Trial Outcomes & Findings for Safety and Clinical Utility Study of SSEC Fentanyl 40 mcg for Acute Post-op Pain Management in Pediatric Participants (NCT NCT02395653)
NCT ID: NCT02395653
Last Updated: 2017-10-26
Results Overview
Investigator's assessment of participant's ability to use the SSEC system safely and effectively. The assessment consisted of a 4-level categorical evaluation (poor, fair, good, and excellent). Because of the descriptive nature of this study, no formal statistical hypothesis testing was performed.
COMPLETED
PHASE3
71 participants
Completed at the time of the participant's termination of study treatment (up to 72 hours after study drug administration)
2017-10-26
Participant Flow
Pediatric participants from 12 to less than 18 years of age who had undergone general or regional anesthesia for elective abdominal, pelvic/genitourinary, orthopedic, or thoracic surgery.
Screening within 3 weeks of study start included review of inclusion/exclusion criteria, informed consent signature, medical history, height, weight, vital signs, American Society of Anesthesiologists physical status, and a review of the Separated System With Enhanced Controller (SSEC) for delivery of 40 micrograms (mcg) fentanyl/dose.
Participant milestones
| Measure |
SSEC Fentanyl
Post-surgery, participants received fentanyl via the active IONSYS® SSEC fentanyl iontophoretic transdermal system that provided on-demand systemic delivery of 40 mcg fentanyl per dose for up to 24 hours, or a maximum of 80 doses, whichever came first, for up to 3 consecutive days (up to 72 hours).
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|---|---|
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Overall Study
STARTED
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71
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Overall Study
Received at Least 1 Dose of Study Drug
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61
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Overall Study
COMPLETED
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59
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Overall Study
NOT COMPLETED
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12
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Reasons for withdrawal
| Measure |
SSEC Fentanyl
Post-surgery, participants received fentanyl via the active IONSYS® SSEC fentanyl iontophoretic transdermal system that provided on-demand systemic delivery of 40 mcg fentanyl per dose for up to 24 hours, or a maximum of 80 doses, whichever came first, for up to 3 consecutive days (up to 72 hours).
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|---|---|
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Overall Study
Exclusion Criteria Met at Screening
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4
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Overall Study
Consent Withdrawn at Screening
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1
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Overall Study
SSEC Application But With 0 Dose
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1
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Overall Study
Investigator Decision at Screening
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1
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Overall Study
Inclusion Criteria Not Met at Screening
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3
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Overall Study
Withdrawal by Subject
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1
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Overall Study
Lost to Follow-up
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1
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Baseline Characteristics
Safety and Clinical Utility Study of SSEC Fentanyl 40 mcg for Acute Post-op Pain Management in Pediatric Participants
Baseline characteristics by cohort
| Measure |
SSEC Fentanyl
n=61 Participants
Post-surgery, participants received fentanyl via the active IONSYS® SSEC fentanyl iontophoretic transdermal system that provided on-demand systemic delivery of 40 mcg fentanyl per dose for up to 24 hours, or a maximum of 80 doses, whichever came first, for up to 3 consecutive days (up to 72 hours).
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|---|---|
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Age, Continuous
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14.7 years
STANDARD_DEVIATION 1.54 • n=5 Participants
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Sex: Female, Male
Female
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45 Participants
n=5 Participants
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Sex: Female, Male
Male
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16 Participants
n=5 Participants
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PRIMARY outcome
Timeframe: Completed at the time of the participant's termination of study treatment (up to 72 hours after study drug administration)Population: The Evaluable Population consists of all participants who received fentanyl from the SSEC for at least 3 hours.
Investigator's assessment of participant's ability to use the SSEC system safely and effectively. The assessment consisted of a 4-level categorical evaluation (poor, fair, good, and excellent). Because of the descriptive nature of this study, no formal statistical hypothesis testing was performed.
Outcome measures
| Measure |
SSEC Fentanyl
n=61 Participants
Post-surgery, participants received fentanyl via the active IONSYS® SSEC fentanyl iontophoretic transdermal system that provided on-demand systemic delivery of 40 mcg fentanyl per dose for up to 24 hours, or a maximum of 80 doses, whichever came first, for up to 3 consecutive days (up to 72 hours).
