Trial Outcomes & Findings for A Multicenter, Open-Label Trial to Evaluate the Safety and Efficacy of the Sufentanil Sublingual Tablet 30 mcg in Patients With Post-Operative Pain (NCT NCT02662556)

Results Overview

The pain intensity difference (PID) at each evaluation time point after the dose of study drug is the difference in pain intensity at the specific evaluation time point and baseline pain intensity \[PID(evaluation time after the first dose) = PI(baseline) - PI(evaluation time after the first dose)\]. A pain intensity score ranging from 0 (no pain) to 10 (worst possible pain) is obtained at baseline and throughout the 12 hour period. The time-weighted SPID12 is the time-weighted summed PID over the 12-hour study period. The scores ranged from -13.75 to 100.5. A negative score indicates an increase in pain intensity and a higher score indicates a greater decrease in pain intensity.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

140 participants

Primary outcome timeframe

12-hours

Results posted on

2017-03-15

Participant Flow

Participant milestones

Participant milestones
Measure	Sufentanil Sublingual Tablet (SST) 30 mcg Sufentanil sublingual tablet (SST) 30 mcg Sufentanil sublingual tablet (SST) 30 mcg: sufentanil sublingual tablet 30 mcg as needed for pain management, but no more frequently than every 60 minutes, for up to 12 hours.
Overall Study STARTED	140
Overall Study COMPLETED	132
Overall Study NOT COMPLETED	8

Reasons for withdrawal

Reasons for withdrawal
Measure	Sufentanil Sublingual Tablet (SST) 30 mcg Sufentanil sublingual tablet (SST) 30 mcg Sufentanil sublingual tablet (SST) 30 mcg: sufentanil sublingual tablet 30 mcg as needed for pain management, but no more frequently than every 60 minutes, for up to 12 hours.
Overall Study Adverse Event	4
Overall Study Lack of Efficacy	4

Baseline Characteristics

A Multicenter, Open-Label Trial to Evaluate the Safety and Efficacy of the Sufentanil Sublingual Tablet 30 mcg in Patients With Post-Operative Pain

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Sufentanil Sublingual Tablet (SST) 30 mcg n=140 Participants Sufentanil sublingual tablet (SST) 30 mcg Sufentanil sublingual tablet (SST) 30 mcg: sufentanil sublingual tablet 30 mcg as needed for pain management, but no more frequently than every 60 minutes, for up to 12 hours.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	116 Participants n=5 Participants
Age, Categorical >=65 years	24 Participants n=5 Participants
Sex: Female, Male Female	75 Participants n=5 Participants
Sex: Female, Male Male	65 Participants n=5 Participants

PRIMARY outcome

Timeframe: 12-hours

The pain intensity difference (PID) at each evaluation time point after the dose of study drug is the difference in pain intensity at the specific evaluation time point and baseline pain intensity \[PID(evaluation time after the first dose) = PI(baseline) - PI(evaluation time after the first dose)\]. A pain intensity score ranging from 0 (no pain) to 10 (worst possible pain) is obtained at baseline and throughout the 12 hour period. The time-weighted SPID12 is the time-weighted summed PID over the 12-hour study period. The scores ranged from -13.75 to 100.5. A negative score indicates an increase in pain intensity and a higher score indicates a greater decrease in pain intensity.

Outcome measures

Outcome measures
Measure	Sufentanil Sublingual Tablet (SST) 30 mcg n=137 Participants Sufentanil sublingual tablet (SST) 30 mcg Sufentanil sublingual tablet (SST) 30 mcg: one sufentanil sublingual tablet 30 mcg as needed for pain management, but no more frequently than every 60 minutes, for up to 12 hours.
Time-weighted Summed Pain Intensity Difference (SPID) Over the 12-hour Study Period (SPID12).	36.04 units on a scale Standard Error 2.22

SECONDARY outcome

Timeframe: 1 hours

The pain intensity difference (PID) at each evaluation time point after the dose of study drug is the difference in pain intensity at the specific evaluation time point and baseline pain intensity \[PID(evaluation time after the first dose) = PI(baseline) - PI(evaluation time after the first dose)\]. A pain intensity score ranging from 0 (no pain) to 10 (worst possible pain) is obtained at baseline and throughout the 1 hour period. The time-weighted SPID1 is the time-weighted summed PID over the 1-hour study period. The scores ranged from -6.67 to 6.77. A negative score indicates an increase in pain intensity and a higher score indicates a greater decrease in pain intensity.

