Trial Outcomes & Findings for Compare Fentanyl Nasal Spray With Intravenous Opioids to Treat Severe Pain (NCT NCT02459964)
NCT ID: NCT02459964
Last Updated: 2021-06-16
Results Overview
The median change in Numeric Rating Scale (NRS) pain intensity scores (assessed on an 11-point Likert scale with 0 = no pain and 10 = worst pain) from randomization, estimate of treatment initiation, to one hour post-treatment calculated for both treatment arms.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
84 participants
Primary outcome timeframe
Baseline, One hour post time of drug delivery/treatment initiation
Results posted on
2021-06-16
Participant Flow
Cancer patients presenting to the M. D. Anderson Cancer Center Emergency Department for treatment of acute breakthrough pain, who met study inclusion criteria.
One (1) participant withdrew consent before treatment and 1 participant was found ineligible due to abnormal EKG.
Participant milestones
| Measure |
Treatment Arm 1 (Intranasal Fentanyl)
Fentanyl Nasal Spray 100mcg delivered at time 0 (defined as the time when intranasal Fentanyl spray is administered) with a rescue dose allowed at time 0.5 hour (h).
|
Treatment Arm 2 (Intravenous Hydromorphone)
Hydromorphone Hydrochloride 1.5mg pushed intravenously (IV) at time 0 (defined as the time of completion of opioid IV push) with a rescue dose allowed at time 0.5 hour (h).
|
No Medication Administered
1 Participant decided not to participate after signing the consent form; 1 Participant was found to have abnormal EKG changes with hypokalemia, hence removed from the study.
|
|---|---|---|---|
|
Overall Study
STARTED
|
42
|
40
|
2
|
|
Overall Study
COMPLETED
|
42
|
40
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
2
|
Reasons for withdrawal
| Measure |
Treatment Arm 1 (Intranasal Fentanyl)
Fentanyl Nasal Spray 100mcg delivered at time 0 (defined as the time when intranasal Fentanyl spray is administered) with a rescue dose allowed at time 0.5 hour (h).
|
Treatment Arm 2 (Intravenous Hydromorphone)
Hydromorphone Hydrochloride 1.5mg pushed intravenously (IV) at time 0 (defined as the time of completion of opioid IV push) with a rescue dose allowed at time 0.5 hour (h).
|
No Medication Administered
1 Participant decided not to participate after signing the consent form; 1 Participant was found to have abnormal EKG changes with hypokalemia, hence removed from the study.
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
1
|
|
Overall Study
Abnormal EKG changes
|
0
|
0
|
1
|
Baseline Characteristics
Compare Fentanyl Nasal Spray With Intravenous Opioids to Treat Severe Pain
Baseline characteristics by cohort
| Measure |
Treatment Arm 1 (Intranasal Fentanyl)
n=42 Participants
Fentanyl Nasal Spray 100mcg delivered at time 0 (defined as the time when intranasal Fentanyl spray is administered) with a rescue dose allowed at time 0.5 hour (h).
|
Treatment Arm 2 (Intravenous Hydromorphone)
n=40 Participants
Hydromorphone Hydrochloride 1.5mg pushed intravenously (IV) at time 0 (defined as the time of completion of opioid IV push) with a rescue dose allowed at time 0.5 hour (h).
|
No Medication Administered
n=2 Participants
1 Participant decided not to participate after signing the consent form; 1 Participant was found to have abnormal EKG changes with hypokalemia, hence removed from the study.
|
Total
n=84 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
35 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
76 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
7 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
|
Age, Continuous
|
54.21 years
STANDARD_DEVIATION 14.452 • n=5 Participants
|
50.33 years
STANDARD_DEVIATION 11.669 • n=7 Participants
|
46 years
STANDARD_DEVIATION 1.000 • n=5 Participants
|
52.32 years
STANDARD_DEVIATION 13.233 • n=4 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
47 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
37 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
11 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
31 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
67 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
10 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
31 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
67 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
42 participants
n=5 Participants
|
40 participants
n=7 Participants
|
2 participants
n=5 Participants
|
84 participants
n=4 Participants
|
|
Baseline NRS Pain Intensity
|
8.69 NRS Pain Score
STANDARD_DEVIATION 1.093 • n=5 Participants
|
8.95 NRS Pain Score
STANDARD_DEVIATION 1.108 • n=7 Participants
|
NA NRS Pain Score
STANDARD_DEVIATION NA • n=5 Participants
|
8.82 NRS Pain Score
STANDARD_DEVIATION 1.101 • n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline, One hour post time of drug delivery/treatment initiationThe median change in Numeric Rating Scale (NRS) pain intensity scores (assessed on an 11-point Likert scale with 0 = no pain and 10 = worst pain) from randomization, estimate of treatment initiation, to one hour post-treatment calculated for both treatment arms.
