A Phase 2 interventional study of Fentanyl and Placebo in Pain, sponsored by INSYS Therapeutics Inc. Completed at 2 sites in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2018-02-14.
Sponsored by INSYS Therapeutics Inc · Phase 2, Interventional, and Treatment
Among 72 studies testing fentanyl in Pain — 4 open to participants now, 4 under way, none of them phase 3. Fentanyl · Pain.
Among the 72 studies testing fentanyl in Pain, this one is the 44th largest by enrollment of the 70 interventional ones, is one of 2 that started in 2016, is one of 6 in phase 2, and was the 55th registered.
10,054 studies on the registry are indexed under Pain; 1,649 are open to participants now.
This study's enrollment of 45 is below the median of 66 across 8,493 interventional studies indexed under Pain.
Browse Pain studies →4 of the 72 studies testing fentanyl in Pain are open now, in 2 countries. Each count lists the studies.
Fentanyl: first FDA approval 1968 (SUBLIMAZE PRESERVATIVE FREE), first EMA approval 2006. What it is approved for, and how studies give it, is on its page →
Of the 929 Pain studies recruiting now, 384 (41%) set no upper age limit and 434 (47%) stop at 75 or younger; 146 take children under 18; 222 take healthy volunteers.
This study: 18 Years to 65 Years · all sexes · no healthy volunteers.
The full table on the hub →72 studies; the count open now beside each. This study's row is marked.
First in 2002; this study’s year is marked. 2 started in 2016.
Median enrollment 62 across the 70 interventional studies. Of the 60 that completed or were terminated, 18 (30%) have results posted.
18 of 72 have an industry lead sponsor. The 10 most frequent:
INSYS Therapeutics Inc is the lead sponsor of 45 studies on the registry; none are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 3 (60%) have results posted.
INSYS Therapeutics Inc has 6 studies filed under Pain — fewer than ten, so there is no comparison to draw.
2 of the studies testing fentanyl in Pain that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06962306Duke UniversityOptimizing Perioperative Analgesia to Lower Pain Following Cleft Palate Surgery | 2027-06-04 |
| NCT06364540Antonios LikourezosNebulized Ketamine to Nebulized Fentanyl for Treating Acute Painful Conditions in the ED | 2027-06-30 |
Among the 72 studies testing fentanyl in Pain, from their registry updates:
Nothing recorded among them since 2026-09-25.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Signs, symptoms or history of any condition that, per protocol or in the opinion of the investigator, might compromise:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Lower dose Fentanyl delivered via sublingual spray every 4 hours.
Drug: Fentanyl
Higher dose Fentanyl delivered via sublingual spray every 4 hours.
Drug: Fentanyl
Placebo (matching Fentanyl) delivered via sublingual spray every 4 hours.
Drug: Placebo
Fentanyl delivered via sublingual spray
Matching placebo delivered via sublingual spray
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.
Time frame: Over 0 to 48 hours after Time 0
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.
Time frame: 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.
Time frame: 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.
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
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.
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
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.)
Time frame: 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.
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)
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.
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 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.)
Time frame: 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.)
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
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.
Time frame: Within 48 hours
| Milestone | Higher Dose Fentanyl Sublingual Spray | Lower Dose Fentanyl | Placebo |
|---|---|---|---|
| Started | 15 | 15 | 15 |
| Completed | 13 | 14 | 15 |
| Not completed | 2 | 1 | 0 |
| Withdrew: Adverse event | 2 | 1 | 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.
| units on a scale | Higher Dose Fentanyl Sublingual Spray | Lower Dose Fentanyl Sublingual Spray | Placebo |
|---|---|---|---|
| Numeric Rating Scale (NRS) Summed Pain Intensity Difference (SPID) Over 0 to 48 Hours (NRS SPID-48) After Time 0 | 151.7 ± 95.52 | 126.4 ± 124.66 | 149.0 ± 115.26 |
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.
| units on a scale | Higher Dose Fentanyl Sublingual Spray | Lower Dose Fentanyl Sublingual Spray | Placebo |
|---|---|---|---|
| Baseline | 6.5 ± 1.64 | 6.1 ± 2.13 | 7.1 ± 2.22 |
| 1 Hour | 3.7 ± 2.46 | 4.3 ± 2.09 | 5.8 ± 2.96 |
| 16 Hours | 2.6 ± 2.18 | 3.9 ± 3.04 | 5.5 ± 2.23 |
| 24 Hours | 2.0 ± 1.96 | 3.2 ± 2.21 | 3.3 ± 2.64 |
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.
