Pain, PostoperativePhase 2NCT03254459
Study of Buprenorphine Sublingual Spray Versus Standard of Care Narcotic Therapy for the Treatment of Post-Operative Pain
A Phase 2 study testing Buprenorphine Sublingual Spray, Morphine and Oxycodone Hydrochloride in people with Pain, Postoperative, run by INSYS Therapeutics Inc at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- Buprenorphine Sublingual Spray, Morphine and Oxycodone Hydrochloride
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesUnited States
- Study dates
- 12 Sep 2017to 13 Nov 2017
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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.
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- 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).
- Has a history of chronic use (defined as daily use for >2 weeks) of NSAIDs, opiates, or glucocorticoids (except inhaled nasal steroids and topical corticosteroids) within 1 month before study drug administration. Aspirin at a daily dose of ≤325 mg is allowed for cardiovascular prophylaxis if the participant has been on a stable dose regimen for ≥30 days before Screening and has not experienced any relevant medical problem.
- Has a significant renal or hepatic disease, as indicated by clinical laboratory assessment (results ≥3 × the upper limit of normal [ULN] for any liver function test, including aspartate aminotransferase, alanine aminotransferase, and lactate dehydrogenase, or creatinine ≥1.5 × ULN).
- Has any clinically significant laboratory or 12-lead electrocardiogram finding at Screening that in the investigator's opinion contraindicates study participation.
- Has screening systolic blood pressure ≥160 mmHg and diastolic blood pressure >100 mmHg (may be repeated one additional time after 5 minutes rest to verify). The investigator may, at his discretion, choose to exclude participants with hypertensive levels lower than these if he deems it in the best interest of the participant.
- Has a history of sleep apnea or other obstructive airway disease.
- Has a history of nausea and vomiting with buprenorphine products.
- Has significant difficulties swallowing capsules or is unable to tolerate oral medication.
- Previously participated in another clinical study of Buprenorphine Sublingual Spray or received any investigational drug or device or investigational therapy within 30 days before Screening.
- Post-surgical eligibility requirements:
- The participant will be assessed for the following postoperative eligibility criteria
- Participants must be awake, breathing spontaneously without significant respiratory depression.
- Participants must not be actively vomiting or complaining of severe nausea.
- Participants must be able to answer questions and follow commands.
- Participants must not have surgical complications that could compromise safety of the participant or confound the results of the study.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Epic Medical Research
Murray, Utah, 84123
Lotus Clinical Research, LLC
Pasadena, California, 91105
About this study
Official title: A Phase 2, Randomized, Open Label, Multiple-Dose, Comparator, Parallel-Group, Safety and Tolerance Study of Buprenorphine Sublingual Spray (0.5 mg TID) Versus Standard of Care Post-Operative 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-operative narcotic therapy is defined as morphine intravenous (IV) injection (4 mg TID) followed by oxycodone hydrochloride tablet (10 mg TID).
- Conditions
- Pain, Postoperative
- Being tested
- Buprenorphine Sublingual Spray, Morphine, Oxycodone Hydrochloride, Zofran
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Buprenorphine Sublingual SprayDrug
0.5 mg Sublingual Spray
MorphineDrug
4 mg Intravenous Injection
Oxycodone HydrochlorideDrug
10 mg tablet
ZofranDrug
4 mg oral disintegrating tablet (ODT) or IV injection given at the investigator's discretion for nausea
| Study group | Role | What they receive |
|---|---|---|
| Buprenorphine Sublingual Spray 0.5 mg | Experimental | Buprenorphine Sublingual Spray 0.5 milligrams (mg) three times a day (TID) for 7 days. Receives: 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. Receives: Drug: Morphine; Drug: Oxycodone Hydrochloride; Drug: Zofran |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Days 1 to 8
Secondary outcomes (6)
Percentage of Participants Provided Rescue Medication for Nausea
Zofran was used at the clinician's discretion as rescue medication for nausea.
Measured: Days 1 to7
Time to First Use of Rescue Medication for Nausea Following Each Dose of the Investigational Product (IP)
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.
Measured: 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
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.
Measured: 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
Pulse oximetry is a non-invasive method to measure a person's oxygen saturation.
Measured: 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
A standard 12-lead ECG will be performed after the participant is in the supine (lying face up) position for 5 minutes.
Measured: Pre-dose and 90 minutes, 12, 24, 48 and 72 hours after first dose
Number of Participants With Abnormal Oral Cavity Examinations
Study staff will perform a sublingual (under the tongue) assessment, noting the color of mucosa and whether inflammation is present.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2017
- Study start12 Sep 2017
- Primary completion13 Nov 2017
- Study completion13 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- INSYS Therapeutics Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Giovanni DeCastro, Study director, INSYS Therapeutics Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03254459
- Sponsor's protocol ID
- INS005-17-111
- Status last verified
- Sep 2018
- First submitted
- 16 Aug 2017
- Last updated
- 29 Oct 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Randomized, Open Label, Multiple-Dose, Comparator, Parallel-Group, Safety and Tolerance Study of Buprenorphine Sublingual Spray (0.5 mg TID) Versus Standard of Care Post-Operative Narcotic Therapy for the Treatment of Post-Operative Pain
- ClinicalTrials.gov ID
- NCT03254459
- Acronym / sponsor ID
- INS005-17-111
- Conditions
- Pain, Postoperative
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- INSYS Therapeutics IncIndustry (pharma, biotech, devices)
- Study start
- 12 Sep 2017 (actual)
- Primary completion
- 13 Nov 2017 (actual)
- Study completion
- 13 Nov 2017 (actual)
- First posted
- 18 Aug 2017 (actual)
- Results
- Posted 29 Oct 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Buprenorphine Sublingual Spray 0.5 mg | Experimental | Drug: Buprenorphine Sublingual Spray, Drug: ZofranBuprenorphine Sublingual Spray 0.5 milligrams (mg) three times a day (TID) for 7 days. |
| Standard of Care Narcotic Therapy | Active comparator | Drug: Morphine, Drug: Oxycodone Hydrochloride, Drug: ZofranMorphine intravenous (IV), 4 mg TID for 24 hours, followed by oxycodone hydrochloride tablet, 10 mg TID for 6 days. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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:
Key exclusion criteria (29 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Buprenorphine Sublingual Spray0.5 mg Sublingual Spray | Drug | Buprenorphine Sublingual Spray 0.5 mg |
| Morphine4 mg Intravenous Injection | Drug | Standard of Care Narcotic Therapy |
| Oxycodone Hydrochloride10 mg tablet | Drug | Standard of Care Narcotic Therapy |
| Zofran4 mg oral disintegrating tablet (ODT) or IV injection given at the investigator's discretion for nausea | Drug | Buprenorphine Sublingual Spray 0.5 mg, Standard of Care Narcotic Therapy |
Primary outcome
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Time frame: 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.
6 secondary outcomes
Percentage of Participants Provided Rescue Medication for Nausea
Time frame: Days 1 to7
Time to First Use of Rescue Medication for Nausea Following Each Dose of the Investigational Product (IP)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Pre-dose and 90 minutes, 12, 24, 48 and 72 hours after first dose
Number of Participants With Abnormal Oral Cavity Examinations
Time frame: 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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Giovanni DeCastro study director
INSYS Therapeutics Inc
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Buprenorphine Sublingual Spray, Morphine and Oxycodone Hydrochloride in people with Pain, Postoperative, run by INSYS Therapeutics Inc at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Oct 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Treatment Emergent Adverse Events (TEAEs) (time frame: Days 1 to 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2018.