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This is a multicenter, open-label study in patients 40 years and older who are undergoing a surgical procedure.
Patients may receive one dose of ST 30 mcg as needed for pain management, but no more frequently than every 60 minutes, for up to 12 hours.
This is a multicenter, open-label study in patients 40 years and older who are undergoing a surgical procedure.
Upon meeting all entrance criteria, patients will be administered the first dose of ST 30 mcg and will remain in the study for up to 12 hours for safety and efficacy measurements. Patients may receive additional doses of ST 30 mcg as needed for pain management, but no more frequently than every 60 minutes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| sufentanil sublingual tablet 30 mcg | Experimental | sufentanil sublingual tablet 30 mcg |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| sufentanil sublingual tablet 30 mcg | Drug | sufentanil sublingual tablet 30 mcg as needed for pain management, but no more frequently than every 60 minutes, for up to 12 hours. |
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| Measure | Description | Time Frame |
|---|---|---|
| Time-weighted Summed Pain Intensity Difference (SPID) Over the 12-hour Study Period (SPID12). | The pain intensity difference (PID) at each evaluation time point after the dose of study drug is the difference in pain intensity at the specific evaluation time point and baseline pain intensity [PID(evaluation time after the first dose) = PI(baseline) - PI(evaluation time after the first dose)]. A pain intensity score ranging from 0 (no pain) to 10 (worst possible pain) is obtained at baseline and throughout the 12 hour period. The time-weighted SPID12 is the time-weighted summed PID over the 12-hour study period. The scores ranged from -13.75 to 100.5. A negative score indicates an increase in pain intensity and a higher score indicates a greater decrease in pain intensity. | 12-hours |
| Measure | Description | Time Frame |
|---|---|---|
| Time-weighted Summed Pain Intensity Difference (SPID) Over the First Hour (SPID1). | The pain intensity difference (PID) at each evaluation time point after the dose of study drug is the difference in pain intensity at the specific evaluation time point and baseline pain intensity [PID(evaluation time after the first dose) = PI(baseline) - PI(evaluation time after the first dose)]. A pain intensity score ranging from 0 (no pain) to 10 (worst possible pain) is obtained at baseline and throughout the 1 hour period. The time-weighted SPID1 is the time-weighted summed PID over the 1-hour study period. The scores ranged from -6.67 to 6.77. A negative score indicates an increase in pain intensity and a higher score indicates a greater decrease in pain intensity. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pamela P. Palmer, MD, PhD | Talphera, Inc | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| HD Research | Houston | Texas | 77401 | United States | ||
| Research Concepts |
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| ID | Title | Description |
|---|---|---|
| FG000 | Sufentanil Sublingual Tablet (SST) 30 mcg | Sufentanil sublingual tablet (SST) 30 mcg Sufentanil sublingual tablet (SST) 30 mcg: sufentanil sublingual tablet 30 mcg as needed for pain management, but no more frequently than every 60 minutes, for up to 12 hours. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| 1 hours |
| Percentage of Patients Who Responded to the Global Assessments as "Excellent" or "Good" | Patients were asked "Overall, how would you rate the method of pain control"? Poor (1), Fair (2), Good (3), or Excellent (4) | 12 hours or at patients' termination from study |
| Percentage of Healthcare Professionals Who Responded to the Global Assessments as "Excellent" or "Good" | Healthcare professionals were asked "Overall, how would you rate the method of pain control"? Poor (1) Fair (2) Good (3) Excellent (4) | 12 hours or until patients' termination from study |
| Houston |
| Texas |
| 77401 |
| United States |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Sufentanil Sublingual Tablet (SST) 30 mcg | Sufentanil sublingual tablet (SST) 30 mcg Sufentanil sublingual tablet (SST) 30 mcg: sufentanil sublingual tablet 30 mcg as needed for pain management, but no more frequently than every 60 minutes, for up to 12 hours. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | All subjects must have been at least 40 years of age at the time of screening | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | 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 | Time-weighted Summed Pain Intensity Difference (SPID) Over the 12-hour Study Period (SPID12). | The pain intensity difference (PID) at each evaluation time point after the dose of study drug is the difference in pain intensity at the specific evaluation time point and baseline pain intensity [PID(evaluation time after the first dose) = PI(baseline) - PI(evaluation time after the first dose)]. A pain intensity score ranging from 0 (no pain) to 10 (worst possible pain) is obtained at baseline and throughout the 12 hour period. The time-weighted SPID12 is the time-weighted summed PID over the 12-hour study period. The scores ranged from -13.75 to 100.5. A negative score indicates an increase in pain intensity and a higher score indicates a greater decrease in pain intensity. | Posted | Mean | Standard Error | units on a scale | 12-hours |
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| Secondary | Time-weighted Summed Pain Intensity Difference (SPID) Over the First Hour (SPID1). | The pain intensity difference (PID) at each evaluation time point after the dose of study drug is the difference in pain intensity at the specific evaluation time point and baseline pain intensity [PID(evaluation time after the first dose) = PI(baseline) - PI(evaluation time after the first dose)]. A pain intensity score ranging from 0 (no pain) to 10 (worst possible pain) is obtained at baseline and throughout the 1 hour period. The time-weighted SPID1 is the time-weighted summed PID over the 1-hour study period. The scores ranged from -6.67 to 6.77. A negative score indicates an increase in pain intensity and a higher score indicates a greater decrease in pain intensity. | Posted | Mean | Standard Error | units on a scale | 1 hours |
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| Secondary | Percentage of Patients Who Responded to the Global Assessments as "Excellent" or "Good" | Patients were asked "Overall, how would you rate the method of pain control"? Poor (1), Fair (2), Good (3), or Excellent (4) | 135 patients completed the scale | Posted | Number | 95% Confidence Interval | percentage of subjects | 12 hours or at patients' termination from study |
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| Secondary | Percentage of Healthcare Professionals Who Responded to the Global Assessments as "Excellent" or "Good" | Healthcare professionals were asked "Overall, how would you rate the method of pain control"? Poor (1) Fair (2) Good (3) Excellent (4) | Posted | Number | 95% Confidence Interval | percentage of healthcare professionals | 12 hours or until patients' termination from study |
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Spontaneous reports throughout patients' participation in study through study completion.
SAEs were reported if occurrence was within 30 days of last dose of study medication.
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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 Sublingual Tablet (SST) 30 mcg | Sufentanil sublingual tablet (SST) 30 mcg Sufentanil sublingual tablet (SST) 30 mcg: sufentanil sublingual tablet 30 mcg as needed for pain management, but no more frequently than every 60 minutes, for up to 12 hours. | 1 | 140 | 45 | 140 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute Stroke | Nervous system disorders | MedDRA (11.0) | Non-systematic Assessment | Occurred after patient's participation in study; Deemed unrelated to study drug |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA (11.0) | Non-systematic Assessment | Events entered in the list were noted as possibly or probably related to study drug |
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| Dizziness | Nervous system disorders | MedDRA (11.0) | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA (11.0) | Non-systematic Assessment |
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| Pruritis | Skin and subcutaneous tissue disorders | MedDRA (11.0) | Non-systematic Assessment |
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| Oxygen saturation decreased | Investigations | MedDRA (11.0) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pamela P. Palmer, MD, PhD, Chief Medical Officer | AcelRx Pharmaceuticals, Inc. | 650-216-3504 | ppalmer@acelrx.com |
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