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Study to Explore Effectiveness of Sublingual Fentanyl Spray in Emergency Department Patients With Acute Pain

NCT02137525 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2017-07-05

No results posted yet for this study

Summary

This study will explore effectiveness of three doses of fentanyl sublingual spray against an active comparator in emergency department (ED) patients with acute pain.

After screening, eligible participants will participate in a treatment period (up to 2 hours) and a post-treatment evaluation period (up to 4 hours or discharge from the ED). Open-label standard of care rescue medication for pain can be given at any time during the study period, based on clinical judgment of the treating physician.

Adverse events will be collected for five days after initial enrollment.

Conditions

  • Acute Pain

Interventions

DRUG

Morphine 6 mg

Intravenous infusion - delivering morphine 6 mg

DRUG

Fentanyl 100 µg

Fentanyl sublingual spray - single unit delivering 100 µg fentanyl

DRUG

Fentanyl 200 µg

Fentanyl sublingual spray - single unit delivering 200 µg fentanyl

DRUG

Fentanyl 400 µg

Fentanyl sublingual spray - single unit delivering 400 µg fentanyl

DRUG

Placebo Sublingual Spray

Matching sublingual spray - single unit delivering 0 µg fentanyl

DRUG

Intravenous Placebo

Matching intravenous infusion - delivering 0 mg morphine

Sponsors & Collaborators

  • INSYS Therapeutics Inc

    lead INDUSTRY

Principal Investigators

  • Giovanni DeCastro · INSYS Therapeutics Inc

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Primary Completion
2017-06-29
FDA Drug
Yes

Countries

  • United States

Study Locations

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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 NCT02137525 on ClinicalTrials.gov