Trial Outcomes & Findings for A Trial Evaluating the Efficacy and Safety of the Sublingual Sufentanil Tablet 30 mcg for Post-Operative Pain After Abdominal Surgery (NCT NCT02356588)

NCT ID: NCT02356588

Last Updated: 2017-02-13

Results Overview

The primary outcome measure is the summed pain intensity difference to baseline 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 observed SPID-12 scores ranged from -42.15 to 71.87 in the active group and -34.96 to 64.37 in the placebo group. 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: 161 participants
• Primary outcome timeframe: 12 hours
• Results posted on: 2017-02-13

Participant Flow

Participant milestones

Measure	Sufentanil Tablet 30 mcg A stratified randomization will be applied in this study with sex as a stratification factor. Patients who meet all inclusion and none of the exclusion criteria at screening, and following surgery, will be randomly assigned at a 2:1 ratio to treatment with ST 30 mcg or PT within one of two groups (male or female) at each study center. Patients may receive a dose of study medication no more frequently than once per hour. The study may last up to 48 hours. Sufentanil Tablet 30 mcg	Placebo Tablet A stratified randomization will be applied in this study with sex as a stratification factor. Patients who meet all inclusion and none of the exclusion criteria at screening, and following surgery, will be randomly assigned at a 2:1 ratio to treatment with ST 30 mcg or PT within one of two groups (male or female) at each study center. Patients may receive a dose of study medication no more frequently than once per hour. The study may last up to 48 hours. Placebo Tablet
Overall Study STARTED	107	54
Overall Study COMPLETED	102	41
Overall Study NOT COMPLETED	5	13

Reasons for withdrawal

Measure	Sufentanil Tablet 30 mcg A stratified randomization will be applied in this study with sex as a stratification factor. Patients who meet all inclusion and none of the exclusion criteria at screening, and following surgery, will be randomly assigned at a 2:1 ratio to treatment with ST 30 mcg or PT within one of two groups (male or female) at each study center. Patients may receive a dose of study medication no more frequently than once per hour. The study may last up to 48 hours. Sufentanil Tablet 30 mcg	Placebo Tablet A stratified randomization will be applied in this study with sex as a stratification factor. Patients who meet all inclusion and none of the exclusion criteria at screening, and following surgery, will be randomly assigned at a 2:1 ratio to treatment with ST 30 mcg or PT within one of two groups (male or female) at each study center. Patients may receive a dose of study medication no more frequently than once per hour. The study may last up to 48 hours. Placebo Tablet
Overall Study Lack of Efficacy	4	10
Overall Study Adverse Event	0	2
Overall Study Withdrawal by Subject	1	0
Overall Study Protocol Violation	0	1

Baseline Characteristics

A Trial Evaluating the Efficacy and Safety of the Sublingual Sufentanil Tablet 30 mcg for Post-Operative Pain After Abdominal Surgery

Baseline characteristics by cohort

Measure	Sufentanil Tablet 30 mcg n=107 Participants A stratified randomization will be applied in this study with sex as a stratification factor. Patients who meet all inclusion and none of the exclusion criteria at screening, and following surgery, will be randomly assigned at a 2:1 ratio to treatment with ST 30 mcg or PT within one of two groups (male or female) at each study center. Patients may receive a dose of study medication no more frequently than once per hour. The study may last up to 48 hours. Sufentanil Tablet 30 mcg	Placebo Tablet n=54 Participants A stratified randomization will be applied in this study with sex as a stratification factor. Patients who meet all inclusion and none of the exclusion criteria at screening, and following surgery, will be randomly assigned at a 2:1 ratio to treatment with ST 30 mcg or PT within one of two groups (male or female) at each study center. Patients may receive a dose of study medication no more frequently than once per hour. The study may last up to 48 hours. Placebo Tablet	Total n=161 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	106 Participants n=5 Participants	53 Participants n=7 Participants	159 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Gender Female	73 Participants n=5 Participants	36 Participants n=7 Participants	109 Participants n=5 Participants
Gender Male	34 Participants n=5 Participants	18 Participants n=7 Participants	52 Participants n=5 Participants

PRIMARY outcome

Timeframe: 12 hours

The primary outcome measure is the summed pain intensity difference to baseline 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 observed SPID-12 scores ranged from -42.15 to 71.87 in the active group and -34.96 to 64.37 in the placebo group. A negative score indicates an increase in pain intensity and a higher score indicates a greater decrease in pain intensity.