Outcome measures

Outcome measures
Measure	Sufentanil Sublingual Tablet (SST) 30 mcg n=137 Participants Sufentanil sublingual tablet (SST) 30 mcg Sufentanil sublingual tablet (SST) 30 mcg: one sufentanil sublingual tablet 30 mcg as needed for pain management, but no more frequently than every 60 minutes, for up to 12 hours.
Time-weighted Summed Pain Intensity Difference (SPID) Over the First Hour (SPID1).	0.87 units on a scale Standard Error 0.16

SECONDARY outcome

Timeframe: 12 hours or at patients' termination from study

Population: 135 patients completed the scale

Patients were asked "Overall, how would you rate the method of pain control"? Poor (1), Fair (2), Good (3), or Excellent (4)

Outcome measures

Outcome measures
Measure	Sufentanil Sublingual Tablet (SST) 30 mcg n=135 Participants Sufentanil sublingual tablet (SST) 30 mcg Sufentanil sublingual tablet (SST) 30 mcg: one sufentanil sublingual tablet 30 mcg as needed for pain management, but no more frequently than every 60 minutes, for up to 12 hours.
Percentage of Patients Who Responded to the Global Assessments as "Excellent" or "Good"	87.4 percentage of subjects Interval 81.81 to 93.0

SECONDARY outcome

Timeframe: 12 hours or until patients' termination from study

Healthcare professionals were asked "Overall, how would you rate the method of pain control"? Poor (1) Fair (2) Good (3) Excellent (4)

Outcome measures

Outcome measures
Measure	Sufentanil Sublingual Tablet (SST) 30 mcg n=123 Participants Sufentanil sublingual tablet (SST) 30 mcg Sufentanil sublingual tablet (SST) 30 mcg: one sufentanil sublingual tablet 30 mcg as needed for pain management, but no more frequently than every 60 minutes, for up to 12 hours.
Percentage of Healthcare Professionals Who Responded to the Global Assessments as "Excellent" or "Good"	90.2 percentage of healthcare professionals Interval 85.0 to 95.49

Adverse Events

Sufentanil Sublingual Tablet (SST) 30 mcg

Serious events: 1 serious events

Other events: 45 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Sufentanil Sublingual Tablet (SST) 30 mcg n=140 participants at risk Sufentanil sublingual tablet (SST) 30 mcg Sufentanil sublingual tablet (SST) 30 mcg: sufentanil sublingual tablet 30 mcg as needed for pain management, but no more frequently than every 60 minutes, for up to 12 hours.
Nervous system disorders Acute Stroke	0.71% 1/140 • Number of events 1 • Spontaneous reports throughout patients' participation in study through study completion. SAEs were reported if occurrence was within 30 days of last dose of study medication.

Other adverse events

Other adverse events
Measure	Sufentanil Sublingual Tablet (SST) 30 mcg n=140 participants at risk Sufentanil sublingual tablet (SST) 30 mcg Sufentanil sublingual tablet (SST) 30 mcg: sufentanil sublingual tablet 30 mcg as needed for pain management, but no more frequently than every 60 minutes, for up to 12 hours.
Gastrointestinal disorders Nausea	27.1% 38/140 • Spontaneous reports throughout patients' participation in study through study completion. SAEs were reported if occurrence was within 30 days of last dose of study medication.
Nervous system disorders Dizziness	4.3% 6/140 • Spontaneous reports throughout patients' participation in study through study completion. SAEs were reported if occurrence was within 30 days of last dose of study medication.
Nervous system disorders Headache	2.9% 4/140 • Spontaneous reports throughout patients' participation in study through study completion. SAEs were reported if occurrence was within 30 days of last dose of study medication.
Skin and subcutaneous tissue disorders Pruritis	2.9% 4/140 • Spontaneous reports throughout patients' participation in study through study completion. SAEs were reported if occurrence was within 30 days of last dose of study medication.
Investigations Oxygen saturation decreased	2.1% 3/140 • Spontaneous reports throughout patients' participation in study through study completion. SAEs were reported if occurrence was within 30 days of last dose of study medication.

Additional Information

Pamela P. Palmer, MD, PhD, Chief Medical Officer

AcelRx Pharmaceuticals, Inc.

Phone: 650-216-3504

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: OTHER