| units on a scale | Higher Dose Fentanyl Sublingual Spray | Lower Dose Fentanyl Sublingual Spray | Placebo |
|---|---|---|---|
| Baseline | 6.5 ± 1.64 | 6.1 ± 2.13 | 7.1 ± 2.22 |
| 1 Hour | 3.7 ± 2.46 | 4.3 ± 2.09 | 5.8 ± 2.96 |
| 16 Hours | 2.6 ± 2.18 | 3.9 ± 3.04 | 5.5 ± 2.23 |
| 24 hours | 2.0 ± 1.96 | 3.2 ± 2.21 | 3.3 ± 2.64 |
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.
| units on a scale | Higher Dose Fentanyl Sublingual Spray | Lower Dose Fentanyl Sublingual Spray | Placebo |
|---|---|---|---|
| Over 24 Hours | 67.4 ± 40.45 | 51.7 ± 53.43 | 51.7 ± 59.38 |
| Over 8 Hours | 13.6 ± 14.59 | 11.2 ± 16.18 | 8.8 ± 19.70 |
| Over 4 Hours | 6.6 ± 7.58 | 5.9 ± 8.79 | 4.8 ± 12.73 |
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.
| units on a scale | Higher Dose Fentanyl Sublingual Spray | Lower Dose Fentanyl Sublingual Spray | Placebo |
|---|---|---|---|
| Over 48 Hours | 98.2 ± 55.25 | 99.9 ± 33.63 | 98.2 ± 33.32 |
| Over 24 Hours | 43.8 ± 22.72 | 46.5 ± 16.87 | 38.3 ± 14.81 |
| Over 8 Hours | 11.6 ± 8.53 | 10.6 ± 6.32 | 7.2 ± 5.33 |
| Over 4 Hours | 5.3 ± 4.54 | 5.1 ± 3.77 | 3.9 ± 4.53 |
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.)
| minutes | Higher Dose Fentanyl Sublingual Spray | Lower Dose Fentanyl Sublingual Spray | Placebo |
|---|---|---|---|
| Time to Onset of Analgesia | 5 (2 to 16) | 184 (1 to NA) | NA (4 to NA) |
Pain relief is determined on a 5-point categorical scale where 0=none, 1=a little, 2=some, 3=a lot, 4=complete.
| Participants | Higher Dose Fentanyl Sublingual Spray | Lower Dose Fentanyl Sublingual Spray | Placebo |
|---|---|---|---|
| 2.5 Minutes After Time 0 — No Relief | 9 | 9 | 11 |
| 2.5 Minutes After Time 0 — A Little Relief | 4 | 3 | 2 |
| 2.5 Minutes After Time 0 — Some Relief | 1 | 3 | 1 |
| 2.5 Minutes After Time 0 — A Lot of Relief | 1 | 0 | 1 |
| 2.5 Minutes After Time 0 — Complete Relief | 0 | 0 | 0 |
| 5 Minutes After Time 0 — No Relief | 6 | 9 | 10 |
| 5 Minutes After Time 0 — A Little Relief | 6 | 3 | 2 |
| 5 Minutes After Time 0 — Some Relief | 2 | 2 | 2 |
| 5 Minutes After Time 0 — A Lot of Relief | 1 | 1 | 1 |
| 5 Minutes After Time 0 — Complete Relief | 0 | 0 | 0 |
| 15 Minutes After Time 0 — No Relief | 5 | 3 | 9 |
| 15 Minutes After Time 0 — A Little Relief | 3 | 9 | 3 |
| 15 Minutes After Time 0 — Some Relief | 2 | 2 | 1 |
| 15 Minutes After Time 0 — A Lot of Relief | 5 | 1 | 1 |
| 15 Minutes After Time 0 — Complete Relief | 0 | 0 | 1 |
| 30 Minutes After Time 0 - No Relief — No Relief | 3 | 3 | 9 |
| 30 Minutes After Time 0 - No Relief — A Little Relief | 4 | 6 | 2 |
| 30 Minutes After Time 0 - No Relief — Some Relief | 1 | 4 | 1 |
| 30 Minutes After Time 0 - No Relief — A Lot of Relief | 5 | 2 | 2 |
| 30 Minutes After Time 0 - No Relief — Complete Relief | 2 | 0 | 1 |