Outcome measures

Measure	Sufentanil Tablet 30 mcg n=107 Participants A stratified randomization will be applied in this study with sex as a stratification factor. Patients who meet all inclusion and none of the exclusion criteria at screening, and following surgery, will be randomly assigned at a 2:1 ratio to treatment with ST 30 mcg or PT within one of two groups (male or female) at each study center. Patients may receive a dose of study medication no more frequently than once per hour. The study may last up to 48 hours. Sufentanil Tablet 30 mcg	Placebo Tablet n=54 Participants A stratified randomization will be applied in this study with sex as a stratification factor. Patients who meet all inclusion and none of the exclusion criteria at screening, and following surgery, will be randomly assigned at a 2:1 ratio to treatment with ST 30 mcg or PT within one of two groups (male or female) at each study center. Patients may receive a dose of study medication no more frequently than once per hour. The study may last up to 48 hours. Placebo Tablet
Time-weighted Summed Pain Intensity Difference (SPID) Over the 12-hour Study Period (SPID12).	25.84 units on a scale Standard Error 1.71	13.14 units on a scale Standard Error 2.35

SECONDARY outcome

Timeframe: 24 hours

The primary outcome measure is the summed pain intensity difference to baseline over the 24-hour study period (SPID-24). A pain intensity score ranging from 0 (no pain) to 10 (worst possible pain) is obtained at baseline and throughout the 24 hour study period. The SPID-24 is calculated by summing the difference between baseline pain score and pain score at each assessment time point. The observed SPID-24 scores ranged from -70.00 to 148.70 in the active group to -58.09 to 160.24 in the placebo group. A negative score indicates an increase in pain intensity and a higher score indicates a greater decrease in pain intensity.

Outcome measures

Measure	Sufentanil Tablet 30 mcg n=107 Participants A stratified randomization will be applied in this study with sex as a stratification factor. Patients who meet all inclusion and none of the exclusion criteria at screening, and following surgery, will be randomly assigned at a 2:1 ratio to treatment with ST 30 mcg or PT within one of two groups (male or female) at each study center. Patients may receive a dose of study medication no more frequently than once per hour. The study may last up to 48 hours. Sufentanil Tablet 30 mcg	Placebo Tablet n=54 Participants A stratified randomization will be applied in this study with sex as a stratification factor. Patients who meet all inclusion and none of the exclusion criteria at screening, and following surgery, will be randomly assigned at a 2:1 ratio to treatment with ST 30 mcg or PT within one of two groups (male or female) at each study center. Patients may receive a dose of study medication no more frequently than once per hour. The study may last up to 48 hours. Placebo Tablet
Time-weighted Summed Pain Intensity Difference (SPID) Over the 24-hour Study Period (SPID24).	57.96 units on a scale Standard Error 3.45	37.28 units on a scale Standard Error 4.75

SECONDARY outcome

Timeframe: 12 hours

Total pain relief over the 12 hours. The observed total pain relief scores ranged from 4.08 to 47.50 in the active group and 1.77 to 33.71 in the placebo group. A higher score indicates greater pain relief.

Outcome measures

Measure	Sufentanil Tablet 30 mcg n=107 Participants A stratified randomization will be applied in this study with sex as a stratification factor. Patients who meet all inclusion and none of the exclusion criteria at screening, and following surgery, will be randomly assigned at a 2:1 ratio to treatment with ST 30 mcg or PT within one of two groups (male or female) at each study center. Patients may receive a dose of study medication no more frequently than once per hour. The study may last up to 48 hours. Sufentanil Tablet 30 mcg	Placebo Tablet n=54 Participants A stratified randomization will be applied in this study with sex as a stratification factor. Patients who meet all inclusion and none of the exclusion criteria at screening, and following surgery, will be randomly assigned at a 2:1 ratio to treatment with ST 30 mcg or PT within one of two groups (male or female) at each study center. Patients may receive a dose of study medication no more frequently than once per hour. The study may last up to 48 hours. Placebo Tablet
TOTPAR12	21.18 units on a scale Standard Error 0.87	15.36 units on a scale Standard Error 1.19

