A Phase 3 interventional study of fentanyl in Pain, Postoperative, sponsored by The Medicines Company. Completed at 10 sites in United States. Open to participants aged 12 Years to 17 Years. Per ClinicalTrials.gov, last updated 2017-10-26.
Sponsored by The Medicines Company (part of Novartis) · Phase 3, Interventional, and Supportive care
The objective of this study is to evaluate the safety and clinical utility of the active, SSEC fentanyl 40 micrograms (mcg) for the management of acute, postoperative pain in pediatric participants.
An open label evaluation of the safety and clinical utility of the active, SSEC fentanyl 40 mcg for the management of acute postoperative pain in pediatric participants 12 to less than 18 years of age.
5,224 studies on the registry are indexed under Pain, Postoperative; 1,154 are open to participants now.
This study's enrollment of 71 is close to the median of 75 across 4,457 interventional studies indexed under Pain, Postoperative.
Browse Pain, Postoperative studies →The Medicines Company is the lead sponsor of 50 studies on the registry; none are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 8 (89%) have results posted.
First submitted before The Medicines Company became part of Novartis.
Counted across the registry records on this site, refreshed daily.
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Exclusion Criteria:
SSEC fentanyl iontophoretic transdermal system, 40 mcg fentanyl per activation.
Drug: fentanyl
An opioid that has been administered parenterally as an anesthetic and analgesic for more than 20 years.
Also known as: IONSYS
Assessment Of Participant's Ability To Use The SSEC
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.
Time frame: Completed at the time of the participant's termination of study treatment (up to 72 hours after study drug administration)
Assessment Of Adherence Of The SSEC System To Skin
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.
Time frame: Immediately prior to removal at each 24-hour time point, or at early withdrawal, for up to 3 consecutive days (up to 72 hours)
Change From Baseline To 1 Hour And 24 Hours In Skin Irritation Score After SSEC Removal
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.
Time frame: Baseline, 1 hour and 24 hours after SSEC removal.
Number Of Participants To Experience Clinically Relevant Respiratory Depression (CRRD)
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).
Time frame: From the time of application of the first system through 7 days following end of study drug administration.
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.
| Milestone | SSEC Fentanyl |
|---|---|
| Started | 71 |
| Received at least 1 dose of study drug | 61 |
| Completed | 59 |
| Not completed | 12 |
| Withdrew: Exclusion criteria met at screening | 4 |
| Withdrew: Consent withdrawn at screening | 1 |
| Withdrew: Ssec application but with 0 dose | 1 |
| Withdrew: Investigator decision at screening | 1 |
| Withdrew: Inclusion criteria not met at screening | 3 |
| Withdrew: Withdrawal by subject | 1 |
| Withdrew: Lost to follow-up | 1 |
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.
| participants | SSEC Fentanyl |
|---|---|
| Poor | 1 |
| Fair | 2 |
| Good | 10 |
| Excellent | 48 |
| Missing | 0 |
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.
| SSEC systems | SSEC Fentanyl |
|---|---|
| ≥90% of area with no edges unattached | 97 |
| 75% to 89% | 6 |
| <75% adhered and not taped | 3 |
| System was secured with tape | 1 |
| Not assessed | 0 |
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.
| units on a scale | SSEC Fentanyl |
|---|---|
| System 1, Hour 1 | 1.1 ± 0.94 |
| System 1, Hour 24 | 1.8 ± 1.43 |
| System 2, Hour 1 | 1.0 ± 0.61 |
| System 2, Hour 24 | 1.6 ± 1.33 |
| System 3, Hour 1 | 1.0 ± 1.22 |
| System 3, Hour 24 | 0.8 ± 1.26 |
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).
| participants | SSEC Fentanyl |
|---|---|
| Bradypnoea | 0 |
| Excessive Sedation | 0 |
| Simultaneous Bradypnoea and Excessive Sedation | 0 |
Collected over Adverse events were collected from the time of application of the first system through 7 days following the end of study drug administration.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| SSEC Fentanyl | 0/61 (0%) | 1/61 (1.6%) | 44/61 (72.1%) |
| Event | SSEC Fentanyl |
|---|---|
| AtelectasisRespiratory, thoracic and mediastinal disorders | 1/61 |
| Event | SSEC Fentanyl |
|---|---|
| VomitingGastrointestinal disorders | 19/61 |
| NauseaGastrointestinal disorders | 18/61 |
| ConstipationGastrointestinal disorders | 11/61 |
| Application site erythemaGeneral disorders | 10/61 |
| Application site papulesGeneral disorders | 10/61 |
| DizzinessNervous system disorders | 7/61 |
| PyrexiaGeneral disorders | 7/61 |
| Pruritus generalisedSkin and subcutaneous tissue disorders | 5/61 |
The Safety Population included all participants who received ≥1 dose of fentanyl from the SSEC.
| Age, Continuous(years) | SSEC Fentanyl |
|---|---|
| Mean | 14.7 ± 1.54 |
| Sex: Female, Male(Participants) | SSEC Fentanyl |
|---|---|
| Female | 45 |
| Male | 16 |
This study is completed, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Fentanyl