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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.

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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

FieldValue
Enrollment Target 45 participants
Start Date 2016-12
Est. Completion 2017-02-10
Phase Phase 2
INSYS Therapeutics

35 total trials

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.

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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Source: ClinicalTrials.gov NCT02915978, the US trial registry maintained by the National Library of Medicine. NCT02915978 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.