SECONDARY outcome

Timeframe: 24 Hours

Total pain relief over the 24 hour study period. The observed total pain relief scores ranged from 12.35 to 95.23 in the active group and 2.61 to 82.04 in the placebo group. A higher score indicates greater pain relief.

Outcome measures

Measure	Sufentanil Tablet 30 mcg n=102 Participants A stratified randomization will be applied in this study with sex as a stratification factor. Patients who meet all inclusion and none of the exclusion criteria at screening, and following surgery, will be randomly assigned at a 2:1 ratio to treatment with ST 30 mcg or PT within one of two groups (male or female) at each study center. Patients may receive a dose of study medication no more frequently than once per hour. The study may last up to 48 hours. Sufentanil Tablet 30 mcg	Placebo Tablet n=41 Participants A stratified randomization will be applied in this study with sex as a stratification factor. Patients who meet all inclusion and none of the exclusion criteria at screening, and following surgery, will be randomly assigned at a 2:1 ratio to treatment with ST 30 mcg or PT within one of two groups (male or female) at each study center. Patients may receive a dose of study medication no more frequently than once per hour. The study may last up to 48 hours. Placebo Tablet
TOTPAR24	45.80 units on a scale Standard Error 1.81	35.45 units on a scale Standard Error 2.49

SECONDARY outcome

Timeframe: 12 hours

Time-weighted summed pain relief intensity difference (SPRID) over the 12 hour study period. The observed SPRID scores ranged from -38.08 to 106.82 in the active group and -20.10 to 95.72 in the placebo group. A negative score indicates an increase in pain intensity and decrease in pain relief, while a higher score indicates a greater decrease in pain intensity and increase in pain relief.

Outcome measures

Measure	Sufentanil Tablet 30 mcg n=102 Participants A stratified randomization will be applied in this study with sex as a stratification factor. Patients who meet all inclusion and none of the exclusion criteria at screening, and following surgery, will be randomly assigned at a 2:1 ratio to treatment with ST 30 mcg or PT within one of two groups (male or female) at each study center. Patients may receive a dose of study medication no more frequently than once per hour. The study may last up to 48 hours. Sufentanil Tablet 30 mcg	Placebo Tablet n=41 Participants A stratified randomization will be applied in this study with sex as a stratification factor. Patients who meet all inclusion and none of the exclusion criteria at screening, and following surgery, will be randomly assigned at a 2:1 ratio to treatment with ST 30 mcg or PT within one of two groups (male or female) at each study center. Patients may receive a dose of study medication no more frequently than once per hour. The study may last up to 48 hours. Placebo Tablet
Time-weighted SPRID12	47.03 units on a scale Standard Error 2.35	28.62 units on a scale Standard Error 3.24

SECONDARY outcome

Timeframe: 24 hours

Time-weighted summed pain relief intensity difference (SPRID) over the 24 hour study period. The observed SPRID scores ranged from -49.67 to 222.04 in the active group and -24.97 to 237.54 in the placebo group. A negative score indicates an increase in pain intensity and decrease in pain relief, while a higher score indicates a greater decrease in pain intensity and increase in pain relief.

