Acute Moderate-to-severe Pain
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DRUGsufentanil sublingual tablet 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.
Sponsors
Talphera, Inc
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Male or female patients who are 40 years of age or older. 2. Patients who have undergone a surgical procedure with general anesthesia or spinal anesthesia that does not include intrathecal opioids during the operation. 3. Patients classified as American Society of Anesthesiologists (ASA) class IIII (Appendix I).
Exclusion criteria
1. Patients who have taken an opioid for more than 30 consecutive days, at a daily dose of more than 15 mg of morphine (or equivalent), within the past 3 months prior to surgery (e.g. more than 3 doses per day of Vicodin®, Norco®, Lortab® with 5 mg hydrocodone per tablet). 2. Patients with a positive drug of abuse screen unless the positive test result is consistent with a prescribed medication. 3. Patients with a history of opioid dependence within 2 years before the start of the study, defined as meeting the DSM-IV-TR™ Criteria for Substance Dependence specified in Appendix II. 4. Patients who have used any illicit drugs of abuse within five years before the start of the study. 5. Patients who have abused any prescription medication or alcohol within one year before the start of the study. 6. Patients with an allergy or hypersensitivity to opioids. 7. Patients who are currently taking monoamine oxidase inhibitors (MAOIs) or have taken MAOIs within 14 days of the first dose of study drug. 8. Patients with current sleep apnea that has been documented by a sleep laboratory study or are on home continuous positive airway pressure (CPAP).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time-weighted Summed Pain Intensity Difference (SPID) Over the 12-hour Study Period (SPID12). | 12-hours | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time-weighted Summed Pain Intensity Difference (SPID) Over the First Hour (SPID1). | 1 hours | 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. |
| Percentage of Patients Who Responded to the Global Assessments as Excellent or Good | 12 hours or at patients' termination from study | Patients were asked Overall, how would you rate the method of pain control? Poor (1), Fair (2), Good (3), or Excellent (4) |
| Percentage of Healthcare Professionals Who Responded to the Global Assessments as Excellent or Good | 12 hours or until patients' termination from study | Healthcare professionals were asked Overall, how would you rate the method of pain control? Poor (1) Fair (2) Good (3) Excellent (4) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 140 |
| Total | 140 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 4 |
| Overall Study | Lack of Efficacy | 4 |
Baseline characteristics
| Characteristic | Sufentanil Sublingual Tablet (SST) 30 mcg |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 24 Participants |
| Age, Categorical Between 18 and 65 years | 116 Participants |
| Sex: Female, Male Female | 75 Participants |
| Sex: Female, Male Male | 65 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 45 / 140 |
| serious Total, serious adverse events | 1 / 140 |
Outcome results
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.
Time frame: 12-hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sufentanil Sublingual Tablet (SST) 30 mcg | Time-weighted Summed Pain Intensity Difference (SPID) Over the 12-hour Study Period (SPID12). | 36.04 units on a scale | Standard Error 2.22 |
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)
Time frame: 12 hours or until patients' termination from study
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Sufentanil Sublingual Tablet (SST) 30 mcg | Percentage of Healthcare Professionals Who Responded to the Global Assessments as Excellent or Good | 90.2 percentage of healthcare professionals |
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)
Time frame: 12 hours or at patients' termination from study
Population: 135 patients completed the scale
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Sufentanil Sublingual Tablet (SST) 30 mcg | Percentage of Patients Who Responded to the Global Assessments as Excellent or Good | 87.4 percentage of subjects |
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.
Time frame: 1 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sufentanil Sublingual Tablet (SST) 30 mcg | Time-weighted Summed Pain Intensity Difference (SPID) Over the First Hour (SPID1). | 0.87 units on a scale | Standard Error 0.16 |