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Safety and Efficacy of Sufentanil NanoTab for Management of Acute Pain Following Bunionectomy

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01710345
Enrollment
101
Registered
2012-10-19
Start date
2012-10-31
Completion date
2013-02-28
Last updated
2015-01-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Pain

Brief summary

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.

Interventions

DRUGSufentanil NanoTab 20 mcg
DRUGSufentanil NanoTab 30 mcg
DRUGPlacebo NanoTab

Sponsors

Talphera, Inc
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* patients scheduled for bunion surgery

Exclusion criteria

* daily opioid use * drug or alcohol abuse * pregnant or breastfeeding women

Design outcomes

Primary

MeasureTime frameDescription
SPID-1212 hoursThe 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.

Countries

United States

Participant flow

Participants by arm

ArmCount
Sufentanil NanoTab 20 mcg
Sufentanil NanoTab 20 mcg as needed every 60 minutes for 12 hours
40
Sufentanil NanoTab 30 mcg
Sufentanil NanoTab 30 mcg as needed every 60 minutes for 12 hours
40
Placebo NanoTab
Placebo NanoTab as needed every 60 minutes for 12 hours
20
Total100

Withdrawals & dropouts

PeriodReasonFG000FG001FG002
Overall StudyAdverse Event020
Overall StudyDrug Dosing Error100
Overall StudyLack of Efficacy231

Baseline characteristics

CharacteristicSufentanil NanoTab 20 mcgSufentanil NanoTab 30 mcgPlacebo NanoTabTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
1 Participants2 Participants1 Participants4 Participants
Age, Categorical
Between 18 and 65 years
39 Participants38 Participants19 Participants96 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
8 Participants5 Participants4 Participants17 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
32 Participants35 Participants16 Participants83 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
1 Participants0 Participants0 Participants1 Participants
Race (NIH/OMB)
Asian
2 Participants1 Participants1 Participants4 Participants
Race (NIH/OMB)
Black or African American
7 Participants12 Participants4 Participants23 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants1 Participants0 Participants1 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
30 Participants26 Participants15 Participants71 Participants
Region of Enrollment
United States
40 participants40 participants20 participants100 participants
Sex: Female, Male
Female
19 Participants20 Participants10 Participants49 Participants
Sex: Female, Male
Male
21 Participants20 Participants10 Participants51 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
— / —— / —— / —
other
Total, other adverse events
23 / 4030 / 401 / 20
serious
Total, serious adverse events
2 / 400 / 400 / 20

Outcome results

Primary

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

ArmMeasureValue (LEAST_SQUARES_MEAN)Dispersion
Sufentanil NanoTab 20 mcgSPID-12-5.65 units on a scaleStandard Error 2.55
Sufentanil NanoTab 30 mcgSPID-126.53 units on a scaleStandard Error 2.56
Placebo NanoTabSPID-12-7.12 units on a scaleStandard Error 3.64
p-value: 0.742ANCOVA
p-value: 0.003ANCOVA

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026