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

NCT03254459 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: INS005-17-111
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

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).

Conditions

Pain, Postoperative

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Treatment Emergent Adverse Events (TEAEs)

  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.

  Days 1 to 8

Secondary Outcomes (6)

• Percentage of Participants Provided Rescue Medication for Nausea

  Days 1 to7

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

  Days 1 to 7

• 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

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

  90 Minutes,12, 24, 48 and 72 Hours

• 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

Study Arms (2)

Buprenorphine Sublingual Spray 0.5 mg

EXPERIMENTAL

Buprenorphine Sublingual Spray 0.5 milligrams (mg) three times a day (TID) for 7 days.

Drug: Buprenorphine Sublingual Spray; Drug: Zofran

Standard of Care Narcotic Therapy

ACTIVE COMPARATOR

Morphine intravenous (IV), 4 mg TID for 24 hours, followed by oxycodone hydrochloride tablet, 10 mg TID for 6 days.

Drug: Morphine; Drug: Oxycodone Hydrochloride; Drug: Zofran

Interventions

Buprenorphine Sublingual Spray DRUG

0.5 mg Sublingual Spray

Buprenorphine Sublingual Spray 0.5 mg

Morphine DRUG

4 mg Intravenous Injection

Standard of Care Narcotic Therapy

Oxycodone Hydrochloride DRUG

10 mg tablet

Standard of Care Narcotic Therapy

Zofran DRUG

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

Buprenorphine Sublingual Spray 0.5 mg; Standard of Care Narcotic Therapy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Is able to speak and understand the language in which the study is being conducted, is able to understand and comply with the procedures and study requirements, and has voluntarily signed and dated an informed consent form approved by an Institutional Review Board before the conduct of any study procedure.
• Is a male or female ≥18 and ≤65 years of age.
• Scheduled for elective bunionectomy, breast augmentation (in women only), or abdominoplasty.
• Is classified using the American Society of Anesthesiologists Physical Status Classification System as P1 to P2.
• If female, is either not of childbearing potential (defined as postmenopausal for at least 1 year or surgically sterile \[bilateral tubal ligation, bilateral oophorectomy, or hysterectomy\]) or practicing one of the following medically acceptable methods of birth control:
• Hormonal methods such as oral, implantable, injectable, vaginal ring, or transdermal contraceptives for a minimum of 1 full cycle (based on the participant's usual menstrual cycle period) before study drug administration;
• Total abstinence from sexual intercourse since the last menses before study drug administration;
• Intrauterine device; OR
• Double-barrier method (condoms, sponge, or diaphragm with spermicidal jellies or cream).
• Has a body weight ≥45 kilograms (kg) and a body mass index (BMI) ≤40 kg/m\^2.
• Is willing and able to comply with study requirements (including diet, alcohol, and smoking restrictions), complete evaluations and diary, remain at the study site for ≥72 hours, and return for follow up Day 8 + 2 days after surgery.

You may not qualify if:

• Has a known history of allergic reaction or clinically significant intolerance to acetaminophen, aspirin, opioids, or any nonsteroidal anti-inflammatory drugs (NSAIDs); history of NSAID-induced bronchospasm (participants with the triad of asthma, nasal polyps, and chronic rhinitis are at greater risk for bronchospasm and should be considered carefully); or hypersensitivity, allergy, or significant reaction to sulfa (including sulfonamide) medicines, ingredients of the study drug, or any other drugs used in the study, including anesthetics and antibiotics that may be required on the day of surgery.
• Has experienced any surgical complications or other issues that, in the investigator's opinion, could compromise the participant's safety if he or she continues into randomized treatment or could confound the results of the study.
• Has a known or suspected history of alcoholism or drug abuse or misuse within 2 years of Screening or evidence of opioid tolerance or physical dependence before dosing with the study drug.
• Has any clinically significant unstable cardiac, respiratory, neurological, immunological, hematological, or renal disease, or any other condition that, in the investigator's opinion, could compromise the participant's welfare, ability to communicate with the study staff, or otherwise contraindicate study participation.
• Has long QT Syndrome, a family history of long QT Syndrome, or is taking Class IA or Class III antiarrhythmic medications
• Has a history or current diagnosis of a significant psychiatric disorder that, in the investigator's opinion, would affect the participant's ability to comply with the study requirements.
• Has tested positive either on the urine drug screen or on the alcohol Breathalyzer test. Participants who test positive at Screening only and can produce a prescription in their name from their physician for the medication producing the positive test may be considered for study enrollment at the investigator's discretion. However, they must test negative on the day of the surgery.
• Has a history of a clinically significant (in the investigator's opinion) gastrointestinal (GI) event within 6 months before Screening or has any history of peptic or gastric ulcers or GI bleeding.
• Has an active infection, mucositis, cold sores, viral lesions, local irritation, or in the investigator's opinion has significant periodontal disease of the oral cavity. In addition, recent (within 1 year) piercing of the tongue or anywhere in the oral cavity.
• Has a surgical or medical condition of the GI or renal system that, in the investigator's opinion, might significantly alter the absorption, distribution, or excretion of any drug substance.
• Is considered by the investigator, for any reason (including, but not limited to, the risks described as precautions, warnings, and contraindications in the current version of the investigator's brochure for Buprenorphine Sublingual Spray), to be an unsuitable candidate to receive the study drug.
• Is receiving systemic chemotherapy, has an active malignancy of any type, or has been diagnosed with cancer within 5 years before Screening (excluding squamous or basal cell carcinoma of the skin).
• Is currently receiving anticoagulants (eg, heparin or warfarin). Low-dose aspirin for cardioprotection is allowed.
• Has used drugs known to be a strong inhibitor or inducer of CYP3A4 within 1 week before surgery.
• Has received a course of systemic corticosteroids (either oral or parenteral) within 1 month before Screening (inhaled nasal steroids and topical corticosteroids are allowed).

Sponsors & Collaborators

• INSYS Therapeutics Inc: lead

Study Sites (2)

Lotus Clinical Research, LLC

Pasadena, California, 91105, United States

Location

Epic Medical Research

Murray, Utah, 84123, United States

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Morphine; Oxycodone; Ondansetron

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Codeine; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Carbazoles; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, 3-Ring

Results Point of Contact

• Title: Director, Clinical Development
• Organization: Insys Therapeutics, Inc.

gdecastro@insysrx.com

4805003105

Study Officials

• Giovanni DeCastro

  INSYS Therapeutics Inc

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 16, 2017
• First Posted: August 18, 2017
• Study Start: September 12, 2017
• Primary Completion: November 13, 2017
• Study Completion: November 13, 2017
• Last Updated: October 29, 2018
• Results First Posted: October 29, 2018

Record last verified: 2018-09

Locations

US (2)