| 45 Minutes After Time 0 — No Relief | 3 | 4 | 7 |
| 45 Minutes After Time 0 — A Little Relief | 6 | 4 | 5 |
| 45 Minutes After Time 0 — Some Relief | 1 | 4 | 0 |
| 45 Minutes After Time 0 — A Lot of Relief | 2 | 3 | 1 |
| 45 Minutes After Time 0 — Complete Relief | 3 | 0 | 2 |
| 1 Hour After Time 0 — No Relief | 3 | 5 | 6 |
| 1 Hour After Time 0 — A Little Relief | 5 | 3 | 5 |
| 1 Hour After Time 0 — Some Relief | 3 | 4 | 2 |
| 1 Hour After Time 0 — A Lot of Relief | 2 | 3 | 0 |
| 1 Hour After Time 0 — Complete Relief | 2 | 0 | 2 |
| 1.5 Hours After Time 0 — No Relief | 5 | 4 | 6 |
| 1.5 Hours After Time 0 — A Little Relief | 4 | 3 | 2 |
| 1.5 Hours After Time 0 — Some Relief | 2 | 4 | 5 |
| 1.5 Hours After Time 0 — A Lot of Relief | 3 | 4 | 0 |
| 1.5 Hours After Time 0 — Complete Relief | 1 | 0 | 2 |
| 2 Hours After Time 0 — No Relief | 7 | 6 | 7 |
| 2 Hours After Time 0 — A Little Relief | 3 | 3 | 4 |
| 2 Hours After Time 0 — Some Relief | 0 | 3 | 2 |
| 2 Hours After Time 0 — A Lot of Relief | 4 | 3 | 0 |
| 2 Hours After Time 0 — Complete Relief | 1 | 0 | 2 |
| 3 Hours After Time 0 — No Relief | 7 | 5 | 7 |
| 3 Hours After Time 0 — A Little Relief | 3 | 4 | 3 |
| 3 Hours After Time 0 — Some Relief | 1 | 4 | 2 |
| 3 Hours After Time 0 — A Lot of Relief | 2 | 2 | 2 |
| 3 Hours After Time 0 — Complete Relief | 2 | 0 | 1 |
| 4 Hours After Time 0 — No Relief | 7 | 6 | 9 |
| 4 Hours After Time 0 — A Little Relief | 4 | 3 | 4 |
| 4 Hours After Time 0 — Some Relief | 0 | 2 | 1 |
| 4 Hours After Time 0 — A Lot of Relief | 3 | 4 | 1 |
| 4 Hours After Time 0 — Complete Relief | 1 | 0 | 0 |
| 5 Hours After Time 0 — No Relief | 8 | 8 | 9 |
| 5 Hours After Time 0 — A Little Relief | 2 | 3 | 5 |
| 5 Hours After Time 0 — Some Relief | 1 | 0 | 1 |
| 5 Hours After Time 0 — A Lot of Relief | 1 | 4 | 0 |
| 5 Hours After Time 0 — Complete Relief | 3 | 0 | 0 |
| 6 Hours After Time 0 — No Relief | 6 | 6 | 8 |
| 6 Hours After Time 0 — A Little Relief | 3 | 2 | 3 |
| 6 Hours After Time 0 — Some Relief | 0 | 3 | 3 |
| 6 Hours After Time 0 — A Lot of Relief | 4 | 3 | 1 |
| 6 Hours After Time 0 — Complete Relief | 2 | 1 | 0 |
| 7 Hours After Time 0 — No Relief | 6 | 5 | 8 |
| 7 Hours After Time 0 — A Little Relief | 2 | 1 | 2 |
| 7 Hours After Time 0 — Some Relief | 0 | 4 | 2 |
| 7 Hours After Time 0 — A Lot of Relief | 4 | 5 | 3 |
| 7 Hours After Time 0 — Complete Relief | 3 | 0 | 0 |
| 8 Hours After Time 0 — No Relief | 5 | 5 | 8 |
| 8 Hours After Time 0 — A Little Relief | 0 | 2 | 2 |
| 8 Hours After Time 0 — Some Relief | 3 | 4 | 1 |
| 8 Hours After Time 0 — A Lot of Relief | 4 | 3 | 4 |
| 8 Hours After Time 0 — Complete Relief | 2 | 1 | 0 |
| 12 Hours After Time 0 — No Relief | 3 | 2 | 2 |
