Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00894699 | 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 | PHASE2 | COMPLETED | 40 | — | — | Jun 1, 2009 | Sep 1, 2009 | Jun 25, 2014 | 1 | United States |
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.
| Arm | Type | Description |
|---|---|---|
| 1 | ACTIVE_COMPARATOR | single dose of sublingual Sufentanil 15 mcg/Triazolam 200 mcg NanoTab™ |
| 2 | PLACEBO_COMPARATOR | single dose of sublingual Placebo NanoTab™ |
| Name | Type | Description |
|---|---|---|
| Sublingual Sufentanil/Triazolam NanoTab™ (ARX-F03) | DRUG | Single dose of sublingual Sufentanil 15 mcg/Triazolam 200 mcg NanoTab™ |
| Placebo NanoTab™ | DRUG | Single dose of sublingual placebo NanoTab™ |
Inclusion Criteria: 1. Patient must have provided written informed consent to participate in the study. 2. Male or female patient between 18 to 60 (inclusive) years of age. 3. Patient is planning to undergo an elective outpatient abdominal liposuction procedure. 4. Patient must be classified as Ame...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Masimo Corporation | MASI | 1 | PHASE1 | Diprivan , Astra-Zeneca |
| Cardinal Health, Inc. | CAH | 1 | — | Undisclosed |
| Medtronic Plc | MDT | 1 | NA | Undisclosed |