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|---|---|
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Assessment Of Participant's Ability To Use The SSEC
Poor
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1 participants
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Assessment Of Participant's Ability To Use The SSEC
Fair
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2 participants
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Assessment Of Participant's Ability To Use The SSEC
Good
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10 participants
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Assessment Of Participant's Ability To Use The SSEC
Excellent
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48 participants
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Assessment Of Participant's Ability To Use The SSEC
Missing
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0 participants
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PRIMARY outcome
Timeframe: Immediately prior to removal at each 24-hour time point, or at early withdrawal, for up to 3 consecutive days (up to 72 hours)Population: The Evaluable Population consists of all participants who received fentanyl from the SSEC for at least 3 hours.
The adhesion of each SSEC was evaluated immediately prior to removal at each 24-hour time point, or at early withdrawal. Adhesion was recorded using the following classification: System adhered to at least 90% of the application area with no edges unattached; System adhered between 75% and 89%; System was \<75% adhered and not taped; System was secured with tape. The number of SSEC systems for all time points in each category is presented. Because of the descriptive nature of this study, no formal statistical hypothesis testing was performed.
Outcome measures
| Measure |
SSEC Fentanyl
n=107 SSEC systems used by 61 participants
Post-surgery, participants received fentanyl via the active IONSYS® SSEC fentanyl iontophoretic transdermal system that provided on-demand systemic delivery of 40 mcg fentanyl per dose for up to 24 hours, or a maximum of 80 doses, whichever came first, for up to 3 consecutive days (up to 72 hours).
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|---|---|
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Assessment Of Adherence Of The SSEC System To Skin
≥90% of area with no edges unattached
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97 SSEC systems
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Assessment Of Adherence Of The SSEC System To Skin
75% to 89%
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6 SSEC systems
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Assessment Of Adherence Of The SSEC System To Skin
<75% adhered and not taped
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3 SSEC systems
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Assessment Of Adherence Of The SSEC System To Skin
System was secured with tape
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1 SSEC systems
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Assessment Of Adherence Of The SSEC System To Skin
Not assessed
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0 SSEC systems
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SECONDARY outcome
Timeframe: Baseline, 1 hour and 24 hours after SSEC removal.Population: The Evaluable Population consists of all participants who received fentanyl from the SSEC for at least 3 hours.
Skin irritation at the SSEC application site was to be assessed immediately prior to placement of the study system and at 1 and 24 hours after removal of each study system. The application site was to be scored using the following scale: 0=No evidence of irritation; 1=Minimal erythema, barely perceptible; 2=Definite erythema, readily visible, minimal edema, or minimal papular response; 3=Erythema and papules; 4=Definite edema; 5=Erythema, edema, and papules; 6=Vesicular eruption; 7=Strong reaction spreading beyond the application site.
Outcome measures
| Measure |
SSEC Fentanyl
n=61 Participants
Post-surgery, participants received fentanyl via the active IONSYS® SSEC fentanyl iontophoretic transdermal system that provided on-demand systemic delivery of 40 mcg fentanyl per dose for up to 24 hours, or a maximum of 80 doses, whichever came first, for up to 3 consecutive days (up to 72 hours).
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|---|---|
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Change From Baseline To 1 Hour And 24 Hours In Skin Irritation Score After SSEC Removal
System 1, Hour 1
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1.1 units on a scale
Standard Deviation 0.94
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Change From Baseline To 1 Hour And 24 Hours In Skin Irritation Score After SSEC Removal
System 1, Hour 24
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1.8 units on a scale
Standard Deviation 1.43
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Change From Baseline To 1 Hour And 24 Hours In Skin Irritation Score After SSEC Removal
System 2, Hour 1
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1.0 units on a scale
Standard Deviation 0.61
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Change From Baseline To 1 Hour And 24 Hours In Skin Irritation Score After SSEC Removal
System 2, Hour 24
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1.6 units on a scale
Standard Deviation 1.33
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Change From Baseline To 1 Hour And 24 Hours In Skin Irritation Score After SSEC Removal
System 3, Hour 1
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1.0 units on a scale
Standard Deviation 1.22
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Change From Baseline To 1 Hour And 24 Hours In Skin Irritation Score After SSEC Removal
System 3, Hour 24
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0.8 units on a scale
Standard Deviation 1.26
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SECONDARY outcome
Timeframe: From the time of application of the first system through 7 days following end of study drug administration.Population: The Evaluable Population consists of all participants who received fentanyl from the SSEC for at least 3 hours.
