Trial Outcomes & Findings for Open-Label Safety and Efficacy of the Sufentanil Sublingual Tablet 30 mcg for Acute Pain (NCT NCT02447848)

Results Overview

The primary efficacy endpoint is the time-weighted SPID1 evaluated from the patient questionnaire data. Pain intensity (PI) will be measured using an 11-point numerical rating scale (NRS) with 0 (no pain) and 10 (worst possible pain). The patient's rating of PI will be measured at baseline and at 0.25 (15 min), 0.5 (30 min), 0.75 (45 min), 1, 2, 3, 4, and 5 hours following the first dose of study drug. The PID at each evaluation time point after the initiation of the first dose is the difference in PI at the specific evaluation time point and baseline pain intensity \[PID (evaluation time after the first dose) = PI(baseline) - PI(evaluation time after the first dose)\]. The time-weighted SPID1 is the time-weighted summed PID over the 1-hour study period. The observed SPID scores ranged from -.70 to 8.00. A negative score indicates an increase in pain intensity and a positive score indicates a decrease in pain intensity.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

76 participants

Primary outcome timeframe

One hour

Results posted on

2017-10-19

Participant Flow

Participant milestones

Participant milestones
Measure	Sufentanil Sublingual Tablet 30 mcg Patients may be administered one tablet every 60 minutes as needed during the study period
Overall Study STARTED	76
Overall Study COMPLETED	65
Overall Study NOT COMPLETED	11

Reasons for withdrawal

Reasons for withdrawal
Measure	Sufentanil Sublingual Tablet 30 mcg Patients may be administered one tablet every 60 minutes as needed during the study period
Overall Study Patient discharged	3
Overall Study Lack of Efficacy	4
Overall Study Withdrawal by Subject	4

Baseline Characteristics

Open-Label Safety and Efficacy of the Sufentanil Sublingual Tablet 30 mcg for Acute Pain

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Sufentanil Sublingual Tablet 30 mcg n=76 Participants Patients may be administered one tablet every 60 minutes as needed during the study period
Age, Categorical <=18 years	0 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	67 Participants n=99 Participants
Age, Categorical >=65 years	9 Participants n=99 Participants
Sex: Female, Male Female	30 Participants n=99 Participants
Sex: Female, Male Male	46 Participants n=99 Participants

PRIMARY outcome

Timeframe: One hour

The primary efficacy endpoint is the time-weighted SPID1 evaluated from the patient questionnaire data. Pain intensity (PI) will be measured using an 11-point numerical rating scale (NRS) with 0 (no pain) and 10 (worst possible pain). The patient's rating of PI will be measured at baseline and at 0.25 (15 min), 0.5 (30 min), 0.75 (45 min), 1, 2, 3, 4, and 5 hours following the first dose of study drug. The PID at each evaluation time point after the initiation of the first dose is the difference in PI at the specific evaluation time point and baseline pain intensity \[PID (evaluation time after the first dose) = PI(baseline) - PI(evaluation time after the first dose)\]. The time-weighted SPID1 is the time-weighted summed PID over the 1-hour study period. The observed SPID scores ranged from -.70 to 8.00. A negative score indicates an increase in pain intensity and a positive score indicates a decrease in pain intensity.

Outcome measures

Outcome measures
Measure	Sufentanil Sublingual Tablet 30 mcg n=76 Participants Patients may be administered one tablet every 60 minutes as needed during the study period
Time-weighted Summed Pain Intensity Difference (SPID) Over the 1-hour (SPID1).	2.11 units on a scale Standard Error 0.24

SECONDARY outcome

Timeframe: 1-hour

The total pain relief (TOTPAR) is the time-weighted sum of the pain relief scores over the first hour (15 minutes, 30 minutes, 45 minutes and 1-hour after the first dose of study drug is taken) of the study period. The minimum score is 0.00 and the maximum score is 4.00. A higher score indicates greater pain relief.

Outcome measures

Outcome measures
Measure	Sufentanil Sublingual Tablet 30 mcg n=76 Participants Patients may be administered one tablet every 60 minutes as needed during the study period
TOTPAR1 (Time-weighted)	1.37 units on a scale Standard Error 0.12

SECONDARY outcome

Timeframe: 5 hours

Population: The first cohort of patients (N=40) received one dose of study drug and the study was completed at two hours. The second cohort of patients (N=36) had the option of remaining in the study through five hours; most patients discontinued the study at 2 hours.

Pain intensity at each evaluation time point after the first dose of study drug up through 5 hours is evaluated using an 11-point NRS where 0 equals no pain and 10 equals worst possible pain. The score was obtained at Baseline, 15- , 30-, 45- minutes, 1-hour, and 2-hours after the first dose for all patients, and at hours 3, 4, and 5 for cohort 2 (patients 41-76). Scores ranged from 0 -10 for the first two hours, and 2 - 10 for hours three to five.

Outcome measures

Outcome measures
Measure	Sufentanil Sublingual Tablet 30 mcg n=76 Participants Patients may be administered one tablet every 60 minutes as needed during the study period
PI at Each Evaluation Time Point Baseline	8.08 units on a scale Standard Error 0.20
PI at Each Evaluation Time Point 15-minutes	6.00 units on a scale Standard Error 0.27
PI at Each Evaluation Time Point 30-minutes	6.23 units on a scale Standard Error 0.30
PI at Each Evaluation Time Point 45-minutes	5.51 units on a scale Standard Error 0.35
PI at Each Evaluation Time Point 1-hour	5.2 units on a scale Standard Error 0.36
PI at Each Evaluation Time Point 2-hours	5.49 units on a scale Standard Error 0.37
PI at Each Evaluation Time Point 3-hours	6.83 units on a scale Standard Error 1.17
PI at Each Evaluation Time Point 4-hours	4.67 units on a scale Standard Error 1.20
PI at Each Evaluation Time Point 5-hours	2 units on a scale

Adverse Events

Sufentanil Sublingual Tablet 30 mcg

Serious events: 1 serious events

Other events: 12 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Sufentanil Sublingual Tablet 30 mcg n=76 participants at risk Patients may be administered one tablet every 60 minutes as needed during the study period
Cardiac disorders Angina Pectoris	1.3% 1/76 • Number of events 1 • For the duration of the patients' participation in the study (while in ER).

Other adverse events

Other adverse events
Measure	Sufentanil Sublingual Tablet 30 mcg n=76 participants at risk Patients may be administered one tablet every 60 minutes as needed during the study period
Gastrointestinal disorders Nausea	6.6% 5/76 • For the duration of the patients' participation in the study (while in ER).
Gastrointestinal disorders Vomiting	3.9% 3/76 • For the duration of the patients' participation in the study (while in ER).
Investigations Oxygen saturation decreased	2.6% 2/76 • For the duration of the patients' participation in the study (while in ER).
Nervous system disorders Somnolence	2.6% 2/76 • For the duration of the patients' participation in the study (while in ER).

Additional Information

Pamela Palmer, MD, PhD

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