| 12 Hours After Time 0 — A Little Relief | 1 | 2 | 4 |
| 12 Hours After Time 0 — Some Relief | 2 | 7 | 5 |
| 12 Hours After Time 0 — A Lot of Relief | 6 | 4 | 4 |
| 12 Hours After Time 0 — Complete Relief | 1 | 0 | 0 |
| 16 Hours After Time 0 — No Relief | 1 | 1 | 4 |
| 16 Hours After Time 0 — A Little Relief | 3 | 4 | 4 |
| 16 Hours After Time 0 — Some Relief | 2 | 3 | 6 |
| 16 Hours After Time 0 — A Lot of Relief | 5 | 6 | 1 |
| 16 Hours After Time 0 — Complete Relief | 2 | 1 | 0 |
| 20 Hours After Time 0 — No Relief | 1 | 1 | 1 |
| 20 Hours After Time 0 — A Little Relief | 4 | 2 | 2 |
| 20 Hours After Time 0 — Some Relief | 1 | 4 | 4 |
| 20 Hours After Time 0 — A Lot of Relief | 3 | 6 | 6 |
| 20 Hours After Time 0 — Complete Relief | 4 | 2 | 2 |
| 24 Hours After Time 0 — No Relief | 0 | 0 | 1 |
| 24 Hours After Time 0 — A Little Relief | 3 | 2 | 2 |
| 24 Hours After Time 0 — Some Relief | 2 | 3 | 4 |
| 24 Hours After Time 0 — A Lot of Relief | 6 | 9 | 6 |
| 24 Hours After Time 0 — Complete Relief | 2 | 1 | 2 |
| 32 Hours After Time 0 — No Relief | 1 | 0 | 2 |
| 32 Hours After Time 0 — A Little Relief | 3 | 2 | 3 |
| 32 Hours After Time 0 — Some Relief | 2 | 3 | 0 |
| 32 Hours After Time 0 — A Lot of Relief | 3 | 8 | 8 |
| 32 Hours After Time 0 — Complete Relief | 4 | 1 | 2 |
| 40 Hours After Time 0 — No Relief | 2 | 0 | 1 |
| 40 Hours After Time 0 — A Little Relief | 1 | 3 | 2 |
| 40 Hours After Time 0 — Some Relief | 2 | 5 | 4 |
| 40 Hours After Time 0 — A Lot of Relief | 3 | 5 | 7 |
| 40 Hours After Time 0 — Complete Relief | 5 | 1 | 1 |
| 48 Hours After Time 0 — No Relief | 1 | 0 | 1 |
| 48 Hours After Time 0 — A Little Relief | 2 | 4 | 0 |
| 48 Hours After Time 0 — Some Relief | 1 | 3 | 4 |
| 48 Hours After Time 0 — A Lot of Relief | 4 | 6 | 6 |
| 48 Hours After Time 0 — Complete Relief | 5 | 1 | 4 |
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.
| Participants | Higher Dose Fentanyl Sublingual Spray | Lower Dose Fentanyl Sublingual Spray | Placebo |
|---|---|---|---|
| A Little Relief | 2 | 0 | 0 |
| Some Relief | 0 | 1 | 2 |
| A Lot of Relief | 5 | 11 | 7 |
| Complete Relief | 8 | 3 | 6 |
| minutes | Higher Dose Fentanyl Sublingual Spray | Lower Dose Fentanyl Sublingual Spray | Placebo |
|---|---|---|---|
| Time (Minutes) to Peak Pain Relief From Time 0 (First Dose of Study Medication) | 300.0 (30 to 955) | 420.0 (90 to 1198) | 1198 (45 to 1912) |
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.)
| minutes | Higher Dose Fentanyl Sublingual Spray | Lower Dose Fentanyl Sublingual Spray | Placebo |
|---|---|---|---|
| Time (Minutes) to First Perceptible Pain Relief From Time 0 (First Dose of Study Medication) | 5 (2 to 15) | 10 (1 to 15) | 20 (3 to NA) |
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.)
