A Phase 2 interventional study of Sufentanil NanoTab 20 mcg and Sufentanil NanoTab 30 mcg in Acute Pain, sponsored by Talphera, Inc. Completed at 2 sites in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2015-01-26.
Sponsored by Talphera, Inc · Phase 2, Interventional, and Treatment
This is a dose-finding study to determine if the sublingual administration of the Sufentanil NanoTab is safe and effective in the treatment of post-operative pain.
876 studies on the registry are indexed under Acute Pain; 154 are open to participants now.
This study's enrollment of 101 is above the median of 90 across 732 interventional studies indexed under Acute Pain.
Browse Acute Pain studies →Talphera, Inc is the lead sponsor of 18 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Sufentanil NanoTab 20 mcg as needed every 60 minutes for 12 hours
Drug: Sufentanil NanoTab 20 mcg
Sufentanil NanoTab 30 mcg as needed every 60 minutes for 12 hours
Drug: Sufentanil NanoTab 30 mcg
Placebo NanoTab as needed every 60 minutes for 12 hours
Drug: Placebo NanoTab
SPID-12
The primary outcome measure is the summed pain intensity difference over the 12-hour study period (SPID-12). A pain intensity score ranging from 0 (no pain) to 10 (worst possible pain) is obtained at baseline and throughout the 12 hour study period. The SPID-12 is calculated by summing the difference between baseline pain score and pain score at each assessment time point. The SPID-12 ranges from -120 (indicative of an increase in pain) to 120 (indicative of a decrease in pain). A higher SPID-12 score is better.
Time frame: 12 hours
| Milestone | Sufentanil NanoTab 20 mcg | Sufentanil NanoTab 30 mcg | Placebo NanoTab |
|---|---|---|---|
| Started | 40 | 40 | 20 |
| Completed | 37 | 35 | 19 |
| Not completed | 3 | 5 | 1 |
| Withdrew: Adverse event | 0 | 2 | 0 |
| Withdrew: Lack of efficacy | 2 | 3 | 1 |
| Withdrew: Drug dosing error | 1 | 0 | 0 |
The primary outcome measure is the summed pain intensity difference over the 12-hour study period (SPID-12). A pain intensity score ranging from 0 (no pain) to 10 (worst possible pain) is obtained at baseline and throughout the 12 hour study period. The SPID-12 is calculated by summing the difference between baseline pain score and pain score at each assessment time point. The SPID-12 ranges from -120 (indicative of an increase in pain) to 120 (indicative of a decrease in pain). A higher SPID-12 score is better.
| units on a scale | Sufentanil NanoTab 20 mcg | Sufentanil NanoTab 30 mcg | Placebo NanoTab |
|---|---|---|---|
| SPID-12 | -5.65 ± 2.55 | 6.53 ± 2.56 | -7.12 ± 3.64 |
Collected over 12 hours and then time discharge. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Sufentanil NanoTab 20 mcg | — | 2/40 (5%) | 23/40 (57.5%) |
| Sufentanil NanoTab 30 mcg | — | 0/40 (0%) | 30/40 (75%) |
| Placebo NanoTab | — | 0/20 (0%) | 1/20 (5%) |
| Event | Sufentanil NanoTab 20 mcg | Sufentanil NanoTab 30 mcg | Placebo NanoTab |
|---|---|---|---|
| OsteomyeolitisMusculoskeletal and connective tissue disorders | 1/40 | 0/40 | 0/20 |
| CellulitisInfections and infestations | 1/40 | 0/40 | 0/20 |
| Event | Sufentanil NanoTab 20 mcg | Sufentanil NanoTab 30 mcg | Placebo NanoTab |
|---|---|---|---|
| NauseaGastrointestinal disorders | 14/40 | 25/40 | 0/20 |
| VomitingGastrointestinal disorders | 11/40 | 13/40 | 0/20 |
| SomnolenceNervous system disorders | 2/40 | 9/40 | 0/20 |
| DizzinessNervous system disorders | 5/40 | 8/40 | 1/20 |
| PruritisSkin and subcutaneous tissue disorders | 5/40 | 4/40 | 0/20 |
| Feeling hotGeneral disorders | 3/40 | 1/40 | 0/20 |
| Age, Categorical(Participants) | Sufentanil NanoTab 20 mcg | Sufentanil NanoTab 30 mcg | Placebo NanoTab | Total |
|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 39 | 38 | 19 | 96 |
| >=65 years | 1 | 2 | 1 | 4 |
| Sex: Female, Male(Participants) | Sufentanil NanoTab 20 mcg | Sufentanil NanoTab 30 mcg | Placebo NanoTab | Total |
|---|---|---|---|---|
| Female | 19 | 20 | 10 | 49 |
| Male | 21 | 20 | 10 | 51 |
| Race (NIH/OMB)(Participants) | Sufentanil NanoTab 20 mcg | Sufentanil NanoTab 30 mcg | Placebo NanoTab | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 1 | 0 | 0 | 1 |
| Asian | 2 | 1 | 1 | 4 |
| Native Hawaiian or Other Pacific Islander | 0 | 1 | 0 | 1 |
| Black or African American | 7 | 12 | 4 | 23 |
| White | 30 | 26 | 15 | 71 |
| More than one race | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Ethnicity (NIH/OMB)(Participants) | Sufentanil NanoTab 20 mcg | Sufentanil NanoTab 30 mcg | Placebo NanoTab | Total |
|---|---|---|---|---|
| Hispanic or Latino | 8 | 5 | 4 | 17 |
| Not Hispanic or Latino | 32 | 35 | 16 | 83 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Region of Enrollment(participants) | Sufentanil NanoTab 20 mcg | Sufentanil NanoTab 30 mcg | Placebo NanoTab | Total |
|---|---|---|---|---|
| United States | 40 | 40 | 20 | 100 |
This study is completed, as verified in Jan 2015. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Talphera, Inc