Outcome measures
| Measure |
Treatment Arm 1 (Intranasal Fentanyl)
n=42 Participants
Fentanyl Nasal Spray 100mcg delivered at time 0 (defined as the time when intranasal Fentanyl spray is administered) with a rescue dose allowed at time 0.5 hour (h).
|
Treatment Arm 2 (Intravenous Hydromorphone)
n=40 Participants
Hydromorphone Hydrochloride 1.5mg pushed intravenously (IV) at time 0 (defined as the time of completion of opioid IV push) with a rescue dose allowed at time 0.5 hour (h).
|
|---|---|---|
|
Non-inferiority of Fentanyl Nasal Spray Versus Intravenous Opioids in the Change in the Numeric Rating Scale (NRS) Pain Intensity Score at One Hour, Starting From the Time of Drug Delivery (Treatment Initiation).
|
5.14 NRS Pain Intensity Score
Standard Deviation 2.16
|
4.90 NRS Pain Intensity Score
Standard Deviation 2.31
|
SECONDARY outcome
Timeframe: One (1) hour after treatment start.Change in NRS pain intensity scores from randomization to one hour after treatment start based on the percentage of participants with severe pain, NRS score = 7-10, one hour after treatment start for both treatment arms. Numeric Rating Scale (NRS) pain intensity scores (assessed on an 11-point Likert scale with 0 = no pain and 10 = worst pain).
Outcome measures
| Measure |
Treatment Arm 1 (Intranasal Fentanyl)
n=42 Participants
Fentanyl Nasal Spray 100mcg delivered at time 0 (defined as the time when intranasal Fentanyl spray is administered) with a rescue dose allowed at time 0.5 hour (h).
|
Treatment Arm 2 (Intravenous Hydromorphone)
n=40 Participants
Hydromorphone Hydrochloride 1.5mg pushed intravenously (IV) at time 0 (defined as the time of completion of opioid IV push) with a rescue dose allowed at time 0.5 hour (h).
|
|---|---|---|
|
Number of Participants With Change in Numeric Rating Scale (NRS) Pain Intensity Score
|
5 Participants
|
10 Participants
|
Adverse Events
Treatment Arm 1 (Intranasal Fentanyl)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Treatment Arm 2 (Intravenous Hydromorphone)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
No Medication Administered
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Treatment Arm 1 (Intranasal Fentanyl)
n=42 participants at risk
Fentanyl Nasal Spray 100mcg delivered at time 0 (defined as the time when intranasal Fentanyl spray is administered) with a rescue dose allowed at time 0.5 hour (h).
|
Treatment Arm 2 (Intravenous Hydromorphone)
n=40 participants at risk
Hydromorphone Hydrochloride 1.5mg pushed intravenously (IV) at time 0 (defined as the time of completion of opioid IV push) with a rescue dose allowed at time 0.5 hour (h).
|
No Medication Administered
n=2 participants at risk
1 Participant decided not to participate after signing the consent form; 1 Participant was found to have abnormal EKG changes with hypokalemia, hence removed from the study.
|
|---|---|---|---|
|
Nervous system disorders
Headache
|
2.4%
1/42 • Within 24 hours after ED discharge or hospital admission
No adverse events were reported prior to ED discharge or hospital admission.
|
7.5%
3/40 • Within 24 hours after ED discharge or hospital admission
No adverse events were reported prior to ED discharge or hospital admission.
|
0.00%
0/2 • Within 24 hours after ED discharge or hospital admission
No adverse events were reported prior to ED discharge or hospital admission.
|
|
General disorders
Fatigue
|
0.00%
0/42 • Within 24 hours after ED discharge or hospital admission
No adverse events were reported prior to ED discharge or hospital admission.
|
5.0%
2/40 • Within 24 hours after ED discharge or hospital admission
No adverse events were reported prior to ED discharge or hospital admission.
|
0.00%
0/2 • Within 24 hours after ED discharge or hospital admission
No adverse events were reported prior to ED discharge or hospital admission.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/42 • Within 24 hours after ED discharge or hospital admission
No adverse events were reported prior to ED discharge or hospital admission.
|
2.5%
1/40 • Within 24 hours after ED discharge or hospital admission
No adverse events were reported prior to ED discharge or hospital admission.
|
0.00%
0/2 • Within 24 hours after ED discharge or hospital admission
No adverse events were reported prior to ED discharge or hospital admission.
|
Additional Information
Sai-Ching J. Yeung, MD, Professor, Emergency Medicine
UT MD Anderson Cancer Center
Phone: (713) 745-9911
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place