MedTrace Logo

Fentanyl Sublingual Spray for the Treatment of Moderate to Severe Post-Operative Pain

NCT02915978 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2018-02-14

Study results available
· View outcomes & findings →

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.

Conditions

Interventions

DRUG

Fentanyl

Fentanyl delivered via sublingual spray

DRUG

Placebo

Matching placebo delivered via sublingual spray

Sponsors & Collaborators

  • INSYS Therapeutics Inc

    lead INDUSTRY

Principal Investigators

  • Giovanni DeCastro · INSYS Therapeutics Inc

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-12-31
Primary Completion
2017-02-10
Completion
2017-02-10

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02915978 on ClinicalTrials.gov