PainPhase 2NCT02915978
Fentanyl Sublingual Spray for the Treatment of Moderate to Severe Post-Operative Pain
A Phase 2 study testing Fentanyl in people with Pain, run by INSYS Therapeutics Inc at 2 sites in United States.
Trial summary
The primary objective of this trial is to evaluate analgesic efficacy of Fentanyl Sublingual Spray compared with placebo in participants with postoperative pain after a bunionectomy. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Pain
- What is being tested?
- Fentanyl
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 2 sitesUnited States
- Study dates
- Dec 2016to 10 Feb 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
- Meets protocol-specified criteria for qualification and contraception
- Willing and able to remain confined in the study unit for the entire duration of each treatment period and comply with restrictions related to food, drink and medications
- Voluntarily consents to participate and provides written informed consent prior to any protocol-specific procedures
Who cannot join
- History or current use of over-the-counter medications, dietary supplements, or drugs (including nicotine and alcohol) outside protocol-specified parameters
- Signs, symptoms or history of any condition that, per protocol or in the opinion of the investigator, might compromise:
- the safety or well-being of the participant or study staff;
- the safety or well-being of the participant's offspring (such as through pregnancy or breast-feeding);
- the analysis of results
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Anaheim Clinical Trials
Anaheim, California, 92801
Arizona Research Center
Phoenix, Arizona, 85023
About this study
Official title: A Phase 2 Multicenter, Randomized, Double-Blind, Multiple-Dose, Parallel-Group, Placebo-Controlled Study of Fentanyl Sublingual Spray for the Treatment of Moderate to Severe Post-Operative Pain
The primary objective of this trial is to evaluate analgesic efficacy of Fentanyl Sublingual Spray compared with placebo in participants with postoperative pain after a bunionectomy.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FentanylDrug
Fentanyl delivered via sublingual spray
PlaceboDrug
Matching placebo delivered via sublingual spray
| Study group | Role | What they receive |
|---|---|---|
| Lower Dose Fentanyl | Experimental | Lower dose Fentanyl delivered via sublingual spray every 4 hours. Receives: Drug: Fentanyl |
| Higher Dose Fentanyl Sublingual Spray | Experimental | Higher dose Fentanyl delivered via sublingual spray every 4 hours. Receives: Drug: Fentanyl |
| Placebo | Placebo comparator | Placebo (matching Fentanyl) delivered via sublingual spray every 4 hours. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric Rating Scale (NRS) Summed Pain Intensity Difference (SPID) Over 0 to 48 Hours (NRS SPID-48) After Time 0
Pain intensity was assessed by the participant using an 11-point NRS from 0=no pain to 10=worst possible pain. Pain intensity scores were collected at Baseline (prior to study drug) and at multiple time points up to 48 hours after Time 0 (administration of first dose of study drug). Pain intensity difference is calculated by subtracting the pain intensity at each time point from the pain intensity at Time 0. The SPID scores are the sum of the differences at each time point multiplied by the duration in hours since the previous time point. Positive numbers indicate a reduction in pain [maximum(max)=10 at each time point], and negative numbers indicate an increase in pain [minimum(min)=-10 at each time point]. The overall min and max are -10 and 10 times the number of hours specified; SPID-48 range is -480 to 480. The NRS SPID-48 was analyzed using an analysis of covariance (ANCOVA) model, which included treatment and site as main effects and Baseline pain intensity as the covariate.
Measured: Over 0 to 48 hours after Time 0
Secondary outcomes (14)
NRS Pain Intensity Difference (NRS PID) at Each Categorical Time Point After Time 0
Pain intensity was assessed by the participant using an 11-point NRS from 0=no pain to 10=worst possible pain. Pain intensity scores were collected at Baseline (prior to study drug administration) and at multiple time points after Time 0 (time of administration of the first dose of study drug). NRS PID is defined as the difference in pain at each scheduled time point relative to Baseline (PID=pain intensity at baseline - pain intensity at time point). A higher value of NRS PID score indicates a higher decrease in pain from Baseline. NRS PID is reported as the least squares mean difference.