Outcome measures

Measure	Sufentanil Tablet 30 mcg n=102 Participants A stratified randomization will be applied in this study with sex as a stratification factor. Patients who meet all inclusion and none of the exclusion criteria at screening, and following surgery, will be randomly assigned at a 2:1 ratio to treatment with ST 30 mcg or PT within one of two groups (male or female) at each study center. Patients may receive a dose of study medication no more frequently than once per hour. The study may last up to 48 hours. Sufentanil Tablet 30 mcg	Placebo Tablet n=41 Participants A stratified randomization will be applied in this study with sex as a stratification factor. Patients who meet all inclusion and none of the exclusion criteria at screening, and following surgery, will be randomly assigned at a 2:1 ratio to treatment with ST 30 mcg or PT within one of two groups (male or female) at each study center. Patients may receive a dose of study medication no more frequently than once per hour. The study may last up to 48 hours. Placebo Tablet
Time-weighted SPRID24	103.88 units on a scale Standard Error 4.81	73.05 units on a scale Standard Error 6.62

SECONDARY outcome

Timeframe: 24 hours

Proportion of patients who responded good or excellent to the global assessment of method of pain control at 24 hours

Outcome measures

Measure	Sufentanil Tablet 30 mcg n=102 Participants A stratified randomization will be applied in this study with sex as a stratification factor. Patients who meet all inclusion and none of the exclusion criteria at screening, and following surgery, will be randomly assigned at a 2:1 ratio to treatment with ST 30 mcg or PT within one of two groups (male or female) at each study center. Patients may receive a dose of study medication no more frequently than once per hour. The study may last up to 48 hours. Sufentanil Tablet 30 mcg	Placebo Tablet n=41 Participants A stratified randomization will be applied in this study with sex as a stratification factor. Patients who meet all inclusion and none of the exclusion criteria at screening, and following surgery, will be randomly assigned at a 2:1 ratio to treatment with ST 30 mcg or PT within one of two groups (male or female) at each study center. Patients may receive a dose of study medication no more frequently than once per hour. The study may last up to 48 hours. Placebo Tablet
Patient Global Assessment	80.4 Percentage of patients Interval 72.85 to 91.37	51.9 Percentage of patients Interval 38.52 to 65.18

SECONDARY outcome

Timeframe: 24 hours

Proportion of Health Care Professionals who responded good or excellent to the global assessment of method of pain control at 24 hours

Outcome measures

Measure	Sufentanil Tablet 30 mcg n=107 Participants A stratified randomization will be applied in this study with sex as a stratification factor. Patients who meet all inclusion and none of the exclusion criteria at screening, and following surgery, will be randomly assigned at a 2:1 ratio to treatment with ST 30 mcg or PT within one of two groups (male or female) at each study center. Patients may receive a dose of study medication no more frequently than once per hour. The study may last up to 48 hours. Sufentanil Tablet 30 mcg	Placebo Tablet n=54 Participants A stratified randomization will be applied in this study with sex as a stratification factor. Patients who meet all inclusion and none of the exclusion criteria at screening, and following surgery, will be randomly assigned at a 2:1 ratio to treatment with ST 30 mcg or PT within one of two groups (male or female) at each study center. Patients may receive a dose of study medication no more frequently than once per hour. The study may last up to 48 hours. Placebo Tablet
Healthcare Professional Global Assessment	80.4 Percentage of HCPs Interval 72.85 to 87.9	53.7 Percentage of HCPs Interval 40.4 to 67.0

SECONDARY outcome

Timeframe: 1 hour

The SPID-1 is calculated by summing the difference to baseline between baseline pain score and the pain score at each assessment time point through 1 hour.

The observed SPID scores ranged from -2.00 to 5.25 in the active group to -4.90 to 3.00 in the placebo group. A negative score indicates an increase in pain intensity and a higher score indicates a greater decrease in pain intensity.

Outcome measures

Measure	Sufentanil Tablet 30 mcg n=107 Participants A stratified randomization will be applied in this study with sex as a stratification factor. Patients who meet all inclusion and none of the exclusion criteria at screening, and following surgery, will be randomly assigned at a 2:1 ratio to treatment with ST 30 mcg or PT within one of two groups (male or female) at each study center. Patients may receive a dose of study medication no more frequently than once per hour. The study may last up to 48 hours. Sufentanil Tablet 30 mcg	Placebo Tablet n=54 Participants A stratified randomization will be applied in this study with sex as a stratification factor. Patients who meet all inclusion and none of the exclusion criteria at screening, and following surgery, will be randomly assigned at a 2:1 ratio to treatment with ST 30 mcg or PT within one of two groups (male or female) at each study center. Patients may receive a dose of study medication no more frequently than once per hour. The study may last up to 48 hours. Placebo Tablet
Summed Pain Intensity Difference	1.09 units on a scale Standard Error 0.15	-0.37 units on a scale Standard Error 0.21