| minutes | Higher Dose Fentanyl Sublingual Spray | Lower Dose Fentanyl Sublingual Spray | Placebo |
|---|---|---|---|
| Time (Minutes) to Meaningful Pain Relief From Time 0 (First Dose of Study Medication) | 49 (10 to 87) | 190 (21 to NA) | 79 (14 to NA) |
| Participants | Higher Dose Fentanyl Sublingual Spray | Lower Dose Fentanyl Sublingual Spray | Placebo |
|---|---|---|---|
| Rescue Medication Used | 11 | 12 | 15 |
| No Rescue Medication Used | 4 | 3 | 0 |
| minutes | Higher Dose Fentanyl Sublingual Spray | Lower Dose Fentanyl Sublingual Spray | Placebo |
|---|---|---|---|
| Time (Minutes) to First Use of Rescue Medication (Duration of Analgesia) Following Each Dose of the Investigational Product (IP) | 204.0 (85 to 370) | 289.0 (98 to 431) | 126.0 (50 to 225) |
| Participants | Higher Dose Fentanyl Sublingual Spray | Lower Dose Fentanyl Sublingual Spray | Placebo |
|---|---|---|---|
| Over 24 Hours | 11 | 12 | 15 |
| Over 48 hours | 11 | 12 | 15 |
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.
| Participants | Higher Dose Fentanyl Sublingual Spray | Lower Dose Fentanyl Sublingual Spray | Placebo |
|---|---|---|---|
| Poor | 2 | 3 | 4 |
| Fair | 3 | 2 | 0 |
| Good | 1 | 3 | 1 |
| Very Good | 3 | 3 | 8 |
| Excellent | 6 | 4 | 2 |
Collected over Baseline up to 37 days approximately.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Higher Dose Fentanyl Sublingual Spray | 0/15 (0%) | 0/15 (0%) | 12/15 (80%) |
| Lower Dose Fentanyl Sublingual Spray | 0/15 (0%) | 0/15 (0%) | 8/15 (53.3%) |
| Placebo | 0/15 (0%) | 0/15 (0%) | 6/15 (40%) |
| Event | Higher Dose Fentanyl Sublingual Spray | Lower Dose Fentanyl Sublingual Spray | Placebo |
|---|---|---|---|
| NauseaGastrointestinal disorders | 10/15 | 4/15 | 1/15 |
| VomitingGastrointestinal disorders | 8/15 | 2/15 | 0/15 |
| DizzinessNervous system disorders | 4/15 | 2/15 | 1/15 |
| HeadacheNervous system disorders | 4/15 | 3/15 | 3/15 |
| Application Site PainGeneral disorders | 3/15 | 0/15 | 1/15 |
| HypoxiaRespiratory, thoracic and mediastinal disorders | 3/15 | 1/15 | 0/15 |
| Pain in ExtremityMusculoskeletal and connective tissue disorders | 2/15 | 0/15 | 2/15 |
| AstheniaGeneral disorders | 1/15 | 0/15 | 0/15 |
| Burning SensationGeneral disorders | 0/15 | 1/15 | 0/15 |
| Upper Respiratory Tract InfectionInfections and infestations | 0/15 | 0/15 | 1/15 |
| Age, Continuous(years) | Higher Dose Fentanyl Sublingual Spray | Lower Dose Fentanyl Sublingual Spray | Placebo | Total |
|---|---|---|---|---|
| Mean | 43.8 ± 14.3 | 50.0 ± 10.6 | 45.5 ± 11.4 | 46.4 ± 12.2 |
| Sex: Female, Male(Participants) | Higher Dose Fentanyl Sublingual Spray | Lower Dose Fentanyl Sublingual Spray | Placebo | Total |
|---|---|---|---|---|
| Female | 12 | 12 | 14 | 38 |
| Male | 3 | 3 | 1 | 7 |
| Ethnicity (NIH/OMB)(Participants) | Higher Dose Fentanyl Sublingual Spray | Lower Dose Fentanyl Sublingual Spray | Placebo | Total |
|---|---|---|---|---|
| Hispanic or Latino | 2 | 1 | 3 | 6 |
| Not Hispanic or Latino | 13 | 14 | 12 | 39 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Higher Dose Fentanyl Sublingual Spray | Lower Dose Fentanyl Sublingual Spray | Placebo | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 |
| Asian | 0 | 0 | 2 | 2 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 4 | 6 | 4 | 14 |
| White | 11 | 9 | 9 | 29 |
| More than one race | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
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Studies of the drug tested here: Fentanyl