Measured: Baseline, 1, 16, and 24 hours
NRS Pain Intensity Score at Each Scheduled Time Point After Time 0
Pain intensity was assessed by the participant using an 11-point NRS from 0=no pain to 10=worst possible pain. Pain intensity scores were collected at Baseline (prior to study drug administration) and at multiple time points after Time 0 (time of administration of the first dose of study drug). A lower value indicates improvement in pain.
Measured: Baseline, 1, 16, and 24 hours
NRS SPID After Time 0
Pain intensity was assessed by the participant using an 11-point NRS from 0=no pain to 10=worst possible pain. Pain intensity scores were collected at Baseline (prior to study drug) and at multiple time points after Time 0 (administration of first dose of study drug). Pain intensity difference is calculated by subtracting the pain intensity at each time point from the pain intensity at Time 0. The SPID scores are the sum of the differences at each time point multiplied by the duration in hours since the previous time point. Positive numbers indicate a reduction in pain [maximum(max)=10 at each timepoint], and negative numbers indicate an increase in pain [minimum(min)=-10 at each timepoint]. The overall min and max are -10 and 10 times the number of hours specified: SPID-4=(-40 to 40), SPID-8=(-80 to 80) and SPID-24=(-240 to 240). The NRS SPID-4, 8 and 24 were analyzed using an ANCOVA model which included treatment and site as main effects and Baseline pain intensity as the covariate.
Measured: Over 0 to 4 hours (NRS SPID-4), over 0 to 8 hours (NRS SPID-8), and over 0 to 24 hours (NRS SPID-24)
Total Pain Relief (TOTPAR) After Time 0
TOTPAR was assessed by the participant using a 5-point NRS (0=no relief, 1=a little, 2=some, 3=a lot, 4=complete relief). TOTPAR scores were collected at Baseline (prior to study drug) and at multiple time points up to 48 hours after Time 0 (first dose of study drug). The TOTPAR scores are the sum of the pain relief at each time point multiplied by the duration in hours since the previous time point. Larger positive numbers indicate more pain relief (maximum=4 at each time point) and smaller positive numbers indicate less pain relief (minimum=0 at each time point). The overall minimum is 0 for each variable and the overall maximum is 4 times the number of hours specified for the variable: TOTPAR-4=(0 to 16), TOTPAR-8=(0 to 32), TOTPAR-24=(0 to 96) and TOTPAR-48=(0 to 192). TOTPAR-4, TOTPAR-8, TOTPAR-24 and TOTPAR-48 were analyzed using an ANCOVA model with factors for treatment, site and baseline pain intensity.
Measured: Over 0 to 4 hours (TOTPAR-4), over 0 to 8 hours (TOTPAR-8), over 0 to 24 hours (TOTPAR-24), and over 0 to 48 hours (TOTPAR-48)
Time to Onset of Analgesia
Measured as time to perceptible pain relief confirmed by meaningful pain relief using the 2-stopwatch method (2 stopwatches will be started as soon as the first dose of study drug is administered. Each participant will be instructed to stop the first stopwatch when he or she experiences any perceptible pain relief and the second stopwatch when he or she experiences pain relief that is meaningful to them.)
Measured: Within 48 hours
Pain Relief at Each Scheduled Time Point After Time 0 (First Dose of Study Medication)
Pain relief is determined on a 5-point categorical scale where 0=none, 1=a little, 2=some, 3=a lot, 4=complete.
Measured: 2.5, 5, 15, 30, and 45 minutes, and 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 12, 16, 20, 24, 32, 40, and 48 hours, as well as immediately before each use of rescue analgesia
Peak Pain Relief From Time 0 (First Dose of Study Medication)
The highest level of pain relief achieved on a 5-point categorical scale where 0=none, 1=a little, 2=some, 3=a lot, 4=complete.
