CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 45 enrolled
Drug / intervention
Fentanyl +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02915978
NCT02915978Phase 2Completed

A Phase 2 Multicenter, Randomized, Double-Blind, Multiple-Dose, Parallel-Group, Placebo-Controlled Study of Fentanyl Sublingual Spray for the Treatment of Moderate to Severe Post-Operative Pain

INSYS Therapeutics Inc·interventional·Posted Sep 27, 2016·Updated Feb 14, 2018

In Brief

A Phase 2 clinical trial evaluating Fentanyl and Placebo for Pain. Completed, enrolled 45 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPain
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedSep 27, 2016
Enrollment StartDec 1, 2016
Primary CompletionFeb 10, 2017
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 9.8 years ago

Interventions

Fentanyldrug

Fentanyl delivered via sublingual spray

Placebodrug

Matching placebo delivered via sublingual spray