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NCT02395653 · ClinicalTrials.gov registry record · Phase 3
Safety and Clinical Utility Study of SSEC Fentanyl 40 mcg for Acute Post-op Pain Management in Pediatric Participants
A Phase 3 study of Pain, Postoperative, sponsored by The Medicines Company.
- Completed
- Registry status
- Phase 3
- Development phase
- 71
- Enrollment target
- 10
- Study locations
NCT02395653: Completed Phase 3 study of Pain, Postoperative, sponsored by The Medicines Company.
NCT02395653 is a Phase 3 study of Pain, Postoperative that has completed, run by The Medicines Company. The registered enrollment target is 71 participants, below the 272-participant average among 113 other Pain, Postoperative trials with a reported enrollment target (74% lower). The trial reports 10 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02395653, a Phase 3 study of Pain, Postoperative, has completed, sponsored by The Medicines Company.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 71 participants
- Enrollment target
- 10
- Study locations
Study Summary
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.
Primary Outcome
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.
Conditions Studied
Interventions
- DRUG fentanyl
Study Locations (10)
Pennsylvania
- The Children's Hospital of Philadelphia - Philadelphia
- Children's Hospital of Pittsburgh of UPMC - Pittsburgh
California
- Packard Children's Hospital at Stanford - Palo Alto
Florida
- University of Miami/Jackson Memorial Hospital - Miami
Georgia
- Children's Healthcare of Atlanta - Atlanta
Maryland
- Johns Hopkins Hospital, Charlotte R. Bloomberg Children's Center - Baltimore
Missouri
- St. Louis Children's Hospital - St Louis
Texas
- Children's Medical Center of Dallas - Dallas
Washington
- Harborview Medical Center - Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 71 participants |
| Start Date | 2015-06-29 |
| Est. Completion | 2016-09-12 |
| Phase | Phase 3 |
What the finished NCT02395653 record still lists
NCT02395653 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 71 participants, a relatively small participant target, below the 272-participant average among 113 other Pain, Postoperative trials with a reported enrollment target (74% lower).
The record links to 1 condition, with Pain, Postoperative appearing as the primary indexed condition, and to 1 intervention - of which fentanyl is the first listed.
NCT02395653 lists 10 locations in 9 states (Pennsylvania, California, Florida).
Frequently Asked Questions
What is clinical trial NCT02395653 about?
NCT02395653 is a clinical study titled "Safety and Clinical Utility Study of SSEC Fentanyl 40 mcg for Acute Post-op Pain Management in Pediatric Participants". 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.
What is the current status of trial NCT02395653?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 71 participants. The study started on 2015-06-29. Estimated completion is 2016-09-12.
What conditions does trial NCT02395653 study?
This clinical trial studies the following conditions: Pain, Postoperative.
What interventions are being tested in trial NCT02395653?
The interventions under investigation include: fentanyl (DRUG).
Who is sponsoring clinical trial NCT02395653?
This trial is sponsored by The Medicines Company, which has 35 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02395653 being conducted?
This trial has 10 study locations across California, Florida, Georgia, Maryland, Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Pain, Postoperative
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02395653's enrollment target sits among peer trials
71 70th of 113 higher than 43 of 113 other Pain, Postoperative trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Pain, Postoperative trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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