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NCT02915978 · ClinicalTrials.gov registry record · Phase 2
Fentanyl Sublingual Spray for the Treatment of Moderate to Severe Post-Operative Pain
A Phase 2 study, sponsored by INSYS Therapeutics.
- Completed
- Registry status
- Phase 2
- Development phase
- 45
- Enrollment target
NCT02915978: Completed Phase 2 study, sponsored by INSYS Therapeutics.
NCT02915978 is a Phase 2 study that has completed, run by INSYS Therapeutics. The registered enrollment target is 45 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (66% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02915978, a Phase 2 study, has completed, sponsored by INSYS Therapeutics.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 45 participants
- Enrollment target
Study Summary
The primary objective of this trial is to evaluate analgesic efficacy of Fentanyl Sublingual Spray compared with placebo in participants with postoperative pain after a bunionectomy.
Primary Outcome
Pain intensity was assessed by the participant using an 11-point NRS from 0=no pain to 10=worst possible pain. Pain intensity scores were collected at Baseline (prior to study drug) and at multiple time points up to 48 hours after Time 0 (administration of first dose of study drug). Pain intensity difference is calculated by subtracting the pain intensity at each time point from the pain intensity at Time 0. The SPID scores are the sum of the differences at each time point multiplied by the dura
Interventions
- DRUG Placebo
- DRUG Fentanyl
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 45 participants |
| Start Date | 2016-12 |
| Est. Completion | 2017-02-10 |
| Phase | Phase 2 |
What the finished NCT02915978 record still lists
NCT02915978 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 45 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (66% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02915978 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02915978 about?
NCT02915978 is a clinical study titled "Fentanyl Sublingual Spray for the Treatment of Moderate to Severe Post-Operative Pain". The primary objective of this trial is to evaluate analgesic efficacy of Fentanyl Sublingual Spray compared with placebo in participants with postoperative pain after a bunionectomy.
What is the current status of trial NCT02915978?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 45 participants. The study started on 2016-12. Estimated completion is 2017-02-10.
What interventions are being tested in trial NCT02915978?
The interventions under investigation include: Placebo (DRUG), Fentanyl (DRUG).
Who is sponsoring clinical trial NCT02915978?
This trial is sponsored by INSYS Therapeutics, which has 35 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02915978's enrollment target sits among peer trials
45 1296th of 2000 higher than 679 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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