Respiratory function and occurrence of CRRD was defined as simultaneous occurrence of bradypnoea (respiratory rate \<10 breaths per minute for participants 9-15 years of age and sustained for 1 minute, or \<8 breaths per minute for participants 16-17 years of age), with excessive sedation (that is, the participant is not easily aroused).
Outcome measures
| Measure |
SSEC Fentanyl
n=61 Participants
Post-surgery, participants received fentanyl via the active IONSYS® SSEC fentanyl iontophoretic transdermal system that provided on-demand systemic delivery of 40 mcg fentanyl per dose for up to 24 hours, or a maximum of 80 doses, whichever came first, for up to 3 consecutive days (up to 72 hours).
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|---|---|
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Number Of Participants To Experience Clinically Relevant Respiratory Depression (CRRD)
Bradypnoea
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0 participants
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Number Of Participants To Experience Clinically Relevant Respiratory Depression (CRRD)
Excessive Sedation
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0 participants
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Number Of Participants To Experience Clinically Relevant Respiratory Depression (CRRD)
Simultaneous Bradypnoea and Excessive Sedation
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0 participants
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Adverse Events
SSEC Fentanyl
Serious adverse events
| Measure |
SSEC Fentanyl
n=61 participants at risk
Post-surgery, participants received fentanyl via the active IONSYS® SSEC fentanyl iontophoretic transdermal system that provided on-demand systemic delivery of 40 mcg fentanyl per dose for up to 24 hours, or a maximum of 80 doses, whichever came first, for up to 3 consecutive days (up to 72 hours).
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|---|---|
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Respiratory, thoracic and mediastinal disorders
Atelectasis
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1.6%
1/61 • Number of events 1 • Adverse events were collected from the time of application of the first system through 7 days following the end of study drug administration.
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Other adverse events
| Measure |
SSEC Fentanyl
n=61 participants at risk
Post-surgery, participants received fentanyl via the active IONSYS® SSEC fentanyl iontophoretic transdermal system that provided on-demand systemic delivery of 40 mcg fentanyl per dose for up to 24 hours, or a maximum of 80 doses, whichever came first, for up to 3 consecutive days (up to 72 hours).
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|---|---|
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Nervous system disorders
Dizziness
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11.5%
7/61 • Number of events 9 • Adverse events were collected from the time of application of the first system through 7 days following the end of study drug administration.
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General disorders
Application site erythema
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16.4%
10/61 • Number of events 10 • Adverse events were collected from the time of application of the first system through 7 days following the end of study drug administration.
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General disorders
Application site papules
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16.4%
10/61 • Number of events 10 • Adverse events were collected from the time of application of the first system through 7 days following the end of study drug administration.
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General disorders
Pyrexia
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11.5%
7/61 • Number of events 7 • Adverse events were collected from the time of application of the first system through 7 days following the end of study drug administration.
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Gastrointestinal disorders
Vomiting
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31.1%
19/61 • Number of events 23 • Adverse events were collected from the time of application of the first system through 7 days following the end of study drug administration.
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Gastrointestinal disorders
Nausea
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29.5%
18/61 • Number of events 19 • Adverse events were collected from the time of application of the first system through 7 days following the end of study drug administration.
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Gastrointestinal disorders
Constipation
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18.0%
11/61 • Number of events 11 • Adverse events were collected from the time of application of the first system through 7 days following the end of study drug administration.
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Skin and subcutaneous tissue disorders
Pruritus generalised
|
8.2%
5/61 • Number of events 6 • Adverse events were collected from the time of application of the first system through 7 days following the end of study drug administration.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place