SECONDARY outcome

Timeframe: Cumulative through 12 hours

Outcome measures

Measure	Sufentanil Tablet 30 mcg n=107 Participants A stratified randomization will be applied in this study with sex as a stratification factor. Patients who meet all inclusion and none of the exclusion criteria at screening, and following surgery, will be randomly assigned at a 2:1 ratio to treatment with ST 30 mcg or PT within one of two groups (male or female) at each study center. Patients may receive a dose of study medication no more frequently than once per hour. The study may last up to 48 hours. Sufentanil Tablet 30 mcg	Placebo Tablet n=54 Participants A stratified randomization will be applied in this study with sex as a stratification factor. Patients who meet all inclusion and none of the exclusion criteria at screening, and following surgery, will be randomly assigned at a 2:1 ratio to treatment with ST 30 mcg or PT within one of two groups (male or female) at each study center. Patients may receive a dose of study medication no more frequently than once per hour. The study may last up to 48 hours. Placebo Tablet
Analysis of Total Number of Doses Used During the 12-Hour Study Period in the ITT Population	4.4 mean number of tablets taken Standard Deviation 2.0	4.7 mean number of tablets taken Standard Deviation 2.3

SECONDARY outcome

Timeframe: 24 hours

Outcome measures

Measure	Sufentanil Tablet 30 mcg n=107 Participants A stratified randomization will be applied in this study with sex as a stratification factor. Patients who meet all inclusion and none of the exclusion criteria at screening, and following surgery, will be randomly assigned at a 2:1 ratio to treatment with ST 30 mcg or PT within one of two groups (male or female) at each study center. Patients may receive a dose of study medication no more frequently than once per hour. The study may last up to 48 hours. Sufentanil Tablet 30 mcg	Placebo Tablet n=54 Participants A stratified randomization will be applied in this study with sex as a stratification factor. Patients who meet all inclusion and none of the exclusion criteria at screening, and following surgery, will be randomly assigned at a 2:1 ratio to treatment with ST 30 mcg or PT within one of two groups (male or female) at each study center. Patients may receive a dose of study medication no more frequently than once per hour. The study may last up to 48 hours. Placebo Tablet
Analysis of Total Number of Doses Used During the 24-Hour Study Period in the ITT Population	7.09 mean number of tablets taken Standard Deviation 3.60	6.40 mean number of tablets taken Standard Deviation 3.80

SECONDARY outcome

Timeframe: Cumulative through 6 hours

Outcome measures

Measure	Sufentanil Tablet 30 mcg n=107 Participants A stratified randomization will be applied in this study with sex as a stratification factor. Patients who meet all inclusion and none of the exclusion criteria at screening, and following surgery, will be randomly assigned at a 2:1 ratio to treatment with ST 30 mcg or PT within one of two groups (male or female) at each study center. Patients may receive a dose of study medication no more frequently than once per hour. The study may last up to 48 hours. Sufentanil Tablet 30 mcg	Placebo Tablet n=57 Participants A stratified randomization will be applied in this study with sex as a stratification factor. Patients who meet all inclusion and none of the exclusion criteria at screening, and following surgery, will be randomly assigned at a 2:1 ratio to treatment with ST 30 mcg or PT within one of two groups (male or female) at each study center. Patients may receive a dose of study medication no more frequently than once per hour. The study may last up to 48 hours. Placebo Tablet
Summary of Number of Rescue Morphine Doses Used by Study Period in the ITT Population	0.3 mean number of doses used Standard Deviation 0.7	1.1 mean number of doses used Standard Deviation 1.1

