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This is a dose-finding study to determine if the sublingual administration of the Sufentanil NanoTab is safe and effective in the treatment of post-operative pain.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sufentanil NanoTab 20 mcg | Experimental | Sufentanil NanoTab 20 mcg as needed every 60 minutes for 12 hours |
|
| Sufentanil NanoTab 30 mcg | Experimental | Sufentanil NanoTab 30 mcg as needed every 60 minutes for 12 hours |
|
| Placebo NanoTab | Placebo Comparator | Placebo NanoTab as needed every 60 minutes for 12 hours |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sufentanil NanoTab 20 mcg | Drug |
| ||
| Sufentanil NanoTab 30 mcg |
| Measure | Description | Time Frame |
|---|---|---|
| SPID-12 | The primary outcome measure is the summed pain intensity difference 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 SPID-12 ranges from -120 (indicative of an increase in pain) to 120 (indicative of a decrease in pain). A higher SPID-12 score is better. | 12 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lotus Clinical Research | Pasadena | California | United States | |||
| Jean Brown Research |
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| ID | Title | Description |
|---|---|---|
| FG000 | Sufentanil NanoTab 20 mcg | Sufentanil NanoTab 20 mcg as needed every 60 minutes for 12 hours |
| FG001 | Sufentanil NanoTab 30 mcg | Sufentanil NanoTab 30 mcg as needed every 60 minutes for 12 hours |
| FG002 | Placebo NanoTab | Placebo NanoTab as needed every 60 minutes for 12 hours |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Sufentanil NanoTab 20 mcg | Sufentanil NanoTab 20 mcg as needed every 60 minutes for 12 hours |
| BG001 | Sufentanil NanoTab 30 mcg | Sufentanil NanoTab 30 mcg as needed every 60 minutes for 12 hours |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Patients must be at least 18 and no more than 80 years of age |
| 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 | SPID-12 | The primary outcome measure is the summed pain intensity difference 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 SPID-12 ranges from -120 (indicative of an increase in pain) to 120 (indicative of a decrease in pain). A higher SPID-12 score is better. | Posted | Least Squares Mean | Standard Error | units on a scale | 12 hours |
|
12 hours and then time discharge
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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 NanoTab 20 mcg | Sufentanil NanoTab 20 mcg as needed every 60 minutes for 12 hours |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Osteomyeolitis | Musculoskeletal and connective tissue disorders | MedDRA (14.0) | Non-systematic Assessment | Started 8 days after discharge |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA (14.0) | Non-systematic Assessment | AEs occurring at a frequency greater than 5% are included on this list whether or not they were related to study drug |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pamela Palmer, MD, PhD | AcelRx Pharmaceuticals, Inc. | 650-216-3504 | ppalmer@acelrx.com |
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| ID | Term |
|---|---|
| D059787 | Acute Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Drug |
|
| Placebo NanoTab | Drug |
|
| Salt Lake City |
| Utah |
| United States |
| Drug Dosing Error |
|
| BG002 | Placebo NanoTab | Placebo NanoTab as needed every 60 minutes for 12 hours |
| BG003 | Total | Total of all reporting groups |
| Count of Participants |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Sufentanil NanoTab 30 mcg as needed every 60 minutes for 12 hours
| OG002 | Placebo NanoTab | Placebo NanoTab as needed every 60 minutes for 12 hours |
|
|
|
| 2 |
| 40 |
| 23 |
| 40 |
| EG001 | Sufentanil NanoTab 30 mcg | Sufentanil NanoTab 30 mcg as needed every 60 minutes for 12 hours | 0 | 40 | 30 | 40 |
| EG002 | Placebo NanoTab | Placebo NanoTab as needed every 60 minutes for 12 hours | 0 | 20 | 1 | 20 |
|
| Cellulitis | Infections and infestations | MedDRA (14.0) | Non-systematic Assessment | Started 11 days after discharge |
|
|
| Vomiting | Gastrointestinal disorders | MedDRA (14.0) | Non-systematic Assessment |
|
| Feeling hot | General disorders | MedDRA (14.0) | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA (14.0) | Non-systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA (14.0) | Non-systematic Assessment |
|
| Pruritis | Skin and subcutaneous tissue disorders | MedDRA (14.0) | Non-systematic Assessment |
|
Sponsor must be able to review and approve all published