Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to compare the efficacy and safety of the Sufentanil NanoTab PCA System/15 mcg to the Placebo Sufentanil NanoTab PCA System for the management of acute moderate to severe post-operative pain after open abdominal surgery.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sufentanil NanoTab PCA System/15 mcg | Experimental |
| |
| Placebo Sufentanil NanoTab PCA System | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sufentanil NanoTab PCA System/15 mcg | Drug | 15 mcg Sufentanil NanoTab dosed sublingually every 20 minutes as needed for pain for up to 48 hours. Patient may elect to remain in study for up to 72 hours. |
| Measure | Description | Time Frame |
|---|---|---|
| Time-weighted Summed Pain Intensity Difference (SPID) Over the 48-hour Study Period (SPID-48). | SPID-48 is the sum of the pain intensity difference (PID) over the 48 hour time period. A pain intensity score of 0 (no pain) to 10 (worse possible pain) is obtained before starting the study and throughout the 48 time period. The pain score at each assessment time is subtracted from the baseline pain score to provide the total sum score or SPID-48. A higher SPID-48 is better and indicates a reduction in pain intensity compared to the baseline score. The range of SPID48 scores were -232 to 326. Time-weighted SPID48 = ∑ [T(i) - T(i-1)] x PID(i), where T(0) = Time 0 (baseline), T(i) is the scheduled or unscheduled assessment time, and PID(i) is the PID score at time i for i=0 to 48 hours. Note: Active group n=114 and placebo group n=58, instead of active n=115 and placebo n=57, due to one "active" patient receiving placebo inadvertently. | 48 hours |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Pamela Palmer, M.D., PhD | Talphera, Inc | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Surgical Associates of Mobile | Mobile | Alabama | 36607 | United States | ||
| Caring Clinical Research Corporation |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25318408 | Background | Ringold FG, Minkowitz HS, Gan TJ, Aqua KA, Chiang YK, Evashenk MA, Palmer PP. Sufentanil sublingual tablet system for the management of postoperative pain following open abdominal surgery: a randomized, placebo-controlled study. Reg Anesth Pain Med. 2015 Jan-Feb;40(1):22-30. doi: 10.1097/AAP.0000000000000152. |
Not provided
Not provided
Patients were excluded per protocol exclusion criteria at Screening as well as post surgery for certain issues including the following:
Recruitment period of 10 months - March 1, 2012 to December 28, 2012; Recruitment and screening occurred at clinical research centers and hospitals.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Sufentanil NanoTab PCA System/15 mcg | Sufentanil NanoTab PCA System/15 mcg : 15 mcg Sufentanil NanoTab dosed sublingually q 20 minutes as needed for pain for at least 48 hours and up to 72 hours |
| FG001 | Placebo Sufentanil NanoTab PCA System |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Placebo Sufentanil NanoTab PCA System | Drug | Placebo NanoTab dosed sublingually every 20 minutes as needed for pain for up to 48 hours. Patient may elect to remain in study for up to 72 hours. |
|
| Laguna Hills |
| California |
| 92653 |
| United States |
| The Stamford Hospital | Stamford | Connecticut | 06904 | United States |
| G&G Research | Vero Beach | Florida | 32960 | United States |
| Rush Pain Center | Chicago | Illinois | 60612 | United States |
| CRC of Jackson | Jackson | Mississippi | 39202 | United States |
| Cooper University Hospital | Camden | New Jersey | 08103 | United States |
| Phoenix OB GYN Associates | Moorestown | New Jersey | 08057 | United States |
| New York Methodist Hospital | Brooklyn | New York | 11215 | United States |
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| Jefferson Hospital | Philadelphia | Pennsylvania | 19107 | United States |
| Memorial Hermann -Memorial City Medical Center | Houston | Texas | 77024 | United States |
Placebo Sufentanil NanoTab PCA System : Placebo NanoTab dosed sublingually q 20 minutes as needed for pain for at least 48 hours and up to 72 hours |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Sufentanil NanoTab PCA System/15 mcg | Sufentanil NanoTab PCA System/15 mcg : 15 mcg Sufentanil NanoTab dosed sublingually q 20 minutes as needed for pain for at least 48 hours. Patient may elect to remain in study for up to 72 hours |
| BG001 | Placebo Sufentanil NanoTab PCA System | Placebo Sufentanil NanoTab PCA System : Placebo NanoTab dosed sublingually q 20 minutes as needed for pain for at least 48 hours. Patient may elect to remain in study for up to 72 hours |
| 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 |
| ||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| 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 48-hour Study Period (SPID-48). | SPID-48 is the sum of the pain intensity difference (PID) over the 48 hour time period. A pain intensity score of 0 (no pain) to 10 (worse possible pain) is obtained before starting the study and throughout the 48 time period. The pain score at each assessment time is subtracted from the baseline pain score to provide the total sum score or SPID-48. A higher SPID-48 is better and indicates a reduction in pain intensity compared to the baseline score. The range of SPID48 scores were -232 to 326. Time-weighted SPID48 = ∑ [T(i) - T(i-1)] x PID(i), where T(0) = Time 0 (baseline), T(i) is the scheduled or unscheduled assessment time, and PID(i) is the PID score at time i for i=0 to 48 hours. Note: Active group n=114 and placebo group n=58, instead of active n=115 and placebo n=57, due to one "active" patient receiving placebo inadvertently. | Posted | Least Squares Mean | Standard Error | Units on a scale | 48 hours |
|
|
|
|
Treatment period of 48 hours (patients could elect to stay in study up to 72 hours). AEs collected from time of first dose of study drug through 12 hours after last dose of study drug.
Not provided
Not provided
| 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 PCA System/15 mcg | Sufentanil NanoTab PCA System/15 mcg : 15 mcg Sufentanil NanoTab dosed sublingually q 20 minutes as needed for pain for at least 48 hours. Patient may elect to remain in study for up to 72 hours | 1 | 114 | 26 | 114 | ||
| EG001 | Placebo Sufentanil NanoTab PCA System | Placebo Sufentanil NanoTab PCA System : Placebo NanoTab dosed sublingually q 20 minutes as needed for pain for at least 48 hours. Patient may elect to remain in study for up to 72 hours | 0 | 58 | 15 | 58 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial Fibrillation | Cardiac disorders | MedDRA (11.0) | Non-systematic Assessment | Investigator deemed event was unrelated to study drug |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal Pain | Gastrointestinal disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Chest Pain | General disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Oxygen Saturation Decreased | Investigations | MedDRA (11.0) | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA (11.0) | Non-systematic Assessment | All adverse events in this table were assessed by the PI as possibly or probably related to study drug |
|
| Vomiting | Gastrointestinal disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (11.0) | Non-systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pamela Palmer, MD, PhD | AcelRx Pharmaceuticals, Inc | 650-216-3504 | ppalmer@acelrx.com |
| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D017409 | Sufentanil |
| ID | Term |
|---|---|
| D005283 | Fentanyl |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
| >=65 years |
|
| Male |
|