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The purpose of this study is to evaluate the safety and effectiveness of a study medication that contains a combination of a pain medication, sufentanil, and a sedative, triazolam. This drug is being designed to provide mild sedation as well as reduce anxiety and pain before and during a procedure (in this case elective abdominal liposuction).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | single dose of sublingual Sufentanil 15 mcg/Triazolam 200 mcg NanoTab™ |
|
| 2 | Placebo Comparator | single dose of sublingual Placebo NanoTab™ |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sublingual Sufentanil/Triazolam NanoTab™ (ARX-F03) | Drug | Single dose of sublingual Sufentanil 15 mcg/Triazolam 200 mcg NanoTab™ |
|
| Measure | Description | Time Frame |
|---|---|---|
| Summed Richmond Agitation Sedation Score (RASS) Over the 4-hour Study Period (SRS-4) | 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. | 4 hour study period |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pamela Palmer, M.D., PhD | Talphera, Inc | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lotus Clinical Research, Inc. | Pasadena | California | 91105 | United States |
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.
Study initiated 22 June 2009 and completed 11 September 2009. One clinical research center participated in the study
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| ID | Title | Description |
|---|---|---|
| FG000 | Sufentanil 15 mcg/Triazolam 200 mcg NanoTab™ | Single dose of sublingual Sufentanil 15 mcg/Triazolam 200 mcg NanoTab™ |
| FG001 | Single Dose of Placebo NanoTab™ | Single dose of sublingual Placebo NanoTab™ |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Placebo NanoTab™ | Drug | Single dose of sublingual placebo NanoTab™ |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Sufentanil/Triazolam NanoTab™ | Single dose of sublingual Sufentanil/Triazolam 15/200 mcg NanoTab™ |
| BG001 | Placebo | Single dose of Placebo |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Summed Richmond Agitation Sedation Score (RASS) Over the 4-hour Study Period (SRS-4) | 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. | ITT population were those patients that took at least one dose of study medication. | Posted | Least Squares Mean | Standard Error | units on a scale | 4 hour study period |
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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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Sufentanil/Triazolam NanoTab™ | Single dose of sublingual Sufentanil 15 mcg/Triazolam 200 mcg NanoTab™ | 0 | 21 | 5 | 21 | ||
| EG001 | Placebo | Single dose of Placebo | 0 | 19 | 1 | 19 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA (11.0) | Non-systematic Assessment | All events listed in this table were considered possibly or probably related to study drug |
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| Dizziness | Nervous system disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Hypoxia | Vascular disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (11.0) | Non-systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pamela Palmer, MD, PhD | AcelRx Pharmaceuticals, Inc. | 650-216-3504 | ppalmer@acelrx.com |
| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D010146 | Pain |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| >=65 years |
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| Male |
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| No |
| Superiority or Other |