SECONDARY outcome

Timeframe: Cumulative through 12 hours

Outcome measures

Measure	Sufentanil Tablet 30 mcg n=107 Participants A stratified randomization will be applied in this study with sex as a stratification factor. Patients who meet all inclusion and none of the exclusion criteria at screening, and following surgery, will be randomly assigned at a 2:1 ratio to treatment with ST 30 mcg or PT within one of two groups (male or female) at each study center. Patients may receive a dose of study medication no more frequently than once per hour. The study may last up to 48 hours. Sufentanil Tablet 30 mcg	Placebo Tablet n=54 Participants A stratified randomization will be applied in this study with sex as a stratification factor. Patients who meet all inclusion and none of the exclusion criteria at screening, and following surgery, will be randomly assigned at a 2:1 ratio to treatment with ST 30 mcg or PT within one of two groups (male or female) at each study center. Patients may receive a dose of study medication no more frequently than once per hour. The study may last up to 48 hours. Placebo Tablet
Summary of Number of Rescue Morphine Doses Used by Study Period in the ITT Population	0.4 mean number of doses used Standard Deviation 1.0	1.6 mean number of doses used Standard Deviation 1.8

SECONDARY outcome

Timeframe: Cumulative through 24 hours

Outcome measures

Measure	Sufentanil Tablet 30 mcg n=107 Participants A stratified randomization will be applied in this study with sex as a stratification factor. Patients who meet all inclusion and none of the exclusion criteria at screening, and following surgery, will be randomly assigned at a 2:1 ratio to treatment with ST 30 mcg or PT within one of two groups (male or female) at each study center. Patients may receive a dose of study medication no more frequently than once per hour. The study may last up to 48 hours. Sufentanil Tablet 30 mcg	Placebo Tablet n=54 Participants A stratified randomization will be applied in this study with sex as a stratification factor. Patients who meet all inclusion and none of the exclusion criteria at screening, and following surgery, will be randomly assigned at a 2:1 ratio to treatment with ST 30 mcg or PT within one of two groups (male or female) at each study center. Patients may receive a dose of study medication no more frequently than once per hour. The study may last up to 48 hours. Placebo Tablet
Summary of Number of Rescue Morphine Doses Used by Study Period in the ITT Population	0.5 mean number of doses used Standard Deviation 1.4	2.1 mean number of doses used Standard Deviation 2.9

Adverse Events

Sufentanil Tablet 30 mcg

Serious events: 0 serious events

Other events: 49 other events

Deaths: 0 deaths

Placebo Tablet

Serious events: 2 serious events

Other events: 21 other events

Deaths: 0 deaths

Serious adverse events

Measure	Sufentanil Tablet 30 mcg n=107 participants at risk A stratified randomization will be applied in this study with sex as a stratification factor. Patients who meet all inclusion and none of the exclusion criteria at screening, and following surgery, will be randomly assigned at a 2:1 ratio to treatment with ST 30 mcg or PT within one of two groups (male or female) at each study center. Patients may receive a dose of study medication no more frequently than once per hour. The study may last up to 48 hours. Sufentanil Tablet 30 mcg	Placebo Tablet n=54 participants at risk A stratified randomization will be applied in this study with sex as a stratification factor. Patients who meet all inclusion and none of the exclusion criteria at screening, and following surgery, will be randomly assigned at a 2:1 ratio to treatment with ST 30 mcg or PT within one of two groups (male or female) at each study center. Patients may receive a dose of study medication no more frequently than once per hour. The study may last up to 48 hours. Placebo Tablet
Cardiac disorders Syncope	0.00% 0/107 • Non serious adverse events reported 12 hours after the first dose of study drug was given were recorded; SAEs reported within 30 days of last dose of study drug were recorded.	1.9% 1/54 • Number of events 1 • Non serious adverse events reported 12 hours after the first dose of study drug was given were recorded; SAEs reported within 30 days of last dose of study drug were recorded.
Nervous system disorders Hemiparesis	0.00% 0/107 • Non serious adverse events reported 12 hours after the first dose of study drug was given were recorded; SAEs reported within 30 days of last dose of study drug were recorded.	1.9% 1/54 • Number of events 1 • Non serious adverse events reported 12 hours after the first dose of study drug was given were recorded; SAEs reported within 30 days of last dose of study drug were recorded.