Measured: Within 48 hours after Time 0
Time (Minutes) to Peak Pain Relief From Time 0 (First Dose of Study Medication)
Measured: Within 48 hours after Time 0
Time (Minutes) to First Perceptible Pain Relief From Time 0 (First Dose of Study Medication)
Time to perceptible and meaningful pain relief will be evaluated using the 2-stopwatch method (after the first dose only) (2 stopwatches will be started as soon as the first dose of study drug is administered. Each participant will be instructed to stop the first stopwatch when he or she experiences any perceptible pain relief and the second stopwatch when he or she experiences pain relief that is meaningful to them.)
Measured: Within 48 hours after Time 0
Time (Minutes) to Meaningful Pain Relief From Time 0 (First Dose of Study Medication)
Time to perceptible and meaningful pain relief will be evaluated using the 2-stopwatch method (after the first dose only) (2 stopwatches will be started as soon as the first dose of study drug is administered. Each participant will be instructed to stop the first stopwatch when he or she experiences any perceptible pain relief and the second stopwatch when he or she experiences pain relief that is meaningful to them.)
Measured: Within 48 hours after Time 0
Number of Participants Using Rescue Medication
Measured: Within 48 hours
Time (Minutes) to First Use of Rescue Medication (Duration of Analgesia) Following Each Dose of the Investigational Product (IP)
Measured: Within 48 hours
Number of Participants Using Rescue Analgesia Over 0 to 24 Hours and Over 0 to 48 Hours
Measured: Over 0 to 24 hours; Over 0 to 48 hours
Participant Global Evaluation of Study Drug
Participants provide a global evaluation of study drug on a 5-point categorical scale where 0=poor, 1=fair, 2=good, 3=very good, and 4=excellent.
Measured: Within 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2016 (estimated)
- Study startDec 2016
- Primary completion10 Feb 2017
- Study completion10 Feb 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 PainStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 45 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
- NCT02915978
- Sponsor's protocol ID
- INS002-16-092
- Status last verified
- Jan 2018
- First submitted
- 23 Sep 2016
- Last updated
- 14 Feb 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Multicenter, Randomized, Double-Blind, Multiple-Dose, Parallel-Group, Placebo-Controlled Study of Fentanyl Sublingual Spray for the Treatment of Moderate to Severe Post-Operative Pain
- ClinicalTrials.gov ID
- NCT02915978
- Acronym / sponsor ID
- INS002-16-092
- Conditions
- Pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- INSYS Therapeutics IncIndustry (pharma, biotech, devices)
- Study start
- Dec 2016 (actual)
- Primary completion
- 10 Feb 2017 (actual)
- Study completion
- 10 Feb 2017 (actual)
- First posted
- 27 Sep 2016 (estimated)
- Results
- Posted 14 Feb 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this trial is to evaluate analgesic efficacy of Fentanyl Sublingual Spray compared with placebo in participants with postoperative pain after a bunionectomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Lower Dose Fentanyl | Experimental | Drug: FentanylLower dose Fentanyl delivered via sublingual spray every 4 hours. |
| Higher Dose Fentanyl Sublingual Spray | Experimental | Drug: FentanylHigher dose Fentanyl delivered via sublingual spray every 4 hours. |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo (matching Fentanyl) delivered via sublingual spray every 4 hours. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Meets protocol-specified criteria for qualification and contraception
- Willing and able to remain confined in the study unit for the entire duration of each treatment period and comply with restrictions related to food, drink and medications
- Voluntarily consents to participate and provides written informed consent prior to any protocol-specific procedures
Key exclusion criteria (5 listed)
- History or current use of over-the-counter medications, dietary supplements, or drugs (including nicotine and alcohol) outside protocol-specified parameters
