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The primary purpose of this study is to evaluate fentanyl buccal tablet (FBT) for analgesia in comparison to standard analgesia, to determine if the FBT allows for faster achievement of "significant analgesia"
The subjects/patients will be asked if they would desire a low dose or high dose pain medication regimen. The low dose (low-FBT) group will receive FBT at a dose of 100 mcg, as well as an oral (pill) placebo preparation. The low dose (low-control) group will receive an "inactive comparator" (lansoprazole rapidly-dissolving buccal 15mg, " FBT placebo") and a dose of 5/325 Percocet tablet (oxycodone/acetaminophen 5/325). The high dose (high-FBT) group will receive 200 mcg FBT plus 2 placebo tablets. The high dose (high-control) group will receive the "FBT placebo" and a dose of 2, 5/325 Percocet tablets.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low-FBT | Experimental | Subject will receive FBT and placebo at a low dose |
|
| High-FBT | Experimental | Subject will receive the high dose regimen of FBT and a high dose placebo |
|
| Low control | Active Comparator | Subject will receive active oxycodone/APAP 5/325 mg and lansoprazole solutab for the fentanyl "placebo" |
|
| High control | Active Comparator | Subject will receive the higher dose of the active comparator, #2 oxycodone/APAP 5/325mg, and lansoprazole solutab for the fentanyl "placebo" |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fentanyl | Drug | Fentanyl buccal tablet 100 mcg once |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Median Time to Significant Analgesia (at Least 2 Units Decrease in Pain Level) | Median time (in minutes) to 2 units decrease in pain level after drug administration. Patients were asked to rate their pain at every 5 minutes intervals from 0 to 60 minutes post drug administration. The 10-point verbally administered numeric pain rating scale (NPRS) was used to have patients rate their level of pain on a scale of 0 (no pain) to 10 (worst pain ever). | 60 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Nausea Level | Subjects' nausea level was recorded to determine how fentanyl buccal tablet compares to standard therapy in causing nausea. Treatment induced nausea and severity of nausea level was assessed. Nausea was assessed by a 10-point verbally administered scale. Patients rated their degree of nausea on a scale of 0 (no nausea) to 10 (worst nausea). At the beginning of the study, literature review found relatively little evidence guiding objective means to rate nausea, but there was some precedent for this approach (Warden C. Prehospital use of ondansetron reduces nausea and episodes of vomiting in adults and children over 12 years old [abstract]. Prehosp Emerg Care. 2007;11:132). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stephen H Thomas, MD MPH | University of Oklahoma | Principal Investigator |
| Annette O Arthur, PharmD | University of Oklahoma | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hillcrest Medical Center Emergency Department | Tulsa | Oklahoma | 74104 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Low-FBT | Subject will receive FBT and placebo at a low dose Fentanyl: Fentanyl buccal tablet 100 mcg once |
| FG001 | High-FBT | Subject will receive the high dose regimen of FBT and a high dose placebo Fentanyl: Fentanyl buccal tablet 200 mcg once |
| FG002 | Low Control | Subject will receive active oxycodone/APAP 5/325 mg and lansoprazole solutab for the fentanyl "placebo" Oxycodone/acetaminophen: Oxycodone/acetaminophen 5/325 mg once |
| FG003 | High Control | Subject will receive the higher dose of the active comparator, #2 oxycodone/APAP 5/325mg, and lansoprazole solutab for the fentanyl "placebo" oxycodone/acetaminophen: Oxycodone/acetaminophen tablet 5/325 mg, 2 tablets one time |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Low-FBT | Subject will receive FBT and placebo at a low dose Fentanyl: Fentanyl buccal tablet 100 mcg once |
| BG001 | High-FBT | Subject will receive the high dose regimen of FBT and a high dose placebo Fentanyl: Fentanyl buccal tablet 200 mcg once |
| 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 |
| 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 | Median Time to Significant Analgesia (at Least 2 Units Decrease in Pain Level) | Median time (in minutes) to 2 units decrease in pain level after drug administration. Patients were asked to rate their pain at every 5 minutes intervals from 0 to 60 minutes post drug administration. The 10-point verbally administered numeric pain rating scale (NPRS) was used to have patients rate their level of pain on a scale of 0 (no pain) to 10 (worst pain ever). | Posted | Median | 95% Confidence Interval | minutes | 60 minutes |
|
All study patients were monitored during the entire study period i.e., 2 hours after medication administration.
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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 | Low-FBT | Subject will receive FBT and placebo at a low dose Fentanyl: Fentanyl buccal tablet 100 mcg once |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Nasir Mushtaw | University of Oklahoma Health Sciences Center Tulsa | 918/660-3680 | Nasir-Mushtaq@ouhsc.edu |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D005283 | Fentanyl |
| C514822 | oxycodone-acetaminophen |
| ID | Term |
|---|---|
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Fentanyl | Drug | Fentanyl buccal tablet 200 mcg once |
|
|
| Oxycodone/acetaminophen | Drug | Oxycodone/acetaminophen 5/325 mg once |
|
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| oxycodone/acetaminophen | Drug | Oxycodone/acetaminophen tablet 5/325 mg, 2 tablets one time |
|
|
| every 5 minutes for the first 60 minutes |
| Number of Participants Experiencing Any Adverse Events | Occurrence of any adverse event. | Full 2 hours of the study period |
| BG002 | Low Control | Subject will receive active oxycodone/APAP 5/325 mg and lansoprazole solutab for the fentanyl "placebo" Oxycodone/acetaminophen: Oxycodone/acetaminophen 5/325 mg once |
| BG003 | High Control | Subject will receive the higher dose of the active comparator, #2 oxycodone/APAP 5/325mg, and lansoprazole solutab for the fentanyl "placebo" oxycodone/acetaminophen: Oxycodone/acetaminophen tablet 5/325 mg, 2 tablets one time |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG002 | Low Control | Subject will receive active oxycodone/APAP 5/325 mg and lansoprazole solutab for the fentanyl "placebo" Oxycodone/acetaminophen: Oxycodone/acetaminophen 5/325 mg once |
| OG003 | High Control | Subject will receive the higher dose of the active comparator, #2 oxycodone/APAP 5/325mg, and lansoprazole solutab for the fentanyl "placebo" oxycodone/acetaminophen: Oxycodone/acetaminophen tablet 5/325 mg, 2 tablets one time |
|
|
| Secondary | Nausea Level | Subjects' nausea level was recorded to determine how fentanyl buccal tablet compares to standard therapy in causing nausea. Treatment induced nausea and severity of nausea level was assessed. Nausea was assessed by a 10-point verbally administered scale. Patients rated their degree of nausea on a scale of 0 (no nausea) to 10 (worst nausea). At the beginning of the study, literature review found relatively little evidence guiding objective means to rate nausea, but there was some precedent for this approach (Warden C. Prehospital use of ondansetron reduces nausea and episodes of vomiting in adults and children over 12 years old [abstract]. Prehosp Emerg Care. 2007;11:132). | Posted | Count of Participants | Participants | every 5 minutes for the first 60 minutes |
|
|
|
| Secondary | Number of Participants Experiencing Any Adverse Events | Occurrence of any adverse event. | Posted | Count of Participants | Participants | Full 2 hours of the study period |
|
|
|
| 0 |
| 6 |
| 0 |
| 6 |
| 1 |
| 6 |
| EG001 | High-FBT | Subject will receive the high dose regimen of FBT and a high dose placebo Fentanyl: Fentanyl buccal tablet 200 mcg once | 0 | 25 | 0 | 25 | 9 | 25 |
| EG002 | Low Control | Subject will receive active oxycodone/APAP 5/325 mg and lansoprazole solutab for the fentanyl "placebo" Oxycodone/acetaminophen: Oxycodone/acetaminophen 5/325 mg once | 0 | 4 | 0 | 4 | 3 | 4 |
| EG003 | High Control | Subject will receive the higher dose of the active comparator, #2 oxycodone/APAP 5/325mg, and lansoprazole solutab for the fentanyl "placebo" oxycodone/acetaminophen: Oxycodone/acetaminophen tablet 5/325 mg, 2 tablets one time | 0 | 25 | 0 | 25 | 10 | 25 |
| Pruritis | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Headache | Nervous system disorders | Non-systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | Non-systematic Assessment |
|
| Drowsy | Nervous system disorders | Non-systematic Assessment |
|
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