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

INSYS Therapeutics

Status and phase: Withdrawn; Phase 2

Conditions: Acute Pain

Treatments: Drug: Fentanyl 200 µg; Drug: Morphine 6 mg; Drug: Placebo Sublingual Spray; Drug: Fentanyl 400 µg; Drug: Fentanyl 100 µg; Drug: Intravenous Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02137525

INS-14-022

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Is able to understand the language in which the study is being conducted and has provided meaningful written informed consent for the study
• Has an acute painful condition requiring parenteral analgesia as deemed necessary by the treating physician or physician extender
• Has a pain score within protocol-specified parameters

Exclusion criteria

• Has allergy to fentanyl or morphine
• Has oxygen-dependent conditions or oxygen saturation <95%
• Has planned or recent drug use outside protocol-specified parameters
• Has any condition that, in the principal investigator's opinion, would place the patient at risk or influence the conduct of the study or interpretation of results

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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0 participants in 4 patient groups

Morphine 6 mg

Active Comparator group

Description:

Placebo Sublingual Spray (PSS) + Intravenous Morphine (IVM 6 mg), every 30 minutes for two hours as needed (or until rescue), maximum exposure morphine 30 mg

Treatment:

Drug: Placebo Sublingual Spray

Drug: Morphine 6 mg

Fentanyl 100 µg

Experimental group

Description:

Intravenous Placebo (IVP) + Fentanyl Sublingual Spray (FSS 100 µg), every 30 minutes for two hours as needed (or until rescue), maximum exposure fentanyl 500 µg

Treatment:

Drug: Intravenous Placebo

Drug: Fentanyl 100 µg

Fentanyl 200 µg

Experimental group

Description:

Intravenous Placebo (IVP) + Fentanyl Sublingual Spray (FSS 200 µg), every 30 minutes for two hours as needed (or until rescue), maximum exposure fentanyl 1000 µg

Treatment:

Drug: Intravenous Placebo

Drug: Fentanyl 200 µg

Fentanyl 400 µg

Experimental group

Description:

Intravenous Placebo (IVP) + Fentanyl Sublingual Spray (FSS 400 µg), every 30 minutes for two hours as needed (or until rescue), maximum exposure fentanyl 2000 µg

Treatment:

Drug: Intravenous Placebo

Drug: Fentanyl 400 µg