Trial Outcomes & Findings for Safety and Efficacy Study of Fentanyl Buccal Tablet Use in the Emergency Department for Isolated Extremity Injury (NCT NCT01270659)
NCT ID: NCT01270659
Last Updated: 2017-06-20
Results Overview
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).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
60 participants
Primary outcome timeframe
60 minutes
Results posted on
2017-06-20
Participant Flow
Participant milestones
| Measure |
Low-FBT
Subject will receive FBT and placebo at a low dose
Fentanyl: Fentanyl buccal tablet 100 mcg once
|
High-FBT
Subject will receive the high dose regimen of FBT and a high dose placebo
Fentanyl: Fentanyl buccal tablet 200 mcg once
|
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
|
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
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
25
|
4
|
25
|
|
Overall Study
COMPLETED
|
6
|
25
|
4
|
25
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety and Efficacy Study of Fentanyl Buccal Tablet Use in the Emergency Department for Isolated Extremity Injury
Baseline characteristics by cohort
| Measure |
Low-FBT
n=6 Participants
Subject will receive FBT and placebo at a low dose
Fentanyl: Fentanyl buccal tablet 100 mcg once
|
High-FBT
n=25 Participants
Subject will receive the high dose regimen of FBT and a high dose placebo
Fentanyl: Fentanyl buccal tablet 200 mcg once
|
Low Control
n=4 Participants
Subject will receive active oxycodone/APAP 5/325 mg and lansoprazole solutab for the fentanyl "placebo"
Oxycodone/acetaminophen: Oxycodone/acetaminophen 5/325 mg once
|
High Control
n=25 Participants
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
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
56 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Continuous
|
25.5 years
STANDARD_DEVIATION 10.01 • n=5 Participants
|
38.4 years
STANDARD_DEVIATION 13.7 • n=7 Participants
|
34.0 years
STANDARD_DEVIATION 13.1 • n=5 Participants
|
35.4 years
STANDARD_DEVIATION 11.9 • n=4 Participants
|
35.6 years
STANDARD_DEVIATION 12.9 • n=21 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
26 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
34 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · White
|
4 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
38 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Black
|
2 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
19 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · American Indian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Hispanic
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=5 Participants
|
25 participants
n=7 Participants
|
4 participants
n=5 Participants
|
25 participants
n=4 Participants
|
60 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 60 minutesMedian 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).
Outcome measures
| Measure |
Low-FBT
n=6 Participants
Subject will receive FBT and placebo at a low dose
Fentanyl: Fentanyl buccal tablet 100 mcg once
|
High-FBT
n=25 Participants
Subject will receive the high dose regimen of FBT and a high dose placebo
Fentanyl: Fentanyl buccal tablet 200 mcg once
|
Low Control
n=4 Participants
Subject will receive active oxycodone/APAP 5/325 mg and lansoprazole solutab for the fentanyl "placebo"
Oxycodone/acetaminophen: Oxycodone/acetaminophen 5/325 mg once
|
High Control
n=25 Participants
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
|
|---|---|---|---|---|
|
Median Time to Significant Analgesia (at Least 2 Units Decrease in Pain Level)
|
15.0 minutes
Interval 5.0 to
Due to small sample size not enough participants achieved response to calculate upper limit.
|
20.0 minutes
Interval 15.0 to 25.0
|
15.0 minutes
Interval 5.0 to
Due to small sample size not enough participants achieved response to calculate upper limit.
|
15.0 minutes
Interval 10.0 to 25.0
|
SECONDARY outcome
Timeframe: every 5 minutes for the first 60 minutesSubjects' 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).
Outcome measures
| Measure |
Low-FBT
n=6 Participants
Subject will receive FBT and placebo at a low dose
Fentanyl: Fentanyl buccal tablet 100 mcg once
|
High-FBT
n=25 Participants
Subject will receive the high dose regimen of FBT and a high dose placebo
Fentanyl: Fentanyl buccal tablet 200 mcg once
|
Low Control
n=4 Participants
Subject will receive active oxycodone/APAP 5/325 mg and lansoprazole solutab for the fentanyl "placebo"
Oxycodone/acetaminophen: Oxycodone/acetaminophen 5/325 mg once
|
High Control
n=25 Participants
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
|
|---|---|---|---|---|
|
Nausea Level
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Full 2 hours of the study periodOccurrence of any adverse event.
