Trial Outcomes & Findings for A Study to Evaluate the Clinical Efficacy, Safety and Tolerability of ARX-F03 Sublingual Sufentanil/Triazolam NanoTab™ in Patients Undergoing an Elective Abdominal Liposuction Procedure (NCT NCT00894699)
NCT ID: NCT00894699
Last Updated: 2014-06-25
Results Overview
The primary efficacy endpoint of the study is the sedation level as assessed by the 10-point RASS, where unarousable is graded as minus 5 (- 5) and combative is graded as plus 4 (+ 4). The RASS was assessed at 15 time points throughout the four hour study period.
COMPLETED
PHASE2
40 participants
4 hour study period
2014-06-25
Participant Flow
Study initiated 22 June 2009 and completed 11 September 2009. One clinical research center participated in the study
Patients were to be between 18 and 60 years of age, generally healthy, and who are expected to require more than 400 cc or less than 700 cc of abdominal fat removal during the procedure.
Participant milestones
| Measure |
Sufentanil 15 mcg/Triazolam 200 mcg NanoTab™
Single dose of sublingual Sufentanil 15 mcg/Triazolam 200 mcg NanoTab™
|
Single Dose of Placebo NanoTab™
Single dose of sublingual Placebo NanoTab™
|
|---|---|---|
|
Overall Study
STARTED
|
21
|
19
|
|
Overall Study
COMPLETED
|
21
|
19
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study to Evaluate the Clinical Efficacy, Safety and Tolerability of ARX-F03 Sublingual Sufentanil/Triazolam NanoTab™ in Patients Undergoing an Elective Abdominal Liposuction Procedure
Baseline characteristics by cohort
| Measure |
Sufentanil/Triazolam NanoTab™
n=21 Participants
Single dose of sublingual Sufentanil/Triazolam 15/200 mcg NanoTab™
|
Placebo
n=19 Participants
Single dose of Placebo
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
21 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
40 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Continuous
|
36.1 years
STANDARD_DEVIATION 9.8 • n=99 Participants
|
37.3 years
STANDARD_DEVIATION 7.7 • n=107 Participants
|
36.7 years
STANDARD_DEVIATION 8.8 • n=206 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
33 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
21 participants
n=99 Participants
|
19 participants
n=107 Participants
|
40 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 4 hour study periodPopulation: ITT population were those patients that took at least one dose of study medication.
The primary efficacy endpoint of the study is the sedation level as assessed by the 10-point RASS, where unarousable is graded as minus 5 (- 5) and combative is graded as plus 4 (+ 4). The RASS was assessed at 15 time points throughout the four hour study period.
Outcome measures
| Measure |
Sublingual Sufentanil 15 mcg/Triazolam NanoTab™ 200 mcg
n=21 Participants
Single dose of sublingual Sufentanil 15 mcg/Triazolam 200 mcg NanoTab™
|
Placebo NanoTab™
n=19 Participants
Single dose of sublingual Placebo NanoTab™
|
|---|---|---|
|
Summed Richmond Agitation Sedation Score (RASS) Over the 4-hour Study Period (SRS-4)
|
-5.44 units on a scale
Standard Error .82
|
0.79 units on a scale
Standard Error .86
|
Adverse Events
Sufentanil/Triazolam NanoTab™
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Sufentanil/Triazolam NanoTab™
n=21 participants at risk
Single dose of sublingual Sufentanil 15 mcg/Triazolam 200 mcg NanoTab™
|
Placebo
n=19 participants at risk
Single dose of Placebo
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
4.8%
1/21 • Number of events 1 • 4 hours.
A telephone call was placed to each patient 24 hours after dosing to inquire about the patients' overall health. If AEs were reported, they were documented in the clinical database.
|
0.00%
0/19 • 4 hours.
A telephone call was placed to each patient 24 hours after dosing to inquire about the patients' overall health. If AEs were reported, they were documented in the clinical database.
|
|
Nervous system disorders
Dizziness
|
9.5%
2/21 • Number of events 2 • 4 hours.
A telephone call was placed to each patient 24 hours after dosing to inquire about the patients' overall health. If AEs were reported, they were documented in the clinical database.
|
5.3%
1/19 • Number of events 1 • 4 hours.
A telephone call was placed to each patient 24 hours after dosing to inquire about the patients' overall health. If AEs were reported, they were documented in the clinical database.
|
|
Vascular disorders
Hypoxia
|
4.8%
1/21 • Number of events 1 • 4 hours.
A telephone call was placed to each patient 24 hours after dosing to inquire about the patients' overall health. If AEs were reported, they were documented in the clinical database.
|
0.00%
0/19 • 4 hours.
A telephone call was placed to each patient 24 hours after dosing to inquire about the patients' overall health. If AEs were reported, they were documented in the clinical database.
|
|
Gastrointestinal disorders
Vomiting
|
4.8%
1/21 • Number of events 1 • 4 hours.
A telephone call was placed to each patient 24 hours after dosing to inquire about the patients' overall health. If AEs were reported, they were documented in the clinical database.
|
0.00%
0/19 • 4 hours.
A telephone call was placed to each patient 24 hours after dosing to inquire about the patients' overall health. If AEs were reported, they were documented in the clinical database.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER