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The study is intended to show that the Sufentanil NanoTab PCA System is as effective as morphine intravenous patient-controlled analgesia (IV PCA) for treating pain after surgery. Each patient will use either the Sufentanil NanoTab PCA System or morphine IV PCA to treat their pain for at least 48 hours and up to 72 hours after surgery while in the hospital.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sufentanil NanoTab PCA System/15 mcg | Experimental |
| |
| morphine IV PCA | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sufentanil NanoTab PCA System/15 mcg | Drug | 15 mcg Sufentanil NanoTab dosed sublingually q 20 minutes as needed for pain for at least 48 hours and up to 72 hours |
|
| Measure | Description | Time Frame |
|---|---|---|
| Patient Global Satisfaction | Proportion of patients responding good or excellent at 48-hour global assessment of method of pain control | 48 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pamela Palmer, M.D., PhD | Talphera, Inc | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eliza Coffee Memorial Hospital | Florence | Alabama | 35630 | United States | ||
| Drug Research and Analysis Corp |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25155134 | Background | Melson TI, Boyer DL, Minkowitz HS, Turan A, Chiang YK, Evashenk MA, Palmer PP. Sufentanil sublingual tablet system vs. intravenous patient-controlled analgesia with morphine for postoperative pain control: a randomized, active-comparator trial. Pain Pract. 2014 Nov;14(8):679-88. doi: 10.1111/papr.12238. Epub 2014 Aug 25. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Sufentanil NanoTab PCA System/15 mcg | |
| FG001 | Morphine IV PCA |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
| morphine IV PCA | Drug | 1 mg morphine administered IV q 6 minutes as needed for pain for at least 48 hours and up to 72 hours |
|
| Montgomery |
| Alabama |
| 36106 |
| United States |
| Shoals Medical Trials, Inc | Sheffield | Alabama | 35660 | United States |
| Arizona Research Center | Phoenix | Arizona | 85023 | United States |
| Lotus Clinical Research | Pasadena | California | 91105 | United States |
| Thorton Hospital | San Diego | California | 92037 | United States |
| Florida Research Associates, LLC | DeLand | Florida | 32720 | United States |
| River City Clinical Research | Jacksonville | Florida | 32207 | United States |
| Pensacola Research Consultants, Inc | Pensacola | Florida | 32504 | United States |
| Gulfcoast Research Institute | Sarasota | Florida | 34232 | United States |
| Phoenix Clinical Research LLC | Tamarac | Florida | 33321 | United States |
| Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | United States |
| The Ohio State University | Columbus | Ohio | 43210 | United States |
| Access Clinical Trials | Nashville | Tennessee | 37203 | United States |
| Endeavor Clinical Trials, PA | San Antonio | Texas | 78229 | United States |
| Jean Brown Research | Salt Lake City | Utah | 84124 | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Sufentanil NanoTab PCA System/15 mcg | |
| BG001 | Morphine IV PCA | |
| 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 | Patient Global Satisfaction | Proportion of patients responding good or excellent at 48-hour global assessment of method of pain control | Posted | Number | 95% Confidence Interval | % patients reporting good or excellent | 48 hours |
|
|
|
|
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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 | 6 | 177 | 123 | 177 | |||
| EG001 | Morphine IV PCA | 7 | 180 | 122 | 180 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| post-procedural bile leak | Injury, poisoning and procedural complications | MedDRA (11.0) | Non-systematic Assessment |
| |
| anaemia | Blood and lymphatic system disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| methaemoglobinaemia | Blood and lymphatic system disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| atrial fibrillation | Cardiac disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| anastomotic haemorrhage | Injury, poisoning and procedural complications | MedDRA (11.0) | Non-systematic Assessment |
| |
| oxygen saturation decreased | Investigations | MedDRA (11.0) | Non-systematic Assessment |
| |
| renal failure | Renal and urinary disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| respiratory depression | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| haematoma | Vascular disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| post-operative ileus | Injury, poisoning and procedural complications | MedDRA (11.0) | Non-systematic Assessment |
| |
| hypotension | Vascular disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| syncope | Nervous system disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| ileus | Gastrointestinal disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| anastomotic leak | Injury, poisoning and procedural complications | MedDRA (11.0) | Non-systematic Assessment |
| |
| respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| sepsis | Infections and infestations | MedDRA (11.0) | Non-systematic Assessment |
| |
| abdominal distension | Gastrointestinal disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| axillary vein thrombosis | Vascular disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| clostridium difficile sepsis | Infections and infestations | MedDRA (11.0) | Non-systematic Assessment |
| |
| peritonitis | Gastrointestinal disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| nausea | Gastrointestinal disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| vomiting | Gastrointestinal disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| constipation | Gastrointestinal disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| dyspepsia | Gastrointestinal disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| oxygen saturation decreased | Investigations | MedDRA (11.0) | Non-systematic Assessment |
| |
| headache | Nervous system disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| dizziness | Nervous system disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| confusional state | Psychiatric disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| urinary retention | Renal and urinary disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| pruritus | Skin and subcutaneous tissue disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| hypotension | Vascular disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| orthostatic hypotension | Vascular disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| tachycardia | Cardiac disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| bradycardia | 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 |
|
| dry mouth | Gastrointestinal disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| abdominal pain | Gastrointestinal disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| abdominal distension | Gastrointestinal disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| pyrexia | General disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| procedural hypotension | Injury, poisoning and procedural complications | MedDRA (11.0) | Non-systematic Assessment |
| |
| blood bilirubin increased | Investigations | MedDRA (11.0) | Non-systematic Assessment |
| |
| hyponatremia | Metabolism and nutrition disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| sedation | Nervous system disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| somnolence | Nervous system disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| insomnia | Psychiatric disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| agitation | Psychiatric disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA (11.0) | Non-systematic Assessment |
|
prior review and approval required
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pamela Palmer | AcelRx | 650-216-3500 | 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 |
|
| Male |
|
| 0.007 |
| Difference in proportion |
| 12.90 |
| 2-Sided |
| 95 |
| No |
| Superiority or Other |