Other adverse events

Measure	Sufentanil Tablet 30 mcg n=107 participants at risk A stratified randomization will be applied in this study with sex as a stratification factor. Patients who meet all inclusion and none of the exclusion criteria at screening, and following surgery, will be randomly assigned at a 2:1 ratio to treatment with ST 30 mcg or PT within one of two groups (male or female) at each study center. Patients may receive a dose of study medication no more frequently than once per hour. The study may last up to 48 hours. Sufentanil Tablet 30 mcg	Placebo Tablet n=54 participants at risk A stratified randomization will be applied in this study with sex as a stratification factor. Patients who meet all inclusion and none of the exclusion criteria at screening, and following surgery, will be randomly assigned at a 2:1 ratio to treatment with ST 30 mcg or PT within one of two groups (male or female) at each study center. Patients may receive a dose of study medication no more frequently than once per hour. The study may last up to 48 hours. Placebo Tablet
Gastrointestinal disorders Nausea	29.0% 31/107 • Non serious adverse events reported 12 hours after the first dose of study drug was given were recorded; SAEs reported within 30 days of last dose of study drug were recorded.	22.2% 12/54 • Non serious adverse events reported 12 hours after the first dose of study drug was given were recorded; SAEs reported within 30 days of last dose of study drug were recorded.
Nervous system disorders Headache	12.1% 13/107 • Non serious adverse events reported 12 hours after the first dose of study drug was given were recorded; SAEs reported within 30 days of last dose of study drug were recorded.	11.1% 6/54 • Non serious adverse events reported 12 hours after the first dose of study drug was given were recorded; SAEs reported within 30 days of last dose of study drug were recorded.
Nervous system disorders Dizziness	5.6% 6/107 • Non serious adverse events reported 12 hours after the first dose of study drug was given were recorded; SAEs reported within 30 days of last dose of study drug were recorded.	3.7% 2/54 • Non serious adverse events reported 12 hours after the first dose of study drug was given were recorded; SAEs reported within 30 days of last dose of study drug were recorded.
Cardiac disorders Hypotension	4.7% 5/107 • Non serious adverse events reported 12 hours after the first dose of study drug was given were recorded; SAEs reported within 30 days of last dose of study drug were recorded.	3.7% 2/54 • Non serious adverse events reported 12 hours after the first dose of study drug was given were recorded; SAEs reported within 30 days of last dose of study drug were recorded.
Gastrointestinal disorders Vomiting	5.6% 6/107 • Non serious adverse events reported 12 hours after the first dose of study drug was given were recorded; SAEs reported within 30 days of last dose of study drug were recorded.	1.9% 1/54 • Non serious adverse events reported 12 hours after the first dose of study drug was given were recorded; SAEs reported within 30 days of last dose of study drug were recorded.
Gastrointestinal disorders Nausea, Procedural	2.8% 3/107 • Non serious adverse events reported 12 hours after the first dose of study drug was given were recorded; SAEs reported within 30 days of last dose of study drug were recorded.	3.7% 2/54 • Non serious adverse events reported 12 hours after the first dose of study drug was given were recorded; SAEs reported within 30 days of last dose of study drug were recorded.
Nervous system disorders Somnolence	2.8% 3/107 • Non serious adverse events reported 12 hours after the first dose of study drug was given were recorded; SAEs reported within 30 days of last dose of study drug were recorded.	3.7% 2/54 • Non serious adverse events reported 12 hours after the first dose of study drug was given were recorded; SAEs reported within 30 days of last dose of study drug were recorded.
Skin and subcutaneous tissue disorders Pruritis	0.93% 1/107 • Non serious adverse events reported 12 hours after the first dose of study drug was given were recorded; SAEs reported within 30 days of last dose of study drug were recorded.	3.7% 2/54 • Non serious adverse events reported 12 hours after the first dose of study drug was given were recorded; SAEs reported within 30 days of last dose of study drug were recorded.

Additional Information

Pamela Palmer, MD, PhD

AcelRx Pharmaceuticals, Inc.

Phone: 650-216-3504

Email: ppalmer@acelrx.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: OTHER