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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 total unilateral knee or total unilateral hip replacement surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sufentanil NanoTab PCA System/15 mcg | Experimental |
| |
| Placebo Sufentanil NanoTab PCA System | Placebo Comparator |
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| 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 at least 48 hours. Patients 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 (SPID48). | 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. Range of SPID48 scores were -239 to 417. 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 | 48 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pamela Palmer, M.D., PhD | Chief Medical Officer, AcelRx Pharmaceuticals, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Deidre Stonestreet | Damascus | Maryland | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26079801 | Background | Jove M, Griffin DW, Minkowitz HS, Ben-David B, Evashenk MA, Palmer PP. Sufentanil Sublingual Tablet System for the Management of Postoperative Pain after Knee or Hip Arthroplasty: A Randomized, Placebo-controlled Study. Anesthesiology. 2015 Aug;123(2):434-43. doi: 10.1097/ALN.0000000000000746. |
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Patients were excluded per protocol exclusion criteria at Screening as well as post surgery for certain conditions including the following:
Recruitment period of 9 months - August 2012 through April 2013
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| 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 |
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| Placebo Sufentanil NanoTab PCA System | Drug | Placebo NanoTab dosed sublingually every 20 minutes as needed for pain for at least 48 hours. Patients may elect to remain in study for up to 72 hours. |
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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 |
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| NOT COMPLETED |
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| 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 |
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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 | Time-weighted Summed Pain Intensity Difference (SPID) Over the 48-hour Study Period (SPID48). | 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. Range of SPID48 scores were -239 to 417. 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 | Posted | Least Squares Mean | Standard Error | Units on a scale | 48 hours |
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AEs were collected from time of first study drug dose taken through 12 hours after last study drug dose taken.
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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 PCA System/15 mcg | Sufentanil NanoTab PCA System/15 mcg : 15 mcg Sufentanil NanoTab dosed sublingually every 20 minutes as needed for pain for up to 48 hours. Patients may elect to remain in study for up to 72 hours. | 8 | 315 | 171 | 315 | ||
| EG001 | Placebo Sufentanil NanoTab PCA System | Placebo Sufentanil NanoTab PCA System/15 mcg : Placebo NanoTab dosed sublingually every 20 minutes as needed for pain for up to 48 hours. Patients may elect to remain in study for up to 72 hours. | 4 | 104 | 35 | 104 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute Renal Failure | Renal and urinary disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Apnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Atrial Fibrillation | Cardiac disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA (11.0) | Non-systematic Assessment |
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| Coagulopathy | Investigations | MedDRA (11.0) | Non-systematic Assessment |
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| Confusional State | Psychiatric disorders | MedDRA (11.0) | Non-systematic Assessment |
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| Epididymitis | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | Non-systematic Assessment |
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| Fecal Infection | Gastrointestinal disorders | MedDRA (11.0) | Non-systematic Assessment | Faecaloma |
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| Hypoxia | Investigations | MedDRA (11.0) | Non-systematic Assessment |
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| Oxygen Saturation Decreased | Investigations | MedDRA (11.0) | Non-systematic Assessment |
| |
| Pneumonia | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Non-systematic Assessment | Aspiration Pneumonia |
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| Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Sinus Tachycardia | Cardiac disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Urinary Tract Infection | Renal and urinary disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Confusional State | Psychiatric disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (11.0) | Non-systematic Assessment | All AEs in this table were assessed by the PI 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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| Dry Mouth | Gastrointestinal 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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| Hypotension | Vascular disorders | MedDRA (11.0) | Non-systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA (11.0) | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA (11.0) | Non-systematic Assessment |
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| Orthostatic Hypotension | Vascular 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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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (11.0) | Non-systematic Assessment |
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| Pyrexia | General disorders | MedDRA (11.0) | Non-systematic Assessment |
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| Sedation | Nervous system disorders | MedDRA (11.0) | Non-systematic Assessment |
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| 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 |
|---|---|
| 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 |
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| ID | Term |
|---|---|
| D017409 | Sufentanil |
| ID | Term |
|---|---|
| D005283 | Fentanyl |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| >=65 years |
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| Male |
|