: Hematoma.

Data from ClinicalTrials.gov NCT03254459 adverse events section.

Sponsor's own description

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).

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.