Outcome measures
| Measure |
Low-FBT
n=6 Participants
Subject will receive FBT and placebo at a low dose
Fentanyl: Fentanyl buccal tablet 100 mcg once
|
High-FBT
n=25 Participants
Subject will receive the high dose regimen of FBT and a high dose placebo
Fentanyl: Fentanyl buccal tablet 200 mcg once
|
Low Control
n=4 Participants
Subject will receive active oxycodone/APAP 5/325 mg and lansoprazole solutab for the fentanyl "placebo"
Oxycodone/acetaminophen: Oxycodone/acetaminophen 5/325 mg once
|
High Control
n=25 Participants
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
|
|---|---|---|---|---|
|
Number of Participants Experiencing Any Adverse Events
|
1 Participants
|
9 Participants
|
3 Participants
|
10 Participants
|
Adverse Events
Low-FBT
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
High-FBT
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Low Control
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
High Control
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Low-FBT
n=6 participants at risk
Subject will receive FBT and placebo at a low dose
Fentanyl: Fentanyl buccal tablet 100 mcg once
|
High-FBT
n=25 participants at risk
Subject will receive the high dose regimen of FBT and a high dose placebo
Fentanyl: Fentanyl buccal tablet 200 mcg once
|
Low Control
n=4 participants at risk
Subject will receive active oxycodone/APAP 5/325 mg and lansoprazole solutab for the fentanyl "placebo"
Oxycodone/acetaminophen: Oxycodone/acetaminophen 5/325 mg once
|
High Control
n=25 participants at risk
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
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/6 • All study patients were monitored during the entire study period i.e., 2 hours after medication administration.
|
12.0%
3/25 • All study patients were monitored during the entire study period i.e., 2 hours after medication administration.
|
0.00%
0/4 • All study patients were monitored during the entire study period i.e., 2 hours after medication administration.
|
20.0%
5/25 • All study patients were monitored during the entire study period i.e., 2 hours after medication administration.
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
16.7%
1/6 • All study patients were monitored during the entire study period i.e., 2 hours after medication administration.
|
4.0%
1/25 • All study patients were monitored during the entire study period i.e., 2 hours after medication administration.
|
75.0%
3/4 • All study patients were monitored during the entire study period i.e., 2 hours after medication administration.
|
8.0%
2/25 • All study patients were monitored during the entire study period i.e., 2 hours after medication administration.
|
|
Nervous system disorders
Headache
|
0.00%
0/6 • All study patients were monitored during the entire study period i.e., 2 hours after medication administration.
|
0.00%
0/25 • All study patients were monitored during the entire study period i.e., 2 hours after medication administration.
|
0.00%
0/4 • All study patients were monitored during the entire study period i.e., 2 hours after medication administration.
|
16.0%
4/25 • All study patients were monitored during the entire study period i.e., 2 hours after medication administration.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/6 • All study patients were monitored during the entire study period i.e., 2 hours after medication administration.
|
8.0%
2/25 • All study patients were monitored during the entire study period i.e., 2 hours after medication administration.
|
0.00%
0/4 • All study patients were monitored during the entire study period i.e., 2 hours after medication administration.
|
0.00%
0/25 • All study patients were monitored during the entire study period i.e., 2 hours after medication administration.
|
|
Nervous system disorders
Drowsy
|
0.00%
0/6 • All study patients were monitored during the entire study period i.e., 2 hours after medication administration.
|
16.0%
4/25 • All study patients were monitored during the entire study period i.e., 2 hours after medication administration.
|
0.00%
0/4 • All study patients were monitored during the entire study period i.e., 2 hours after medication administration.
|
4.0%
1/25 • All study patients were monitored during the entire study period i.e., 2 hours after medication administration.
|
Additional Information
Dr. Nasir Mushtaw
University of Oklahoma Health Sciences Center Tulsa
Phone: 918/660-3680
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place