- Signs, symptoms or history of any condition that, per protocol or in the opinion of the investigator, might compromise:
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 |
|---|---|---|
| FentanylFentanyl delivered via sublingual spray | Drug | Higher Dose Fentanyl Sublingual Spray, Lower Dose Fentanyl |
| PlaceboMatching placebo delivered via sublingual spray | Drug | Placebo |
Primary outcome
Numeric Rating Scale (NRS) Summed Pain Intensity Difference (SPID) Over 0 to 48 Hours (NRS SPID-48) After Time 0
Time frame: Over 0 to 48 hours after Time 0
Pain intensity was assessed by the participant using an 11-point NRS from 0=no pain to 10=worst possible pain. Pain intensity scores were collected at Baseline (prior to study drug) and at multiple time points up to 48 hours after Time 0 (administration of first dose of study drug). Pain intensity difference is calculated by subtracting the pain intensity at each time point from the pain intensity at Time 0. The SPID scores are the sum of the differences at each time point multiplied by the duration in hours since the previous time point. Positive numbers indicate a reduction in pain [maximum(max)=10 at each time point], and negative numbers indicate an increase in pain [minimum(min)=-10 at each time point]. The overall min and max are -10 and 10 times the number of hours specified; SPID-48 range is -480 to 480. The NRS SPID-48 was analyzed using an analysis of covariance (ANCOVA) model, which included treatment and site as main effects and Baseline pain intensity as the covariate.
14 secondary outcomes
NRS Pain Intensity Difference (NRS PID) at Each Categorical Time Point After Time 0
Time frame: Baseline, 1, 16, and 24 hours
NRS Pain Intensity Score at Each Scheduled Time Point After Time 0
Time frame: Baseline, 1, 16, and 24 hours
NRS SPID After Time 0
Time frame: Over 0 to 4 hours (NRS SPID-4), over 0 to 8 hours (NRS SPID-8), and over 0 to 24 hours (NRS SPID-24)
Total Pain Relief (TOTPAR) After Time 0
Time frame: Over 0 to 4 hours (TOTPAR-4), over 0 to 8 hours (TOTPAR-8), over 0 to 24 hours (TOTPAR-24), and over 0 to 48 hours (TOTPAR-48)
Time to Onset of Analgesia
Time frame: Within 48 hours
Pain Relief at Each Scheduled Time Point After Time 0 (First Dose of Study Medication)
Time frame: 2.5, 5, 15, 30, and 45 minutes, and 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 12, 16, 20, 24, 32, 40, and 48 hours, as well as immediately before each use of rescue analgesia
Peak Pain Relief From Time 0 (First Dose of Study Medication)
Time frame: Within 48 hours after Time 0
Time (Minutes) to Peak Pain Relief From Time 0 (First Dose of Study Medication)
Time frame: Within 48 hours after Time 0
Time (Minutes) to First Perceptible Pain Relief From Time 0 (First Dose of Study Medication)
Time frame: Within 48 hours after Time 0
Time (Minutes) to Meaningful Pain Relief From Time 0 (First Dose of Study Medication)
Time frame: Within 48 hours after Time 0
Number of Participants Using Rescue Medication
Time frame: Within 48 hours
Time (Minutes) to First Use of Rescue Medication (Duration of Analgesia) Following Each Dose of the Investigational Product (IP)
Time frame: Within 48 hours
Number of Participants Using Rescue Analgesia Over 0 to 24 Hours and Over 0 to 48 Hours
Time frame: Over 0 to 24 hours; Over 0 to 48 hours
Participant Global Evaluation of Study Drug
Time frame: Within 48 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 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 Fentanyl in people with Pain, 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 3 inclusion and 5 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 14 Feb 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. Some participants in this study may receive a placebo. 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 14 Feb 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?
Numeric Rating Scale (NRS) Summed Pain Intensity Difference (SPID) Over 0 to 48 Hours (NRS SPID-48) After Time 0 (time frame: Over 0 to 48 hours after Time 0). 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 14 Feb 2018; AzTrials last refreshed its copy on 8 Nov 2026.